01/10/2011
Exciting NEWS VX-770!
  

UPDATE 1-Vertex to apply for approval of CF drug in 2011

* Plans to file VX-770 in US, Europe in 2H 2011

* Will not seek marketing partner for CF drug

* Says ready to launch telaprevir for hepatitis C

By Bill Berkrot

NEW YORK, Jan 10 (Reuters) - Vertex Pharmaceuticals Inc (VRTX.O) plans to seek U.S. and European approval for its experimental cystic fibrosis drug later this year, Chief Executive Matthew Emmens said on Monday.

The company expects pivotal data from a trial of adult cystic fibrosis (CF) patients shortly, with results from two other key trials expected soon after, Emmens told investors at the JP Morgan Healthcare conference in San Francisco.

"We will have a lot of data in the next few weeks and months," Emmens said, adding that the company will file its applications seeking approval of the CF drug, VX-770, "in the U.S. and Europe in the second half of this year."

The company does not plan to seek a sales partner for VX-770, which would allow Vertex to claim all future revenue for the drug.

"We will market VX-770 ourselves," he told investors.

Emmens believes Vertex will have the first CF drug that treats the underlying cause of the fatal lung disease rather than tackling symptoms, saying VX-770 "makes patient's lungs work better."

The average life expectancy is just 37 years for patients with CF, a disease in which damage to the lungs progresses, severely limiting the ability to breathe.

Meanwhile, Vertex is awaiting a U.S. approval decision on its high profile hepatitis C treatment, telaprevir, which has demonstrated an ability to cure roughly 75 percent of patients when used in combination with current standard drugs.

Sanford Bernstein analyst Geoffrey Porges recently raised his likelihood-of-approval rating on telaprevir to 100 percent.

Telaprevir is widely expected to become a multibillion-dollar medicine due to its much higher cure rate than standard drugs alone, and its ability in some cases to cut in half the current 48-week treatment duration.

"We are ready to launch this product," Emmens declared, saying Vertex was about three quarters done with hiring a telaprevir sales force. The hepatitis drug will be Vertex's first commercial product.

Emmens said Vertex had about $1 billion in cash on hand, "enough to get us through the launch of telaprevir."

 

With hepatitis C a leading cause of more serious liver problems, including cancer and need for transplant, Emmens said he does not expect reimbursement roadblocks for telaprevir once the drug is approved.

"Managed care will not only welcome that drug," he said, "but it will save them money in the long term."

Vertex shares were up 27 cents at $36.42 in early afternoon trading on Nasdaq.

(Reporting by Bill Berkrot; editing by Gunna Dickson)