TARRYTOWN, N.Y. and
PARIS, July
8, 2015 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc.
(NASDAQ: REGN) and Sanofi today announced that the Phase 3
ODYSSEY JAPAN trial of the
investigational therapy Praluent® (alirocumab) Injection
met its primary endpoint. At week 24, patients in the Praluent
group experienced an average 64 percent greater reduction from
baseline in their bad cholesterol, known as low-density lipoprotein
cholesterol (LDL-C), when added to current standard of care
including statins, compared to standard of care alone (p less than
0.0001). Patients were started on the lower dose of 75 mg, with the
option to adjust their dose to 150 mg if they had not achieved
their LDL-C goal (as defined by the Japan Atherosclerosis Society
guidelines) at week 8. At week 24, 97 percent of patients in the
Praluent group reached their LDL-C treatment goal, compared to 10
percent for placebo (p less than 0.0001). Ninety-nine percent of
patients treated with Praluent remained on the lower dose; two
patients required adjustment to the higher dose.
The trial involved 216 Japanese patients with
hypercholesterolemia at high cardiovascular (CV) risk and/or with
an inherited form of high cholesterol known as heterozygous
familial hypercholesterolemia (HeFH). Results were presented today
for the first time at the Annual Scientific Meeting of the Japan
Atherosclerosis Society (JAS) in Sendai, Japan. Praluent is an investigational fully
human monoclonal antibody targeting PCSK9 (proprotein convertase
subtilisin/kexin type 9).
"These results demonstrate the significant cholesterol-lowering
ability of Praluent among patients with some of the greatest unmet
needs in Japan. This includes
those with an inherited form of high cholesterol or pre-existing
cardiovascular disease, such as a history of heart attack," said
lead investigator Tamio Teramoto,
MD, PhD, Director of Teikyo Academic Research Center. "Despite
current treatment options, many Japanese patients with
hypercholesterolemia are still unable to reach their LDL-C goals,
highlighting the need for additional treatment options. Notably,
almost all patients reached their LDL-C target levels while
remaining on the 75 mg dose, avoiding the need for
overtreatment."
ODYSSEY JAPAN evaluated
Praluent (n=144) compared to placebo (n=72), both on top of
standard care, in Japanese patients with hypercholesterolemia, with
either HeFH or at high CV risk, and who could not reach their LDL-C
treatment goal as defined by the JAS guidelines despite
lipid-lowering treatments that included statins. The mean LDL-C
value at baseline was 141.2 mg/dL. Patients were initially
randomized to receive either Praluent 75 mg every two weeks
administered as a single 1 milliliter (mL) injection, or placebo.
Patients in both groups received statins, with or without other
lipid-lowering therapies.
Ninety-nine percent of patients who received Praluent at week 8
remained on the initial 75 mg dose, while one percent of patients
had their dose adjusted to receive 150 mg every two weeks, also as
a single 1 mL injection. The most common adverse events (occurring
in at least 5 percent of patients in the Praluent group) were
nasopharyngitis, injection site reaction, and back pain.
On June 9, the Endocrinologic and
Metabolic Drugs Advisory Committee (EMDAC) of the U.S. Food and
Drug Administration (FDA) recommended the approval of Praluent. The
FDA has a target action date of July
24; and while the FDA takes the Committee's advice into
consideration, the FDA is not bound by its recommendation. In
addition, the Marketing Authorization Application for Praluent in
the European Union is currently under review by the European
Medicines Agency (EMA). The safety and efficacy of Praluent have
not been fully evaluated by any regulatory authority.
About Sanofi
Sanofi, 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).
About Regeneron Pharmaceuticals, Inc.
Regeneron
(NASDAQ: REGN) is a leading science-based biopharmaceutical company
based in Tarrytown, New York that
discovers, invents, develops, manufactures, and commercializes
medicines for the treatment of serious medical conditions.
Regeneron commercializes medicines for eye diseases, and a rare
inflammatory condition and has product candidates in development in
other areas of high unmet medical need, including
hypercholesterolemia, oncology, rheumatoid arthritis, asthma, and
atopic dermatitis. For additional information about the company,
please visit www.regeneron.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, 2014. Other than as required by
applicable law, Sanofi does not undertake any obligation to update
or revise any forward-looking information or statements.
Regeneron Forward-Looking Statements
This news
release includes forward-looking statements that involve risks and
uncertainties relating to future events and the future performance
of Regeneron Pharmaceuticals, Inc. ("Regeneron"), and actual events
or results may differ materially from these forward-looking
statements. Words such as "anticipate," "expect," "intend," "plan,"
"believe," "seek," "estimate," variations of such words, and
similar expressions are intended to identify such forward-looking
statements, although not all forward-looking statements contain
these identifying words. These statements concern, and these risks
and uncertainties include, among others, the nature, timing, and
possible success and therapeutic applications of Regeneron's
products, product candidates, and research and clinical programs
now underway or planned, including without limitation
Praluent® (alirocumab); unforeseen safety issues
resulting from the administration of products and product
candidates in patients, including serious complications or side
effects in connection with the use of Regeneron's product
candidates in clinical trials; the likelihood and timing of
possible regulatory approval and commercial launch of Regeneron's
late-stage product candidates, including without limitation
Praluent, and the impact of the recommendation of the
Endocrinologic and Metabolic Drugs Advisory Committee of the U.S.
Food and Drug Administration discussed in the news release on the
possible regulatory approval of Praluent; ongoing regulatory
obligations and oversight impacting Regeneron's marketed products,
research and clinical programs, and business, including those
relating to patient privacy; determinations by regulatory and
administrative governmental authorities which may delay or restrict
Regeneron's ability to continue to develop or commercialize
Regeneron's products and product candidates; competing drugs and
product candidates that may be superior to Regeneron's products and
product candidates; uncertainty of market acceptance and commercial
success of Regeneron's products and product candidates; the ability
of Regeneron to manufacture and manage supply chains for multiple
products and product candidates; coverage and reimbursement
determinations by third-party payers, including Medicare and
Medicaid; unanticipated expenses; the costs of developing,
producing, and selling products; the ability of Regeneron to meet
any of its sales or other financial projections or guidance and
changes to the assumptions underlying those projections or
guidance; the potential for any license or collaboration agreement,
including Regeneron's agreements with Sanofi and Bayer HealthCare
LLC, to be cancelled or terminated without any further product
success; and risks associated with intellectual property of other
parties and pending or future litigation relating thereto. A more
complete description of these and other material risks can be found
in Regeneron's filings with the United States Securities and
Exchange Commission, including its Form 10-K for the year ended
December 31, 2014 and its Form
10-Q for the quarter ended March 31,
2015. Any forward-looking statements are made based on
management's current beliefs and judgment, and the reader is
cautioned not to rely on any forward-looking statements made by
Regeneron. Regeneron does not undertake any obligation to update
publicly any forward-looking statement, including without
limitation any financial projection or guidance, whether as a
result of new information, future events, or otherwise.
Contacts Sanofi:
Media Relations
|
Investor Relations
|
Jack Cox
|
Sebastien Martel
|
Tel: +33 (0) 1 53 77 94 74
|
Tel: +33 (0)1 53 77 45 45
|
Mobile: +33 (0) 6 78 52 05 36
|
IR@sanofi.com
|
Jack.Cox@sanofi.com
|
|
|
|
Global Communications, PCSK9 Development &
Launch Unit
|
|
Elizabeth
Baxter
|
|
Tel: +1 (908) 981-5360
|
|
Mobile: +1 (908)
340-7811
|
|
Elizabeth.Baxter@sanofi.com
|
|
Contacts Regeneron:
Media Relations
Arleen
Goldenberg
Tel: +1 (914)
847-3456
Mobile: +1 (914)
260-8788
arleen.goldenberg@regeneron.com
|
Investor Relations
Manisha
Narasimhan, Ph.D.
Tel: +1 (914)
847-5126
manisha.narasimhan@regeneron.com
|
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SOURCE Regeneron Pharmaceuticals, Inc.