Astellas announced Thursday that a US district court dismissed the company’s request for a preliminary injunction to stop the FDA from approving generic versions of oral immunosuppressant drugs. The drugmaker, which markets Prograf (tacrolimus) to prevent organ rejection in transplant patients, said it “is disappointed in the court’s decision and is currently evaluating its next course of action.”

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The Japanese company made the complaint to the court earlier this week after the agency denied its citizen petition requesting that generic versions of immunosuppressant drugs undergo bioequivalence studies in organ-transplant patients as a requirement for approval. The petition had also asked that the agency implement certain labelling changes related to prescribing procedures for substitute products.

Shares in Astellas have fallen around 8 percent since Novartis’ Sandoz unit launched the first generic version of Prograf in the US on August 11.

Source: FirstWord

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The FDA granted tentative approval to Mylan’s generic version of one dosage of Merck & Co.’s Singulair (montelukast), the generic drugmaker reported.

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US sales of the branded product were $2.6 billion in the 12-month period that ended March 31, according to Mylan. The drug, a treatment for allergies and asthma, is expected to lose patent protection in 2012.

Source: FirstWord

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AstraZeneca announced Thursday that a US district court granted its request for a temporary restraining order barring Apotex from marketing a generic version of Pulmicort Respules (budesonide). The order will remain in effect until at least April 27, when the presiding judge will begin a hearing into whether Apotex’s version of the asthma medication should stay off the market until a patent infringement lawsuit involving the drug is resolved.

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Earlier this month, AstraZeneca filed a motion with the US District Court for the District of New Jersey, seeking to block Apotex’s generic product. AstraZeneca stated that patents for Pulmicort Respules continue until 2018, with paediatric exclusivity until 2019.

Source: FirstWord

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Sanofi-aventis announced Thursday that it acquired Mexican generic drugmaker Laboratorios Kendrick for an undisclosed sum. The company said the takeover is intended “to accelerate sales growth and further extend its pharmaceutical portfolio in emerging markets.”

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Kendrick, which is estimated to hold 15 percent of the Mexican generic market, has a portfolio that incorporates more than 50 active ingredients in the therapeutic areas of analgesics, antihistamines, anti-infectives, antirheumatics, cardiovascular and central nervous system drugs. The generic company generated sales of approximately 26 million euros ($35 million) last year, sanofi-aventis noted.

In addition, sanofi-aventis is said to have signed a letter of intent to acquire Brazilian drugmaker Medley for around $660 million, according to a newspaper report in that country late last month. However sanofi-aventis spokesperson Jean-Marc Podvin declined to comment on the matter.

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Bristol-Myers Squibb is paying $2.1 million to end the FTC probe into its negotiations to delay generic competition for Plavix, the company’s blockbuster blood thinner. Those 2006 negotiations were something of a debacle — a generics maker wound up briefly flooding the market with generic Plavix, and the Bristol-Myers CEO left the company. Here’s a story from today’s WSJ.

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More broadly, the settlement is a reminder that regulators really don’t like it when pharma companies look to cut these sorts of deals with generics manufacturers.

Earlier this year, the FTC sued a company called Solvay over a generics deal regarding AndroGel, a testosterone product. (The company said the deal was lawful and would lead to earlier generic competition.) And last year, the FTC sued Cephalon in a similar matter involving the anti-drowsiness drug Provigil. (Cephalon says it followed the law.)

Look for these kind of suits to continue. Christine Varney, President Obama’s nominee to be the chief antitrust enforcer at the Justice Department, said earlier this month that she supports the FTC’s challenges to the so-called pay-for-delay generics deals. Just yesterday, a Senate panel approved Varney’s nomination.

Source: The Wall Street Journal

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According to a report in Handelsblatt, which cited the president of Pfizer’s established products unit, David Simmons, the company is considering acquisitions and licensing deals to further bolster its presence in the generic drug market.

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Simmons said Thursday that “we want to expand our product portfolio in this area,” and he noted that the company’s recent agreement with Aurobindo to licence generic products in the US and Europe will not be adequate for Pfizer to accomplish its strategic growth goals.

Simmons declined to comment on whether the company may attempt to buy Actavis or Ratiopharm.

Source: FirstWord

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Another big drug company is fighting with a generics maker over how soon a top-selling drug can go generic.

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Merck and Israeli generics maker Teva have a date set for Monday in federal court in Trenton, N.J., over the patent protecting the allergy and asthma drug Singulair. Teva is challenging the validity of Singulair’s patent, which expires in 2012, Dow Jones Newswires reports.

The stakes are high for Merck. The company’s top-selling drug, Singulair brought in $4.3 billion in sales in 2008, or 18% of total sales. But the drug’s sales slipped 3% in the fourth quarter, and sales of another major product, the blockbuster cervical-cancer vaccine Gardasil, have fallen too.

Some analysts told Dow Jones they think Merck has the stronger case. It’s also possible the companies could settle.

One thing is clear: Teva can be a tough competitor. The company surprised Wyeth with a launch of a generic version heartburn drug Protonix and briefly came to market with a generic version of AstraZeneca’s Pulmicort Respules asthma treatment.

Source: The Wall Street Journal

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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.

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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

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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.

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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

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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

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