Astellas, Daiichi Move Ahead With Factor Xa Programs

Astellas and Daiichi Sankyo both are on track to proceed to Phase III for their respective oral Factor Xa inhibitors, the companies indicated in second quarter earnings presentations on Nov. 7.

Astellas has seen positive data from a Phase IIb 960-patient dose-finding study comparing YM150 to enoxaparin (Sanofi-Aventis' Lovenox) in patients undergoing hip replacement surgery.

"We obtained good results in the primary endpoint," rate of venous thromboembolism and incidence of major bleeding, Astellas CEO Masafumi Nogimori said during a conference call with investors.

The detailed Phase IIb results will be presented at the American Society of Hematology in December, he added.

Daiichi is conducting a Phase IIb study of its anticoagulant DU-176b in prevention of deep vein thrombosis following hip replacement surgery, and expects to make a go or no-go decision regarding Phase III by the end of 2007 or early 2008.

The Japanese pharmas would face considerable competition in the Factor Xa space, with several other candidates further ahead in development.

J&J and Bayer plan to file an NDA in 2008 for their jointly developed rivaroxaban (Xarelto) for VTE prevention after major orthopedic surgery ("The Pink Sheet" DAILY, July 9, 2007).

Following behind are Bristol and Pfizer, which are developing apixaban in Phase III studies for prevention of VTE and prevention of stroke in patients with atrial fibrillation. The firms intend to file for approval of apixaban to prevent VTE in the second half of 2009 ("The Pink Sheet" DAILY, April 26, 2007).

In an interview this summer with "The Pink Sheet" DAILY, Daiichi Sankyo U.S. CEO Joe Pieroni acknowledged the Factor Xa market is "a high-risk area." Despite the potential competition, he characterized DU-176b as a "great opportunity" for the firm ("The Pink Sheet" DAILY, Aug. 6, 2007).

During their respective calls, Astellas and Daiichi also provided updates on other major projects.

Astellas said FDA has pushed back the action date for its candin antifungal agent FK463 (micafungin) three months to January 2008.

The agency also recently moved the user fee date for the anti-arrhythmic agent vernakalant, in development with Cardiome, from October to Jan. 19, 2008, to allow FDA's Cardiovascular and Renal Drugs Advisory Committee to review the drug in December ("The Pink Sheet" DAILY, Aug. 30, 2007).

Astellas said Theravance, its partner on the antibiotic telavancin, is still in discussions with FDA over an "approvable" letter issued in October, in which the agency requested revised labeling or additional or re-analyzed clinical data ("The Pink Sheet" DAILY, Oct. 22, 2007).

In addition to DU-176b, Daiichi's other "high priority" development project, antiplatelet agent DZ-697b, will move into Phase II this year, the company said.

The firm also reported that it has moved its PPAR agonist CS-011 (rivoglitazone) into Phase III for diabetes.

-Brooke McManus

This article is reprinted from "The Pink Sheet" DAILY – November 8, 2007

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