Tuesday, July 2, 2013

Achillion Hepatitis C Drug Trial on Hold on Liver Concern

Achillion Hepatitis C Drug Trial on Hold on Liver Concern

By Mary Camille Izlar & Robert Langreth - Jul 2, 2013 4:09 PM ET

Achillion Hepatitis C Drug Trial on Hold on Liver Concern U.S. regulators put the hepatitis C drug trial on hold after some patients experienced elevated liver enzymes, Achillion said in a statement yesterday. 

The elevations were observed in healthy patients when Achillion’s sovaprevir was combined with two medicines used to treat HIV infections in order to test for possible drug interactions. The combination may have resulted in a drug interaction that produced higher-than-expected blood levels of the therapies, Achillion said.

“Achillion voluntarily stopped further dosing” and “promptly notified” the Food and Drug Administration of the finding in the early-stage trial involving sovaprevir, the New Haven, Connecticut-based company said. The hold doesn’t affect a current second-stage study of the drug in hepatitis C patients.

Achillion has three drugs in clinical testing for hepatitis C, a liver disease that affects 170 million people worldwide. The company said April 23 that one of the treatments, ACH-3102, appeared effective in five out of eight patients, reducing the amount of the liver-destroying virus in their bloodstream to undetectable levels after 12 weeks of treatment.

Achillion is competing with drugmakers including AbbVie Inc. (ABBV) and Gilead Sciences Inc. (GILD) to develop new treatments for the disease, a market analysts’ estimate may be $20 billion.

To resolve the hold, the regulatory agency has asked for data from two drug interaction studies as well as a safety analysis of continuing sovaprevir studies, which the company said it plans to provide in about six weeks.

Achillion shares had gained 35 percent in the past 12 months through yesterday.

To contact the reporters on this story: Mary Camille Izlar in New York at mizlar@bloomberg.net; Robert Langreth in New York at rlangreth@bloomberg.net

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net 


Liver toxins delay CT Achillion's hep C trial
July 2, 2013
Achillion Pharmaceuticals Inc. got a dose of bad news about its efforts to develop a treatment for hepatitis C.

The New Haven biopharmaceutical company said Monday the U.S. Food & Drug Administration suspended one of its clinical trials for its hepatitis C drug sovaprevir after a trial subject built up an unusually high amount of toxic liver enzymes.

Despite the setback, however, the FDA is allowing Achillion to continue enrollment and the 12-week treatment of patients in Phase 2 trials involving sovaprevir and Achillion's ACH-3102 formulation, the company said.

The company was due to elaborate on the FDA notification and other clinical-trial data during a Monday afternoon conference call with financial analysts and reporters.


UPDATE 1-FDA places clinical hold on Achillion's hep C drug, shares plunge

Mon Jul 1, 2013 6:27pm EDT

* Co says liver enzymes elevated in drug interaction with HIV drug
* Co says hold does not affect mid-stage study
* Co could potentially lose access to market for HIV patients - analysts
* Shares fall 22 percent in extended trading

By Vrinda Manocha
July 1 (Reuters) - Achillion Pharmaceuticals Inc said the U.S. Food and Drug Administration had placed a clinical hold on its hepatitis C drug sovaprevir after elevations in liver enzymes were noted in an early-stage study of the drug's interaction with an HIV drug.
Shares of the company fell 22 percent in extended trading.

The company said the FDA had asked for study reports from two drug-drug interaction studies involving the drug and a safety analysis of ongoing trials.

Achillion was testing sovaprevir's interaction with an antiretroviral drug atazanavir, which was boosted by another drug called ritonavir.

The company said it had detected elevations in liver enzymes, an indication of liver damage, in multiple subjects, but none of the elevations met the criteria of a serious adverse event.
"We don't know what's going on. What we know is that when Achillion's drug is evaluated with a pretty typical HIV drug, we get a toxic combination," Maxim Group analyst Jason Kolbert told Reuters.

"Clearly now the profile of this drug is not perfect at a time when the market wants to see drugs with a very clean profile."

William Blair analyst Katherine Xu said if the drug-drug interaction was real, then the company may not be able to target patients taking atazanavir.

"I think about 20 percent of hepatitis C patients are infected with HIV, and then within these HIV patients, probably 10 percent are taking atazanavir. It's not that much, it's more a perception. It might be a nuisance for doctors to prescribe", she said.

Maxim's Kolbert also said that some people had thought that Achillion was positioning itself to be sold, and the news would hurt their chances that a buyer would want to acquire the entire company.
The company said none of its other drug-drug interaction studies had showed such elevations in liver enzymes.

The FDA issues clinical holds to delay the clinical investigation of a drug, or to suspend an ongoing investigation. Companies may not recruit new subjects when an ongoing study is placed on a clinical hold.

The clinical hold does not affect the company's mid-stage trial testing sovepravir in combination with another of its hepatitis C drugs and a standard therapy ribavirin.
The company said it expected to provide the information to the FDA within about six weeks.
Shares of the company, which were halted prior to the news, closed at $8.36 on Monday on the Nasdaq.


July 1, 2013
Achillion Provides Update on Sovaprevir Development Program
Following Phase 1 drug-drug interaction study with ritonavir-boosted atazanavir showing elevated liver enzymes, sovaprevir placed on clinical hold by FDA
Ongoing enrollment and treatment of patients remains unaffected in Phase 2 -007 combination trial evaluating 12-weeks of sovaprevir and ACH-3102 for treatment-naive genotype 1 patients
Conference call and webcast to be hosted today at 4:15 p.m. EDT
NEW HAVEN, Conn., July 1, 2013 (GLOBE NEWSWIRE) -- Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN) today announced that the Company has received notice from the U.S. Food and Drug Administration (FDA) that a clinical hold has been placed on sovaprevir after elevations in liver enzymes associated with significantly higher than anticipated exposures to atazanivir and sovaprevir were noted in a Phase 1 healthy subject drug-drug interaction (DDI) study evaluating the effects of concomitant administration of sovaprevir with ritonavir-boosted atazanavir. The FDA has allowed continued enrollment and treatment of patients in the Phase 2 -007 clinical trial evaluating 12-weeks of sovaprevir in combination with ACH-3102 and ribavirin for patients with treatment-naive genotype 1 hepatitis C viral infection (HCV).

In a Phase 1 drug-drug interaction study, Achillion was evaluating the effects of concomitant administration of sovaprevir with ritonavir-boosted atazanavir. While conducting this study, Achillion detected unanticipated elevations in ALT liver enzymes (grade 3 or 4) in multiple subjects, although none of these met the criteria for a serious adverse event (SAE). Achillion voluntarily stopped further dosing in the DDI study and promptly notified the FDA of these findings. Preliminary pharmacokinetic results indicate a metabolic interaction whereby plasma concentrations of both atazanavir and sovaprevir were substantially increased upon co-administration. Such ALT elevations have not been seen in the 12-week combination -007 trial, the 12-week combination -005 trial with ACH-3102 and ribavirin, or in any other drug-drug interaction studies completed with sovaprevir to date.

With the preliminary draft data on hand at the time of notification, the FDA placed sovaprevir on clinical hold. In order to resolve the clinical hold, the FDA has asked for study reports from two drug-drug interaction studies and an integrated safety analysis of on-going sovaprevir trials, each of which Achillion expects to provide to the FDA within approximately six weeks.
With respect to the ongoing -007 Phase 2 clinical trial, Achillion is treating patients in the first segment of the study and plans to release interim clinical trial results, including rapid virologic response (RVR) during the third quarter and sustained viral response (SVR) during the fourth quarter, as previously anticipated. To date, patients enrolled in the trial have received up to six weeks of combination treatment with no safety issues noted.

Conference Call
The Company will host a conference call and simultaneous webcast on Monday, July 1, 2013 at 4:15 p.m. Eastern time. To participate in the conference call, please dial (877) 266-0482 in the U.S. or (631) 291-4567 for international callers. A live audio webcast of the call will be accessible at http://www.achillion.com or http://ir.achillion.com. Please connect to Achillion's website several minutes prior to the start of the broadcast to ensure adequate time for any software download that may be necessary.

A replay of the webcast will be available on www.achillion.com. Alternatively, a replay of the conference call will be available starting at 7:15 p.m. Eastern time on July 1, 2013, through 11:59 p.m. Eastern time on July 7, 2013 by dialing (855) 859-2056 or (404) 537-3406. The replay passcode is 14259844.

About Achillion Pharmaceuticals
Achillion is an innovative pharmaceutical company dedicated to bringing important new treatments to patients with infectious disease. Achillion's discovery, clinical development, and commercial teams have advanced multiple novel product candidates with proven mechanisms of action into studies and toward the market. Achillion is focused on solutions for the most challenging problems in infectious disease including HCV and resistant bacterial infections. For more information on Achillion Pharmaceuticals, please visit www.achillion.com or call 1-203-624-7000.

Forward-Looking Statements
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other important factors that could cause actual results to differ materially from those indicated by such forward-looking statements, including statements with respect to: the potential causative factors for the unexpected results in Achillion's Phase 1 drug-drug interaction study of sovaprevir and ritonavir; Achillion's expectations regarding timing for the completion and reporting of results of its clinical trial of ACH-3102 in combination with sovaprevir and ribavirin; and Achillion's expectations regarding timelines for submitting additional data to FDA in response to the clinical hold. We may use words such as "expect," "anticipate," "project," "intend," "plan," "believe," "seek," " estimate," and "may" and similar expressions to identify such forward-looking statements. Among the important factors that could cause actual results to differ materially from those indicated by such forward-looking statements are risks relating to, among other things Achillion's ability to: satisfactorily respond to regulatory actions with regard to its clinical development programs, including the FDA's request for further information and data regarding the Phase 1 drug-drug interaction study; successfully resolve the partial clinical hold with regard to sovaprevir; continue to advance sovaprevir in clinical trials; replicate in later clinical trials positive results found in preclinical and earlier stage clinical trials of sovaprevir, ACH-3102, and its other product candidates; advance the development of its drug candidates under the timelines it anticipates in current and future clinical trials; obtain necessary regulatory approvals; obtain patent protection for its drug candidates and the freedom to operate under third party intellectual property; establish commercial manufacturing arrangements; identify, enter into and maintain collaboration agreements with appropriate third-parties; compete successfully with other companies that are seeking to develop improved therapies for the treatment of HCV; manage expenses; and raise the substantial additional capital needed to achieve its business objectives. These and other risks are described in the reports filed by Achillion with the U.S. Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2013 and its subsequent SEC filings.

In addition, any forward-looking statement in this press release represents Achillion's views only as of the date of this press release and should not be relied upon as representing its views as of any subsequent date. Achillion disclaims any duty to update any forward-looking statement, except as required by applicable law.


No comments:

Post a Comment