Pharmabiz reuter has informed the whole matter that Natco Pharma, a Rs 400 crore Hyderabad-based pharma company, is planning to suitably respond to Teva Pharma's Citizen Petition with the US FDA regarding Glatiramer Acetate product. Teva had alleged, that there is a significant difference between Natco's product and its Copaxone. According to Natco Pharma the petition is intended to prolong Teva's monopoly on Copaxone, used in the treatment of multiple sclerosis. This Citizen Petition is very similar to another petition which Teva had filed in 2008, which was rejected by US FDA earlier this year.
Natco and Mylan's abbreviated new drug application for Glatiramer Acetate has been accepted for review by the US FDA in September 2009 and the review is presently on going. This attempt of Teva is to delay the approval of the ANDA. This product is extremely important for Teva's sales (US$ 11.1 billion in 2008) and it is the largest product in their portfolio. For Natco, this product, on approval, represents a significant upside. Natco is the only generic producer in world of this product, involving complex peptide chemistry.
Natco press release said that the company stands firmly behind the safety and integrity of its marketed Glatiramer Acetate product and it will respond to Teva's unfounded claims.
Friday, November 27, 2009
Tuesday, October 27, 2009
India going harder : India may ask exporters to boycott KLM to deter EU for holding up drug cargo
Even as the Indian government is planning to file a complaint with World Trade Organisation (WTO) against the European Union (EU) on the issue of seizure of Indian drug shipments at EU ports, the government is also exploring other options to pressurise the EU nations to change the patent laws, amended some time back, to make them more stringent.
According to pharmabiz sources, the Union Commerce Ministry is contemplating to motivate the pharmaceutical exporters in the country not to send their cargo through KLM Airlines of Netherlands as a retaliatory measure against that country. It may be noted that Netherlands has been one of the EU countries which has been seizing Indian drug shipments at its ports on charges of counterfeit/patent infringement. For instance, the customs authorities at Rotterdam in the Netherlands had some months back seized shipments of the generic drug losartan, which was manufactured in India and was in transit to Brazil. Losartan, indicated to treat high blood pressure, is not under patent protection either in India or Brazil.
Due to its competitive prices, most of the Indian pharmaceutical exporters have been using the services of KLM Airlines to send their cargo to Latin American and African countries. As the volume is quite large, if the Indian pharmaceutical exporters take the retaliatory measures in this regard, it will be a huge loss to the Netherlands company, sources said.
The Indian government's contemplation in this regard comes in the wake of near total collapse of all efforts at different international forums to find an amicable solution to the nagging issue. The entire issue was triggered last year when the EU countries began implementing local patent rules rigidly some months back. These EU rules stipulate that any product patent that has been granted in EU countries, if being transported through their countries, is also liable for confiscation under their patent law.
Though the country had engaged in hectic negotiations at different international forums during the last several months to find an amicable solution to this vexed issue, there have been no desired results with no abatement in the seizure of Indian drug shipments at different EU ports. There were several instances of seizures by EU/US Custom authorities of the Indian generic medicines in transit to various developing countries in Latin America and Africa on the grounds of counterfeit/patent infringement, patent litigations in US courts, etc.
The government so far failed to cut much ice with the EU authorities in relaxing regulations on patent and trade mark issues so that at least the drug shipments on transit cannot be seized at the EU ports on charges of counterfeiting and patents infringement. Though the government had provided data of Indian drug shipments which were seized at EU ports, the EU authorities have so far defended their action.
According to pharmabiz sources, the Union Commerce Ministry is contemplating to motivate the pharmaceutical exporters in the country not to send their cargo through KLM Airlines of Netherlands as a retaliatory measure against that country. It may be noted that Netherlands has been one of the EU countries which has been seizing Indian drug shipments at its ports on charges of counterfeit/patent infringement. For instance, the customs authorities at Rotterdam in the Netherlands had some months back seized shipments of the generic drug losartan, which was manufactured in India and was in transit to Brazil. Losartan, indicated to treat high blood pressure, is not under patent protection either in India or Brazil.
Due to its competitive prices, most of the Indian pharmaceutical exporters have been using the services of KLM Airlines to send their cargo to Latin American and African countries. As the volume is quite large, if the Indian pharmaceutical exporters take the retaliatory measures in this regard, it will be a huge loss to the Netherlands company, sources said.
The Indian government's contemplation in this regard comes in the wake of near total collapse of all efforts at different international forums to find an amicable solution to the nagging issue. The entire issue was triggered last year when the EU countries began implementing local patent rules rigidly some months back. These EU rules stipulate that any product patent that has been granted in EU countries, if being transported through their countries, is also liable for confiscation under their patent law.
Though the country had engaged in hectic negotiations at different international forums during the last several months to find an amicable solution to this vexed issue, there have been no desired results with no abatement in the seizure of Indian drug shipments at different EU ports. There were several instances of seizures by EU/US Custom authorities of the Indian generic medicines in transit to various developing countries in Latin America and Africa on the grounds of counterfeit/patent infringement, patent litigations in US courts, etc.
The government so far failed to cut much ice with the EU authorities in relaxing regulations on patent and trade mark issues so that at least the drug shipments on transit cannot be seized at the EU ports on charges of counterfeiting and patents infringement. Though the government had provided data of Indian drug shipments which were seized at EU ports, the EU authorities have so far defended their action.
Wednesday, August 19, 2009
Forest, Glenmark drug fails against smoker's cough (oglemilast)
Glenmark Pharmaceuticals and U.S. partner Forest Laboratories said a drug they were developing to treat smoker's cough failed in a mid-stage trial, knocking Glenmark shares down more than 17 percent on Wednesday.
The Indian firm had been banking heavily on the drug's success, and its breakdown means it will miss out on a potentially lucrative multi-billion dollar market, analysts said.
The drug was to treat chronic obstructive pulmonary disease (COPD), a persistent blockage of airways caused by emphysema or chronic bronchitis that affects an estimated 14 million Americans and is the fourth most common cause of death.
Glenmark and Forest said a Phase IIb study meant to determine the best appropriate dosing for the medicine, called oglemilast, did not show statistically significant results.
"Everybody had built in some kind of an upside because of commercialisation of this molecule," said Sarabjit Kour Nangra, analyst with Angel Broking.
"So, once there is no visibility or lesser visibility in terms of those coming through, the stock is taking a knock. The shares depend on how the R&D unfolds from here."
PIPELINE LOSES SHINE
Glenmark has two other drugs in mid-stage trials: one to treat Type II diabetes, and one for osteoarthritic pain, incontinence and neuropathic pain, according to the company's website.
It also has several other molecules, including those to treat rheumatoid arthritis, obesity and cardiovascular disorders that are in earlier-stage trials.
"Big multinationals may think twice about partnering with Glenmark because of this failure," said Verma, noting pharmaceutical giants were looking to keep their costs in check and would not want to risk spending on drug development only to see the compound fail in later-stage trials.
"We need to re-evaluate whether the trial was designed appropriately, what were the shortcomings ... we need to internally analyse all that," Glenmark Managing Director Glen Saldanha told a conference call.
Oglemilast did not show a statistically meaningful benefit, compared with a dummy drug, in a 12-week study that evaluated three doses of the medicine in patients with moderate to very severe forms of the ailment, Forest and Glenmark said.
The Indian firm had been banking heavily on the drug's success, and its breakdown means it will miss out on a potentially lucrative multi-billion dollar market, analysts said.
The drug was to treat chronic obstructive pulmonary disease (COPD), a persistent blockage of airways caused by emphysema or chronic bronchitis that affects an estimated 14 million Americans and is the fourth most common cause of death.
Glenmark and Forest said a Phase IIb study meant to determine the best appropriate dosing for the medicine, called oglemilast, did not show statistically significant results.
"Everybody had built in some kind of an upside because of commercialisation of this molecule," said Sarabjit Kour Nangra, analyst with Angel Broking.
"So, once there is no visibility or lesser visibility in terms of those coming through, the stock is taking a knock. The shares depend on how the R&D unfolds from here."
PIPELINE LOSES SHINE
Glenmark has two other drugs in mid-stage trials: one to treat Type II diabetes, and one for osteoarthritic pain, incontinence and neuropathic pain, according to the company's website.
It also has several other molecules, including those to treat rheumatoid arthritis, obesity and cardiovascular disorders that are in earlier-stage trials.
"Big multinationals may think twice about partnering with Glenmark because of this failure," said Verma, noting pharmaceutical giants were looking to keep their costs in check and would not want to risk spending on drug development only to see the compound fail in later-stage trials.
"We need to re-evaluate whether the trial was designed appropriately, what were the shortcomings ... we need to internally analyse all that," Glenmark Managing Director Glen Saldanha told a conference call.
Oglemilast did not show a statistically meaningful benefit, compared with a dummy drug, in a 12-week study that evaluated three doses of the medicine in patients with moderate to very severe forms of the ailment, Forest and Glenmark said.
Monday, August 3, 2009
Pharmaceutical Companies's Net Dips and Ups (2)
The results declared by the individual companies are derived from the reliable sources likewise Pharmabiz, economic times, india profit etc.
Indoco Remedies net profit dips by 31%, net sales by 10
Indoco Remedies hit by lower domestic sales during the quarter ended June 2009 and its net profit declined sharply by 31.4 per cent to Rs 16.88 crore from Rs 24.60 crore in the similar period of last year. Despite higher exports its net sales declined by 10.2 per cent to Rs 98.34 crore from Rs 109.49 crore. The fall in profit impacted earning per share, which nosedived to Rs 13.74 from Rs 20.02 in the last period.
The company's exports increased by 16.1 per cent, but its domestic formulation sales declined by 17.5 per cent. The sales declined due to it introduction certain credit control measures in the current and previous quarters. However, the de-growth in domestic sales was much lower as compared to earlier quarters. The products like Cyclopam, Tuspel Plus, MCBM-69, Clokit, Febrex Plus Drops, etc., achieved positive trend during the quarter under review.
Exports to regulated market registered a growth of 15 per cent to Rs 22.47 crore from Rs 19.54 crore. Its Baddi facility received UK MHRA approval. The AOK (Germany) tender dispatches are in full swing and its API plant at Patalganga received approval for supply of metformin API for the OAK tender. The exports to emerging markets increased by 24.09 per cent to Rs 4.48 crore from Rs 3.61 crore.
Sanofi-aventis net profit moves up by 29% to €2.3 bn in Q2
Sanofi-aventis, the third largest pharma giant in the World, has clocked impressive performance during the second quarter ended June 2009 on account of better performance by its products like Lantus, Lovenox and Taxotere. Its net profit increased by 29.4 per cent to €2,268 million from €1,753 million in the corresponding period of last year. Its net sales increased by 11.2 per cent to €7,438 million from €6,689 million. The earning per share improved to €1.74 during the quarter from €1.34.
Its consolidated pharmaceutical sales increased to €6,726 million during the second quarter ended June 2009 from €6032 million, representing a growth of 11.5 per cent and consolidated sales of vaccines increased by 8.4 per cent to €712 million from €657 million. The company's sales in Europe improved by 4.6 per cent to €3,079 million. US sales increased by 5.4 per cent to €2,438 million, driven by fine performances from Lantus (up by 28.7 per cent), Taxotere (up by 9.6 per cent) and Eloxatin (up by 10 per cent).
Christopher A Viehbacher, CEO, said, "The group delivered very strong results in the second quarter, driven by solid growth of key pharmaceutical brands and vaccines, strong sales in emerging markets and recent acquisitions. Multaq has just been launched in the US in July. The strong progression of our earnings has led us to raise our guidance for 2009 to EPS growth of around 10 per cent. Since the beginning of the year, we have launched a new R&D approach to increase innovation, we have strengthened our growth platforms through acquisitions, and we are moving forward with the transformation of our company. Those achievements constitute another step toward our vision of becoming a leading diversified global healthcare company with a sustainable growth profile by 2013."
During the first half of 2009, sanofi recorded net sales growth of 6.7 per cent to €14,545 million from €13,626 million in the corresponding period of last year mainly due to appreciation of US Dollar against Euro. Its net profit increased by 22.3 per cent to €4,446 million from €3,636 million. Its R&D expenditure moved up by 3.7 per cent to €2,260 million from €2,180 million.
Dishman Pharma consolidated net surges by 41% in Q1
Dishman Pharmaceutical and Chemicals, a Rs 1062 crore pharma from Ahmedabad, has reported strong growth in profitability during the first quarter ended June 2009 and its consolidated net profit moved up by 41.4 per cent to Rs 39.20 crore from Rs 27.73 crore in the corresponding period of last year. However, its net sales declined by 3.5 per cent to Rs 227.71 crore from Rs 235.87 crore. Its other operating income increased to Rs 15.48 crore from Rs 0.33 crore. With strong growth in profits, its earning per share during the quarter went up to Rs 4.85 from Rs 3.44.
The income from CRAMS activities declined to Rs 168.35 crore from Rs 182.48 crore in the similar period of last year. Its income from marketable molecules went up by 11.2 per cent to Rs 59.36 crore from Rs 53.39 crore.
Orchid Chemicals' net loss at Rs 29.76 cr in Q1
Orchid Chemicals & Pharmaceuticals Ltd. (Orchid) has suffered a setback during the first quarter on account of interest burden, foreign exchange loss and lower operating income. It posted slightly lower net loss for the first quarter ended June 2009 to Rs 29.76 crore as against Rs 31.65 crore in the corresponding period of last year. However, its net sales moved up by 8.2 per cent to Rs 305.82 crore from Rs 282.55 crore.
The profit before interest, depreciation and taxation also moved down by 26.6 per cent to Rs 64.92 crore from Rs 88.33 crore The company provided Rs 29.98 for foreign exchange loss during the quarter under review as against a gain of Rs 3.50 crore. Further its interest burden jumped by 70.8 per cent to Rs 51.66 crore from Rs 30.24 crore. Orchid's other operating income declined to Rs 3.01 crore from Rs 23.77 crore.
The business performance of Orchid during the first quarter of this fiscal remained steady in terms of volumes and revenues. The US generics business gained from an increased demand for Orchid's oral cephalosporin products which has served to counteract the impact of competition in certain injectable products. Orchid's EU generics business has taken off well with the company dispatching key cephalosporin products based on additional approvals secured by the partner, and with Tazobactam-Piperacillin, the key penicillin injection continuing to increase its market share at a steady pace.
During the first quarter of this fiscal, Orchid received its final ANDA approvals for amlodipine besylate tablets and levetiracetam tablets. With this, the cumulative count of Orchid's final ANDA approvals moved to 32, out of which 26 are in the cephalosporin segment and 6 are in the NPNC segment.
Orchid's cumulative ANDA filings in the US market total to 58. The break-up of the total ANDA filings is 29 in the cephalosporins space, 5 in the betalactams space, 21 in NPNC (includes 7 Para IV, First-to-File filings) segment and 3 in the carbapenems segments.
Additional ANDAs which are in the advanced stages of development and analysis will be filed progressively in the ensuing quarters.
The cumulative filing count of applications of Marketing Authorizations in Europe is 29 of which 4 have received approval. The break-up of the total MA filings is 23 in the cephalosporin segment, one in the betalactam segment, two in the carbapenem segment and three in the NPNC segment. In the API (Active Pharmaceutical Ingredients) segment Orchid's cumulative US DMF count is 72. The break-up of the total filings is 26 in the cephalosporin segment, 33 in the NPNC segment, two in the betalactam segment and 11 in the carbapenems segment. In the European market space the cumulative filings of CoS (Certificate of Suitability) count remained at 20 which includes 12 in cephalosporin segment, seven in NPNC segment and one in the betalactam segment. Orchid's Japanese DMF filings remained at three.
Tuesday, July 28, 2009
Pharmaceutical Companies's Net Dips and Ups
The results declared by the individual companies are derived from the reliable sources likewise Pharmabiz, economic times, india profit etc.
Cadila Healthcare consolidated net jumps by 39% inQ1
Pharma major Zydus Cadila on Monday reported a growth of 39 per cent in its consolidated net profit for the first quarter ended June 30 to Rs 124.79 crore, over the same period a year earlier.
Consolidated total income of the company also rose to Rs 907.76 crore during the April-June period of this fiscal from Rs 715.62 crore of the same period last year, Cadila Healthcare (Zydus Cadila) said in a filing to the Bombay Stock Exchange (BSE).
On a standalone basis, the drug maker posted a net profit of Rs 122.56 crore in the latest quarter of FY'10, whereas the same was at Rs 55.64 crore in the corresponding period a year ago. “The standalone figures for the current quarter are not comparable with the figures of the corresponding quarter of the previous year because of demerger of consumer products division, which got merged with Zydus Wellness, a subsidiary of Cadila Healthcare,” the filing said. Shares of Cadila Healthcare were trading at Rs 399.05, up 2.54 per cent in afternoon trade on the BSE.
GlaxoSmithKline's net profit moves up 8% in Q2
Glaxosmithkline (GSK) Pharmaceuticals has recorded a 8.2% growth in net profit for the second quarter ended June 30, propped up by a higher treasury income and launch of its new products.
The company’s net profit stood at Rs 124.4 crore this quarter compared with Rs 114.9 crore for the same period of the previous financial year. GSK Pharma’s revenues jumped 9.7% to Rs 457.4 crore from Rs 416.9 crore in the corresponding quarter last year.
GSK Pharma MD Hasit Joshipura told economic times: “Net profit was positively impacted by treasury income, while sales growth was on account of the launch of new products, ahead of schedule. Recent launches include Arixtra (antithrombotic agent), Rotarix (rotavirus diarrhoea vaccine) and Tykerb (refractory breast cancer drug).” GSK Pharma has seen sales doubling in the vaccines segment. Vaccines, which earlier comprised 6% of the sales, accounted for 12% for the most recent quarter. According to Mr Joshipura, future growth will be driven by new product launches from the stable of the parent company. On Tuesday, the GSK Pharma stock was up 0.28% to close at Rs 1351.15 on BSE.
GSK Pharma currently has $350 million (approximately Rs 1,685 crore) of cash on its books and is looking at utilising this money in two ways. “We are looking at acquiring brands for which some have already been shortlisted. We are looking for a strategic fit and if that exists, we will go out and buy them.”
Glenmark Q1 net profit dips 54% on forex loss
Drug maker Glenmark Pharmaceuticals today reported a decline of 54 per cent in its consolidated net profit to Rs 53.45 crore on account of forex losses and higher interest cost for the first quarter ended June 30, 2009 over the same period last year.
Total income rose to Rs 551.28 crore in the latest quarter, as against Rs 471.74 crore in the same period previous fiscal, Glenmark Pharmaceuticals said in a filing to the Bombay Stock Exchange.
"Sales growth across regions for the quarter has been encouraging. Even though the environment across markets remains subdued, we still managed to accelerate sales growth in the first quarter," Glenmark Pharmaceuticals CEO and MD Glenn Saldanha said.
On the standalone basis, the company has posted a decline of 90.79 per cent to Rs 5.22 crore for the quarter ended June, compared to same quarter last year.
Total income rose to Rs 221.97 crore in the quarter ended June 30, against Rs 194.41 crore in the same quarter last year.
Alembic net up to Rs 12.25 cr, sales at Rs 292 cr
Alembic Ltd, a Rs 1100 crore Vadodara-based pharma major, has announced strong bottom line during the first quarter ended June 2009 as against a net loss due to foreign exchange loss in the corresponding period of last year. The company earned a net profit of Rs 12.25 crore as compared a net loss of Rs 4.70 crore. Its net sales went up by 26.7 per cent to Rs 290.64 crore from Rs 229.34 crore
The company's export sales moved up to Rs 133.97 crore from Rs 114.13 crore, a growth of 17.4 per cent and its domestic sales increased by 29.6 per cent to Rs 158.52 crore from Rs 122.27 crore in the quarter ended June 2008. Total sales to regulated market increased by 33 per cent to Rs 109 crore from Rs 83 crore.
The profit before interest, depreciation and taxation also increased by 29.8 per cent to Rs 30.76 crore from Rs 23.70 crore. The company incurred R&D expenditure of Rs 9.23 crore during the quarter ended June 2009 as compared to Rs 8.52 crore in the corresponding period of last year. It has launched two ANDAs in US market during the quarter. It filed one ANDA and its cumulative total reached to 20 ANDAs and 32 DMFs till the end of first quarter of 2009-10.
Alembic has bought back 21,21,882 equity shares as at the end of June 2009, at an average price of Rs 35.28 for a total consideration of Rs 7.49 crore, which is about 22.69 per cent of the total buy-back size of Rs 33 crore.
Wanbury's net profit jumps to Rs 9.47 cr
Wanbury Ltd has posted strong growth in its net profit during the quarter ended June 2009 and its net profit went up sharply to Rs 9.47 crore from Rs 1.43 crore in the corresponding period of last year. Its net sales also moved up by 25.6 per cent to Rs 83.74 crore from Rs 66.66 crore. With smart improvement in profits, its earning per share reached at Rs 6.15 as against Rs 0.97 in the last period.
The profit before interest, depreciation, taxation and forex gains, improved by 155 per cent to Rs 18.13 crore from Rs 7.12 crore in the similar period of last year. The interest burden increased sharply by almost 75 per cent to Rs 6.15 crore from Rs 3.52 crore.
For the six months ended June 2009, Wanbury has shown a net loss of Rs 31.28 crore on sales of Rs 167.66 crore. The loss is basically due to provision of Rs 14.06 crore for the foreign exchange loss.
According to a company release, the merger scheme of The Pharmaceutical Products of India Ltd is still pending with BIFR.
In order to hedge its foreign currency earnings, when the Rupees was strengthening, Wanbury entered into derivative hedging structures protecting its dollar receivables. As at the end of June 2009, Mark to Market losses on thee derivatives amounted to Rs 29.07 crore. As an abundant caution, it had made a provision of Rs 35 crore as at the end of March 2009 to meet such anticipated forex losses and balance out of the same as at the end of June 2009 worked out to Rs 26.56 crore. The company has fully utilized Rs 85.28 crore raised from the proceeds of the FCCB issue.
Dabur India Q1 net up 15%
Dabur India Ltd reported a net profit of Rs 80.83 crore for the first quarter ended June 30, 2009 where as the same was at Rs 70.14 crore in the same quarter in 2008.
Total income for the quarter has increased to Rs 616.13 crore as compared with Rs 535.29 crore in the year-ago period.
Ranbaxy incurs net loss of Rs 363 cr before foreign exchange gains in Q2
Fortis Healthcare net zooms to Rs 7.6 cr in Q1
Aventis Pharma net up by 12.7% in Q2, interim dividend of 350%
Hikal net moves up by 25% in Q1
Wockhardt Ltd has sold its nutritional businesses to Abbott Laboratories
Mumbai-based drug major Wockhardt Ltd which is battling a debt pile of over Rs 3,700 crore, has sold its nutritional businesses and a few facilities to Abbott Laboratories of the US for around $130 million (nearly Rs 626 crore) in cash.
Wockhardt has well-known products in the pediatric nutritional category such as Farex, Dexolac and Nusobee infant formulas. The transaction also includes nutrition manufacturing facilities in Lalru and Jagraon (in Punjab).
Earlier, Wockhardt had acquired nutritional supplement maker Dumex India Pvt Ltd, along with its products Protinex and Farex, in June 2006.
Abbott has confirmed it would acquire Wockhardt's nutrition businesses, Carol Info Services Ltd, and certain Wockhardt subsidiaries and group companies. The acquisition includes around 600 employees. Abbott expects the transactions to close in the second half of 2009, but they are not being conducted by its publicly traded subsidiary, Abbott India Ltd, it said.
Abbott offers Isomil, PediaSure, Ensure and Glucerna in India and plans to introduce additional products from its broad based nutritional portfolio to Indian consumers in the coming years, said the Abbott statement.
"This acquisition is an excellent strategic fit for Abbott to accelerate growth of its nutrition business in India, where the nutritional market is expected to experience strong growth in the coming years.
So from now onwards the new generation will see Abbott tag on Farex, Dexolac and Nusobee (infant formulas) instead of Wockhardt.
Wockhardt has well-known products in the pediatric nutritional category such as Farex, Dexolac and Nusobee infant formulas. The transaction also includes nutrition manufacturing facilities in Lalru and Jagraon (in Punjab).
Earlier, Wockhardt had acquired nutritional supplement maker Dumex India Pvt Ltd, along with its products Protinex and Farex, in June 2006.
Abbott has confirmed it would acquire Wockhardt's nutrition businesses, Carol Info Services Ltd, and certain Wockhardt subsidiaries and group companies. The acquisition includes around 600 employees. Abbott expects the transactions to close in the second half of 2009, but they are not being conducted by its publicly traded subsidiary, Abbott India Ltd, it said.
Abbott offers Isomil, PediaSure, Ensure and Glucerna in India and plans to introduce additional products from its broad based nutritional portfolio to Indian consumers in the coming years, said the Abbott statement.
"This acquisition is an excellent strategic fit for Abbott to accelerate growth of its nutrition business in India, where the nutritional market is expected to experience strong growth in the coming years.
So from now onwards the new generation will see Abbott tag on Farex, Dexolac and Nusobee (infant formulas) instead of Wockhardt.
WIPO plans to implant "Global Patenting System" on developing nations through PCT II
The new world patent order is being sought to be introduced through a comprehensive proposal drafted by the US by floating a new Patent Cooperation Treaty, PCT II, in the General Assembly of WIPO at Geneva. The trilaterals with the support of WIPO and World Health Organization are trying their best to get the proposal approved by the General Assembly by inducing some of developing nations.
The US, European Union and Japan are pushing a new international patent agenda through World Intellectual Property Organization on behalf of the powerful big pharma of the developed countries. WIPO, controlled by these trilaterals, is trying hard to impose a 'Global Patenting System' at the forthcoming General Assembly session of WIPO in September.
A session of the PCT Working Group of WIPO held last May to push this agenda got withdrawn as the developing countries led by India, Brazil South, Africa and Argentina had strongly opposed the move. India' diplomatic mission in Geneva played a crucial role in defeating the proposal for Global Patenting piloted by Director General of WIPO at the Working Group meeting, it is learnt Informed sources said that the WIPO plan is to institute a system similar to the one that exists for international registration of Trade Marks under the Madrid System, a treaty already administered by WIPO. With the approval of Global Patenting at the General Assembly, developed nations are seeking to dilute the sovereignty of developing nations in determining patentability of applications for inventions and do way with flexibilities granted under TRIPS Agreement.
Under the TRIPS Agreement, developing nations are free to consider all the flexibilities before granting a patent to any new invention. While many developing nations do not have the expertise to scrutinize and determine patentability of a patent claim, India has adequate capabilities with full fledged patent control offices in the country.
The US, European Union and Japan are pushing a new international patent agenda through World Intellectual Property Organization on behalf of the powerful big pharma of the developed countries. WIPO, controlled by these trilaterals, is trying hard to impose a 'Global Patenting System' at the forthcoming General Assembly session of WIPO in September.
A session of the PCT Working Group of WIPO held last May to push this agenda got withdrawn as the developing countries led by India, Brazil South, Africa and Argentina had strongly opposed the move. India' diplomatic mission in Geneva played a crucial role in defeating the proposal for Global Patenting piloted by Director General of WIPO at the Working Group meeting, it is learnt Informed sources said that the WIPO plan is to institute a system similar to the one that exists for international registration of Trade Marks under the Madrid System, a treaty already administered by WIPO. With the approval of Global Patenting at the General Assembly, developed nations are seeking to dilute the sovereignty of developing nations in determining patentability of applications for inventions and do way with flexibilities granted under TRIPS Agreement.
Under the TRIPS Agreement, developing nations are free to consider all the flexibilities before granting a patent to any new invention. While many developing nations do not have the expertise to scrutinize and determine patentability of a patent claim, India has adequate capabilities with full fledged patent control offices in the country.
The strategy of developed nations backed WIPO is to introduce 'automatic grant of patents in all member states' once PCT II is adopted at the General Assembly. This is what is 'combining of international and national processing of patent applications' as suggested by the USPTO to WIPO.
A serious implication of the proposed new global patent system is that patent laws adopted by the developing countries become irrelevant and ineffective. Besides this, challenging of patent claims will become almost impossible making monopoly marketing of pharmaceutical products quite easy for MNCs in India.
Now, India being a major manufacturer and exporter of generic drugs threatening sales of branded business of the big pharma, the target of this new agenda of developed nations seems to be mainly Indian pharma industry. Indian Pharmaceutical Alliance (IPA), representing large generic companies of the country, has already alerted the cabinet secretary, commerce secretary and ministry of external affairs in this regard.
Monday, July 27, 2009
M/s Teva on settlement phase: Settle with Ortho-McNeil-Janssen on Ortho Tri-Cyclen Lo litigation
ORTHO TRI-CYCLEN® Lo Tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.
ORTHO TRI-CYCLEN® Lo Tablets is a combination oral contraceptive containing the progestational compound norgestimate and the estrogenic compound ethinyl estradiol.
Earlier Teva announced that to its press release dated July 7, 2009, the Company and Ortho McNeil Janssen have extended their agreement to cease shipments of generic versions of Ortho Tri-Cyclen Lo®, until the earlier of (a) the Court's ruling on the motion for preliminary injunction or (b) July 29.
Teva Pharmaceutical Industries Ltd has entered into a definitive agreement with Ortho-McNeil-Janssen to settle the patent infringement lawsuit in the US District Court for the District of New Jersey related to Teva's generic version of the oral contraceptive, Ortho Tri-Cyclen Lo.
Under the terms of the settlement, Teva will obtain a release for past sales of its generic product, in exchange for an undisclosed royalty payment. Teva also will obtain a license to re-enter the market on December 31, 2015, or earlier in certain circumstances. The settlement will not become effective until the court enters a proposed consent judgment upholding the validity and enforceability of Ortho's patent.
ORTHO TRI-CYCLEN® Lo Tablets is a combination oral contraceptive containing the progestational compound norgestimate and the estrogenic compound ethinyl estradiol.
Earlier Teva announced that to its press release dated July 7, 2009, the Company and Ortho McNeil Janssen have extended their agreement to cease shipments of generic versions of Ortho Tri-Cyclen Lo®, until the earlier of (a) the Court's ruling on the motion for preliminary injunction or (b) July 29.
Teva Pharmaceutical Industries Ltd has entered into a definitive agreement with Ortho-McNeil-Janssen to settle the patent infringement lawsuit in the US District Court for the District of New Jersey related to Teva's generic version of the oral contraceptive, Ortho Tri-Cyclen Lo.
Under the terms of the settlement, Teva will obtain a release for past sales of its generic product, in exchange for an undisclosed royalty payment. Teva also will obtain a license to re-enter the market on December 31, 2015, or earlier in certain circumstances. The settlement will not become effective until the court enters a proposed consent judgment upholding the validity and enforceability of Ortho's patent.
Sunday, July 12, 2009
Daiichi Sankyo and Lilly Receive U.S. FDA Approval for Effient
"After more than a decade of research and testing, finally Daiichi Sankyo and Eli Lilly and Company today announced that the U.S. Food and Drug Administration (FDA) approved Effient (prasugrel) tablets for the reduction of thrombotic cardiovascular events (including stent thrombosis) in patients with acute coronary syndromes who are managed with an artery-opening procedure known as percutaneous coronary intervention (PCI).
PCI usually includes the placement of a stent to help keep the artery open.
Taking Effient with aspirin after PCI has been shown to reduce the chances of having a cardiac event (such as a heart attack) and stent-related blood clots (known as stent thrombosis) among patients with acute coronary syndromes (ACS), a common cardiovascular condition. "The FDA approval of Effient is a major step forward in the treatment of acute coronary syndromes
The approval was based on results from the pivotal Phase 3 TRITON-TIMI 38 clinical trial, which compared Effient with Plavix(R) (clopidogrel bisulfate) in reducing cardiovascular events in 13,608 acute coronary patients managed with PCI. The study showed that Effient taken with aspirin had a 19 percent relative risk reduction of the combined endpoint of cardiovascular death, non-fatal heart attack or non-fatal stroke versus Plavix taken with aspirin. This benefit was driven predominantly by reduction in heart attacks. The benefit of Effient compared with Plavix was seen as early as three days and continued over the 15 months of the trial. In addition, there were fewer stent-related clots (known as stent thrombosis) in patients treated with Effient compared with Plavix (a relative risk reduction of approximately 50 percent).
Important Safety Information about Effient
Antiplatelet medicines, including Effient, can increase the risk of bleeding. If patients have unexplained or excessive bleeding while on Effient, they should contact their doctor right away as some bleeding can be serious, and sometimes may lead to death. Patients should not take Effient if they have a stomach ulcer or other conditions that cause bleeding or if they have a history of stroke or "mini-stroke" (transient ischemic attack or TIA).
If patients are 75 or older, or if they weigh less than 132 pounds, or if they are taking anticoagulants (eg, warfarin) or taking NSAIDs (eg, ibuprofen or naproxen) for a long time, they should talk to their doctor, as they may be at an increased risk of bleeding.
If patients plan to have surgery or a dental procedure, they should tell their doctors that they are taking Effient.
Patients should not stop taking Effient without first talking to the doctor who prescribed it for them, as this may result in increased risk of a clot in their stent, a heart attack or death.
Patients should get medical attention right away if they develop any of the following unexpected symptoms: fever, weakness, yellowing of the skin or eyes, or if skin becomes very pale or dotted with purple spots. These symptoms may be signs of a rare but potentially life-threatening condition called TTP, which has been reported with other medicines in this class.
For more information about Effient, including prescribing information, please visit www.Effient.com.
PCI usually includes the placement of a stent to help keep the artery open.
Taking Effient with aspirin after PCI has been shown to reduce the chances of having a cardiac event (such as a heart attack) and stent-related blood clots (known as stent thrombosis) among patients with acute coronary syndromes (ACS), a common cardiovascular condition. "The FDA approval of Effient is a major step forward in the treatment of acute coronary syndromes
The approval was based on results from the pivotal Phase 3 TRITON-TIMI 38 clinical trial, which compared Effient with Plavix(R) (clopidogrel bisulfate) in reducing cardiovascular events in 13,608 acute coronary patients managed with PCI. The study showed that Effient taken with aspirin had a 19 percent relative risk reduction of the combined endpoint of cardiovascular death, non-fatal heart attack or non-fatal stroke versus Plavix taken with aspirin. This benefit was driven predominantly by reduction in heart attacks. The benefit of Effient compared with Plavix was seen as early as three days and continued over the 15 months of the trial. In addition, there were fewer stent-related clots (known as stent thrombosis) in patients treated with Effient compared with Plavix (a relative risk reduction of approximately 50 percent).
Important Safety Information about Effient
Antiplatelet medicines, including Effient, can increase the risk of bleeding. If patients have unexplained or excessive bleeding while on Effient, they should contact their doctor right away as some bleeding can be serious, and sometimes may lead to death. Patients should not take Effient if they have a stomach ulcer or other conditions that cause bleeding or if they have a history of stroke or "mini-stroke" (transient ischemic attack or TIA).
If patients are 75 or older, or if they weigh less than 132 pounds, or if they are taking anticoagulants (eg, warfarin) or taking NSAIDs (eg, ibuprofen or naproxen) for a long time, they should talk to their doctor, as they may be at an increased risk of bleeding.
If patients plan to have surgery or a dental procedure, they should tell their doctors that they are taking Effient.
Patients should not stop taking Effient without first talking to the doctor who prescribed it for them, as this may result in increased risk of a clot in their stent, a heart attack or death.
Patients should get medical attention right away if they develop any of the following unexpected symptoms: fever, weakness, yellowing of the skin or eyes, or if skin becomes very pale or dotted with purple spots. These symptoms may be signs of a rare but potentially life-threatening condition called TTP, which has been reported with other medicines in this class.
For more information about Effient, including prescribing information, please visit www.Effient.com.
Monday, July 6, 2009
Budget exempts pharma industry from duty increament
Giving a big sigh of relief to the pharma industry, especially the small and medium sectors, Union finance minister Pranab Mukherjee has left it unharmed while raising the excise duty on the most of the sectors from 4 per cent to 8 per cent, in his budget presented in the Parliament on Monday.
True to the apprehensions of the industry as a whole, the finance minister rolled back the blanket cut in excise duty from 8 per cent to 4 per cent announced as part of a stimulus package some months back. However, he spared the pharma industry from harsh step, while presenting his general budget which could enthuse many."With the government's proclaimed objective of introducing a Goods and Services Tax (GST) both at the national and State level, some more steps in that direction are necessary.
One measure that would facilitate the process is the further convergence of central excise duty rates to a mean rate - currently 8 per cent. I have reviewed the list of items currently attracting the rate of 4 per cent, the only rate below the mean rate. There is a case for enhancing the rate on many items appearing in this list to 8 per cent, which I propose to do, with the following major exceptions," he said, while including drugs and pharmaceuticals and medical equipment among exempted categories.
"The basic customs duty on influenza vaccine and nine specified life saving drugs used for the treatment of breast cancer, hepatitis-B, rheumatic arthiritis etc. on the bulk drugs used for the manufacture of such drugs, has been reduced from 10 per cent to 5 per cents. They will also be totally exempt from excise duty and countervailing duty," according to the budget proposal.
In another relief to the medical devices industry, the customs duty will also be reduced from 7.5 per cent to 5 per cent on two specified life-saving devises used in treatment of heart conditions. These devises will be fully exempt from excise duty and CVD also.Besides, along with the other small scale units, the pharma sector also will benefit from the budget proposal for boosting the bank loans for them. Besides, in a relief to the SME sector, the existing special incentive upto two per cent for exports will continue further.
Though the industry was looking for further increase in the weighted deduction for R & D in the pharma sector from the current 150 per cent, it did not come through though the finance minister extended the benefit to more areas. The budget has allocated Rs 155.25 crore for the pharmaceutical department.
True to the apprehensions of the industry as a whole, the finance minister rolled back the blanket cut in excise duty from 8 per cent to 4 per cent announced as part of a stimulus package some months back. However, he spared the pharma industry from harsh step, while presenting his general budget which could enthuse many."With the government's proclaimed objective of introducing a Goods and Services Tax (GST) both at the national and State level, some more steps in that direction are necessary.
One measure that would facilitate the process is the further convergence of central excise duty rates to a mean rate - currently 8 per cent. I have reviewed the list of items currently attracting the rate of 4 per cent, the only rate below the mean rate. There is a case for enhancing the rate on many items appearing in this list to 8 per cent, which I propose to do, with the following major exceptions," he said, while including drugs and pharmaceuticals and medical equipment among exempted categories.
"The basic customs duty on influenza vaccine and nine specified life saving drugs used for the treatment of breast cancer, hepatitis-B, rheumatic arthiritis etc. on the bulk drugs used for the manufacture of such drugs, has been reduced from 10 per cent to 5 per cents. They will also be totally exempt from excise duty and countervailing duty," according to the budget proposal.
In another relief to the medical devices industry, the customs duty will also be reduced from 7.5 per cent to 5 per cent on two specified life-saving devises used in treatment of heart conditions. These devises will be fully exempt from excise duty and CVD also.Besides, along with the other small scale units, the pharma sector also will benefit from the budget proposal for boosting the bank loans for them. Besides, in a relief to the SME sector, the existing special incentive upto two per cent for exports will continue further.
Though the industry was looking for further increase in the weighted deduction for R & D in the pharma sector from the current 150 per cent, it did not come through though the finance minister extended the benefit to more areas. The budget has allocated Rs 155.25 crore for the pharmaceutical department.
Thursday, July 2, 2009
German drugmaker Bayer sued Israeli generic competitor Teva
German drugmaker Bayer (BAYG.DE) sued Israeli generic competitor Teva (TEVA.TA) in a U.S. court for infringing its patent covering “Levitra".
The patent at issue in the suit is Bayer Schering Pharma's U.S. Patent No. 6,362,178, expiring in 2018." Levitra, was first approved by U.S. regulators in 2003, and is sold by Schering-Plough and GlaxoSmithKline Plc in the U.S. and competes with Pfizer Inc.’s Viagra and Eli Lilly & Co.’s Cialis.
The drug, whose active ingredient is vardenafil hydrochloride, generated $341 million in sales last year for Bayer, the company said in its annual report.
Teva is seeking U.S. Food and Drug Administration approval to sell a generic version of the drug. Teva filed ANDA application with Paragraph IV certification, in which Teva contends that it won’t infringe any valid or enforceable patent on this medicine. Under federal law, Bayer’s suit triggers an automatic 30-month period in which the FDA can’t approve Teva’s application, unless a judge rules in the generic-drug maker’s favor before then.
Denise Bradley, a spokeswoman for Petak Tikva, Israel-based Teva, said the company has no comment on the suit, which was filed in federal court in Wilmington, Delaware. Teva is the world’s biggest generic-drug maker.
Lets wait and watch who will win!!!!!!!!!!!
The patent at issue in the suit is Bayer Schering Pharma's U.S. Patent No. 6,362,178, expiring in 2018." Levitra, was first approved by U.S. regulators in 2003, and is sold by Schering-Plough and GlaxoSmithKline Plc in the U.S. and competes with Pfizer Inc.’s Viagra and Eli Lilly & Co.’s Cialis.
The drug, whose active ingredient is vardenafil hydrochloride, generated $341 million in sales last year for Bayer, the company said in its annual report.
Teva is seeking U.S. Food and Drug Administration approval to sell a generic version of the drug. Teva filed ANDA application with Paragraph IV certification, in which Teva contends that it won’t infringe any valid or enforceable patent on this medicine. Under federal law, Bayer’s suit triggers an automatic 30-month period in which the FDA can’t approve Teva’s application, unless a judge rules in the generic-drug maker’s favor before then.
Denise Bradley, a spokeswoman for Petak Tikva, Israel-based Teva, said the company has no comment on the suit, which was filed in federal court in Wilmington, Delaware. Teva is the world’s biggest generic-drug maker.
Lets wait and watch who will win!!!!!!!!!!!
Sunday, June 28, 2009
Pfizer Sues Matrix (Mylan) on worlds largest selling drug “Atorvastatin”.
Pfizer is suing Matrix (Mylan) for filing an ANDA to manufacture a version of the blockbuster cholesterol drug Lipitor in 10-, 20-, 40- and 80-mg strength tablets.
Pfizer Inc., the world’s biggest drugmaker, sued rival Mylan Inc. asking a judge to prohibit sales of a generic version of its cholesterol-fighting medicine Lipitor until 2017.
Pfizer’s patents on Atorvastatin which are in the light:
US5969156 (Expiry: Jan 8, 2017): Which covers crystalline Polymorphic Form I, II and IV
US6087511 (Expiry: July 16, 2016): Which covers a process for the preparation of amorphous Atorvastatin where crystalline Form I of Atorvastatin is dissolved in a non-hydroxylic solvent and after removal of the solvent affords amorphous Atorvastatin.
US6274740 (Expiry: July 16, 2016): Which covers a process for the preparation of amorphous Atorvastatin or hydrates thereof which comprises: (a) dissolving crystalline Form I Atorvastatin in a non-hydroxylic solvent at a concentration of about 25% to about 40%; and (b) removing the solvent by drying to afford said amorphous atorvastatin or hydrates thereof.
As per complaint, Matrix (Mylan) has filed ANDA with amorphous form of Atorvastatin and notified innovator about ANDA filing by Paragraph IV notice letter dated May 1, 2009.
In federal court papers filed today in Wilmington, Delaware, lawyers for New York-based Pfizer contend a Mylan affiliate has applied to the U.S. Food and Drug Administration for permission to sell copies of Lipitor, the world’s best- selling drug, before three Pfizer patents expire.
“Defendants have taken immediate and active steps” to sell Lipitor copies in the U.S. and “Pfizer will be irreparably harmed” if Canonsburg, Pennsylvania-based Mylan succeeds, according to the complaint.
Pfizer officials have said they’re looking for cooperative ventures with other pharmaceutical makers to increase generic sales as patents expire. Lipitor logged $12.4 billion in revenue last year, $7.7 billion of it in the U.S.
Ranbaxy Laboratories Ltd., India’s biggest drugmaker and majority owned by Japan’s Daiichi Sankyo Co., settled a lawsuit filed by Pfizer and plans to enter the market in November 2011. Pfizer already is suing Apotex Inc. and Teva Pharmaceutical Industries Ltd. to prevent them from selling copies of the medicine before then.
Mike Laffin, a spokesman for Mylan, didn’t immediately return voice and e-mail messages seeking comment on the lawsuit.
Pfizer fell 63 cents to $14.13 in New York Stock Exchange composite trading at 4:15 p.m. Mylan fell 56 cents to $13.06 in Nasdaq Stock Market trading.
The case is Pfizer Inc. v. Mylan Inc., U.S. District Court, District of Delaware (Wilmington).
Pfizer Inc., the world’s biggest drugmaker, sued rival Mylan Inc. asking a judge to prohibit sales of a generic version of its cholesterol-fighting medicine Lipitor until 2017.
Pfizer’s patents on Atorvastatin which are in the light:
US5969156 (Expiry: Jan 8, 2017): Which covers crystalline Polymorphic Form I, II and IV
US6087511 (Expiry: July 16, 2016): Which covers a process for the preparation of amorphous Atorvastatin where crystalline Form I of Atorvastatin is dissolved in a non-hydroxylic solvent and after removal of the solvent affords amorphous Atorvastatin.
US6274740 (Expiry: July 16, 2016): Which covers a process for the preparation of amorphous Atorvastatin or hydrates thereof which comprises: (a) dissolving crystalline Form I Atorvastatin in a non-hydroxylic solvent at a concentration of about 25% to about 40%; and (b) removing the solvent by drying to afford said amorphous atorvastatin or hydrates thereof.
As per complaint, Matrix (Mylan) has filed ANDA with amorphous form of Atorvastatin and notified innovator about ANDA filing by Paragraph IV notice letter dated May 1, 2009.
In federal court papers filed today in Wilmington, Delaware, lawyers for New York-based Pfizer contend a Mylan affiliate has applied to the U.S. Food and Drug Administration for permission to sell copies of Lipitor, the world’s best- selling drug, before three Pfizer patents expire.
“Defendants have taken immediate and active steps” to sell Lipitor copies in the U.S. and “Pfizer will be irreparably harmed” if Canonsburg, Pennsylvania-based Mylan succeeds, according to the complaint.
Pfizer officials have said they’re looking for cooperative ventures with other pharmaceutical makers to increase generic sales as patents expire. Lipitor logged $12.4 billion in revenue last year, $7.7 billion of it in the U.S.
Ranbaxy Laboratories Ltd., India’s biggest drugmaker and majority owned by Japan’s Daiichi Sankyo Co., settled a lawsuit filed by Pfizer and plans to enter the market in November 2011. Pfizer already is suing Apotex Inc. and Teva Pharmaceutical Industries Ltd. to prevent them from selling copies of the medicine before then.
Mike Laffin, a spokesman for Mylan, didn’t immediately return voice and e-mail messages seeking comment on the lawsuit.
Pfizer fell 63 cents to $14.13 in New York Stock Exchange composite trading at 4:15 p.m. Mylan fell 56 cents to $13.06 in Nasdaq Stock Market trading.
The case is Pfizer Inc. v. Mylan Inc., U.S. District Court, District of Delaware (Wilmington).
Friday, June 26, 2009
COMPLIANCE WITH cGMP IS MUST ---OTHERWISE FDA CAN TAKE ACTION
U.S. Marshals, at the request of the Food and drug Adminstration , seized drug products manufactured at Caraco Pharmaceutical laboratories limited (Caraco), at the company’s Michigan facilities in Detroit, Farmington Hills, and Wixom. The seizure also includes ingredients held at these same facilities.
This action follows Caraco’s continued failure to meet the FDA’s Current Good Manufacturing practice (cGMP) requirements, which assure the quality of manufactured drugs. Through this seizure, the FDA seeks to immediately stop the firm from further distributing drugs until there is assurance that the firm complies with good manufacturing requirements.
Since January 2009, Caraco has initiated voluntary recalls of drug products to protect the public from potentially defective medications. The recalls involved manufacturing defects, including oversized tablets and possible formulation error.
The FDA’s most recent inspection of Caraco, completed in May 2009, FDA again found unresolved violations of cGMP requirements. Now this seizure is intended to lead to major changes at Caraco’s facilities.
Now all the pharmaceutical industries intended to sell their product in US, must be aware that their manufacturing facilities should be in compliance with cGMP. As FDA is committed to taking enforcement action against firms that do not manufacture drugs in accordance with our good manufacturing practice requirements, said by Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.
If the FDA identifies further significant problems, which pose risks to patient safety with any Caraco drug products on the market, the agency will take appropriate additional regulatory action and immediately notify the public. "The FDA will continue to take swift, aggressive enforcement action when firms are identified as being in violation of our manufacturing requirements," said Michael Chappell, FDA acting associate commissioner for regulatory affairs.
Seizure of drug products is considered to be an effective remedy when there is evidence of continued poor compliance with cGMPs. Following a drug product seizure, companies often agree to a wide range of changes and improvements to their drug manufacturing practices at their facilities.
But such drug seizure may create a shortage of the drug product seized. In case of Caraco's drugs FDA has determined that the seizure of Caraco's drugs may create a shortage of one product, magnesium trisalicylate oral tablets, which are commonly used as pain relievers. So FDA recommends in the event of a shortage, health care providers consider alternative treatments that are safe and effective.
Consumers and health care providers who are unable to obtain any of Caraco’s products should contact the FDA Drug Shortage Program by e-mail at drugshortages@fda.hhs.gov.
This action follows Caraco’s continued failure to meet the FDA’s Current Good Manufacturing practice (cGMP) requirements, which assure the quality of manufactured drugs. Through this seizure, the FDA seeks to immediately stop the firm from further distributing drugs until there is assurance that the firm complies with good manufacturing requirements.
Since January 2009, Caraco has initiated voluntary recalls of drug products to protect the public from potentially defective medications. The recalls involved manufacturing defects, including oversized tablets and possible formulation error.
The FDA’s most recent inspection of Caraco, completed in May 2009, FDA again found unresolved violations of cGMP requirements. Now this seizure is intended to lead to major changes at Caraco’s facilities.
Now all the pharmaceutical industries intended to sell their product in US, must be aware that their manufacturing facilities should be in compliance with cGMP. As FDA is committed to taking enforcement action against firms that do not manufacture drugs in accordance with our good manufacturing practice requirements, said by Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.
If the FDA identifies further significant problems, which pose risks to patient safety with any Caraco drug products on the market, the agency will take appropriate additional regulatory action and immediately notify the public. "The FDA will continue to take swift, aggressive enforcement action when firms are identified as being in violation of our manufacturing requirements," said Michael Chappell, FDA acting associate commissioner for regulatory affairs.
Seizure of drug products is considered to be an effective remedy when there is evidence of continued poor compliance with cGMPs. Following a drug product seizure, companies often agree to a wide range of changes and improvements to their drug manufacturing practices at their facilities.
But such drug seizure may create a shortage of the drug product seized. In case of Caraco's drugs FDA has determined that the seizure of Caraco's drugs may create a shortage of one product, magnesium trisalicylate oral tablets, which are commonly used as pain relievers. So FDA recommends in the event of a shortage, health care providers consider alternative treatments that are safe and effective.
Consumers and health care providers who are unable to obtain any of Caraco’s products should contact the FDA Drug Shortage Program by e-mail at drugshortages@fda.hhs.gov.
Tuesday, June 23, 2009
Sanofi sued Teva over Eloxatin patent: Court Grants Teva Summary Judgment of Non-Infringement on Eloxatin®
Sanofi-Aventis has sued Teva Industries Ltd. over Teva's plans to sell a generic version of the French drugmaker's cancer treatment Eloxatin.
The lawsuit, filed in federal court in New Jersey, comes on the heels of a similar suit filed by Sanofi against Sandoz, a unit of Novartis.
Eloxatin had nearly 1.7 billion euros in sales in 2006 for Sanofi, the world's third largest drugmaker.
In an amended complaint, Sanofi alleged that Teva's plan to make and sell a generic version of the drug infringed a patent for which it was an exclusive licensee.
Teva filed a new drug application with the FDA for a generic product, oxaliplatin injection, according to the complaint. Oxaliplatin is the active ingredient in Eloxatin.
Sanofi is seeking an order blocking Teva from making or selling the generic product in the United States.
Teva and Sanofi could not be reached immediately for comment.
Recently
Teva Pharmaceutical Industries Ltd. announced that the US District Court for the District of New Jersey has granted summary judgment in Teva's favour on the issue of non-infringement with regard to Debiopharm's US Patent No. 5,338,874.
The patent is listed in the Orange Book for Sanofi-Aventis' chemotherapy medication Eloxatin, which had annual sales of approximately $1.3 billion in the United States for the twelve months that ended December 31, 2008, based on IMS sales data. Teva intends to inform the FDA of the court's decision and expects that its 505(b)(2) New Drug Application will receive final approval shortly.
The lawsuit, filed in federal court in New Jersey, comes on the heels of a similar suit filed by Sanofi against Sandoz, a unit of Novartis.
Eloxatin had nearly 1.7 billion euros in sales in 2006 for Sanofi, the world's third largest drugmaker.
In an amended complaint, Sanofi alleged that Teva's plan to make and sell a generic version of the drug infringed a patent for which it was an exclusive licensee.
Teva filed a new drug application with the FDA for a generic product, oxaliplatin injection, according to the complaint. Oxaliplatin is the active ingredient in Eloxatin.
Sanofi is seeking an order blocking Teva from making or selling the generic product in the United States.
Teva and Sanofi could not be reached immediately for comment.
Recently
Teva Pharmaceutical Industries Ltd. announced that the US District Court for the District of New Jersey has granted summary judgment in Teva's favour on the issue of non-infringement with regard to Debiopharm's US Patent No. 5,338,874.
The patent is listed in the Orange Book for Sanofi-Aventis' chemotherapy medication Eloxatin, which had annual sales of approximately $1.3 billion in the United States for the twelve months that ended December 31, 2008, based on IMS sales data. Teva intends to inform the FDA of the court's decision and expects that its 505(b)(2) New Drug Application will receive final approval shortly.
Friday, June 19, 2009
David Kappos: The successor of USPTO after John Dudas
Congratulations to Mr. David Kappos from CGI (CrispyGeneric IP) team!
The White House says “If he is confirmed by the U.S. Senate, Kappos will take control of an office that provides incentives to encourage technological advancement and helps businesses protect their investments, promote their goods and safeguard against deception in the marketplace. The office continues to deal with a patent application backlog of more than 770,000, long waiting periods for patent review, information technology systems that are regarded as outdated and an application process in need of reform.”
The White House has announced its intent to nominate David J. Kappos as Director of the United States Patent and Trademark Office (USPTO) with the official title of Under Secretary of Commerce for Intellectual Property.
Introduction of Mr. Kappos
Mr. Kappos has spent his entire career with IBM – both as an electrical engineer and later as a patent attorney. Kappos will end his IBM career as Vice President and Assistant General Counsel, Intellectual Property Law. He is a board member of both AIPLA and IPO.
From the get-go, Mr. Kappos has been a rumored frontrunner to replace Director Jon Dudas and Interim Director John Doll.
A very necessary quality of being a patent office director who can understand patents and who has been fully involved with all aspects of the patent system for the past twenty years.
I believe that Kappos will be a careful shepherd of the system - leaving it better off in six years than it is today.”
As someone who writes daily about US Patent Law, I am excited about the Kappos nomination because he is likely to open access to previously hidden data and information. He will also work to create systems that work and measures that are meaningful.
I suspect that the biggest challenge for Mr. Kappos will be moving beyond the unique IBM perspective. Big Blue is an atypical patent owner in its internal systems, patenting volume, and licensing power. As I discussed earlier, it will be important for him to spend time understanding how the rest of the patent community operates.
The White House says “If he is confirmed by the U.S. Senate, Kappos will take control of an office that provides incentives to encourage technological advancement and helps businesses protect their investments, promote their goods and safeguard against deception in the marketplace. The office continues to deal with a patent application backlog of more than 770,000, long waiting periods for patent review, information technology systems that are regarded as outdated and an application process in need of reform.”
The White House has announced its intent to nominate David J. Kappos as Director of the United States Patent and Trademark Office (USPTO) with the official title of Under Secretary of Commerce for Intellectual Property.
Introduction of Mr. Kappos
Mr. Kappos has spent his entire career with IBM – both as an electrical engineer and later as a patent attorney. Kappos will end his IBM career as Vice President and Assistant General Counsel, Intellectual Property Law. He is a board member of both AIPLA and IPO.
From the get-go, Mr. Kappos has been a rumored frontrunner to replace Director Jon Dudas and Interim Director John Doll.
A very necessary quality of being a patent office director who can understand patents and who has been fully involved with all aspects of the patent system for the past twenty years.
I believe that Kappos will be a careful shepherd of the system - leaving it better off in six years than it is today.”
As someone who writes daily about US Patent Law, I am excited about the Kappos nomination because he is likely to open access to previously hidden data and information. He will also work to create systems that work and measures that are meaningful.
I suspect that the biggest challenge for Mr. Kappos will be moving beyond the unique IBM perspective. Big Blue is an atypical patent owner in its internal systems, patenting volume, and licensing power. As I discussed earlier, it will be important for him to spend time understanding how the rest of the patent community operates.
Tuesday, June 16, 2009
One more hurdle for Ranbaxy:Medicis Pharma files suit against Ranbaxy for infringing patent claims on its acne drug
US-based speciality pharma company Medicis Pharma Corporation has filed a suit against Delaware-based Ranbaxy Inc, a wholly-owned subsidiary of Ranbaxy Laboratories Ltd, in the district court of Delaware, alleging patent infringement of its acne product-solodyn tablets.
In the petition filed with the District Court of Delaware, US, Medicis alleges that Ranbaxy has violated one or more claims three, four, 12 and 13 of the US Patent No.5,908,838 for method for the treatment of acne, issued on June, 1999. Ranbaxy has filed an abbreviated new drug application (ANDA) with the US Food and Drugs Administration (FDA) to manufacture and sell the minocycline HCL with a Para IV certification.The petition sought an adjudication that will restrain Ranbaxy from manufacturing and selling the generic product prior to the expiry of `838 patent and that the FDA should only issue approval for sales after the expiry of the said patent.
The annual sales of this product stood at approximately $365 million in the US market for the 12 months that ended January 31 this year, as per IMS sales data. Medicis Pharma, which specialises in dermatological products, has accused Ranbaxy of infringing patent claims of the company by attempting to obtain approval from the United States Food and Drug Administration (USFDA) to commercially manufacture and sell the generic version of the said acne product.
“Medicis received a letter dated May 6 from Ranbaxy Inc, stating that Ranbaxy Labs had filed the Ranbaxy abbreviated new drug application (Anda), seeking approval to manufacture, use, offer for sale and sell a generic version of solodyn extended release tablets for the treatment of acne before the expiration of the patent,” Jack Blumenfeld, counsel for Medicis, has told the court.
In its suit, Medicis has sought a permanent injunction against Ranbaxy so that the drug maker is prevented from manufacturing, using, selling the generic version of solodyn and has pleaded with the court to bar Ranbaxy from selling and marketing the drug till the patent litigation is resolved conclusively. A Ranbaxy spokesperson refused to comment on the issue.
Teva is reportedly one of the first companies to file ANDA with a Para IV certification for minocycline HCL. It has also been awarded a 180-day period of marketing exclusivity. It is also learnt that the FDA has denied Medicis' petition seeking a 30 month ban on making generic version of the drug.
The other high-profile patent litigation involving Ranbaxy include an agreement with Pfizer Inc to settle worldwide patent litigation involving Pfizer’s cholesterol-lowering medication, lipitor, which generated $12.7 billion in sales in 2007. The agreement allowed Ranbaxy to introduce a generic version of the drug in November 2011, with 180 days of exclusivity, which implies that no other manufacturers can start selling the drug until 180 days after that in the US. Ranbaxy also settled a patent infringement lawsuit with AstraZeneca in April 2008, which allowed the company to distribute the only generic version of esomeprazole magnesium product in the US.
In the petition filed with the District Court of Delaware, US, Medicis alleges that Ranbaxy has violated one or more claims three, four, 12 and 13 of the US Patent No.5,908,838 for method for the treatment of acne, issued on June, 1999. Ranbaxy has filed an abbreviated new drug application (ANDA) with the US Food and Drugs Administration (FDA) to manufacture and sell the minocycline HCL with a Para IV certification.The petition sought an adjudication that will restrain Ranbaxy from manufacturing and selling the generic product prior to the expiry of `838 patent and that the FDA should only issue approval for sales after the expiry of the said patent.
The annual sales of this product stood at approximately $365 million in the US market for the 12 months that ended January 31 this year, as per IMS sales data. Medicis Pharma, which specialises in dermatological products, has accused Ranbaxy of infringing patent claims of the company by attempting to obtain approval from the United States Food and Drug Administration (USFDA) to commercially manufacture and sell the generic version of the said acne product.
“Medicis received a letter dated May 6 from Ranbaxy Inc, stating that Ranbaxy Labs had filed the Ranbaxy abbreviated new drug application (Anda), seeking approval to manufacture, use, offer for sale and sell a generic version of solodyn extended release tablets for the treatment of acne before the expiration of the patent,” Jack Blumenfeld, counsel for Medicis, has told the court.
In its suit, Medicis has sought a permanent injunction against Ranbaxy so that the drug maker is prevented from manufacturing, using, selling the generic version of solodyn and has pleaded with the court to bar Ranbaxy from selling and marketing the drug till the patent litigation is resolved conclusively. A Ranbaxy spokesperson refused to comment on the issue.
Teva is reportedly one of the first companies to file ANDA with a Para IV certification for minocycline HCL. It has also been awarded a 180-day period of marketing exclusivity. It is also learnt that the FDA has denied Medicis' petition seeking a 30 month ban on making generic version of the drug.
The other high-profile patent litigation involving Ranbaxy include an agreement with Pfizer Inc to settle worldwide patent litigation involving Pfizer’s cholesterol-lowering medication, lipitor, which generated $12.7 billion in sales in 2007. The agreement allowed Ranbaxy to introduce a generic version of the drug in November 2011, with 180 days of exclusivity, which implies that no other manufacturers can start selling the drug until 180 days after that in the US. Ranbaxy also settled a patent infringement lawsuit with AstraZeneca in April 2008, which allowed the company to distribute the only generic version of esomeprazole magnesium product in the US.
Wednesday, June 10, 2009
India again raises issue of seizure of generic drugs by European nations at World Trade Organization (WTO)
Three consignments of Indian-manufactured generic medicines – seized last year while in transit in the EU – have been earmarked for destruction by EU authorities.
These consignments – of clopidogrel, rivastigmine and olanzapine – were being exported from India to other developing countries to treat patients with serious and life-threatening conditions such as heart attacks, strokes, Alzheimer's disease, Parkinson's disease and psychosis. Yet they were seized by Dutch customs authorities on the basis of alleged patent infringement.
Although these medicines are not under patent in India or in the destination countries, EU customs legislation still permits the destruction of these life-saving medicines. A humanitarian organisation, Médecins Sans Frontières (MSF), has highlighted several other recent cases of generic medicines in transit in the EU that have been detained, seized or destroyed.
According to Pharmexcil, companies whose consignments also ran into similar trouble (other than as listed below) include JB Chemicals and Pharmaceuticals Ltd, Medico Remedies Pvt. Ltd, Titan Pharma India Pvt. Ltd, and Mission Pharmaceuticals Ltd, all based in Mumbai, and Hyderabad-based Sainor Pharma Pvt. Ltd.
Listed below are the consignments of Indian companies that were seized on grounds of patent infringement by the Dutch customs authorities.
1.15.10.08: Ind-Swift Laboratories Ltd (Clopidogrel Bilsulphate- API): Destined for Columbia
A consignment valued at some $100,000 (Rs 49 lakh) of Ind-Swift in transit for Venezuela was seized in November by customs authorities in the Netherlands under suspicions of being counterfeit.
The product was the generic drug Pantoprazole, used for treating ulcers, in the form of pellets that were to be filled in capsules and sold in Venezuela, where Ind-swift has marketing rights for it.
2. 27.11.08: Cipla Ltd, through Uni World Pharma Ltd, Dubai
(Olanzapine 10 mg Tabs): Destined for Peru.
3. 27.11.08: Cipla Ltd, through Uni World Pharma Ltd, Dubai
(Rivastigmine 3 mg Tabs): Peru.
4. 24.12.08: Dr Reddy’s Laboratories Ltd (Losartan - API): Destined for Brazil
A DRL shipment of the generic version of losartan was seized in transit in the Netherlands. This shipment, on its way to Brazil, was held by the customs authority at Rotterdam, which said it infringed the patent of the original drug-Cozaar. Losartan is not patented in India or Brazil. The patent for Cozaar in the Netherlands is held by DuPont, while US-based pharma multinational Merck and Co. holds the marketing rights."
5. A consignment of HIV/AIDS medicines by Aurobindo Pharma Ltd meant for use in Nigeria was seized by Dutch officials. The grounds on which they were allegedly seized again is that they contained counterfeit goods.
Concerned over the continued seizure of generic drug consignments at different European ports on charges of counterfeiting and patents infringement, India has once again raised the issue at the WTO seeking the world body's intervention to ask the European Commission (EC) to urgently review the EC Regulation 1383/2003 and the actions of the national authorities based on the Regulation, and bring them in conformity with the letter and spirit of the TRIPS Agreement.
Even though the Indian government had raised the issue at the WTO's last meeting in March this year, the seizure of Indian drugs destined for other developing countries continued at EU ports. On May 5, a shipment of a generic antibiotic, Amoxicillin, manufactured in India and destined for a least developed country, the Republic of Vanuatu in the Pacific, was seized by customs officials, while in transit through Frankfurt, Germany.
Amoxicillin is an essential medicine used to treat a wide range of bacterial infections. The consignment worth approximately 28,000 Euros consisted of 3,047,000 tablets of Amoxicillin (250 mg), equivalent to 76,000 courses of treatment. The seizures were made on grounds of alleged trademark violation although GlaxoSmithKline (GSK) has confirmed to the German authorities that GSK is the former patent holder for 'Amoxil', a brand name for amoxicillin. Seeking WTO intervention on the issue, the Indian representative at the WTO said that there seems to be no valid reason for detaining these medicines especially since the name 'Amoxicillin' is an international non-proprietary name (INN).
Seizures have continued to take place at EC ports. The multitude of allegations and the spread across several EC ports, imply an emerging pattern to disrupt and create barriers to legitimate trade of generic drugs and to challenge the Doha Declaration on Public Health. The basic principle of transparency of procedures has also been violated by the inability of the authorities to share and explain the specific cause of action under EU regulations.
"EC has sought to justify the action of customs authorities to control goods in transit suspected of infringing IPRs as a means to stop traffic of potentially dangerous products, such as fake medicines, even when the shipments were destined for any country. It seems that it has been ingrained very deeply within the EC authorities that IP violative products are synonymous with potentially dangerous substances," the Indian representative said at the WTO.
Widespread and repeated seizures have an adverse systemic impact on legitimate trade of generic medicines, South-South commerce, national public health policies and the principle of universal access to medicines. The importance of generic drugs to public health in developing countries and particularly in the LDCs is obvious. Such barriers to legitimate trade of generic drugs will also seriously impair the efforts of civil society organisations engaged in providing medicines and improving public health in the least developed parts of the world.
It is ironical that while on one hand WTO has taken steps to promote access to affordable medicines and remove obstacles to proper use of TRIPS flexibilities, on the other hand some members seek to negate the same by seizing drug consignments in transit and creating barriers to legitimate trade, the representative said.
These consignments – of clopidogrel, rivastigmine and olanzapine – were being exported from India to other developing countries to treat patients with serious and life-threatening conditions such as heart attacks, strokes, Alzheimer's disease, Parkinson's disease and psychosis. Yet they were seized by Dutch customs authorities on the basis of alleged patent infringement.
Although these medicines are not under patent in India or in the destination countries, EU customs legislation still permits the destruction of these life-saving medicines. A humanitarian organisation, Médecins Sans Frontières (MSF), has highlighted several other recent cases of generic medicines in transit in the EU that have been detained, seized or destroyed.
According to Pharmexcil, companies whose consignments also ran into similar trouble (other than as listed below) include JB Chemicals and Pharmaceuticals Ltd, Medico Remedies Pvt. Ltd, Titan Pharma India Pvt. Ltd, and Mission Pharmaceuticals Ltd, all based in Mumbai, and Hyderabad-based Sainor Pharma Pvt. Ltd.
Listed below are the consignments of Indian companies that were seized on grounds of patent infringement by the Dutch customs authorities.
1.15.10.08: Ind-Swift Laboratories Ltd (Clopidogrel Bilsulphate- API): Destined for Columbia
A consignment valued at some $100,000 (Rs 49 lakh) of Ind-Swift in transit for Venezuela was seized in November by customs authorities in the Netherlands under suspicions of being counterfeit.
The product was the generic drug Pantoprazole, used for treating ulcers, in the form of pellets that were to be filled in capsules and sold in Venezuela, where Ind-swift has marketing rights for it.
2. 27.11.08: Cipla Ltd, through Uni World Pharma Ltd, Dubai
(Olanzapine 10 mg Tabs): Destined for Peru.
3. 27.11.08: Cipla Ltd, through Uni World Pharma Ltd, Dubai
(Rivastigmine 3 mg Tabs): Peru.
4. 24.12.08: Dr Reddy’s Laboratories Ltd (Losartan - API): Destined for Brazil
A DRL shipment of the generic version of losartan was seized in transit in the Netherlands. This shipment, on its way to Brazil, was held by the customs authority at Rotterdam, which said it infringed the patent of the original drug-Cozaar. Losartan is not patented in India or Brazil. The patent for Cozaar in the Netherlands is held by DuPont, while US-based pharma multinational Merck and Co. holds the marketing rights."
5. A consignment of HIV/AIDS medicines by Aurobindo Pharma Ltd meant for use in Nigeria was seized by Dutch officials. The grounds on which they were allegedly seized again is that they contained counterfeit goods.
Concerned over the continued seizure of generic drug consignments at different European ports on charges of counterfeiting and patents infringement, India has once again raised the issue at the WTO seeking the world body's intervention to ask the European Commission (EC) to urgently review the EC Regulation 1383/2003 and the actions of the national authorities based on the Regulation, and bring them in conformity with the letter and spirit of the TRIPS Agreement.
Even though the Indian government had raised the issue at the WTO's last meeting in March this year, the seizure of Indian drugs destined for other developing countries continued at EU ports. On May 5, a shipment of a generic antibiotic, Amoxicillin, manufactured in India and destined for a least developed country, the Republic of Vanuatu in the Pacific, was seized by customs officials, while in transit through Frankfurt, Germany.
Amoxicillin is an essential medicine used to treat a wide range of bacterial infections. The consignment worth approximately 28,000 Euros consisted of 3,047,000 tablets of Amoxicillin (250 mg), equivalent to 76,000 courses of treatment. The seizures were made on grounds of alleged trademark violation although GlaxoSmithKline (GSK) has confirmed to the German authorities that GSK is the former patent holder for 'Amoxil', a brand name for amoxicillin. Seeking WTO intervention on the issue, the Indian representative at the WTO said that there seems to be no valid reason for detaining these medicines especially since the name 'Amoxicillin' is an international non-proprietary name (INN).
Seizures have continued to take place at EC ports. The multitude of allegations and the spread across several EC ports, imply an emerging pattern to disrupt and create barriers to legitimate trade of generic drugs and to challenge the Doha Declaration on Public Health. The basic principle of transparency of procedures has also been violated by the inability of the authorities to share and explain the specific cause of action under EU regulations.
"EC has sought to justify the action of customs authorities to control goods in transit suspected of infringing IPRs as a means to stop traffic of potentially dangerous products, such as fake medicines, even when the shipments were destined for any country. It seems that it has been ingrained very deeply within the EC authorities that IP violative products are synonymous with potentially dangerous substances," the Indian representative said at the WTO.
Widespread and repeated seizures have an adverse systemic impact on legitimate trade of generic medicines, South-South commerce, national public health policies and the principle of universal access to medicines. The importance of generic drugs to public health in developing countries and particularly in the LDCs is obvious. Such barriers to legitimate trade of generic drugs will also seriously impair the efforts of civil society organisations engaged in providing medicines and improving public health in the least developed parts of the world.
It is ironical that while on one hand WTO has taken steps to promote access to affordable medicines and remove obstacles to proper use of TRIPS flexibilities, on the other hand some members seek to negate the same by seizing drug consignments in transit and creating barriers to legitimate trade, the representative said.
Sunday, June 7, 2009
Net profit of top 10 Indian Pharmaceutical companies decline by 61% in 2008-09
Although Indian Pharmaceutical companies done well in this fiscal year but as compared to previous year’s estimation for this year the calculation quite varied.
Here is the overview given regarding performance of top 10 Indian pharmaceutical manufacturers: the study done by Pharmabiz team.
Profitability of the pharmaceutical sector in the country is on steep decline for first time after several years of excellent performance. A Pharmabiz study of top 10 pharmaceutical companies having turnover of above Rs 2500 crore shows that their net profits came down by 60.9 per cent during the year ended 2008-09.
The consolidated net profit of these 10 companies declined to Rs 2,082 crore in 2008-09 from Rs 5,322 crore reported in the previous year. One of the main reasons for the poor performances was the foreign exchange losses. The aggregate provision for foreign exchange loss reached at Rs 3,031 crore during the year under review as against a gain of Rs 628 crore in 2007-08.
Apart from foreign exchange losses, these companies also experienced stiff competition, economic slowdown, volatile exchange rates and regulatory problems in the global markets during the year 2008-09.
Overall sales of the 10 companies, however, moved up during the year. The consolidated sales of the Pharmabiz sample of ten leading companies increased by 26.1 per cent to Rs 43,454 crore during 2008-09 from Rs 34,467 crore in the previous year. Ranbaxy Laboratories, now a subsidiary of Daiichi Sankyo of Japan, has remained on top with consolidated net sales of Rs 7,421 crore followed by Dr Reddy's Labs (Rs 6,791 crore), Cipla (Rs 4,973 crore), Sun Pharmaceutical (4,272 crore), Lupin (Rs 3,776 crore), Wockhardt (Rs 3,593 crore), Jubilant Organosys (Rs 3,518 crore), Piramal Healthcare (Rs 3,281 crore), Aurobindo Pharma (Rs 2,966 crore) and Cadila Healthcare (Rs 2,862 crore).
Pharmabiz analysis shows that there are 21 pharma companies in India with consolidated net sales of above Rs 1,000 crore during 2008-09. Two new companies viz., Dishman Pharma and Strides Arcolab achieved the milestone of Rs 1000 crore during 2008-09 and another two companies viz., Aventis Pharm India (Rs 983 crore) and Ankur Drugs (Rs 964 crore) are very close to touch Rs 1,000 crore marks in the current year.
The highest growth in net sales was recorded by Jubilant Organosys of 41.3 per cent. This was followed by Lupin 39.5 per cent, Dr Reddy's Labs by 38.2 per cent, Wockhardt by 35.4 per cent. Cipla, Sun Pharma, Aurobindo and Cadila Healthcare recorded sales growth of above 20 per cent during 2008-09. Only Ranbaxy achieved single digit growth of 9.4 per cent in sales. These players have established there brand image in cardiovasculars, gastrointestinals, central nervous system, respirator, musculoskeletal and pain management.
The profitability was quite bad for Ranbaxy Laboratories, Dr Reddy's Laboratories, Aurobindo Pharma, Piramal Healthcare and Jubilant Organosys. Out of ten companies, net profit of six companies declined or ended up in net losses. Three companies viz., Ranbaxy, Dr Reddy's Lab and Wockhardt incurred net losses of Rs 951 crore, Rs 917 crore and Rs 139 crore respectively as against profits made during 2007-08. Ranbaxy provided Rs 1,855 crore for foreign exchange loss and DRL provided Rs 1,463 crore for impairment of goodwill and intangibles. The net profit of Aurobind declined by 58.1 per cent to Rs 100 crore from Rs 238 crore in the previous year.
Ranbaxy provided a total Rs 1,855 crore for foreign exchange loss during 2008-09 as against a gain of Rs 508 crore in the previous year. Similarly, Wockhardt, Jubilant Aurobind also incurred a foreign exchange loss of Rs 711 crore, Rs 104 crore and Rs 255 crore in 2008-09. Piramal Healthcare provided Rs 255 crore for foreign exchange loss and Cadila of Rs 23 crore. DRL, Cipla, Sun Pharma and Lupin have not incurred any foreign exchange loss or gain during 2008-09.These provisions put pressure on aggregate profitability of 10 companies.
Sun Pharma remained star performer in profitability terms and its net profit touched to Rs 1,818 crore as compared to Rs 1,487 crore in the last year, a growth of 22.2 per cent. Similarly, net profit of Lupin also moved up by 22.9 per cent to Rs 501.54 crore from Rs 408.25 crore. The net profit of Cipla improved only by single digit of 9.5 per cent to Rs 768 crore. Cadila Healthcare recorded a profit growth of 17.7 per cent to Rs 303 crore.
The aggregate other income, including in-licensing income, of 10 companies increased by 23.6 per cent to Rs 1,373 crore from Rs 1,111 crore in the previous year. The raw material cost remained relatively stable and increased by 22.1 per cent to Rs 16,924 crore as compared to Rs 13,861.07 crore. The interest cost of these 10 companies went up sharply by 77.1 per cent to Rs 904 crore from Rs 511 crore. Though Sun Pharma earned interest income of Rs 122 crore, the interest burden of all other companies moved up during 2008-09. The provision for depreciation increased by 29.6 per cent to Rs 1,797 crore from Rs 1,387 crore.
The huge foreign exchange losses have not stopped Indian pharma companies from investing in R&D activities. Even after demerger of R&D activities the spending is rising. Out of ten companies, six have provided figures for R&D expenditure during 2008-09 which showed an increase of 12.6 per cent to Rs 1,541 crore from Rs 1,368 crore. Lupin's research spending went up by 40 per cent to Rs 232 crore from Rs 166 crore in the previous year. Ranbaxy's R&D expenditure reached at Rs 431 crore, a marginal growth of 0.8 per cent. Dr Reddy's spending moved up by 18.7 per cent to Rs 409.27 crore and that of Sun Pharma, which de-merged its R&D activities, increased by 11.1 per cent to Rs 332.04 crore.
The profit before tax, foreign exchange loss and other adjustments increased modestly by 18.1 per cent to Rs 6,807 crore from Rs 5,762 crore in 2007-08. Aurobindo's profit before tax has taken a quantum jump of 74 per cent and touched to Rs 386 crore from Rs 222 crore. Similarly, DRL's profit before tax moved up by 48 per cent to Rs 806 crore. However, the extra ordinary items of foreign exchange loss and impairment of goodwill and intangibles put pressure on bottom line of these two companies. Sun Pharma's profit before tax reached at Rs 1,949 crore as compared to Rs 1,599 crore, a growth of almost 22 per cent and that of Cipla amounted to Rs 910 crore as against Rs 838 crore representing a growth of 8.6 per cent. Ranbaxy's profit before tax, however, declined by 27.4 per cent to Rs 355 crore.
Despite negative growth in profit, several companies have declared handsome dividend during 2008-09. Sun Pharma recommended equity dividend of 275 per cent, Piramal Healthcare announced dividend of 210 per cent, DRL and Lupin declared 125 per cent; Jubilant stepped up dividend to 150 per cent. But, Ranbaxy and Wockhardt did not declare any dividend for the year.
Here is the overview given regarding performance of top 10 Indian pharmaceutical manufacturers: the study done by Pharmabiz team.
Profitability of the pharmaceutical sector in the country is on steep decline for first time after several years of excellent performance. A Pharmabiz study of top 10 pharmaceutical companies having turnover of above Rs 2500 crore shows that their net profits came down by 60.9 per cent during the year ended 2008-09.
The consolidated net profit of these 10 companies declined to Rs 2,082 crore in 2008-09 from Rs 5,322 crore reported in the previous year. One of the main reasons for the poor performances was the foreign exchange losses. The aggregate provision for foreign exchange loss reached at Rs 3,031 crore during the year under review as against a gain of Rs 628 crore in 2007-08.
Apart from foreign exchange losses, these companies also experienced stiff competition, economic slowdown, volatile exchange rates and regulatory problems in the global markets during the year 2008-09.
Overall sales of the 10 companies, however, moved up during the year. The consolidated sales of the Pharmabiz sample of ten leading companies increased by 26.1 per cent to Rs 43,454 crore during 2008-09 from Rs 34,467 crore in the previous year. Ranbaxy Laboratories, now a subsidiary of Daiichi Sankyo of Japan, has remained on top with consolidated net sales of Rs 7,421 crore followed by Dr Reddy's Labs (Rs 6,791 crore), Cipla (Rs 4,973 crore), Sun Pharmaceutical (4,272 crore), Lupin (Rs 3,776 crore), Wockhardt (Rs 3,593 crore), Jubilant Organosys (Rs 3,518 crore), Piramal Healthcare (Rs 3,281 crore), Aurobindo Pharma (Rs 2,966 crore) and Cadila Healthcare (Rs 2,862 crore).
Pharmabiz analysis shows that there are 21 pharma companies in India with consolidated net sales of above Rs 1,000 crore during 2008-09. Two new companies viz., Dishman Pharma and Strides Arcolab achieved the milestone of Rs 1000 crore during 2008-09 and another two companies viz., Aventis Pharm India (Rs 983 crore) and Ankur Drugs (Rs 964 crore) are very close to touch Rs 1,000 crore marks in the current year.
The highest growth in net sales was recorded by Jubilant Organosys of 41.3 per cent. This was followed by Lupin 39.5 per cent, Dr Reddy's Labs by 38.2 per cent, Wockhardt by 35.4 per cent. Cipla, Sun Pharma, Aurobindo and Cadila Healthcare recorded sales growth of above 20 per cent during 2008-09. Only Ranbaxy achieved single digit growth of 9.4 per cent in sales. These players have established there brand image in cardiovasculars, gastrointestinals, central nervous system, respirator, musculoskeletal and pain management.
The profitability was quite bad for Ranbaxy Laboratories, Dr Reddy's Laboratories, Aurobindo Pharma, Piramal Healthcare and Jubilant Organosys. Out of ten companies, net profit of six companies declined or ended up in net losses. Three companies viz., Ranbaxy, Dr Reddy's Lab and Wockhardt incurred net losses of Rs 951 crore, Rs 917 crore and Rs 139 crore respectively as against profits made during 2007-08. Ranbaxy provided Rs 1,855 crore for foreign exchange loss and DRL provided Rs 1,463 crore for impairment of goodwill and intangibles. The net profit of Aurobind declined by 58.1 per cent to Rs 100 crore from Rs 238 crore in the previous year.
Ranbaxy provided a total Rs 1,855 crore for foreign exchange loss during 2008-09 as against a gain of Rs 508 crore in the previous year. Similarly, Wockhardt, Jubilant Aurobind also incurred a foreign exchange loss of Rs 711 crore, Rs 104 crore and Rs 255 crore in 2008-09. Piramal Healthcare provided Rs 255 crore for foreign exchange loss and Cadila of Rs 23 crore. DRL, Cipla, Sun Pharma and Lupin have not incurred any foreign exchange loss or gain during 2008-09.These provisions put pressure on aggregate profitability of 10 companies.
Sun Pharma remained star performer in profitability terms and its net profit touched to Rs 1,818 crore as compared to Rs 1,487 crore in the last year, a growth of 22.2 per cent. Similarly, net profit of Lupin also moved up by 22.9 per cent to Rs 501.54 crore from Rs 408.25 crore. The net profit of Cipla improved only by single digit of 9.5 per cent to Rs 768 crore. Cadila Healthcare recorded a profit growth of 17.7 per cent to Rs 303 crore.
The aggregate other income, including in-licensing income, of 10 companies increased by 23.6 per cent to Rs 1,373 crore from Rs 1,111 crore in the previous year. The raw material cost remained relatively stable and increased by 22.1 per cent to Rs 16,924 crore as compared to Rs 13,861.07 crore. The interest cost of these 10 companies went up sharply by 77.1 per cent to Rs 904 crore from Rs 511 crore. Though Sun Pharma earned interest income of Rs 122 crore, the interest burden of all other companies moved up during 2008-09. The provision for depreciation increased by 29.6 per cent to Rs 1,797 crore from Rs 1,387 crore.
The huge foreign exchange losses have not stopped Indian pharma companies from investing in R&D activities. Even after demerger of R&D activities the spending is rising. Out of ten companies, six have provided figures for R&D expenditure during 2008-09 which showed an increase of 12.6 per cent to Rs 1,541 crore from Rs 1,368 crore. Lupin's research spending went up by 40 per cent to Rs 232 crore from Rs 166 crore in the previous year. Ranbaxy's R&D expenditure reached at Rs 431 crore, a marginal growth of 0.8 per cent. Dr Reddy's spending moved up by 18.7 per cent to Rs 409.27 crore and that of Sun Pharma, which de-merged its R&D activities, increased by 11.1 per cent to Rs 332.04 crore.
The profit before tax, foreign exchange loss and other adjustments increased modestly by 18.1 per cent to Rs 6,807 crore from Rs 5,762 crore in 2007-08. Aurobindo's profit before tax has taken a quantum jump of 74 per cent and touched to Rs 386 crore from Rs 222 crore. Similarly, DRL's profit before tax moved up by 48 per cent to Rs 806 crore. However, the extra ordinary items of foreign exchange loss and impairment of goodwill and intangibles put pressure on bottom line of these two companies. Sun Pharma's profit before tax reached at Rs 1,949 crore as compared to Rs 1,599 crore, a growth of almost 22 per cent and that of Cipla amounted to Rs 910 crore as against Rs 838 crore representing a growth of 8.6 per cent. Ranbaxy's profit before tax, however, declined by 27.4 per cent to Rs 355 crore.
Despite negative growth in profit, several companies have declared handsome dividend during 2008-09. Sun Pharma recommended equity dividend of 275 per cent, Piramal Healthcare announced dividend of 210 per cent, DRL and Lupin declared 125 per cent; Jubilant stepped up dividend to 150 per cent. But, Ranbaxy and Wockhardt did not declare any dividend for the year.
Tuesday, June 2, 2009
Good opportunity for the Patent Analysts to earn 50,000 US dollars: “Article One Partners” Pay you for analyzing the patent
Are you surprised!!!!!!!!!!!!
Yes, it is true “Article One Partners” is offering individuals a cash reward of up to US$50,000 and the possibility of profit sharing. All you have to do is provide clear and concrete evidence for or against specific patents.
Article One Partners, an online community and a for-profit group formed by a group of patent attorneys and financial advisors, provides the general public an opportunity to come up with proofs for the invalidation of a valid patent as by doing this they have widest possible base of people to find the evidence required to prove or disprove a patent claim. In return of these evidences, company pay US$50,000 to the persons who could come up with invalidating prior art.
Recently they have made “Montelukast Sodium” as their target. The U.S. Patent and Trademark Office (PTO) ordered the reexamination of Merck’s biggest selling product, Singulair. The challenged patent, US 5,565,473 was granted on 15/10/1996. This patent covers montelukast sodium, the active ingredient in allergy and asthma drug.
For more information for “Article One Partners” visit the site http://www.articleonepartners.com/
Yes, it is true “Article One Partners” is offering individuals a cash reward of up to US$50,000 and the possibility of profit sharing. All you have to do is provide clear and concrete evidence for or against specific patents.
Article One Partners, an online community and a for-profit group formed by a group of patent attorneys and financial advisors, provides the general public an opportunity to come up with proofs for the invalidation of a valid patent as by doing this they have widest possible base of people to find the evidence required to prove or disprove a patent claim. In return of these evidences, company pay US$50,000 to the persons who could come up with invalidating prior art.
Recently they have made “Montelukast Sodium” as their target. The U.S. Patent and Trademark Office (PTO) ordered the reexamination of Merck’s biggest selling product, Singulair. The challenged patent, US 5,565,473 was granted on 15/10/1996. This patent covers montelukast sodium, the active ingredient in allergy and asthma drug.
For more information for “Article One Partners” visit the site http://www.articleonepartners.com/
Saturday, May 30, 2009
FDA has moved Electronic Orange Book
Hello guys!!!!!
Kindly attention generic pharma players please!!!
FDA has moved the path of Electronic Orange Book which is utilised to access patent data of approved drugs.
Here we have given the link to access Electronic Orange Book.
Check it out by your own.
The link is http://www.accessdata.fda.gov/scripts/cder/ob/default.cfm
Kindly attention generic pharma players please!!!
FDA has moved the path of Electronic Orange Book which is utilised to access patent data of approved drugs.
Here we have given the link to access Electronic Orange Book.
Check it out by your own.
The link is http://www.accessdata.fda.gov/scripts/cder/ob/default.cfm
Friday, May 29, 2009
Teva settles patent suit with Zydus Pharmaceuticals Inc on Coreg® (Carvedilol) in Round 2
Teva Pharmaceuticals, the Israel based generic major, has reportedly settled its patent litigation with the Ahmedabad-based Cadila Healthcare and its US-based subsidiary Zydus Pharmaceuticals Inc concerning the process of making carvedilol
First of all Teva sent enquiry letters to lot of companies and then sued some of them in round one and followed by the settlement. Teva purportedly settled first with DRL then Cadila and Torrent; but later, they sued a whole bunch of companies excluding DRL in round 2 including some of those who had settled in 1st round.
Teva has sent enquiry letters to some companies for Carvedilol and has already sued Zentiva for the same. This action should be worrying for other generic companies that are about to enter Carvedilol space
Teva is the drug manufacturer for the technology that goes into manufacturing carvedilol. The other companies included Ranbaxy Laboratories, Cadila Healthcare, Lupin and Orchid Chemicals. But Teva went ahead and withdrew the case against Dr Reddy’s as Dr Reddy’s had asked for a summary judgement from the New Jersey District Court. Now once the core patent against which Dr Reddy’s was sued is withdrawn by Teva, Dr Reddy’s will be able to sell this particular drug. It’s quite a big drug; now Zydus is also in the big list of Teva for the settlement.
Originally it is licensed by Roche to GSK in the US and it’s a very strong product as far as Teva is concerned. So there will be hindrances put by Teva for any other company which want to market that product.
It should be noted that the market size of the carvedilol would be upwards of USD 400 million.
So, war will be continued with other giants……..
First of all Teva sent enquiry letters to lot of companies and then sued some of them in round one and followed by the settlement. Teva purportedly settled first with DRL then Cadila and Torrent; but later, they sued a whole bunch of companies excluding DRL in round 2 including some of those who had settled in 1st round.
Teva has sent enquiry letters to some companies for Carvedilol and has already sued Zentiva for the same. This action should be worrying for other generic companies that are about to enter Carvedilol space
Teva is the drug manufacturer for the technology that goes into manufacturing carvedilol. The other companies included Ranbaxy Laboratories, Cadila Healthcare, Lupin and Orchid Chemicals. But Teva went ahead and withdrew the case against Dr Reddy’s as Dr Reddy’s had asked for a summary judgement from the New Jersey District Court. Now once the core patent against which Dr Reddy’s was sued is withdrawn by Teva, Dr Reddy’s will be able to sell this particular drug. It’s quite a big drug; now Zydus is also in the big list of Teva for the settlement.
Originally it is licensed by Roche to GSK in the US and it’s a very strong product as far as Teva is concerned. So there will be hindrances put by Teva for any other company which want to market that product.
It should be noted that the market size of the carvedilol would be upwards of USD 400 million.
So, war will be continued with other giants……..
Thursday, May 28, 2009
Cinacalcet (Sensipar®): Teva has fired off a suit accusing Amgen Inc. of infringing its patent by making and selling Sensipar®
Teva Pharmaceutical Industries Ltd. has fired off a suit accusing Amgen Inc. of infringing its patent by making and selling Sensipar®, a drug indicated for the treatment of secondary hyperparathyroidism in patients with chronic disease on dialysis.
Teva has filed patent infringement lawsuit against Innovator Company Amgen for Cinacalcet process patent infringement in District court for Eastern district of Pennsylvania.
Teva got following process patent issued on the date of Nov 11, 2008.US7449603 (Plaintiff: Teva): Which covers process for the synthesis of Cincalcet having independent claims 1, 10, 16, 32, 41 and 42
Earlier, M/s Amgen sued Barr (Now, subsidiary of Teva) for filing Para IV on Cinacalcet (Sensipar) 30, 60 and 90 mg tablets in March, 2008. Subsequently, M/s Amgen sued Teva and Barr in Delaware district court in July, 2008.
(The Brigham and Women’s Hospital, NPS Pharmaceuticals and Amgen filed the lawsuit in the U.S. District Court for the District of Delaware after receiving notices that Teva and Barr planned to make generic versions of Sensipar (cinacalcet HCl). Both firms’ generic Sensipar ANDAs contained Paragraph IV certifications on the ’244, ’146, ’068 and ’003 patents. The ’244 patent expires in October 2015, and the others expire in December 2016.
NPS is the sole owner of the ’244 patent and owns the other patents with the Brigham and Women’s Hospital. Amgen holds exclusive licenses for each of the patents.
The three plaintiffs asked the court to order that the effective date of any FDA approval of generic Sensipar be no earlier than the expiration of the patents or any later date of exclusivity.
Based on IMS data, Sensipar had annual sales of approximately $377 million in the U.S for the 12-month period ending in May, according to Barr. The drug was approved in March 2004 by the FDA after a priority review. )
Now, it will be interesting to monitor counter litigation strategy of Teva against M/s Amgen.
So wait and watch!!!!!!
Teva has filed patent infringement lawsuit against Innovator Company Amgen for Cinacalcet process patent infringement in District court for Eastern district of Pennsylvania.
Teva got following process patent issued on the date of Nov 11, 2008.US7449603 (Plaintiff: Teva): Which covers process for the synthesis of Cincalcet having independent claims 1, 10, 16, 32, 41 and 42
Earlier, M/s Amgen sued Barr (Now, subsidiary of Teva) for filing Para IV on Cinacalcet (Sensipar) 30, 60 and 90 mg tablets in March, 2008. Subsequently, M/s Amgen sued Teva and Barr in Delaware district court in July, 2008.
(The Brigham and Women’s Hospital, NPS Pharmaceuticals and Amgen filed the lawsuit in the U.S. District Court for the District of Delaware after receiving notices that Teva and Barr planned to make generic versions of Sensipar (cinacalcet HCl). Both firms’ generic Sensipar ANDAs contained Paragraph IV certifications on the ’244, ’146, ’068 and ’003 patents. The ’244 patent expires in October 2015, and the others expire in December 2016.
NPS is the sole owner of the ’244 patent and owns the other patents with the Brigham and Women’s Hospital. Amgen holds exclusive licenses for each of the patents.
The three plaintiffs asked the court to order that the effective date of any FDA approval of generic Sensipar be no earlier than the expiration of the patents or any later date of exclusivity.
Based on IMS data, Sensipar had annual sales of approximately $377 million in the U.S for the 12-month period ending in May, according to Barr. The drug was approved in March 2004 by the FDA after a priority review. )
Now, it will be interesting to monitor counter litigation strategy of Teva against M/s Amgen.
So wait and watch!!!!!!
Wednesday, May 27, 2009
Hello to all IP guys
Hi
I am Madhav, one of all.
I have masters in organic chemistry and bachelors in Law.
I am engaged in pharmaceutical IP field with a pharmaceutical company.
My fields of interest are chemistry and IP especially of generic pharmaceutical.
I am Madhav, one of all.
I have masters in organic chemistry and bachelors in Law.
I am engaged in pharmaceutical IP field with a pharmaceutical company.
My fields of interest are chemistry and IP especially of generic pharmaceutical.
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