An experimental drug combination from Abbott Laboratories (ABT) wiped out all traces of the virus that causes hepatitis C in 99 percent of patients with the liver disease, a study showed.
The 571 patients in the trial took a two- or three-drug mixture of Abbott therapies for 8 to 24 weeks, along with the antiviral ribavirin. A 79-patient group on the combination of three medicines plus ribavirin for 12 weeks responded best, the Abbott Park, Illinois-based company said today in a statement.
Abbott is among several companies racing to develop hepatitis C pills to replace the standard yearlong injectable treatment. Bristol-Myers Squibb Co. (BMY) also reported today that one of its drug combinations helped patients who hadn’t previously been treated for the viral infection. Hepatitis C is estimated to affect 180 million people worldwide with the market for new therapies forecast to reach $20 billion by 2020.
“We feel this regimen is going to be bringing significant efficacy, safety and convenience benefits to patients,” Scott Brun, head of Abbott’s virology development, said in a telephone interview.
In the competition for a new therapy, Gilead Sciences Inc. (GILD) will have to produce data that shows its combination of drugs is about as effective as Abbott’s, said Mark Schoenebaum, an analyst with International Strategy & Investment Group in New York. “Gilead’s got to produce 90 percent” rates of clearing the virus, he said. “If they don’t, people are going to get worried.”
Gilead is conducting an 800-person trial with fewer pills than Abbott’s regimen.
Abbott gained 4 percent to $72.05 at 4 p.m. New York time, the biggest single-day gain since August 2011. Gilead fell less than 1 percent to $67.32. Bristol-Myers rose 2.5 percent to $33.93.
Bristol-Myers and Abbott could cut into a market that Gilead had been expected to dominate, said Catherine Arnold, an analyst with Credit Suisse Group AG in New York. In a note to clients today, she predicted that Gilead would have $3.8 billion in hepatitis C sales in 2020, and Abbott would follow with $2.5 billion and Bristol-Myers with $1.3 billion.
In Abbott’s clinical trial, 93 percent of a different 45- patient group, so-called null responders who had failed prior therapies, were cleared of the virus as well, Abbott said. The standard of care typically makes the virus undetectable in 30 percent of patients, Brun said.
“What we find really exciting is the results of the null responders,” he said.
The company will next test the combination of these drugs, ABT-450, ABT-267, ABT-333, in the last of three stages of trials typically required for U.S. regulatory approval.
The treatment for hepatitis C for the past decade has been a combination of ribavirin with interferon, an immune-boosting protein. Patients receive weekly shots of interferon for as long as a year, which can cause side effects such as fatigue and flu- like symptoms.
There are four new classes of drugs under development to cure hepatitis C. Each work in different ways to stop the virus from replicating, and can be effective against one or several subtypes of the disease.
Achillion Pharmaceuticals Inc. (ACHN), Bristol-Myers, Gilead, Idenix Pharmaceuticals Inc. (IDIX), Merck & Co. (MRK) and Vertex Pharmaceuticals Inc. (VRTX) are testing therapies, either alone or together, with varying degrees of success. The promise of the market spurred at least three acquisitions since October.
Gilead announced in July it would drop ribavirin as part of a combination and test two experimental medicines, GS-7977 and GS-5885 in a trial of 800 patients, with the possibility to apply for regulatory approval in the middle of 2014. Results may be reported at the American Association for the Study of Liver Diseases’ annual meeting next month in Boston. Abbott could have its drug on the market by 2015, Brun said.
“I would argue the ball is still in Gilead’s court,” Schoenebaum said. “In my view the Abbott data are really good. But Abbott suffers from the same Achilles’ heel, which is that the regimen contains ritonavir, which physicians don’t want to use, and the higher pill burden.”
Brun said the number of different medicines involved may not matter, if the company can find ways to combine them into fewer pills.
“The pure number of drugs does not necessarily represent complexity,” Brun said, also arguing that for a viral disease like hepatitis, the company’s research had found that patients would tolerate a more complicated dosing regimen.
Rising hepatitis C deaths among so-called baby boomers from the infection prompted U.S. health officials to declare in May that all of those born from 1946 to 1964 are at risk and should be tested.
Bristol-Myers is testing a new combination of its experimental drugs without using ribavirin and interferon. Instead, the therapy uses daclatasvir, asunaprevir and BMS- 791325, all of which act directly on the virus. In a 32-person trial of patients who hadn’t been treated before, 94 percent cleared the virus from their bodies after 12 weeks on the New York-based company’s combination therapy.
The trial is in the second of three phases of testing before a possible approval. Bristol-Myers’ hepatitis C program suffered a major setback this summer, when it ended development of the drug it paid $2.5 billion for with its February purchase of Inhibitex Inc. after patients developed heart failure.
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