Achillion Pharmaceuticals Inc.'s (>> Achillion Pharmaceuticals, Inc.) shares declined Monday as Phase II study data for its lead hepatitis C treatment was deemed disappointing in light of the recent success of peers.
Bristol-Myers Squibb Co. (>> Bristol Myers Squibb Co.), Gilead Sciences Inc. (>> Gilead Sciences, Inc.) and others, including Abbott Laboratories (>> Abbott Laboratories), are racing to bring an all-oral hepatitis C regimen to market, hoping to tap what is expected to be a multibillion-dollar market for such a therapy. Gilead shares surged last week as it appeared to be leading the race: it hopes to bring a GS-7977-based therapy to market late next year or in 2014.
Achillion shares were down 12% at $7.25 in recent trading, pushing their decline for the past three months to 21%.
Over the weekend, Achillion presented final results of a 12-week study of its ACH-1625 treatment in combination with standard-of-care treatment at a European Association for the Study of the Liver conference in Barcelona, along with plans to combine a study of the oral drug candidate with another treatment later this year.
The company on Saturday had reported that in the second segment of its Phase 2a trial of ACH-1625, 94% to 100% of patients achieved a complete early virologic response after 12 weeks of the experimental treatment in combination with pegylated interferon alfa-2a and ribavirin. The company also reported the combined treatments were safe and well tolerated and produced high viral response rates.
J.P. Morgan Chase & Co. (JPM) said in a research note the data Achillion presented on Saturday "raises eyebrows" as it downgraded the stock to market perform from market outperform.
"Overall, the data were confusing and raised questions regarding the interim safety and efficacy analysis, particularly regarding the compounds ability to clear the virus relative to other competitive agents, liver elevations, and gastrointestinal symptoms," the analysts said. "As such, we are waiting on the sidelines until we get a better handle on the breadth of the therapeutic window."
Achillion on Monday aimed to clarify data regarding end-of-treatment data included in the data presented over the weekend.
The company in a statement said that 58 patients were given a once-daily dose of 200 milligrams, 400 milligrams or 800 milligrams of ACH-1625 pegylated interferon and ribavirin for 12 weeks. At the time of the presentation, 22 of the patients had completed 12 weeks of ACH-1625 plus the other two drugs followed by 12 weeks of pegylated interferon and ribavirin. At the end of 24 weeks all 22 patients had undetectable levels of the virus.
"We are providing these results as we recognized that some of the data was not clear" during its presentation at the conference, Achillion President and Chief Executive Michael Kishbauch said.
Oppenheimer analysts said earlier Monday that based on the results, "we believe '1625 has meaningful strategic value and could play a role in an all-oral combination regimen."
However, the analysts also said that despite their favorable view of 1625 and Achillion's earlier hepatitis C pipeline they believe the stock currently "reflects appropriate value for these programs."
The study data was released a few days after another study found a regimen combining experimental drugs from Gilead and Bristol-Myers suppressed the hepatitis C virus in most patients four weeks after completing treatment. In a separate study, Gilead also said a combination of its drug, GS-7977, with an older drug, ribavirin, suppressed the liver-disease-causing virus in most patients four weeks after treatment.
The results bolster the prospects for an all-oral regimen for hepatitis C that eliminates an injectable drug used in the current standard treatment, interferon, which can be difficult for patients to tolerate.
-By Tess Stynes, Dow Jones Newswires; 212-416-2481; [email protected]