Pfizer is looking to expand its anti-thrombotic market presence into oral, chronic therapy through its acquisition of Schering AG's portfolio of preclinical anti-platelet compounds.

The deal, announced Feb. 2, grants Pfizer worldwide license to develop and market Schering AG's oral reversible adenosine diphosphate receptor antagonists, developed by the German company's Berlex subsidiary.

The ADP antagonists are targeted for use in chronic prophylaxis of arterial thrombosis, as well as prevention of stroke and myocardial infarction in patients at high risk for cardiovascular events, including those with previous stroke or MI, Pfizer said.

Although Pfizer's CV portfolio consists of top-selling drugs such as Lipitor (atorvastatin) for cholesterol and Norvasc (amlodipine) for hypertension, as well as the new atorvastatin/amlodipine combination Caduet , the company's sole marketed anti-thrombotic is the injectable low-molecular-weight heparin Fragmin (dalteparin).

Pfizer also currently does not have any disclosed anti-thrombotics in clinical development. The firm discontinued a Phase II Factor Xa inhibitor for thrombosis in 2003.

A new oral ADP receptor antagonist could provide a significant market opportunity; Sanofi-Aventis/Bristol-Myers Squibb's oral ADP-targeting platelet aggregation inhibitor Plavix (clopidogrel) netted $2.33 bil. worldwide in 2004 (¹ Also see "Sanofi-Aventis' Once-Daily Allegra-D To Launch Mid-Year" - Pink Sheet, 26 January, 2005.).

According to Schering AG, the series of compounds licensed by Pfizer provides a "significant improved therapeutic window" in terms of the unwanted bleeding often associated with platelet inhibitors.

The deal comes as part of Schering AG's efforts to shut down its CV business. The company terminated all cardiovascular R&D in June 2004, with an eye toward outlicensing the more promising agents (including the ADP inhibitor program). A Phase II Factor Xa inhibitor for acute coronary syndromes has yet to be licensed.

According to F-D-C Reports' ² NDA Pipeline , the most advanced oral ADP receptor antagonist in development is Sankyo/Lilly's prasugrel, currently being compared to Plavix in a Phase III trial. AstraZeneca's AZD-6140 is in Phase II.

- Alla Rutstein Bobbitt

Pfizer Looks To Enter Oral Anti-Thrombotic Market Through Schering AG Deal

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