Vertex Telaprevir Starting FDA Approval This Summ

Vertex Telaprevir Starting FDA Approval This Summer

Vertex to begin telaprevir application this summer
* To apply to FDA via "rolling submission"
Analysts expect the drug to be approved in 2011 and provide a significant advance in the treatment of the serious liver disease, which is the biggest cause of liver transplants in the United States.


NEW YORK, April 21 (Reuters) - Vertex Pharmaceuticals Inc (VRTX.O) said it will begin the process this summer of seeking U.S. approval for telaprevir, its eagerly anticipated experimental treatment for hepatitis C.

Vertex said on Wednesday that the application would be done through a "rolling submission" -- meaning paperwork supporting approval will be delivered to the U.S. Food and Drug Administration in installments -- a process that typically ensures a swifter regulatory review.

Vertex said it expects to complete the marketing application in the second half of 2010, in line with earlier plans.

Analysts expect the drug to be approved in 2011 and provide a significant advance in the treatment of the serious liver disease, which is the biggest cause of liver transplants in the United States.

Vertex said it lost $165 million, or 83 cents per share, in the first quarter. That compared with a loss of $163 million, or $1.04 per share, in the year-earlier period.

Excluding special items, Vertex lost 70 cents per share.

The company, based in Cambridge, Massachusetts, had revenue of $22.4 million in the quarter, below Wall Street expectations of about $30 million.

Vertex is developing telaprevir in partnership with Johnson & Johnson (JNJ.N), which has European rights to the medicine.

PiperJaffray analyst Edward Tenthoff has forecast peak annual U.S. telaprevir sales of $3.9 billion in 2013, putting it squarely in the category of a major blockbuster.

Merck is developing a similar treatment, a so-called protease inhibitor, which analysts believe also has blockbuster sales potential even though it will likely reach the market long after telaprevir.