CAMBRIDGE, Mass.--(BUSINESS WIRE)--Genzyme,
a Sanofi company (EURONEXT: SAN and NYSE: SNY), announced it has
received a Refuse to File letter from the U.S. Food and Drug
Administration (FDA) in response to the supplemental Biologics License
Application (sBLA) for the approval of LEMTRADA™ (alemtuzumab) as a
treatment for relapsing multiple sclerosis.
“We have had constructive dialogue with the FDA, and we are very
confident in our ability to address the agency’s request and resubmit
rapidly”
After collaborative consultations with the FDA, the agency requested
that the company modify the presentation of the data sets to enable the
agency to better navigate the application. The FDA has not requested
additional data or further studies. Genzyme will work with the FDA over
the coming weeks to resubmit the application as soon as possible.
“We have had constructive dialogue with the FDA, and we are very
confident in our ability to address the agency’s request and resubmit
rapidly,” said David Meeker, President and CEO, Genzyme.
The company’s marketing authorization application submitted to the
European Medicines Agency has been accepted and the review process is
underway.
Genzyme is developing LEMTRADA in MS in collaboration with Bayer
HealthCare.
About Alemtuzumab/LEMTRADA™
Alemtuzumab is a monoclonal antibody that selectively targets CD52, a
protein abundant on T and B cells. Treatment with alemtuzumab results in
the depletion of circulating T and B cells thought to be responsible for
the damaging inflammatory process in MS. Alemtuzumab has minimal impact
on other immune cells. The acute anti-inflammatory effect of alemtuzumab
is immediately followed by the onset of a distinctive pattern of T and B
cell repopulation that continues over time, rebalancing the immune
system in a way that potentially reduces MS disease activity.
Genzyme holds the worldwide rights to alemtuzumab and has primary
responsibility for its development and commercialization in multiple
sclerosis. Bayer HealthCare retains an option to co-promote alemtuzumab
in multiple sclerosis. Bayer HealthCare has notified Genzyme of its
intention to co-promote under this option. Upon regulatory approval and
commercialization, Bayer would receive contingent payments based on
sales revenue.
*LemtradaTM is the proprietary name submitted to health
authorities for the company’s investigational multiple sclerosis agent
alemtuzumab.
About Genzyme, a Sanofi Company
Genzyme has pioneered the development and delivery of transformative
therapies for patients affected by rare and debilitating diseases for
over 30 years. We accomplish our goals through world-class research and
with the compassion and commitment of our employees. With a focus on
rare diseases and multiple sclerosis, we are dedicated to making a
positive impact on the lives of the patients and families we serve. That
goal guides and inspires us every day. Genzyme’s portfolio of
transformative therapies, which are marketed in countries around the
world, represents groundbreaking and life-saving advances in medicine.
As a Sanofi company, Genzyme benefits from the reach and resources of
one of the world’s largest pharmaceutical companies, with a shared
commitment to improving the lives of patients. Learn more at www.genzyme.com.
About Sanofi
Sanofi, a global and diversified healthcare leader, discovers, develops
and distributes therapeutic solutions focused on patients’ needs. Sanofi
has core strengths in the field of healthcare with seven growth
platforms: diabetes solutions, human vaccines, innovative drugs,
consumer healthcare, emerging markets, animal health and the new
Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York
(NYSE: SNY).
About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the
fields of health care, nutrition and high-tech materials. Bayer
HealthCare, a subgroup of Bayer AG with annual sales of EUR 17.2 billion
(2011), is one of the world’s leading, innovative companies in the
healthcare and medical products industry and is based in Leverkusen,
Germany. The company combines the global activities of the Animal
Health, Consumer Care, Medical Care and Pharmaceuticals divisions. Bayer
HealthCare’s aim is to discover, develop, manufacture and market
products that will improve human and animal health worldwide. Bayer
HealthCare has a global workforce of 55,700 employees (Dec 31, 2011) and
is represented in more than 100 countries. Find more information at www.bayerhealthcare.com.
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,
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regarding future performance. Forward-looking statements are generally
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“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, the Group’s
ability to benefit from external growth opportunities, trends in
exchange rates and prevailing interest rates, the impact of cost
containment policies 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, 2011. Other than as required by applicable
law, Sanofi does not undertake any obligation to update or revise any
forward-looking information or statements.
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