Global Insight Perspective | |
Significance | The launch is a bold move by Teva before the expiry of Protonix's patent in 2010. Teva's management have also revised its 2007 guidance, acknowledging that the development has increased its earnings per share (EPS) range from US$2.34 to US$2.36. |
Implications | This is doubly troublesome for Wyeth on the back of only a second approvable letter from the U.S. FDA regarding its Viviant application, thereby further delaying the launch of the new drug. Even as the negotiations between the two firms were ongoing, the Protonix launch seems to have caught Wyeth off guard. The U.S. company is evaluating its options, which include cutting costs in order to stem some of the losses associated with the generic introduction. |
Outlook | A settlement is still possible between the two, but Teva seems to have the upper hand, as a potential court decree on the issue is only expected in 2009. Wyeth will seek to mitigate and fight off other generic threats for Protonix from firms such as Dr Reddy's and Sun Pharma (both India). |
Teva Launches Generic Protonix
U.S. pharma major Wyeth Pharmaceuticals' Christmas holidays have been soured by news of a setback hitting its bottom line for 2007, and even more so for 2008. Israeli generic giant Teva Pharmaceuticals has announced the launch of generic pantoprazole sodium delayed-release tablets in dosages of 20 mg and 40 mg. The product is indicated for the treatment of erosive oesophagitis associated with gastroesophageal reflux disease (GERD). The branded drug Protonix was licensed to Wyeth by Altana AG (Germany). The Israeli firm was awarded a 180-day marketing exclusivity period. In a conference call held earlier, Teva's management said that the launch is limited to the United States and that the new shipments will not be received well into 2008, the Associated Press reports. The development, however, hit Wyeth's shares, sparking a 3% fall. Wyeth CEO Bernard Poussot was quoted as stating that the company is to lower its EPS estimate for 2008 to reflect the development, and will pursue patent infringement litigation claims for lost profits and other damages against Teva. In fact, in September this year, a U.S. District Court denied Wyeth and Altana's motion for preliminary injunction, which sought to block Teva from launching its generic version. Settlement talks ensued wherein Teva entered into a standstill agreement to hold back on shipments for 30 days.
The Viviant Setback
There was more disconcerting news for Wyeth when it received a second approvable letter from the FDA for its drug application concerning Viviant (bazedoxifene) for the prevention of postmenopausal osteoporosis. The FDA had requested further analyses and discussion relating to incidences of stroke and venous thrombotic events. Furthermore, the regulator has raised some issues concerning data collection and reporting in its approvable letter seeking clarification and additional support documents, the pharma major said. While new trials have not been requested, the FDA's next action will be a review conference with Wyeth in order to address the issues. Wyeth received its first approvable letter for Viviant in April.
Outlook and Implications
The at-risk Protonix generic launch is building up to a potential settlement deal between both the parties. The move by Teva to launch the generic is bold, but it seems to be calculated, with the company potentially assured of covering most legal grounds. Teva will be mindful of the fact that in the event of legal proceedings going against it, it may be required to pay up to three times in damages to Wyeth. Teva is seeking to invalidate Wyeth and Altana's patent and has so far been successful in blocking the preliminary injunction by the patent holders earlier this year. Along with Sun Pharma, which was also slapped with an injunction claim, the generic manufacturers were able to raise sufficient questions on the validity of Altana and Wyeth's patent to preclude a preliminary injunction. In fact, hearings for the patent infringement claim pursued by Wyeth post-generic launch announcement is expected only in the second half of 2008, which means a potential decision will be forthcoming in 2009. Meanwhile, Wyeth is evaluating options to stem some of the losses posed by the generic launch, which recorded sales of US$1.4 billion during the January-September period of 2007. This includes cost cutting in manufacturing, R&D, and other operations. Besides this, Wyeth will also have to brace itself for other at-risk launches from Sun Pharma, which secured FDA approval for pantoprazole, and Dr Reddy's, which received a tentative approval for its generic version of Protonix.
The second approvable letter for bazedoxifene will put the spanner in the works for Wyeth. This year, the company has seen three of its most promising drug candidates unsuccessful in gaining FDA approvals. This includes the Prempro-Premarin replacement, Pristiq, the anti-menopause treatment, and the schizophrenia drug bifeprunox, which has been developed along with Belgium's Solvay.
Related Articles
- United States: 16 November 2007: Wyeth Secures FDA Approval for New Form of Protonix
- United States: 28 September 2007: Tough Challenges Ahead for Wyeth's New CEO
- United States - Israel: 7 September 2007: Teva Scores Double Victory in Two Days as Wyeth Regroups Resources After Protonix Court Decision
- United States - Israel: 3 August 2007: Teva Cleared to Launch Protonix Generic, Pending Court Decision
- United States - Israel: 1 August 2007: Wyeth Defends Protonix from Teva and Sun, Reiterates Pristiq's Approval Chances