Sanofi: FDA lifts clinical hold on fitusiran
15 Dezembro 2017 - 10:01AM
Press ReleaseSource: Sanofi (EURONEXT: SAN)
(NYSE: SNY)
FDA lifts clinical hold on fitusiran
- Clinical trial dosing to resume around year-end 2017
Paris and Cambridge, Mass. - December 15,
2017 - Sanofi Genzyme, the specialty care global business unit
of Sanofi, and Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the
leading RNAi therapeutics company, announced today that the U.S.
Food and Drug Administration (FDA) has lifted the hold on clinical
studies with fitusiran, including the Phase 2 open-label extension
(OLE) study and the ATLAS Phase 3 program.
Alnylam and the FDA had previously reached
alignment on new clinical risk mitigation measures, including
protocol-specified guidelines and additional investigator and
patient education concerning reduced doses of replacement factor or
bypassing agent to treat any breakthrough bleeds in fitusiran
studies.
The FDA has now approved the protocol amendments
and other updated clinical materials for fitusiran studies.
Fitusiran is an investigational RNAi therapeutic targeting
antithrombin (AT) for the treatment of patients with hemophilia A
and B. It is designed to lower levels of AT with the goal of
promoting sufficient thrombin generation to restore hemostasis and
prevent bleeding.
"We are pleased with the FDA's decision to lift
the clinical hold, as fitusiran holds the potential to help improve
the lives of people living with hemophilia," said Akin Akinc,
Ph.D., Vice President and General Manager, Fitusiran at Alnylam.
"With the additional risk mitigation measures in place, we look
forward to the continued late-stage development of fitusiran and
expect to resume dosing around year-end."
The clinical significance of the fitusiran
mechanism of action is under investigation. Fitusiran has not been
approved by the FDA, EMA or any other regulatory authority for any
indication and no conclusions can or should be drawn regarding the
safety or effectiveness of this investigational therapeutic.
Sanofi has an alliance with Alnylam
Pharmaceuticals to co-develop and co-commercialize fitusiran in the
United States, Canada and Western Europe. In addition, Sanofi has
the exclusive right to commercialize fitusiran in the rest of the
world.
About Sanofi Sanofi is dedicated to supporting
people through their health challenges. We are a global
biopharmaceutical company focused on human health. We prevent
illness with vaccines, provide innovative treatments to fight pain
and ease suffering. We stand by the few who suffer from rare
diseases and the millions with long-term chronic conditions. With
more than 100,000 people in 100 countries, Sanofi is transforming
scientific innovation into healthcare solutions around the globe.
Sanofi Genzyme focuses on developing specialty treatments for
debilitating diseases that are often difficult to diagnose and
treat, providing hope to patients and their families. Learn more at
www.sanofigenzyme.com. Sanofi, Empowering Life About Alnylam
Pharmaceuticals Alnylam (Nasdaq: ALNY) is leading the
translation of RNA interference (RNAi) into a whole new class of
innovative medicines with the potential to transform the lives of
people afflicted with rare genetic, cardio-metabolic, and hepatic
infectious diseases. Based on Nobel Prize-winning science, RNAi
therapeutics represent a powerful, clinically validated approach
for the treatment of a wide range of severe and debilitating
diseases. Founded in 2002, Alnylam is delivering on a bold vision
to turn scientific possibility into reality, with a robust
discovery platform and deep pipeline of investigational medicines,
including four product candidates that are in late-stage
development. Looking forward, Alnylam will continue to execute on
its "Alnylam 2020" strategy of building a multi-product,
commercial-stage biopharmaceutical company with a sustainable
pipeline of RNAi-based medicines to address the needs of patients
who have limited or inadequate treatment options. Alnylam employs
over 600 people in the U.S. and Europe and is headquartered in
Cambridge, MA. For more information about our people, science and
pipeline, please visit www.alnylam.com and engage with us on
Twitter at @Alnylam or on LinkedIn. |
Sanofi Contacts Media
Relations Ashleigh Koss Tel. : +1 (908) 981-8745 Mobile:
+1 (908) 205-2572 mr@sanofi.com Alnylam Contacts Investor and
Media Relations Christine Regan Lindenboom Tel: +1 (617)
682-4340 |
Investor Relations
George Grofik Tel.: +33 (0)1 53 77 45 45 ir@sanofi.com Investor
Relations Josh Brodsky Tel: +1 (617) 551-8276 |
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
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intentions and expectations with respect to future financial
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Forward-looking statements are generally identified by the words
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results and developments to differ materially from those expressed
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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. Alnylam
Forward Looking Statements Various statements in this release
concerning Alnylam's future expectations, plans and prospects,
including without limitation, Alnylam's views with respect to the
potential for fitusiran for the treatment of people with
hemophilia, expectations regarding the timing for resumption of
dosing in the fitusiran Phase 2 OLE study and Phase 3 ATLAS
program, and expectations regarding its "Alnylam 2020" guidance for
the advancement and commercialization of RNAi therapeutics,
constitute forward-looking statements for the purposes of the safe
harbor provisions under The Private Securities Litigation Reform
Act of 1995. Actual results and future plans may differ materially
from those indicated by these forward-looking statements as a
result of various important risks, uncertainties and other factors,
including, without limitation, Alnylam's ability to discover and
develop novel drug candidates and delivery approaches, successfully
demonstrate the efficacy and safety of its product candidates, the
pre-clinical and clinical results for its product candidates, which
may not be replicated or continue to occur in other subjects or in
additional studies or otherwise support further development of
product candidates for a specified indication or at all, actions or
advice of regulatory agencies, which may affect the design,
initiation, timing, continuation and/or progress of clinical trials
or result in the need for additional pre-clinical and/or clinical
testing, delays, interruptions or failures in the manufacture and
supply of its product candidates, obtaining, maintaining and
protecting intellectual property, Alnylam's ability to enforce its
intellectual property rights against third parties and defend its
patent portfolio against challenges from third parties, obtaining
and maintaining regulatory approval, pricing and reimbursement for
products, progress in establishing a commercial and ex-United
States infrastructure, competition from others using
technology similar to Alnylam's and others developing products for
similar uses, Alnylam's ability to manage its growth and operating
expenses, obtain additional funding to support its business
activities, and establish and maintain strategic business alliances
and new business initiatives, Alnylam's dependence on third parties
for development, manufacture and distribution of products, the
outcome of litigation, the risk of government investigations, and
unexpected expenditures, as well as those risks more fully
discussed in the "Risk Factors" filed with Alnylam's most recent
Quarterly Report on Form 10-Q filed with the Securities and
Exchange Commission(SEC) and in other filings that Alnylam makes
with the SEC. In addition, any forward-looking statements
represent Alnylam's views only as of today, and should not be
relied upon as representing its views as of any subsequent date.
Alnylam explicitly disclaims any obligation, except to the extent
required by law, to update any forward-looking statements. |
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