TARRYTOWN, N.Y. and PARIS, Aug. 29,
2016 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi 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 less than 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 greater than 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 less than 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 the 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 @Regeneron on Twitter.
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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
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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
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2015 and its Form 10-Q for the quarterly period ended June 30, 2016. Any forward-looking
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SOURCE Regeneron Pharmaceuticals, Inc.