Gilead Gets the Payoff

Gilead Sciences (Nasdaq: GILD  )  received good news on Friday when the FDA approved its pulmonary arterial hypertension (PAH) treatment, Letairis (formerly ambrisentan), for marketing.

The success Gilead has had with Letairis at the FDA sharply contrasts with a rival compound by Encysive Pharmaceuticals (Nasdaq: ENCY  ) that failed to gain regulatory approval on Friday. With this head start on Thelin, if it can even get approved, Gilead now only has to face U.S. competition from Actelion's Tracleer in the oral endothelin receptor antagonist market.  

How well ambrisentan competes with Tracleer is still up in the air. Worldwide Tracleer sales were more than $700 million last year. Ambrisentan was approved to treat earlier-stage PAH patients with what is known as the World Health Organization class II or III symptoms, whereas Tracleer is approved to treat patients with the worse class III and IV symptoms (and is in testing for early-stage sufferers as well).

Ambrisentan may have some important safety advantages over Tracleer, with a lower incidence of liver-related adverse events in its clinical studies. But the drug also suffers from a very strict black box warning. Tracleer also carries a black box warning, and requires a patient access program.

After paying $2.5 billion to acquire Myogen last year, Gilead will now start to reap the rewards from this buyout, with sales of Letairis set to begin next week. With the release of positive clinical trial results for several pipeline compounds in the past two months and now the Letairis regulatory success, Gilead has had a strong first half of 2007.

Encysive is a Rule Breakers recommendation. You can check out all our recommendations as well as get access to our message boards and exclusive content with a 30-day free trial.

Fool contributor Brian Lawler does not own shares of any company mentioned in this article. The Fool has a disclosure policy.

Read/Post Comments (0) | Recommend This Article (6)

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: 529742, ~/Articles/ArticleHandler.aspx, 10/24/2016 8:45:12 AM

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 2 days 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 0.00 0.00%

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

10/21/2016 4:00 PM
GILD $74.29 Down +0.00 +0.00%
Gilead Sciences CAPS Rating: *****