Sanofi and Regeneron Present Positive Phase 3 Investigational Data for Praluent® (alirocumab) Injection in Patients Undergoing LDL Apheresis Therapy at ESC Congress 2016
(Thomson Reuters ONE) -
Sanofi and Regeneron Present Positive Phase 3 Investigational Data for
Praluent(®) (alirocumab) Injection in Patients Undergoing LDL Apheresis Therapy
at ESC Congress 2016
- ODYSSEY ESCAPE data concurrently published in the European Heart Journal -
Paris, France and Tarrytown, New York - August 29, 2016 - Sanofi and Regeneron
Pharmaceuticals, Inc. today announced detailed positive results from ODYSSEY
ESCAPE, a Phase 3 trial which evaluated Praluent(®) (alirocumab) Injection in
patients with an inherited form of high cholesterol known as heterozygous
familial hypercholesterolemia (HeFH) who require regular weekly or bi-weekly
apheresis treatment. The trial demonstrated that adding Praluent to existing
therapy reduced LDL cholesterol by approximately 50 percent from baseline
(compared to 2 percent increase for placebo). Praluent significantly reduced the
need for apheresis treatment by 75 percent compared to placebo (p<0.0001), the
primary endpoint of the study. Results will be presented today at a Hot Line
session at the ESC Congress 2016 in Rome, Italy.
Apheresis is a procedure similar to kidney dialysis where bad (LDL) cholesterol
is removed from the blood, and is usually reserved for high-risk patients with
very high cholesterol unable to achieve their cholesterol-lowering goals on any
other therapy. Despite being treated with apheresis and entering ODYSSEY ESCAPE
with very high LDL cholesterol levels (4.7 millimoles/liter [mmol/L] or 181
milligrams/deciliter [mg/dL]), nearly two-thirds (63 percent) of patients
treated with Praluent no longer required apheresis therapy after six weeks of
receiving Praluent. At this same time point, the average LDL cholesterol level
among the Praluent-treated group was 2.3 mmol/L (90 mg/dL), compared to 4.8
mmol/L (185 mg/dL) in the placebo group. European guidelines recommend LDL
cholesterol target levels between 1.8-3.0 mmol/L (70-115 mg/dL), depending on
cardiovascular risk.
"Findings from ODYSSEY ESCAPE suggest a role for Praluent in the overall
management of patients with HeFH undergoing regular apheresis therapy, with the
potential to reduce the need for burdensome apheresis treatments," said Patrick
M Moriarty, MD, Professor, Department of Internal Medicine; Director,
Atherosclerosis and Lipoprotein Apheresis Center, University of Kansas Medical
Center, United States. "This is a significant development in the continued
investigation of this drug in HeFH patients, because it is the first clinical
trial to demonstrate that Praluent reduced the frequency of apheresis therapy."
Apheresis therapy is an invasive, time-consuming and expensive treatment for
some of the most difficult-to-treat patients. Treatment may cost up to $100,000
for each patient per year in the U.S. or up to ?60,000 in Germany, where there
are 200 centers and LDL apheresis is more frequently used. In the U.S. there are
only approximately 60 apheresis centers and many patients must travel
significant distances for the procedure.
Other key results from ODYSSEY ESCAPE, which will be concurrently published in
the European Heart Journal, include:
* Ninety-three percent of patients treated with Praluent experienced at least
a 50 percent reduction in their apheresis procedures (p>0.0001).
* Throughout the trial, patients treated with Praluent experienced significant
reductions in their LDL cholesterol starting at week 6 (55 percent greater
reduction compared to placebo), and lasting until the trial ended, at week
18 (46 percent greater reduction compared to placebo) (p<0.0001).
* A similar proportion of patients experienced adverse events (AEs) in both
the Praluent and placebo groups (76 percent both groups). The most common
AEs (occurring in at least 5 percent of the Praluent group) were: fatigue
(15 percent Praluent; 10 percent placebo), nasopharyngitis (10 percent
Praluent; 10 percent placebo), diarrhea (10 percent Praluent; 0 percent
placebo), myalgia (10 percent Praluent; 5 percent placebo), upper
respiratory infection (7 percent Praluent; 19 percent placebo), headache (7
percent Praluent; 5 percent placebo), arthralgia (7 percent Praluent; 10
percent placebo), and back pain (5 percent Praluent; 10 percent placebo).
About ODYSSEY ESCAPE
The completed Phase 3 placebo-controlled ODYSSEY ESCAPE trial involved 62
patients from 14 treatment centers in the U.S. and Germany. These patients were
receiving regular baseline apheresis therapy at fixed intervals of every week or
every 2 weeks prior to randomization. Average LDL cholesterol at baseline was
4.7 mmol/L (181 mg/dL). Eighty-six percent (placebo group) and 90 percent
(Praluent group) of patients had a history of coronary heart disease.
Patients were randomized to receive Praluent 150 mg (n=41) subcutaneously every
2 weeks or placebo (n=21), in addition to their existing treatment regimen. The
double-blind treatment period comprised two intervals: for the first 6 weeks,
patients remained on their established apheresis schedule at baseline, and for
the following 12 weeks, apheresis frequency was adjusted based on the patient's
LDL cholesterol response to treatment. ODYSSEY ESCAPE is part of the overarching
Phase 3 ODYSSEY program, which includes more than 25,000 patients.
About Praluent
Praluent inhibits the binding of PCSK9 (proprotein convertase subtilisin/kexin
type 9) to the LDL receptor and thereby increases the number of available LDL
receptors on the surface of liver cells, which results in lower LDL cholesterol
levels in the blood. Praluent is the only PCSK9 inhibitor available in two
dosages with two levels of efficacy (75 mg and 150 mg), allowing physicians to
select dose based on a patient's LDL cholesterol lowering needs.
Praluent is approved in approximately 40 countries worldwide, including the
U.S., Japan, Canada, Switzerland, Mexico, Brazil and the European Union (EU). In
the U.S., Praluent is approved for use as adjunct to diet and maximally
tolerated statin therapy for the treatment of adults with HeFH or clinical
atherosclerotic CV disease, who require additional lowering of LDL cholesterol.
In the E.U., Praluent is approved for the treatment of adult patients with
primary hypercholesterolemia (HeFH and non-familial) or mixed dyslipidemia as an
adjunct to diet: a) in combination with a statin, or statin with other lipid-
lowering therapies in patients unable to reach their LDL cholesterol goals with
the maximally-tolerated statin or b) alone or in combination with other lipid-
lowering therapies for patients who are statin intolerant, or for whom a statin
is contraindicated. The effect of Praluent on CV morbidity and mortality has not
yet been determined. ODYSSEY OUTCOMES is prospectively evaluating the effect of
Praluent on the occurrence of CV events in approximately 18,000 patients who
have experienced an acute coronary syndrome.
This medicinal product is subject to additional monitoring. This will allow
quick identification of new safety information. Healthcare professionals are
asked to report any suspected adverse reactions.
Important Safety Information for U.S.
Do not use PRALUENT if you are allergic to alirocumab or to any of the
ingredients in PRALUENT.
Before you start using PRALUENT, tell your healthcare provider about all your
medical conditions, including allergies, and if you are pregnant or plan to
become pregnant or if you are breastfeeding or plan to breastfeed.
Tell your healthcare provider or pharmacist about any prescription and over-the-
counter medicines you are taking or plan to take, including natural or herbal
remedies.
PRALUENT can cause serious side effects, including allergic reactions that can
be severe and require treatment in a hospital. Call your healthcare provider or
go to the nearest hospital emergency room right away if you have any symptoms of
an allergic reaction including a severe rash, redness, severe itching, a swollen
face, or trouble breathing.
The most common side effects of PRALUENT include: redness, itching, swelling, or
pain/tenderness at the injection site, symptoms of the common cold, and flu or
flu-like symptoms. Tell your healthcare provider if you have any side effect
that bothers you or that does not go away.
Talk to your doctor about the right way to prepare and give yourself a PRALUENT
injection and follow the "Instructions for Use" that comes with Praluent.
You are encouraged to report negative side effects of prescription drugs to the
FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please click here for the full Prescribing Information
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, high LDL-cholesterol, and a
rare inflammatory condition and has product candidates in development in other
areas of high unmet medical need, including rheumatoid arthritis, asthma, atopic
dermatitis, pain, cancer and infectious diseases. For additional information
about the company, please visit www.regeneron.com or follow (at)Regeneron on
Twitter.
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
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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
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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
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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, 2015. 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 and Use of Digital Media
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" or the "Company"), 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) Injection; unforeseen safety issues and
possible liability resulting from the administration of products (including
without limitation Praluent) and product candidates in patients; serious
complications or side effects in connection with the use of Regeneron's products
and product candidates in clinical trials, such as the ODYSSEY OUTCOMES trial
prospectively assessing the potential of Praluent to demonstrate cardiovascular
benefit; coverage and reimbursement determinations by third-party payers,
including Medicare, Medicaid, and pharmacy benefit management companies; ongoing
regulatory obligations and oversight impacting Regeneron's marketed products
(such as Praluent), research and clinical programs, and business, including
those relating to the enrollment, completion, and meeting of the relevant
endpoints of post-approval studies (such as the ODYSSEY OUTCOMES trial);
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; the likelihood,
timing, and scope of possible regulatory approval and commercial launch of
Regeneron's late-stage product candidates and new indications for marketed
products; 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 and the
impact of studies (whether conducted by Regeneron or others and whether mandated
or voluntary) on the 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; 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 (or their respective affiliated companies, as
applicable), 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, 2015 and its Form 10-Q for the quarterly period ended June
30, 2016. 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.
Regeneron uses its media and investor relations website and social media outlets
to publish important information about the Company, including information that
may be deemed material to investors. Financial and other information about
Regeneron is routinely posted and is accessible on Regeneron's media and
investor relations website (http://newsroom.regeneron.com) and its Twitter feed
(http://twitter.com/regeneron).
Contacts Sanofi: Investor Relations
Media Relations George Grofik
Mai Tran Tel: +33 (0)1 53 77 45 45
Tel: +33 (0)1 53 77 49 86 ir(at)sanofi.com
mr(at)sanofi.com
Contacts Regeneron: Investor Relations
Manisha Narasimhan, Ph.D.
Media Relations Tel: +1 (914) 847-5126
Arleen Goldenberg manisha.narasimhan(at)regeneron.com
Tel: +1 (914) 847-3456
Mobile: +1 (914) 260-8788
arleen.goldenberg(at)regeneron.com
Press release (PDF):
http://hugin.info/152918/R/2037662/759270.pdf
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Source: Sanofi via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 29.08.2016 - 08:00 Uhr
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News-ID 491454
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"Sanofi and Regeneron Present Positive Phase 3 Investigational Data for Praluent® (alirocumab) Injection in Patients Undergoing LDL Apheresis Therapy at ESC Congress 2016"
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