Sanofi Genzyme, the specialty care global business unit of
Sanofi, today announced that positive new brain volume data from an
ongoing clinical study of Lemtrada® (alemtuzumab) will be presented
at the 68th American Academy of Neurology (AAN) Annual Meeting. In
addition, new data from an exploratory study will be presented
which demonstrate the impact of Lemtrada on retinal nerve
fibers.
Lemtrada Investigational Brain Volume
Data: Relapsing-remitting multiple sclerosis (RRMS) patients
treated with interferon beta-1a in CARE-MS I and II for two years
who switched to Lemtrada in the extension study experienced a
reduced rate of brain volume loss over the next three years.
Median yearly brain volume loss in interferon beta-1a treated
patients in year two in CARE-MS I (-0.50%) and CARE-MS II (-0.33%)
was reduced in years one, two and three after switching to Lemtrada
(CARE-MS I: -0.07%, -0.13%, -0.09%; CARE-MS II: 0.02%, -0.05%,
-0.14%).
Lemtrada Investigational Retinal
Data: A measurable improvement in retinal nerve fiber layer
(RNFL) thickness was seen in 26 Lemtrada-treated RRMS patients.
Over two years, the change in average RNFL thickness for all eyes
was +1.5 micrometers (95% CI 0.2, 2.9; p=0.032). The observed
thickening of retinal fibers may reflect protection of retinal
axons in these patients.
“The Lemtrada data being presented at AAN from the ongoing
extension study demonstrating slowed brain volume loss over three
years are consistent with sustained effects seen in prior clinical,
imaging and atrophy analyses,” said Dr. Anthony Traboulsee,
Associate Professor of Neurology and Medical Director of the UBC
Hospital MS Clinic of Vancouver Coastal Health. “In addition, given
the critical importance of neuroprotection in the treatment of MS,
the retinal nerve fiber data are also exciting and support further
investigation.”
In clinical trials, serious side effects associated with
Lemtrada included infusion-associated reactions, autoimmune
disorders (such as thyroid disease, autoimmune cytopenias, and
nephropathies), infections and pneumonitis. Risk management
programs incorporating education and monitoring help support early
detection and management of key identified and potential risks. The
most common side effects of Lemtrada are rash, headache, pyrexia,
nasopharyngitis, nausea, urinary tract infection, fatigue,
insomnia, upper respiratory tract infection, herpes viral
infection, urticaria, pruritus, thyroid gland disorders, fungal
infection, arthralgia, pain in extremity, back pain, diarrhea,
sinusitis, oropharyngeal pain, paresthesia, dizziness, abdominal
pain, flushing, and vomiting. (See Important Safety Information
below.)
About Lemtrada® (alemtuzumab)Lemtrada
is approved in more than 50 countries, with additional marketing
applications under review by regulatory authorities globally.
Lemtrada is supported by a comprehensive and extensive clinical
development program that involved nearly 1,500 patients worldwide
and 5,400 patient-years of follow-up.
In CARE-MS I, Lemtrada was significantly more effective than
interferon beta-1a at reducing annualized relapse rates; the
difference observed in slowing disability progression did not reach
statistical significance. In CARE-MS II, Lemtrada was significantly
more effective than interferon beta-1a at reducing annualized
relapse rates, and accumulation of disability was significantly
slowed in patients given Lemtrada vs. interferon beta-1a.
The precise mechanism by which alemtuzumab exerts its
therapeutic effects in MS is unknown. Alemtuzumab is a monoclonal
antibody that targets CD52, a protein abundant on T and B cells.
Circulating T and B cells are thought to be responsible for the
damaging inflammatory process in MS. Lemtrada depletes circulating
T and B lymphocytes after each treatment course. Lymphocyte counts
then increase over time with a reconstitution of the lymphocyte
population that varies for the different lymphocyte subtypes.
Genzyme holds the worldwide rights to alemtuzumab and has
responsibility for its development and commercialization in
multiple sclerosis. Bayer Healthcare receives contingent payments
based on global sales revenue.
Lemtrada® (alemtuzumab) U.S.
IndicationLEMTRADA is a prescription medicine used to treat
adults with relapsing forms of multiple sclerosis (MS). Because of
its risks, LEMTRADA is generally used in people who have tried 2 or
more MS medicines that have not worked well enough. It is not known
if LEMTRADA is safe and effective for use in children under 17
years of age.
Do not receive LEMTRADA if you are infected with human
immunodeficiency virus (HIV).
IMPORTANT SAFETY INFORMATION
LEMTRADA can cause serious side effects including:
Serious autoimmune problems: Some people receiving
LEMTRADA develop a condition where the immune cells in your body
attack other cells or organs in the body (autoimmunity), which can
be serious and may cause death. Serious autoimmune problems may
include:
• Immune thrombocytopenia, which is when
reduced platelet counts in your blood cause severe bleeding that,
if not treated, may cause life-threatening problems. Call your
healthcare provider right away if you have any of the following
symptoms: easy bruising; bleeding from a cut that is hard to stop;
heavier menstrual periods than normal; bleeding from your gums or
nose that is new or takes longer than usual to stop; small,
scattered spots on your skin that are red, pink, or purple
• Kidney problems called anti-glomerular
basement membrane disease, which can, if untreated, lead to severe
kidney damage, kidney failure that needs dialysis, a kidney
transplant, or death. Call your healthcare provider right away if
you have any of the following symptoms: blood in the urine (red or
tea-colored urine); swelling of legs or feet; coughing up blood
It is important for you to have blood and urine tests before you
receive, while you are receiving and every month, for 4 years or
longer, after you receive your last LEMTRADA infusion.
Serious infusion reactions: LEMTRADA can cause serious
infusion reactions that may cause death. Serious infusion reactions
may happen while you receive, or up to 24 hours or longer after you
receive LEMTRADA.
• You will receive your infusion at a
healthcare facility with equipment and staff trained to manage
infusion reactions, including serious allergic reactions, and
urgent heart or breathing problems. You will be watched while you
receive, and for 2 hours or longer after you receive, LEMTRADA. If
a serious infusion reaction happens while you are receiving
LEMTRADA, your infusion may be stopped.
Tell your healthcare provider right away if you have any of the
following symptoms of a serious infusion reaction during the
infusion, and after you have left the healthcare facility:
• swelling in your mouth or throat
• trouble breathing
• weakness
• fast, slow, or irregular heartbeat
• chest pain
• rash
To lower your chances of getting a serious infusion reaction,
your healthcare provider will give you a medicine called
corticosteroids before your first 3 infusions of a treatment
course. You may also be given other medicines before or after the
infusion to try to reduce your chances of having these reactions or
to treat them after they happen.
Certain cancers: Receiving LEMTRADA may increase your
chance of getting some kinds of cancers, including thyroid cancer,
skin cancer (melanoma), and blood cancers called
lymphoproliferative disorders and lymphoma. Call your healthcare
provider if you have the following symptoms that may be a sign of
thyroid cancer:
• new lump
• swelling in your neck
• pain in front of neck
• hoarseness or other voice changes that do
not go away
• trouble swallowing or breathing
• cough that is not caused by a cold
Have your skin checked before you start receiving LEMTRADA and
each year while you are receiving treatment to monitor for symptoms
of skin cancer.
Because of risks of autoimmunity, infusion reactions, and
some kinds of cancers, LEMTRADA is only available through a
restricted program called the LEMTRADA Risk Evaluation and
Mitigation Strategy (REMS) Program.
Thyroid problems: Some patients taking LEMTRADA may get
an overactive thyroid (hyperthyroidism) or an underactive thyroid
(hypothyroidism). Call your healthcare provider if you have any of
these symptoms:
• excessive sweating
• unexplained weight loss
• eye swelling
• nervousness
• fast heartbeat
• unexplained weight gain
• feeling cold
• worsening tiredness
• constipation
Low blood counts (cytopenias): LEMTRADA may cause a
decrease in some types of blood cells. Some people with these low
blood counts have increased infections. Call your doctor right away
if you have symptoms of cytopenias such as:
• weakness
• chest pain
• yellowing of the skin or whites of the eyes
(jaundice)
• dark urine
• fast heartbeat
Serious infections: LEMTRADA may cause you to have a
serious infection while you receive and after receiving a course of
treatment. Serious infections may include:
• Herpes viral infections. Some people
taking LEMTRADA have an increased chance of getting herpes viral
infections. Take any medicines as prescribed by your healthcare
provider to reduce your chances of getting these infections.
• Tuberculosis. Your healthcare
provider should check you for tuberculosis before you receive
LEMTRADA.
• Hepatitis. People who are at high
risk of, or are carriers of, hepatitis B (HBV) or hepatitis C (HCV)
may be at risk of irreversible liver damage.
These are not all the possible infections that could happen
while on LEMTRADA. Call your healthcare provider right away if you
have symptoms of a serious infection such as fever or swollen
glands. Talk to your healthcare provider before you get
vaccinations after receiving LEMTRADA. Certain vaccinations may
increase your chances of getting infections.
Swelling of lung tissue (pneumonitis): Some people have
had swelling of the lung tissue while receiving LEMTRADA. Call your
healthcare provider right away if you have the following
symptoms:
• shortness of breath
• cough
• wheezing
• chest pain or tightness
• coughing up blood
Before receiving LEMTRADA, tell your healthcare provider if
you:
• are taking a medicine called Campath® (alemtuzumab)
• have bleeding, thyroid, or kidney problems
• have HIV
• have a recent history of infection
• have received a live vaccine in the past 6 weeks before
receiving LEMTRADA or plan to receive any live vaccines. Ask your
healthcare provider if you are not sure if your vaccine is a live
vaccine
• are pregnant or plan to become pregnant. LEMTRADA may harm
your unborn baby. You should use birth control while receiving
LEMTRADA and for 4 months after your course of treatment
• are breastfeeding or plan to breastfeed. You and your
healthcare provider should decide if you should receive LEMTRADA or
breastfeed. You should not do both.
Tell your healthcare provider about all the medicines you
take, including prescription and over-the-counter medicines,
vitamins, and herbal supplements. LEMTRADA and other medicines may
affect each other, causing side effects. Especially tell your
healthcare provider if you take medicines that increase your chance
of getting infections, including medicines used to treat cancer or
to control your immune system.
The most common side effects of LEMTRADA include:
• rash
• headache
• thyroid problems
• fever
• swelling of your nose and throat
• nausea
• urinary tract infection
• feeling tired
• trouble sleeping
• upper respiratory infection
• herpes viral infection
• hives
• itching
• fungal infection
• joint pain
• pain in your arms or legs
• back pain
• diarrhea
• sinus infection
• mouth pain or sore throat
• tingling sensation
• dizziness
• stomach pain
• sudden redness in face, neck, or chest
• vomiting
Tell your healthcare provider if you have any side effect that
bothers you or that does not go away. These are not all the
possible side effects of LEMTRADA.
You are encouraged to report side effects of prescription
drugs to the FDA. Visit http://www.fda.gov/medwatch
or call 1-800-FDA-1088
Please click here for full U.S. Prescribing
Information, including boxed WARNING and Medication
Guide, for additional Important Safety Information.
About SanofiSanofi, a global healthcare leader,
discovers, develops and distributes therapeutic solutions focused
on patients' needs. Sanofi has core strengths in diabetes
solutions, human vaccines, innovative drugs, consumer healthcare,
emerging markets, animal health and Genzyme. Sanofi is listed in
Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
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® is a registered trademark of Sanofi. Genzyme® and
Lemtrada® are registered trademarks of Genzyme Corporation. All
rights reserved.
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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
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Forward-looking statements are generally identified by the words
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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
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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 initiatives and subsequent changes thereto, the
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identified in the public filings with the SEC and the AMF made by
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than as required by applicable law, Sanofi does not undertake any
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Sanofi GenzymeMedia RelationsErin Pascal, + 1
617-768-6864erin.pascal@genzyme.comorSanofiMedia
RelationsJack Cox, +33 (0) 1 53 77 46
46mr@sanofi.comorSanofiInvestor RelationsSébastien
Martel, +33 (0) 1 53 77 45 45ir@sanofi.com
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