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Effect of Genzyme’s LEMTRADA™ Maintained in Patients Beyond Two-Year Pivotal MS Studies

  Effect of Genzyme’s LEMTRADA™ Maintained in Patients Beyond Two-Year Pivotal
  MS Studies

-- In more than 70 percent of patients, disability scores improved or remained
                          stable over three years --

 -- More than 80 percent of patients treated with LEMTRADA did not receive a
       third course of treatment in the first year of the extension --

Business Wire

CAMBRIDGE, Mass. -- March 21, 2013

Genzyme, a Sanofi Company (EURONEXT: SAN and NYSE: SNY),  announced today
interim results from the first year of the extension study of LEMTRADA™
(alemtuzumab), being developed for the treatment for multiple sclerosis (MS).

In this analysis of the first year of the extension study, relapse rates and
sustained accumulation of disability remained low among patients who had
previously received LEMTRADA in either of the Phase III CARE-MS I and CARE-MS
II studies. In these pivotal studies, LEMTRADA was given as two annual
courses, at the start of the study and 12 months later. More than 80 percent
of patients did not receive further treatment with LEMTRADA during the first
year of the extension study.

“These findings are important because they suggest that the benefits of
LEMTRADA as observed in the Phase III studies are maintained, even though most
patients did not receive further dosing,” said Edward Fox, M.D., Director of
the Multiple Sclerosis Clinic of Central Texas, who presented the study
results today at the annual meeting of the American Academy of Neurology in
San Diego, Calif.

Extension Study Results

The Phase III trials of LEMTRADA were randomized, two-year pivotal studies
comparing treatment with LEMTRADA to Rebif^® (subcutaneous interferon beta-1a
44 mcg) in patients with relapsing-remitting MS who were either new to
treatment (CARE-MS I) or who had relapsed while on prior therapy (CARE-MS II).

More than 90 percent of the patients who participated in the Phase III pivotal
trials enrolled in the extension study. Patients who originally received
LEMTRADA were eligible to receive additional treatment in the extension study
if they experienced at least one relapse or at least two new or enlarging
brain or spinal lesions.

These interim results are from the first year of the extension study for
patients who previously received LEMTRADA in the two-year studies. Findings
stated below are based on patients who enrolled in the extension study:

  *More than half of patients (67 percent in CARE-MS I and 55 percent in
    CARE-MS II) who received LEMTRADA in the pivotal trials and enrolled in
    the extension study were still relapse-free through the first year of the
    extension study.
  *In the first year of the extension phase, the annualized relapse rate for
    patients who received LEMTRADA in the pivotal trials was 0.24 and 0.25,
    comparable to the annualized relapse rate for those patients in CARE MS I
    and CARE-MS II, respectively.
  *Through year three, 72.4 percent of patients in CARE MS I and 70.0 percent
    in CARE MS II had improved or stable disability as measured by EDSS.
  *At three years, 88 percent and 80 percent of patients who received
    LEMTRADA in the pivotal trials, respectively, did not experience six-month
    confirmed sustained accumulation of disability.
  *More than 80 percent of patients treated with LEMTRADA in the pivotal
    studies did not receive a third course of treatment within a year of
    entering the extension study.

“These results underscore the tremendous promise that LEMTRADA holds for MS
patients,” said David Meeker, M.D., Genzyme’s President and Chief Executive
Officer. “We’re pleased to be able to present these three-year results that
provide us with important new information about LEMTRADA and are consistent
with the published results from our Phase II extension study.”

Safety results from the first year of the extension study were reported for
patients who received LEMTRADA in the Phase III pivotal studies. No new risks
were identified. The frequency and type of common and serious adverse events
in the first year of the extension study were generally similar to those in
the Phase III pivotal studies. The most common adverse events during this
period of time were infections, including predominantly mild to moderate upper
respiratory and urinary tract infections. There were two deaths.One, as
previously reported, was from sepsis. The other death was presumed accidental
and deemed unrelated to study treatment. The cumulative incidence of
autoimmune thyroid disease over three years was 29.9 percent, as expected
based on the Phase II study experience. Additionally, over three years,
approximately 1 percent of patients developed immune thrombocytopenia (ITP)
and 0.3 percent developed nephropathy, all of whom responded to treatment.
These cases were detected early through routine monitoring. Patient monitoring
for autoimmune disorders is incorporated in all Genzyme-sponsored trials of
LEMTRADA.

Genzyme’s applications to market LEMTRADA for the treatment of MS are
currently being reviewed by the European Medicines Agency and the U.S. Food
and Drug Administration. The company expects action on both applications this
year.

About CARE-MS

The CARE-MS trials are Phase III, global, randomized clinical trials designed
to evaluate whether the investigational MS therapy LEMTRADA could achieve
meaningful efficacy and safety improvements over the approved, active
comparator Rebif (subcutaneous interferon beta-1a 44 mcg), a standard
treatment for relapsing-remitting MS. The CARE-MS I study evaluated 581
patients naïve to prior MS treatment, except for steroids. The CARE-MS II
study evaluated 840 patients who have had at least one relapse occurring while
on MS therapy, including standard injectable disease modifying therapies.
Genzyme announced publication of results of these studies in The Lancet in
November 2012.

In both the trials, LEMTRADA was given as an IV administration a total of
eight times over the course of the two-year study. The first treatment course
of LEMTRADA was administered on five consecutive days, and the second course
was administered on three consecutive days 12 months later. Rebif 44 mcg was
administered by subcutaneous injection three times per week, each week,
throughout the two years of study. In the third-year following initial
treatment, starting the extension phase of the trials, patients who
experienced resumed disease activity were retreated with LEMTRADA once daily
for three days. Patients who took Rebif in the pivotal study phase and crossed
over to receive LEMTRADA in the extension phase received LEMTRADA once daily
for five days and then once daily for three days one year later.

About LEMTRADA™ (alemtuzumab)

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.

LEMTRADA^TM 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).

Genzyme^® is the registered trademark of Genzyme Corporation. All rights
reserved.

Rebif^® is a registered trademark of EMD Serono, Inc. or affiliates.

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.

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, 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, 2012. Other than as
required by applicable law, Sanofi does not undertake any obligation to update
or revise any forward-looking information or statements.

Multimedia materials available here:
http://smp.businesswire.com/pages/genzyme-ms-multimedia-materials

Contact:

Sanofi Media Relations
Marisol Péron, +33 (0) 1 53 77 46 46
mr@sanofi.com
or
Sanofi Investor Relations
Sébastien Martel, +33 (0) 1 53 77 45 45
ir@sanofi.com
or
Genzyme Media Relations
Erin Walsh, 617-768-6881
Erin.Walsh@genzyme.com
or
Sanofi Investor Relations
Kristen Galfetti, +1 908-981-5560
ir@sanofi.com
 
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