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HCV drug Telaprevir......anticipate accelerated approval by May 23rd.....A target review date of May 23, 2011
In the report, Piper Jaffray states, "Vertex ended 2010 with $1.03 billion in cash, sufficient to launch blockbuster HCV drug Telaprevir and reach cash flow profitability in 4Q:11. We anticipate accelerated approval by May 23rd PDUFA date and forecast rapid Telaprevir adoption as U.S. hepatologists treat motivated HCV patients. We anticipate Vertex will either buy or partner for additional HCV drugs to build out its combination is clear that telaprevir launch preparations are well underway (sales force training has begun)
"Vertex enters 2011 in a strong financial position as we prepare for the planned launch of telaprevir," said Matthew Emmens, Chairman, President and Chief Executive Officer of Vertex Pharmaceuticals. "Our primary focus remains on making telaprevir available to people with hepatitis C as quickly as possible, and we are encouraged that regulatory agencies in the U.S., Europe and Canada will each provide an accelerated review of telaprevir, with the first approval decision currently expected in the U.S. in May of this year.
In a press release issued on January 9, 2011, Vertex provided a comprehensive business update, including planned clinical development milestones for 2011. Vertex today provided the following additional updates, reflecting recent progress in its development programs:
* Accelerated Reviews of Telaprevir Application from U.S., E.U. and Canadian Regulatory Authorities
· In January, the U.S. FDA accepted for filing Vertex's New Drug Application (NDA) for telaprevir and granted the company's request for six-month Priority Review. A target review date of May 23, 2011 was set under the Prescription Drug User Fee Act (PDUFA) for the FDA's approval decision. Also in January, Vertex completed a New Drug Submission (NDS) to the Therapeutic Product Directorate (TPD) of Health Canada seeking approval for telaprevir in Canada. Telaprevir was also granted Priority Review in Canada.
· Vertex today announced that the European Medicines Agency (EMA) has notified our collaborator Janssen that its telaprevir Marketing Authorisation Application (MAA) was valid and acceptable for review. The EMA previously accepted the telaprevir MAA for accelerated assessment, which is granted to new medicines of major public health interest.
* Continued Progress in Phase 2 Study of Telaprevir and VX-222
· Vertex is conducting a Phase 2 clinical trial evaluating multiple 12-week and 24-week, response-guided regimens of telaprevir, Vertex's lead medicine in development for hepatitis C, dosed in combination with its hepatitis C virus polymerase inhibitor VX-222. The study currently includes three treatment arms. Two of the treatment arms are fully enrolled and are evaluating four-drug combinations of telaprevir (1,125 mg; BID), VX-222 (400 mg or 100 mg; BID), Pegasys® (pegylated-interferon alfa-2a) and Copegus® (ribavirin). All of the people in the four-drug treatment arms will have reached the 12-week timepoint in the study by the end of February.
· On-treatment data from the study are expected in the first quarter of 2011 from both of the four-drug treatment arms.
· In addition, enrollment is expected to begin in the first quarter of 2011 for a three-drug treatment arm of this study designed to evaluate the potential of an all-oral, interferon-free regimen of telaprevir (1,125 mg), VX-222 (400 mg) and ribavirin dosed twice daily.
Vertex books bigger 4Q loss on research costs
Vertex Pharmaceuticals Inc. reported a larger fourth-quarter loss on Thursday as it spent more money to develop its hepatitis C drug candidate telaprevir, along with a potential cystic fibrosis treatment and other drugs.
With its research and development costs up 25 percent, Vertex said it lost $180.4 million, or 90 cents per share, in the last three months of 2010. A year ago it booked a smaller loss of $158.6 million, or 86 cents per share. Revenue nearly doubled to $65.5 million from $33.9 million.
Analysts had expected a loss of 92 cents per share and $38.8 million in revenue, according to FactSet.
Vertex has applied for marketing approval of telaprevir in the U.S., Europe, and Canada. The Food and Drug Administration is expected to make a decision by May 23. Vertex is also waiting for data from a late-stage clinical trial of VX-770, its cystic fibrosis drug, and running a mid-stage clinical trial of a regimen that combines telaprevir with another one of its hepatitis C drug candidates, VX-222. The company expects results from that study later in the first quarter.
Vertex said it plans to file for approval of VX-770 in the U.S. and Europe in the second half of 2011.
The company said its research and development costs climbed to $168.9 million from $135.2 million a year ago. However revenue from partnerships more than doubled to $57.1 million from $25.5 million. Royalty revenue was unchanged at $8.4 million.
For the full year, Vertex lost $754.6 million, or $3.77 per share, compared with a loss of $642.2 million, or $3.71 per share, in 2009. Revenue grew 41 percent, to $143.4 million from $101.9 million.
"We believe that our financial position will support our key business objectives through 2012, at which time we expect to begin generating earnings as a cashflow positive company," said Matthew Emmens, chairman, president and CEO, in a statement.
Shares of Vertex fell 17 cents to close at $38.80 on Thursday.
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