Vertex draws collaboration interest for hepatitis C combo
The company’s VX-135 pill is one of the last in a class of medicines called nucleotides that may be an important part of combination therapy to treat hepatitis C after setbacks among other drugmakers.
Vertex Pharmaceuticals Inc. (VRTX), maker of the hepatitis C drug Incivek, has received interest from other companies to collaborate on tests of one of its experimental medicines for the liver disease, Chief Executive Officer Jeffrey Leiden said.
The company’s VX-135 pill is one of the last in a class of medicines called nucleotides that may be an important part of combination therapy to treat hepatitis C after setbacks among other drugmakers, Leiden said in an interview yesterday at Vertex’s headquarters in Cambridge, Massachusetts.
“That potentially makes us a very attractive partner,” Leiden said.
The field ignited last year as drugmakers made deals to pursue combination treatments taken orally for a disease that affects as many as 170 million people worldwide. Currently treated with injections, hepatitis C may grow to a $15 billion market by 2018, according to GBI Research, a business analysis firm. Combinations of different drugs are thought to be the most effective way to combat the disease, because they enable therapy to strike at the various ways the virus infects the body.
“We want to use the assets we have and explore them both with our own assets together and potentially with other companies’ assets in collaboration to come up with the best regimens,” Leiden said. “And we want to do it quickly.”
Leiden didn’t specify which partners or drugs Vertex would prefer, and said the company would be open to more than one collaborator. Johnson & Johnson (JNJ), Vertex’s partner on Incivek, and Achillion Pharmaceuticals Inc. (ACHN), maker of several experimental hepatitis C therapies, may be likely collaborators, according to Brian Abrahams, an analyst with Wells Fargo Securities.
J&J, based in New Brunswick, New Jersey, would consider exploring an expansion of its partnership with Vertex in hepatitis C, Gaston Picchio, hepatitis disease area leader for J&J’s Janssen unit, said in an interview in April. Achillion doesn’t comment on business development, and is focused on advancing its therapies through clinical development, said Glenn Schulman, a spokesman, for the New Haven, Connecticut-based company.
Dawn Kalmar, a spokeswoman for Vertex, said the company can’t comment on any specific potential partners or their medicines in development.
Vertex declined 2.5 percent to $52.63 at 4 p.m. New York time. The company has gained 58 percent this year.
Vertex plans to test VX-135 -- also known as ALS-2200 -- in combination with Incivek and another of its experimental medicines, VX-222. Leiden said the company may have data next year from those studies and on combinations with other companies’ drugs. It aims to use that information to choose the one or two best regimens to take into the last stage of tests needed to gain regulatory approval.
Vertex licensed the drug from Alios BioPharma Inc. The companies reported last month that it helped fight the hepatitis C virus in an eight-patient, week-long trial. Vertex discontinued development of another nucleotide licensed from Alios, ALS-2158, for lack of efficacy.
Incivek, known chemically as telaprevir, was approved in May 2011, days after another drug from Merck & Co. (MRK), boceprevir or Victrelis, cleared U.S. regulators. They were the first therapies for hepatitis C in almost a decade to win U.S. Food and Drug Administration approval.
Both pills are given in combination with interferon, which -- in addition to being administered through injection -- is associated with flu-like symptoms that make it hard to tolerate. The new therapies aim to avoid interferon.
Vertex forecasts that Incivek will draw as much as $1.25 billion in 2012 revenue. After an initial surge in use for patients who had been waiting for new therapies before being treated, revenue has slowed as some patients again put off treatment in anticipation of new options, Leiden said.
“We saw this just explosive launch,” Leiden said. “It is very unusual in the pharmaceutical industry to have thousands of patients waiting for drug, and that’s the situation we were in.”
Vertex treated tens of thousands of patients in the first few months telaprevir was on the market, Leiden said. After that, treatment steadied to a rate of tens of thousands of patients a year, he said. When it became clear a new generation of medicines were on the horizon that could be taken just as pills, some patients have started to wait again.
Some patients can put off treatment because their disease hasn’t manifested to the point that it’s causing noticeable liver damage, which may lead to cancer or the need for a transplant. Those with more advanced hepatitis C are still getting treated with drugs on the market, Leiden said. People can live with hepatitis C for many years without realizing they’re infected.
The quest for a combination to better treat hepatitis C without interferon was kick-started last year with Gilead Sciences Inc. (GILD)’s $11 billion acquisition of Pharmasset Inc. to gain its nucleotide, now called GS-7977 and in late-stage clinical trials. Bristol-Myers Squibb Co. (BMY) followed in January with a $2.5 billion deal to buy Inhibitex Inc. to gain its nucleotide, INX-189.
That program was discontinued in August by New York-based Bristol-Myers after the drug was linked to the death of a patient and the hospitalization of others with heart and kidney problems. Idenix Pharmaceuticals Inc. (IDIX), another maker of hepatitis C therapies, had two of its nucleotides put on clinical hold by the FDA because of concerns over similarities to Bristol-Myers’ drug. Idenix contends there are enough differences between the drugs to support potential use of its therapies.
Abbott Laboratories (ABT) and others are also competing to develop next-generation combination treatments. Researchers, physicians and those from the financial community will meet in Boston in November for the annual meeting of the American Association for the Study of Liver Diseases, where data on new therapies will be presented and discussed.
Other classes of drugs in development include protease inhibitors, a group that includes Vertex’s Incivek, NS5A inhibitors and non-nucleoside inhibitors.
Because of all the work being done, within three to five years patients will likely have access to multiple new combo regimens that are highly effective, tolerable and short in duration, Leiden said.
“That’s a tremendous advance in a short period of time,” he said. “We hope we’ll be a part of that. That’s what we’re trying to do.”
Leiden became Vertex’s CEO in February, succeeding Matthew Emmens. He joined Vertex’s board in 2009, and previously worked in venture capital, as chief operating officer of Abbott Laboratories, and in medicine as a cardiologist and molecular biologist.
By Meg Tirrell