Achillion Announces Presentation of Data From OMEGA-1 Phase 2b Trial With Odalasvir, AL-335, and Simeprevir (JNJ-4178) at the...
October 23 2017 - 7:00AM
Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN)
reported today Phase 2b data on JNJ-4178, the triple combination
consisting of odalasvir, AL-335, simeprevir, following
presentations at the 2017 Liver Meeting™ organized by the American
Association for the Study Liver Diseases (AASLD), held in
Washington D.C., on October 20 – 24, 2017.
SVR12 data from OMEGA-1, a global open-label
Phase 2b study of the efficacy and safety of JNJ-4178 in
non-cirrhotic patients with HCV genotypes 1, 2, 4, 5 and 6, were
presented at the conference by Dr. Stefan Zeuzem, Professor of
Medicine and Chief of the Department of Medicine I at the Goethe
University Hospital, Frankfurt, Germany.
The results showed that 98.9% (181/183) of
patients treated with JNJ-4178 for 6 weeks achieved SVR12, while
97.8% (178/182) of patients treated with JNJ-4178 for 8 weeks
achieved SVR12, with both arms meeting the pre-specified endpoint
of statistical non-inferiority compared to historic controls. The
triple combination was generally well-tolerated in both arms of the
study, with the most frequent adverse events being headache and
fatigue. Further information on the study can be found at
www.clinicaltrials.gov (NCT02765490).
Achillion announced on September 11, 2017, the
termination of the worldwide license and collaboration arrangement
on hepatitis C with Janssen Pharmaceuticals, Inc. (Janssen), one of
the Janssen Pharmaceutical Companies of Johnson & Johnson. The
notice followed the decision by Janssen to discontinue the
development of the investigational hepatitis C treatment regimen
JNJ-4178.
About Achillion
Pharmaceuticals
Achillion Pharmaceuticals, Inc. (NASDAQ:ACHN) is
a science-driven, patient-focused company seeking to leverage its
strengths across the continuum from discovery to commercialization
in its goal of providing better treatments for people with serious
diseases. The company employs a highly-disciplined discovery and
development approach that has allowed it to pursue best-in-class
oral antiviral therapy for chronic hepatitis C (HCV) and build a
platform of potent and specific complement inhibitors. Achillion is
rapidly advancing its efforts to become a fully-integrated
pharmaceutical company with a goal of bringing life-saving
medicines to patients with rare diseases. More information is
available at http://www.achillion.com.
Cautionary Note Regarding
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.
Achillion may use words such as “expect,” “anticipate,” “project,”
“intend,” “plan,” “aim,” “believe,” “seek,” “estimate,” “can,”
“focus,” “will,” “look forward,” “goal,” and “may” and similar
expressions to identify such forward-looking statements. These
forward-looking statements also include statements concerning the
Company’s strategic goals, milestone plans, and prospects. 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:
obtain and maintain patent protection for its drug candidates and
the freedom to operate under third party intellectual property;
demonstrate in any current and future clinical trials the requisite
safety, efficacy and combinability of its drug candidates; obtain
and maintain necessary regulatory approvals; identify, enter into
and maintain collaboration agreements with third-parties; compete
successfully in the markets in which it seeks to develop and
commercialize its product candidates and future products; manage
expenses; manage litigation; raise the substantial additional
capital needed to achieve its business objectives; and successfully
execute on its business strategies. Furthermore, Janssen is no
longer responsible for the development and commercialization of
Achillion’s HCV assets under the terminated worldwide
license. These and other risks are described in the reports
filed by Achillion with the U.S. Securities and Exchange
Commission, including its Annual Report on Form 10-Q for the fiscal
quarter ended June 30, 2017, 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.
Investors & Media:
Glenn Schulman, PharmD
Achillion Pharmaceuticals, Inc.
Tel. (203) 752-5510
gschulman@achillion.com
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