CV Therapeutics Feels the Love

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.

Read/Post Comments (0) | Recommend This Article (5)

Comments from our Foolish Readers

Help us keep this a respectfully Foolish area! This is a place for our readers to discuss, debate, and learn more about the Foolish investing topic you read about above. Help us keep it clean and safe. If you believe a comment is abusive or otherwise violates our Fool's Rules, please report it via the Report this Comment Report this Comment icon found on every comment.

Be the first one to comment on this article.

Compare Brokers

Fool Disclosure

Sponsored Links

Leaked: Apple's Next Smart Device
(Warning, it may shock you)
The secret is out... experts are predicting 458 million of these types of devices will be sold per year. 1 hyper-growth company stands to rake in maximum profit - and it's NOT Apple. Show me Apple's new smart gizmo!

DocumentId: 631713, ~/Articles/ArticleHandler.aspx, 10/22/2016 11:10:13 PM

Report This Comment

Use this area to report a comment that you believe is in violation of the community guidelines. Our team will review the entry and take any appropriate action.

Sending report...

Today's Market

updated 1 day ago Sponsored by:
DOW 18,145.71 -16.64 -0.09%
S&P 500 2,141.16 -0.18 -0.01%
NASD 5,257.40 15.57 0.30%

Create My Watchlist

Go to My Watchlist

You don't seem to be following any stocks yet!

Better investing starts with a watchlist. Now you can create a personalized watchlist and get immediate access to the personalized information you need to make successful investing decisions.

Data delayed up to 5 minutes

Related Tickers

4/17/2009 4:00 PM
CVTX.DL $20.01 Down +0.00 +0.00%
CV Therapeutics CAPS Rating: **
MDCO $36.33 Down -0.18 -0.49%
The Medicines Comp… CAPS Rating: ****
SNY $37.75 Down -0.32 -0.84%
Sanofi CAPS Rating: *****