CAMBRIDGE, Mass.--(BUSINESS WIRE)--Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today reported consolidated financial results for the quarter ended June 30, 2011 and provided an update on the launch of INCIVEKTM (telaprevir) tablets and its development programs.
“Upon approval in May, Vertex was prepared to immediately make INCIVEK available to people with hepatitis C, and the first person was able to begin treatment just three days after approval. We are very pleased with the launch of this important new medicine.”
The company reported approximately $75 million in net product revenues for INCIVEK in the second quarter. Vertex ended the quarter with a cash position of approximately $593 million and expects to become a cash flow and earnings positive company for 2012. The company also today provided several updates to its development-stage programs in hepatitis C, cystic fibrosis (CF), rheumatoid arthritis and influenza. The company noted that it plans to submit its New Drug Application (NDA) in the United States and Marketing Authorization Application (MAA) in the European Union for VX-770 in October 2011 for people with CF who have a specific mutation known as G551D. Vertex is also preparing to initiate multiple additional studies in CF, including two studies to evaluate combinations of Vertex’s investigational CF medicines planned for later this year and three additional studies of VX-770 planned to begin in the first half of 2012.
“The second quarter of 2011 was marked by several defining events for our company, including the approval and launch of INCIVEK for the treatment of hepatitis C and the completion of the Phase 3 program for VX-770 in cystic fibrosis,” said Matthew Emmens, Chairman, President and Chief Executive Officer of Vertex.
“Upon approval in May, Vertex was prepared to immediately make INCIVEK available to people with hepatitis C, and the first person was able to begin treatment just three days after approval. We are very pleased with the launch of this important new medicine.”
Recent Clinical Development Progress
Hepatitis C:
Positive Opinion Issued by European Committee for Medicinal Products for Human Use (CHMP) for Telaprevir
Vertex’s collaborator, Tibotec Virco-Virology BVBA, one of the Janssen Pharmaceutical companies of Johnson & Johnson, announced last week that the CHMP adopted a positive opinion to recommend the approval of telaprevir in Europe. The positive opinion will be considered by the European Commission, which has authority to approve new medicines for use throughout the European Union.
Vertex expects that Tibotec will receive a response from the European Commission on their application for approval in the third quarter of 2011. Following marketing authorization approvals, telaprevir will be marketed in the European Union and certain other global territories under the brand name INCIVOTM by the Janssen companies.
Enrollment Complete in Phase 3b Study of Twice-daily Dosing of INCIVEK
Patient enrollment is complete in a Phase 3b clinical trial to evaluate twice-daily dosing of INCIVEK (1,125 mg; BID) compared to three-times-daily dosing of INCIVEK (750 mg; q8h) in combination with Pegasys® (pegylated-interferon alfa-2a) and Copegus® (ribavirin) for people with chronic genotype 1 hepatitis C. Sustained viral response (SVR, or viral cure) data from OPTIMIZE are expected as early as the second half of 2012, which could support the submission of a supplemental NDA for twice-daily dosing of INCIVEK by the end of 2012.
Interim Results from Phase 2 Combination Study of INCIVEK and VX-222
In a separate press release issued earlier this week, Vertex announced results from an interim analysis of the two, four-drug (quad) arms of an ongoing Phase 2 clinical trial evaluating multiple 12- and 24-week response-guided regimens of Vertex’s lead investigational hepatitis C virus polymerase inhibitor, VX-222, dosed in combination with INCIVEK.
The study currently includes four treatment arms. Two of the arms are fully enrolled and are evaluating four-drug combinations of VX-222 (400 mg or 100 mg; BID), INCIVEK (1,125 mg; BID), pegylated-interferon and ribavirin. The third and fourth arms are three-drug treatment arms that are evaluating a twice-daily, all-oral, interferon-free regimen of INCIVEK (1,125 mg), VX-222 (400 mg) and ribavirin in people with genotype 1a or 1b chronic hepatitis C. Vertex expects to complete enrollment in the all-oral arms in the third quarter of 2011.
Data from this study will be submitted for presentation at a medical meeting later this year.
Phase 2 Study of INCIVEK Combination Treatment Evaluating 12-week Regimens on Track to Begin in the Third Quarter
IL28B gene
Vertex plans to begin a Phase 2 trial in the third quarter that will evaluate a treatment regimen of INCIVEK dosed in combination with pegylated-interferon and ribavirin for people who have a specific genetic marker, known as CC, near the IL28B gene. All people in the study will receive 12 total weeks of treatment. The trial is expected to include approximately 400 people with genotype 1 chronic hepatitis C who have not previously been treated. Data from this trial are expected in 2012.
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UPDATE 2-New Vertex hepatitis drug shines out of gate
* EPS loss of $0.85 vs Street view loss $0.96
* Incivek sales $74.5 million in first five weeks
* Shares rise 3.9 percent (Adds analyst comment, expectations, share move)
By Bill Berkrot
NEW YORK, July 28 (Reuters) - Vertex Pharmaceuticals Inc's (VRTX.O) new hepatitis C drug stormed out of the gate, posting sales of nearly $75 million in its first five weeks on the market, and the company's shares rose nearly 4 percent.
Incivek, which is likely to become part of the standard of care for hepatitis C and widely expected to become a multibillion-dollar seller, won U.S. approval in May.
"This is a really, really impressive revenue ramp," Sanford Bernstein analyst Geoffrey Porges said. "You run this trend forward and you get to $200 million in revenue in the third quarter."
Investors who have been shorting the Vertex stock with a view that Incivek was bound to fall shy of sky-high expectations "are going to be in a world of pain tomorrow," Porges predicted.
The company reported a narrower and smaller-than-expected second-quarter net loss as the high cost of launching its first commercial product and higher research and development expenses were offset by strong early demand for the new medicine.
The biotechnology company on Thursday posted a net loss of $174.1 million, or 85 cents per share, compared with a loss of $200 million, or $1 per share, a year ago.
Analysts on average expected a loss of 96 cents per share, according to Thomson Reuters I/B/E/S.
Total revenue for the quarter of $114.4 million, including $74.5 million from Incivek sales, sailed past Wall Street revenue estimates of $54.3 million, according to Thomson Reuters I/B/E/S.
A review of recent analyst expectations for early Incivek sales compiled by ISI Group analyst Mark Schoenebaum found a mean estimate of $31 million.
Incivek is competing with a similar new drug from Merck & Co (MRK.N) called Victrelis. Incivek prescriptions have been outpacing Victrelis at a rate of better than 3-to-1 in the early going, according to data compiled by Wolters Kluwer's inThought unit.
"Physicians are opting for the drug that's easier to use and that's Incivek," Porges said.
Vertex shares rose 3.8 percent to $49.80 in extended trading from their Nasdaq close at $47.98.
Vertex also said it would file an application seeking U.S. approval of its experimental cystic fibrosis drug VX-770 in October. It had previously said it would file sometime in the second half of the year.
(Reporting by Bill Berkrot; Editing by Tim Dobbyn and Gunna Dickson)
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