HCV New Drugs

Vertex Joins Glaxo, J&J in Testing Hepatitis C Combos
By Meg Tirrell on November 01, 2012

Source - Bloomberg

Vertex Pharmaceuticals Inc. (VRTX), maker of the hepatitis C drug Incivek, said it agreed to test one of its experimental therapies for the disease with other drugs from Johnson & Johnson (JNJ) and GlaxoSmithKline Plc. (GSK)

The drug, VX-135, will be tested with J&J’s simeprevir and Glaxo’s GSK2336805 in separate 12-week trials to determine whether the combinations help rid patients of the virus, Cambridge, Massachusetts-based Vertex said in two statements today. The companies will split development costs with Vertex.

Vertex Chief Executive Officer Jeffrey Leiden said in an interview last month that the company had been drawing collaborator interest for VX-135, one of the last viable experimental therapies in a class called nucleotides thought to be an important part of combination therapy to treat hepatitis C. The disease affects an estimated 170 million people worldwide, and drugmakers have been rushing to bring to market next-generation therapies that don’t require injections.

“We view this as a best case path forward for Vertex, as it allows the company to explore VX-135 with two different classes, partnered with major pharmaceutical companies who are fairly dependent on the success of these respective combinations to remain competitive in the all-oral hepatitis-C virus race,”Brian Abrahams, an analyst with Wells Fargo Securities, wrote in a research note today.

The drug combinations will be tested in the second of three stages of clinical trials generally required for regulatory approval. J&J’s drug, partnered with Sweden’s Medivir AB (MVIRB), is in a class of therapies called protease inhibitors, which includes Incivek, also known as telaprevir. Glaxo’s drug is in a class called NS5A inhibitors.

Combination Therapy
Combinations of different kinds of drugs are thought to be the most effective way to combat hepatitis C because they strike at the various ways the virus infects the body. Gilead Sciences Inc. (GILD), Abbott Laboratories (ABT) and Bristol-Myers Squibb Co. (BMY) are among other drugmakers testing therapies for the disease.

Vertex rose 3.5 percent to $49.98 at 9:48 a.m. in New York trading, after increasing 45 percent this year through yesterday. The shares of New Brunswick, New Jersey-based J&J, which has a partnership with Vertex already on Incivek, gained less than 1 percent to $71.07. Glaxo rose 0.3 percent to 1,391 pence in London.

Vertex also plans to test VX-135 in combination with its own therapies, Incivek and the experimental medicine VX-222, Leiden said last month. The company licensed VX-135 from Alios BioPharma Inc. along with another nucleotide, ALS-2158. Vertex discontinued development of the second compound in September for lack of efficacy.

“This is a good move for Vertex and should help quell concerns from some investors that the company wanted to prioritize Incivek combo regimens,” Mark Schoenebaum, an analyst with ISI Group in New York, wrote in a note to clients today. “Recall, however, that there is very little data available for Vertex’s nuc at this point - thus development risk remains high.”

To contact the reporter on this story: Meg Tirrell in New York at mtirrell@bloomberg.net
To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net

Source - Bloomberg

Related -Hepatitis C: Vertex Enters Agreement with GlaxoSmithKline - Phase 2 All-Oral Study of VX-135 and GSK2336805

 Hepatitis C: Vertex Announces Collaboration with Janssen - Phase 2 All-Oral Study of VX-135 and Simeprevir (TMC435)