Global Insight Perspective | |
Significance | Besides Teva, generic drug-makers Sun Pharma (India) and Sandoz (Switzerland) are expected to benefit from the decision. For Teva, this is the third instance of good news to emerge in the past two days, with previous upturns involving Famvir (famciclovir) and Coreg (carvedilol). |
Implications | The decree is a definite setback for Wyeth, which will now look towards obtaining a trial date for the patent litigation against Teva and Sun. Teva is hoping to invalidate Wyeth's patent on Protonix, which runs until 19 July 2010. |
Outlook | The court ruling is likely to tempt Teva to launch the drug at risk in the United States, potentially affecting Wyeth's Protonix-branded sales. Wyeth will look to regroup its resources. It may look to strike a deal with Teva to block the launch in the short term and pursue the lawsuit aggressively. |
The U.S. District Court of New Jersey has denied a preliminary injunction motion by pharmaceutical firms Wyeth and Altana Pharma in a bid to block the marketing of the generic version of their drug Protonix in the United States by Israeli generic drug-maker Teva Pharma, Reuters reports. Teva has received a final approval from the U.S. FDA to market pantaprazole tablets in strengths of 20 mg and 40 mg. The company cited IMS data for FY 2006/07 (ended 30 June) for Protonix brand sales at US$2.5 billion. The Israeli firm is recognised as one of the first to file an Abbreviated New Drug Application (ANDA) with a para IV certification enabling a potential 180-day exclusivity starting from the date of commercial marketing or court decision on the patent litigation. Apart from Teva, two other firms have also received tentative approvals for generic versions of Protonix— Sun Pharma (India) and Sandoz (Switzerland). Teva is believed to have an understanding with Sun for sharing marketing exclusivity of the drug. Interestingly, in a press release, Teva said ”it intends to complete a thorough analysis of the decision before taking the next course of action.” However, this has not stopped speculation over Teva’s planned generic launch, despite risks associated with the ongoing patent litigation between it and the patent holders.
The decision will be a blow for Wyeth, especially in the context of recent setbacks it has suffered in its product pipeline. This includes approval for its hot flashes treatment Pristiq (desvenlafaxine succinate), for which the company is now conducting further trials. Additionally, earlier in August, the company announced the termination of Pristiq for the indication of fibromyalgia—a chronic condition associated with muscle and joint pain and fatigue—after results indicated the drug will not outperform placebos in pain-reduction measures. Other developments include its bifeprunox schizophrenia drug that was deemed not approvable by the U.S. FDA. Furthermore, Wyeth's partner, ViroPharma, said the companies were stopping a clinical trial related to a hepatitis C drug of the medicine due to safety concerns.
Outlook and Implications
The setbacks for Wyeth described above may affect investor confidence in the short term. The company is expected to regroup its resources and assess its medium-term growth strategy, taking into account the potential of some of its blockbuster drugs facing generic competition before patent expiry. Wyeth will also take a look at its discovery drug pipeline to study investments into major therapeutic areas. Although Wyeth has experienced a string of setbacks since the start of the year, the company has benefited from two new drug approvals—Torisel (temsirolimus) for the treatment of advanced renal cell carcinoma and Lybrel (levonorgestrel and ethinyl estradiol), a contraceptive. The ongoing patent litigation concerning Protonix could go either way, but Wyeth will be mindful of the fact that the judge ruling on the preliminary injunction is also expected to preside over the infringement lawsuit. The U.S. firm could consider striking an agreement with Teva and Sun to delay the entry of generics until 2011. Still, the U.S. firm is expected to pursue the litigation wherein the generic drug-maker seeks to invalidate the patents on Protonix.
Teva, on the other hand, will look at launching its generic version ahead of the court decision despite the risks involved. If the decision does not go Teva’s way, it will be expected to pay damages related to loss of sales to Wyeth and Altana. However, the generic drug-maker, along with Sun, is expected to make a decision shortly, and as mentioned earlier, there are other deals that could influence it. The week has been good for Teva, having gaining three favourable product decisions out of four court decrees, with the others being the Famvir decision wherein a court denied a injunction to block marketing of generic copies and the FDA approval of cardiovascular drug carvedilol's ANDA; the one decision that did not favour Teva was related to the Lexapro (escitalopram) patent, which was upheld for Danish firm Lundbeck.
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- United States - Belgium: 13 August 2007: FDA Action Letter Dashes U.S. Approval Hopes for Solvay and Wyeth's Bifeprunox
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