Sanofi Alliance Partner Alnylam Gives Update on Fitusiran

Sanofi Alliance Partner Alnylam Gives Update on Fitusiran

ID: 559146

(Thomson Reuters ONE) -



Sanofi Alliance Partner Alnylam
Provides Update on Fitusiran Development Program
Paris, France - September 7, 2017 - Sanofi alliance partner Alnylam
Pharmaceuticals today provided an update on the clinical development program for
fitusiran, an investigational RNAi therapeutic in development for the treatment
of hemophilia A and B with or without inhibitors. Sanofi has an alliance with
Alnylam Pharmaceuticals to co-develop and co-commercialize fitusiran. Alnylam
has primary responsibility for execution of the development program.

As disclosed by Alnylam, a fatal thrombotic event occurred in a patient with
hemophilia A without inhibitors enrolled in the Phase 2 Open Label Extension
(OLE) study of fitusiran. As a result, Alnylam, the sponsor of this study, has
suspended dosing in all ongoing fitusiran studies pending further review of the
safety event and development of a risk mitigation strategy. Based on overall
consideration of fitusiran's benefit-risk profile, Alnylam aims to resume dosing
as soon as it is feasible upon agreement with global regulatory authorities and
with appropriate protocol amendments for enhanced patient safety monitoring in
place.

About Sanofi
Sanofi, a global healthcare leader, discovers, develops and distributes
therapeutic solutions focused on patients' needs. Sanofi is organized into five
global business units: Diabetes and Cardiovascular, General Medicines and
Emerging Markets, Sanofi Genzyme, Sanofi Pasteur and Consumer Healthcare. Sanofi
is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).

Sanofi Forward-Looking Statements
This press release contains forward-looking statements as defined in the Private
Securities Litigation Reform Act of 1995, as amended. Forward-looking statements




are statements that are not historical facts. These statements include
projections and estimates and their underlying assumptions, statements regarding
plans, objectives, intentions and expectations with respect to future financial
results, events, operations, services, product development and potential, and
statements regarding future performance. Forward-looking statements are
generally identified by the words "expects", "anticipates", "believes",
"intends", "estimates", "plans" and similar expressions. Although Sanofi's
management believes that the expectations reflected in such forward-looking
statements are reasonable, investors are cautioned that forward-looking
information and statements are subject to various risks and uncertainties, many
of which are difficult to predict and generally beyond the control of Sanofi,
that could cause actual results and developments to differ materially from those
expressed in, or implied or projected by, the forward-looking information and
statements. These risks and uncertainties include among other things, the
uncertainties inherent in research and development, future clinical data and
analysis, including post marketing, decisions by regulatory authorities, such as
the FDA or the EMA, regarding whether and when to approve any drug, device or
biological application that may be filed for any such product candidates as well
as their decisions regarding labelling and other matters that could affect the
availability or commercial potential of such product candidates, the absence of
guarantee that the product candidates if approved will be commercially
successful, the future approval and commercial success of therapeutic
alternatives, Sanofi's ability to benefit from external growth opportunities
and/or obtain regulatory clearances, risks associated with intellectual property
and any related pending or future litigation and the  ultimate outcome of such
litigation,  trends in exchange rates and prevailing interest rates, volatile
economic conditions, the impact of cost containment initiatives and subsequent
changes thereto, the average number of shares outstanding as well as those
discussed or identified in the public filings with the SEC and the AMF made by
Sanofi, including those listed under "Risk Factors" and "Cautionary Statement
Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for
the year ended December 31, 2016. Other than as required by applicable law,
Sanofi does not undertake any obligation to update or revise any forward-looking
information or statements.



Contacts:

Media Relations Investor Relations
Ashleigh Koss George Grofik
Tel. : +1 908 981 8745 Tel.: +33 (0)1 53 77 45 45
Ashleigh.Koss(at)sanofi.com ir(at)sanofi.com



Press Release (PDF):
http://hugin.info/152918/R/2132199/814850.pdf



This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.

Source: Sanofi via GlobeNewswire




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Bereitgestellt von Benutzer: hugin
Datum: 07.09.2017 - 13:03 Uhr
Sprache: Deutsch
News-ID 559146
Anzahl Zeichen: 5716

contact information:
Town:

PARIS



Kategorie:

Business News



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