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.

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 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.

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.

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.

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!!!!!!!!!!!