12:00 AM
Dec 04, 2006
 |  BioCentury  |  Product Development

Unmet, but maybe unattractive

Cardiovascular company Speedel Holding Ltd. is best known for its renin inhibitor Tekturna aliskiren, which is awaiting approval in the U.S. and Europe. The company has three other products in mid- to late-stage clinical development. At its R&D day last week, it disclosed that one could be dropped for market-related reasons.

The second thoughts relate to SPP200 pegmusirudin, a direct thrombin inhibitor that has completed some Phase II testing to prevent vascular graft occlusion (VGO) in chronic hemodialysis patients. Speedel (SWX:SPPN, Basel, Switzerland) said it plans to decide in the first quarter whether to move SPP200 forward or terminate it after finishing discussions with FDA, payers and distributors.

No products are approved to prevent VGO, although unfractionated heparin (UFH) is used off label. And studies estimate the annual rate of VGO at 30-65% in hemodialysis patients receiving UFH, according to Chris Jensen, head of scientific affairs at SPPN.

Nevertheless, three questions are hanging over SPP200's future: whether it might be too expensive to develop, the likelihood that Medicare will reimburse for the product at an acceptable level and whether dialysis centers are likely to...

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