In the pharma days of yore, drug approvals were bountiful -- and for some companies, they still are. Last week, CV Therapeutics (Nasdaq: CVTX ) announced its second regulatory thumbs-up this month, after its lead drug Ranexa was essentially approved in the European Union.
Technically, the European Medicines Agency simply issued a "positive opinion" on Ranexa, but those positive opinions always lead to full European drug approval approximately 60 to 90 days later. The EU approved Ranexa as a second-line agent, just like its U.S. label, although CVT hopes to certify Ranexa as a first-line angina treatment later this year.
Ironically, CVT states that this seemingly more restrictive label is actually preferable to a frontline angina label in the EU. A second-line label allows CVT to price Ranexa higher than it would if the drug were approved as a frontline agent, where it would compete more directly against cheaper genericized rivals.
Other cardiovascular and heart-related medicines, including The Medicines Company's (Nasdaq: MDCO ) anticoagulant Angiomax, have struggled to gain traction in Europe. To smooth Ranexa's European rollout, CVT plans to find a local marketing partner -- hopefully one that knows heart drugs, like Astellas, Servier, or Sanofi-Aventis (NYSE: SNY ) . CVT hopes to seal a partnership deal and begin generating EU Ranexa sales (presumably first in the U.K. and Germany) "in the first part of 2009."
On its first-quarter earnings conference call Friday, CVT's CEO Louis Lange described the company's regulatory experiences over the past two weeks as "an amazing fortnight." When you add to this the very nice monetization deal that CVT inked last week for Lexiscan, it appears that the company's been succeeding on all fronts so far this year. We'll find out whether that streak can continue in a few short months, when the FDA decides on CVT's label expansions.