IMPAX Laboratories, Inc. announced that the U.S. Food and Drug Administration (FDA) granted final approval of the Company’s Abbreviated New Drug Application (ANDA) for a generic version of Wellbutrin® XL 150 mg Extended-release Tablets on Wednesday, November 26, 2008. GlaxoSmithKline markets Wellbutrin® XL for the management of depression. IMPAX’s Global Pharmaceuticals division launched the product immediately following approval.

According to Wolters Kluwer Health, U.S. sales of Wellbutrin® XL 150 mg tablets were approximately $950 million in the 12 months ended September 2008.

About IMPAX Laboratories, Inc.
IMPAX Laboratories, Inc. is a technology based specialty pharmaceutical company applying its formulation expertise and drug delivery technology to the development of controlled-release and specialty generics in addition to the development of branded products. IMPAX markets its generic products through its Global Pharmaceuticals division and markets its branded products through the IMPAX Pharmaceuticals division. Additionally, where strategically appropriate, IMPAX has developed marketing partnerships to fully leverage its technology platform. IMPAX Laboratories is headquartered in Hayward, California, and has a full range of capabilities in its HaywardPhiladelphia facilities. For more information, please visit the Company’s Web site at: www.impaxlabs.com.

“Safe Harbor” statement under the Private Securities Litigation Reform Act of 1995:

To the extent any statements made in this news release contain information that is not historical, these statements are forward-looking in nature and express the beliefs and expectations of management. Such statements are based on current expectations and involve a number of known and unknown risks and uncertainties that could cause IMPAX’s future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Such risks and uncertainties include, but are not limited to, possible adverse effects resulting from the delisting of and suspension of trading in IMPAX’s stock, IMPAX’s failure to file any periodic reports subsequent to its quarterly report on Form 10-Q for the quarter ended September 30, 2004, the SEC’s revocation of the registration of IMPAX’s common stock under section 12 of the Securities Exchange Act of 1934, the actual time that will be required to, file a registration statement on Form 10 with respect to such stock, IMPAX’s ability to obtain sufficient capital to fund its operations, the difficulty of predicting FDA filings and approvals, consumer acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, IMPAX’s ability to successfully develop and commercialize pharmaceutical products, IMPAX’s reliance on key strategic alliances, the uncertainty of patent litigation, the availability of raw materials, the regulatory environment, dependence on patent and other protection for innovative products, exposure to product liability claims, fluctuations in operating results and other risks detailed from time to time in IMPAX’s filings with the Securities and Exchange Commission. Forward-looking statements speak only as to the date on which they are made, and IMPAX undertakes no obligation to update publicly or revise any forward-looking statement, regardless of whether new information becomes available, future developments occur or otherwise.

Source: Business Wire

Popularity: 13% [?]

AstraZeneca stated Thursday that it was granted a temporary restraining order by a US court to halt sales of Teva’s generic version of the drugmaker’s Pulmicort Respules asthma treatment. Under the ruling, AstraZeneca and partner Par Pharmaceuticals will also suspend distribution of AstraZeneca’s own authorised generic form of the product.

The move follows Teva’s announcement on November 19 that the FDA approved its generic version of AstraZeneca’s drug and that shipment of the product had begun. The temporary restraining order is valid until further court order, and a preliminary injunction hearing regarding the issue is scheduled to start on November 25, according to the Anglo-Swedish drugmaker. AstraZeneca indicated that the marketing and distribution of branded Pulmicort Respules is not affected. The company stated that it has “full confidence” in the strength of its intellectual-property rights protecting the product and will continue to “vigorously defend and enforce” its intellectual property.

Analysts at Panmure Gordon commented that “we regard any delay to the launch of generic Pulmicort Respules as positive, but remain watchful of the situation ahead of the preliminary injunction hearing.” AstraZeneca and Teva are currently involved in patent litigation in the US over the drug, with a trial scheduled for January 12, 2009.

Source: FirstWord

Popularity: 15% [?]

This is what it’s come to: Pfizer, the flagship of the American brand-name drug industry, is moving into generics in a big way.

Yes, the company’s Greenstone unit has quietly been turning out generic versions of some of Pfizer’s own off-patent products for a while. But now the company wants to be a bigger player in the rough-and-tumble, low-margins generics business — and plans to start selling generic versions of competitors’ off-patent drugs, Dow Jones Newswires reports.

“We were kind of looking at the off-patent market like ‘OK, it’s horrible and margins are low,’ ” David Simmons, a Pfizer exec, told DJ Newswires, describing the company’s traditional attitude toward the sector.

But the worldwide generics market is set to balloon to $520 billion in 2012, up from about $270 billion now, Pfizer estimates. And generics growth is coming not only because payers are trying to slow the rise in health costs, but also because lots of megablockbusters (including Pfizer’s Lipitor) are losing patent protection.

So Pfizer, which now holds about 4% of the fragmented global generics market, is trying to get a bigger piece of the growing generics pie. Much of that responsibility will fall to Simmons, who is running Pfizer’s new “Established Products” unit.

As far as we can tell, “Established” is basically a euphemism for old — the unit sells products such as amlodipine, the off-patent hypertension drug that was sold under the brand name Norvasc before it lost patent protection; and Ibupirac, a version of ibuprofen sold primarily in Argentina.

It sounds like the company plans to pick its spots. Pfizer is looking at niche products such as certain hard-to-make injectable drugs, as well as new formulations, such as a form of Xanax that dissolves under the tongue, DJ Newswires reports.

The prevailing winds of the drug industry are blowing other drug makers in the same direction. GlaxoSmithKline recently cut a deal with a South African manufacturer to sell off-patent drugs in the developing world. A deal is in the works for Japan’s Daiichi Sankyo to buy a majority stake in generics giant Ranbaxy. And Novartis’ Sandoz unit has been selling generics since before it was all the rage.

Source: The Wall Street Journal

Popularity: 24% [?]

Pfizer and GlaxoSmithKline—the number one and two drug companies by pharmaceutical sales—are reshaping their R&D organizations, with job cuts likely.

Pfizer’s biannual drug pipeline update highlighted candidates in Phase III development, most of which are in its high-priority research areas of oncology, pain, inflammation, diabetes, schizophrenia, and Alzheimer’s disease.

Separately, Martin Mackay, president of Pfizer global R&D, told managers in an internal memo that Pfizer is ending research in anemia, bone health, obesity, gastrointestinal disease, and some cardiovascular diseases. “We are investing in the most promising disease areas, where there is strong unmet medical need, favorable markets, and an opportunity to advance medical science,” Mackay said. Read the full story

Popularity: 29% [?]

SAN ANTONIO, TX– Vanguard Pharmaceutical Corp. (PINKSHEETS: VGPH), a company providing the market with affordable and safe generic medicines, has signed an exclusive distribution agreement with Mac Mohan Pharma Ltd., a leading anticancer manufacturer in India. Vanguard has been granted Mac Mohan’s exclusive importer and distributor in Peru, Brazil, Paraguay, and Cameroon. Read the full story

Popularity: 17% [?]

Decision Resources, one of the world’s leading research and advisory firms for pharmaceutical and healthcare issues, finds that GlaxoSmithKline’s Lamictal (lamotrigine) and generic lamotrigine will continue to dominate the epilepsy drug market through 2017, aided in part by the launch of an extended-release formulation of Lamictal in the United States. Lamotrigine is the current market leader in epilepsy, owing to its use as a preferred first-line adjunctive therapy, Read the full story

Popularity: 47% [?]

Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) and Kowa Company, Ltd. today announced that they have signed a definitive agreement to establish a leading generic pharmaceutical company in Japan. The company, Teva-Kowa Pharma Co., Ltd. will seek to leverage the marketing, research and development, manufacturing and distribution capabilities of each company to become a broad based supplier of high quality generic pharmaceutical products for the Japanese market and reach sales of $1 billion in 2015. Each company will have a 50% stake in Teva-Kowa Pharma, which will become operational in 2009.

“Combining Kowa’s knowledge of and established reputation within the Japanese market with Teva’s global leadership and expertise in generics should enable us to maximize the opportunity available in this important growth market,” said Shlomo Yanai, Teva’s President and Chief Executive Officer. “Our objective is to provide the Japanese generic market, which is expected to double in volume in the next 5 years, with high quality and affordable pharmaceuticals, supporting the government’s stated objective of increasing generic penetration. This strategic partnership is an important milestone in executing Teva’s five year strategic plan, as it provides a robust platform for Teva to further strengthen its global leadership and establishes a strong presence in the Japanese market.”

Yoshihiro Miwa, Kowa’s President and Chief Executive Officer, added, “I am delighted to be able to report this agreement with Teva, the world’s top generic pharmaceutical company, which will enable us to offer high quality generic pharmaceutical products to patients in Japan. The strategic alliance between Kowa and Teva will leverage both companies’ respective strengths to meet the needs of medical institutions and patients for high quality and cost-effective generic pharmaceuticals. For Kowa, this agreement will enhance our efforts to establish a strong management platform to support diversified business operations in the prescription, over-the-counter and generic pharmaceutical products areas. By combining our respective capabilities in a new company, Kowa and Teva are creating a unique business model and a robust base in Japan’s generic pharmaceuticals market.”

Japan is the second largest pharmaceutical market in the world, valued at approximately $80 billion (1$=100 JPY). Generics represent only 5.7% in value (approximately $4.6 billion) or 16.9% in volume in 2006 according to the IMS and the data from the Japanese Generics Manufacturing Association. In 2007, the Ministry of Finance announced a plan to double generic utilization to 30% by 2012.

About Teva
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 pharmaceutical companies in the world and is the world’s leading generic pharmaceutical company. The Company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients, as well as animal health pharmaceutical products. Over 80 percent of Teva’s sales are in North America and Europe.

About Kowa
Kowa Company, Ltd. started operations as a cotton wholesaler in Nagoya in 1894 and has currently grown into a multinational Japanese company with approximately 50 affiliated companies. Kowa actively engages in various businesses from two main aspects: Merchandise which deals with daily commodities like textile goods, machinery, building materials and chemical products, and Maker which manufactures and sells innovative pharmaceutical products, OTC products, consumer healthcare products, electro-optical apparatus and information and communication systems. For pharmaceutical business, Kowa is responsible for sales and marketing of innovative drugs and focuses on promoting cardiovascular drugs, such as treatment drug for hypercholesterolemia “Livalo tablet” and hypertension drug “Olmetec tablet” through its wholly owned subsidiary, Kowa Pharmaceutical Co. Ltd. In addition, Kowa has focused on lifestyle diseases (arteriosclerosis, kidney disorder and diabetes) as main strategic therapeutic area for research and development. Kowa is also responsible for sales and marketing of OTC and consumer healthcare products such as CabaginKOWA, VantelinKOWA, Q&PKOWA etc through another wholly owned subsidiary, Kowa Shinyaku Co. Ltd with the concepts of conditioning medication/self-care medication for the contribution of maintaining and controlling health condition of people. Paid-in Capital 3,840 million yen, Annual Sales, 221.4 billion yen (Consolidated in FY2007), Total number of employee 4,432 (As of end of March 2008 (consolidated).

Source: Teva Pharmaceutical Industries Ltd.

Popularity: 43% [?]