Vertex drug aids lung function

The pharmaceutical said a phase three study on a cystic fibrosis drug candidate improved lung function in children with a particular genetic mutation, backing similar results in older patients. The study is ongoing with updated results expected after the 48-week mark. Vertex (VRTX) said it's on track to seek regulatory approval in the U.S. and Europe in the second half of 2011. The drug would join the company's eagerly anticipated hepatitis C drug. Shares rose 3.3% to 48.90

Vertex's New Cystic Fibrosis Drug Treats the Cause, Not Just the Symptoms See full article from DailyFinance: http://srph.it/fLuDUB

Vertex Pharmaceutical (VRTX) shares soared 15% Wednesday as Wall Street cheered the results of a late-stage study of its new cystic fibrosis drug, an experimental treatment that targets the underlying cause of the disease rather than just its symptoms.

In patients with cystic fibrosis, a defective gene and the protein it creates cause the body to produce unusually thick, sticky mucus that builds up in the lungs and the pancreas, leading to life-threatening lung infections and an impairment of the body's ability to properly break down and absorb food.

The drug, VX-770, is a pill that targets the defective protein. It showed sustained improvements in lung function of over 10% in patients with a specific gene mutation. The caveat, though, is that the specific mutation being targeted by the drug, G551D, affects just 4% of the CF population. But it's possible that the results of this trial will provide a basis for the use of VX-770 to treat other mutations. VX-770 is currently being tested in combination with another drug, VX-809, in people with two copies of the more common Delta F508 mutation.

In the trial, patients also showed improvement across all key secondary goals of the study, Vertex said, including decreased pulmonary and respiratory symptoms and weight gain (seven pounds on average). In addition, average sweat chloride (salt) levels, a key clinical indicator of CF, dropped toward normal levels, indicating that the drug is having an effect on the underlying defect.

VX-770 helps "open the gate" at the cell surface -- enabling the protein to pass through, as it would in healthy cells. This restores a proper flow of salt and fluids on the surface of the lung, the company explained.

"Treating the underlying cause of cystic fibrosis with VX-770 led to clinical improvements that were far beyond our expectations, providing support for an entirely new approach to the treatment of this disease," said Peter Mueller, executive VP of global research and development, and chief scientific officer for Vertex.

Vertex CEO Unfazed By Hepatitis-C Drug Matchup Against Merck

Vertex Pharmaceuticals Inc. (VRTX) Chief Executive Matthew Emmens is ready to go toe-to-toe with one of the world's biggest pharmaceutical companies, Merck & Co. (MRK). Cambridge, Mass., based Vertex has filed for Food and Drug Administration approval of telaprevir, which has shown a sharp increase in cure rates of hepatitis C in multiple studies when added to current treatments. Merck also has shown success with its similar drug, boceprevir, and has filed for approval with expedited review granted in both the U.S. and Europe

Vertex Pharmaceuticals Announces Webcast of its Presentation at the Credit Suisse Annual Healthcare Conference

Vertex Pharmaceuticals Incorporated today announced that it will webcast its presentation at the Credit Suisse Annual Healthcare Conference on Thursday, November 11, 2010 at 1:30 p.m. MST (3:30 p.m. EST).

The presentation will be webcast live and may be accessed from 'Events & Presentations' on the home page of Vertex's website at A replay of the webcast will also be available on the Company's website for two weeks following the presentation. To ensure a timely connection, it is recommended that users register at least 15 minutes prior to the scheduled webcast.

About Vertex

Vertex Pharmaceuticals Incorporated is a global biotechnology company committed to the discovery and development of breakthrough small molecule drugs for serious diseases. The Company's strategy is to commercialize its products both independently and in collaboration with major pharmaceutical companies. Vertex's product pipeline is focused on viral diseases, cystic fibrosis, inflammation, autoimmune diseases, epilepsy, cancer, and pain. Vertex co-discovered the HIV protease inhibitor, Lexiva, with GlaxoSmithKline.

Vertex Pharmaceuticals and Mitsubishi Tanabe Pharma Corporation Amend Agreement to Develop and Commercialize Telaprevir in Asia

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) and Mitsubishi Tanabe Pharma Corporation today amended their agreement for the development and commercialization of telaprevir for the treatment of hepatitis C virus (HCV) infection in Japan and other countries in the Far East. Telaprevir is an HCV protease inhibitor currently in Phase 3 clinical trials in Japan, as well as in the United States and in Europe. Under the terms of the amended agreement, Vertex will receive $105 million following signing, and will be eligible to receive further milestones upon approval and commercialization in Japan.

The previous agreement signed in 2004 between Vertex and Mitsubishi Tanabe provided certain development and commercial rights to telaprevir as a potential monotherapy for the treatment of Hepatitis C. The amended agreement announced today provides a fully-paid license to commercialize telaprevir as part of a combination regimen with interferon and ribavirin to treat hepatitis C in Japan and the Far East. Vertex retains exclusive development and commercial rights to telaprevir in North America. Janssen Pharmaceutica, an affiliate of Johnson & Johnson, holds development and commercial rights to telaprevir in Europe, South America, Australia, and the Middle East.

"This amendment recognizes the value of telaprevir-based combination therapy as a potential major advance in the treatment of hepatitis C in Japan and Asian countries, aligning the telaprevir development program on a global basis,” said Kurt Graves, Vertex Executive Vice President, Chief Commercial Officer and Head of Corporate Development. "Moreover, following this amendment, the cash received strengthens our corporate financial position during an important period of investment and growth as we advance two Phase 3 programs in hepatitis C and cystic fibrosis.”

Terms of the Agreement

Under the amended development and commercialization agreement, Mitsubishi Tanabe will receive a license in its territory for telaprevir-based combination therapy with interferon and ribavirin, as well as rights to manufacture telaprevir for sale in its territory. Mitsubishi Tanabe will pay Vertex $105 million upon signing. In addition, the parties have reached other commercial agreements in the amendment, including potential bonus milestone payments in lieu of royalties, that if realized would range between $15 million and $65 million.

Vertex Pharmaceuticals Announces Agreements to Exchange $103.3 Million of its 2013 Convertible Senior Subordinated Notes into Common Stock

CAMBRIDGE, -Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that holders of its 4.75% Convertible Senior Subordinated Notes due 2013 have agreed to exchange approximately $103.3 million in aggregate principal amount of those notes for approximately 4.8 million shares of the Company’s common stock, which is approximately 287,000 shares more than the number of shares into which the notes were convertible under their original terms. The additional shares largely relate to unpaid interest through February 2010, when the notes would have been callable by the Company.

The Company anticipates that the exchanges will be completed by the close of business on June 10, 2009. Upon completion of the exchanges, the aggregate principal amount of the Company’s 4.75% Convertible Senior Subordinated Notes due 2013 will be reduced to approximately $184.2 million. Upon issuance of the common stock in exchange for the notes, the Company will have approximately 178 million shares of common stock outstanding.

This announcement is neither an offer to exchange nor a solicitation of an offer to exchange any of these securities. The exchanges are exempt from registration under Section 3(a)(9) of the Securities Act of 1933.

Safe Harbor Statement

This press release contains forward-looking statements, including the statement that Vertex expects to close the exchanges by June 10, 2009. While the Company believes the forward-looking statements contained in this press release are accurate, those statements are subject to risks and uncertainties that could cause our results to vary materially. Those risks and uncertainties include the risk and uncertainty that the closing will not occur in a timely manner and other risks and uncertainties listed under Risk Factors in Vertex’s annual report and quarterly reports filed with the Securities and Exchange Commission. Vertex disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, unless required by law.

Telaprevir-Based Drugs Show Promise to Treat Hepatitis C

Phase 2 clinical trials of treatment regimens based on telaprevir in combination with peginterferon alfa-2a and ribavirin show significantly improved virologic responses in chronic hepatitis C virus patients, according to two studies published in the April 30 issue of the New England Journal of Medicine.

John G. McHutchison, M.D., of Duke University in Durham, N.C., and colleagues conducted a trial of 250 patients infected with hepatitis C virus genotype 1 who were randomized to one of three telaprevir treatment groups, and found that all three treatment groups had a higher rate of significantly improved virologic response, but higher rates of discontinuation due to adverse effects.

Christophe Hezode, M.D., of the University of Paris in France, and colleagues conducted a study of 334 chronic, previously untreated hepatitis C virus genotype 1 patients who were randomized to treatment with one of four combinations of telaprevir, peginterferon alfa-2a and ribavirin, and discovered that the 81 patients who received telaprevir, peginterferon alfa-2a and ribavirin for 12 weeks, followed by peginterferon alfa-2a and ribavirin for 12 more weeks, had the best sustained virologic response. The lowest response was seen in the group lacking ribavirin.

"A drug-induced rash necessitated that telaprevir be discontinued in some patients," Hezode and colleagues write. "Larger and longer studies are required to assess the efficacy and safety of telaprevir for hepatitis C virus infection."

Both studies were supported by Vertex Pharmaceuticals Inc., of Cambridge, Mass. Authors of both studies also disclosed financial relationships with a variety of pharmaceutical companies.