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
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.
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.
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.
CONTACT: Company Contact:
Achillion Pharmaceuticals, Inc.
Tel. (203) 624-7000
Mary Kay Fenton
Achillion Pharmaceuticals, Inc.
Tel. (203) 624-7000
The Trout Group, LLC
Tel. (646) 378-2952
Achillion Pharmaceuticals logo
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