Achillion Pharmaceuticals (ACHN) has been all over the news in the last week (and up more than 100%), the latest target of takeover fever in small-cap biotech following Merck’s (MRK) purchase of Idenix (IDIX) for its HCV drug candidates. Meanwhile, AbbVie (ABBV) announced on Tuesday that the EMA (European Medicines Association) has validated the company’s Marketing Authorization Applications (MAAs) for its all-oral treatment regimen for chronic genotype 1 hepatitis C virus (HCV) infection. The MAAs are being evaluated under an accelerated assessment, which was granted in May. ABBV believes the regimen, a fixed-dose combination of protease inhibitor ABT-450/ritonavir, NS5A inhibitor ombitasvir/ABT-267, and polymerase inhibitor dasabuvir/ABT-333 with or without ribavirin, could be on the European market as early as Q1 2015. Validation signals the start of the centralized review process at EMA.
In the U.S., the regimen has received both Priority Review and Breakthrough designations. The company developed the regimen in partnership with Enanta Pharmaceuticals (ENTA).
Read more on Enanta in PropThink’s previous coverage, here.
Gilead Sciences (GILD) launched the hepatitis C drug Sovaldi late last year (sales of $2B in its first full quarter on the market), and will receive a decision from the FDA on its own application for an all-oral regimen (Sovaldi plus ledipasvir) in the second half of this year. AbbVie and Enanta bringing competition to the market isn’t news. Wall Street has focused heavily in the last six months on the market split between these and other rival soon-to-be-approved HCV products. Merck (MRK), for instance, bought Idenix (IDIX) early this month in a nearly $4 billion deal to finalize its own, earlier regimen. Although years behind many of its rivals, Merck hopes to differentiate by offering much faster cure rates – less than 2 months compared to Sovaldi’s 12-weeks.
One or more of PropThink’s contributors are long ENTA.
