18:57, Monday 10 January 2011
* Plans to file VX-770 in US, Europe (news) in 2H 2011
* Will not seek marketing partner for CF drug
* says ready to launch telaprevir for hepatitis C
NEW YORK (Xetra: A0DKRK – news) , Jan 10 (Reuters) – Vertex Pharmaceuticals inc (NASDAQ: VRTX – news) plans to seek U.S. and European approval for itsexperimental cystic fibrosis drug later this year, ChiefExecutive Matthew Emmens said on Monday.
the company expects pivotal data from a trial of adultcystic fibrosis (CF) patients shortly, with results from twoother key trials expected soon after, Emmens told investors atthe JP Morgan Healthcare conference in San Francisco.
“We will have a lot of data in the next few weeks andmonths,” Emmens said, adding that the company will file itsapplications seeking approval of the CF drug, VX-770, “in theU.S. and Europe in the second half of this year.”
the company does not plan to seek a sales partner forVX-770, which would allow Vertex to claim all future revenuefor the drug.
“We will market VX-770 ourselves,” he told investors.
Emmens believes Vertex will have the first CF drug thattreats the underlying cause of the fatal lung disease ratherthan tackling symptoms, saying VX-770 “makes patient’s lungswork better.”
the average life expectancy is just 37 years for patientswith 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 onits high profile hepatitis C treatment, telaprevir, which hasdemonstrated an ability to cure roughly 75 percent of patientswhen used in combination with current standard drugs.
Sanford Bernstein analyst Geoffrey Porges recently raisedhis likelihood-of-approval rating on telaprevir to 100percent.
Telaprevir is widely expected to become amultibillion-dollar medicine due to its much higher cure ratethan standard drugs alone, and its ability in some cases to cutin 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 atelaprevir sales force. the hepatitis drug will be Vertex’sfirst 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 liverproblems, including cancer and need for transplant, Emmens saidhe does not expect reimbursement roadblocks for telaprevir oncethe 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 afternoontrading on Nasdaq (NASDAQ: news) .
(Reporting by Bill Berkrot; editing by Gunna Dickson)