The News
Ablynx announces that its VWF NANOBODY® programme has been granted orphan drug designation and provides a business update for the first quarter 2009
07/05/2009
GHENT, Belgium, 7 May 2009 - Ablynx [Euronext Brussels: ABLX], a pioneer in the discovery and development of Nanobodies®, a novel class of antibody-derived therapeutic proteins, announced today that its anti-thrombotic Nanobody® programme targeting von Willebrand Factor (vWF), has been granted orphan drug designation by both the U.S. Food and Drug Administration and the European Commission for the treatment of thrombotic thrombocytopenic purpura (TTP), a rare life-threatening blood disorder. Ablynx also provided a business update, in compliance with the EU transparency directive, summarising material events and Ablynx's financial position for the first quarter of 2009.Q1 Highlights
• 127% increase in revenues
• Cash, cash equivalents and available-for-sale financial assets at €111.8 million
• Positive Phase Ib data supporting progression of ALX-0081 (vWF) into Phase II
• vWF Nanobody® programme granted orphan drug designation
During the first quarter, Ablynx announced positive detailed results from the ALX-0081 Phase Ib study. The primary endpoint of this study, demonstrating the complete inhibition of the target protein as measured by a specific biomarker, was reached in December 2008. These positive data support the progression of ALX-0081 into Phase II testing, still on track to commence in Q3 2009.
ALX-0681 is a subcutaneous form of Ablynx's lead anti-thrombotic programme, ALX-0081, and is designed to selectively prevent unwanted thrombus formation in blood vessels. ALX-0681 is being developed for TTP and, if it reaches market, it will benefit from a market exclusivity period of 7 years in the USA and 10 years in Europe, based on the granted orphan drug designation.
Also during the first quarter, both Novartis and Wyeth Pharmaceuticals extended their research collaborations with Ablynx for a further 12 months.
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