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Natco Pharma tightened the belt to fight against Teva's citizen petition for Glatiramer Acetate

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.

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.

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.

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.

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.