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 -- 
MISSISSAUGA, ON, March 28, 2013 /CNW/ - Genzyme, a Sanofi Company announced 
interim results from the first year of the extension study of LEMTRADA™ 
(alemtuzumab), being developed for the treatment for multiple sclerosis (MS). 
The data were presented March 21 at the American Academy of Neurology meeting 
in San Diego, California. 
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. 
"These results clearly show that LEMTRADA is interesting as a treatment option 
for relapsing-remitting MS for three reasons. First, it reduces the relapse 
rate to a greater degree than an active comparator. Second, disability remains 
stable or improves in most patients for at least up to three years. Third, the 
drug usually only requires five infusions in the first year and three 
infusions in the second year for long term efficacy," said François 
Grand'Maison, MD, neurologist at Hôpital Charles LeMoyne and director of the 
Neuro Rive-Sud MS Clinic in Greenfield Park, Québec. 
"However LEMTRADA may cause auto-immune reactions for which frequent blood 
monitoring is required. Fortunately, these reactions are easily treated. 
Overall, it is likely that this drug will make it easier for MS patients to 
deal with their disease and go on with their lives." 
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.

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 the both 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.

Media Contacts: Noëlle-Dominique Willems (905) 267-3176 
noelle-dominique.willems@genzyme.com

Max Nchama (647) 259-3269 max.nchama@cohnwolfe.ca

SOURCE: Genzyme, a Sanofi Company

To view this news release in HTML formatting, please use the following URL: 
http://www.newswire.ca/en/releases/archive/March2013/28/c8563.html

CO: Genzyme, a Sanofi Company
ST: Ontario
NI: MTC HEA 

-0- Mar/28/2013 13:00 GMT


 
Press spacebar to pause and continue. Press esc to stop.