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Regeneron Pharmaceuticals, Inc.

Partner : Sanofi-Aventis

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REGENERON AND SANOFI ANNOUNCE PRALUENT® (ALIROCUMAB) CARDIOVASCULAR OUTCOMES TRIAL WILL CONTINUE AS PLANNED FOLLOWING INTERIM ANALYSIS

ODYSSEY OUTCOMES trial is designed to prospectively assess the effect of Praluent on cardiovascular events in high-risk patients

TARRYTOWN, N.Y. and PARIS, Nov. 17, 2016 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the ongoing Praluent® (alirocumab) ODYSSEY OUTCOMES trial will continue as planned, based on the recommendation of an independent Data Monitoring Committee (DMC) after it completed a second pre-specified interim analysis. The DMC will continue to monitor the ongoing safety and efficacy of Praluent as planned.

The Phase 3, multi-center, randomized, double-blind, placebo-controlled ODYSSEY OUTCOMES trial involves more than 18,000 patients from 57 countries. All patients who entered the trial had experienced a heart attack or unstable angina requiring hospitalization within a year of entering the trial, and were unable to control their LDL cholesterol despite receiving maximally-tolerated statins and potentially other lipid-lowering therapies. Patients receiving maximally-tolerated statin therapy were randomized to receive either Praluent 75 milligrams (mg) every two weeks or placebo. Patients on Praluent had their dose increased to 150 mg every two weeks at week 8 if their LDL cholesterol remained above 50 milligrams/deciliter (mg/dL).1
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Source: press release, 11/17/16. http://investor.regeneron.com/releaseDetail.cfm?ReleaseID=999878

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November 24, 2015
Regeneron and Sanofi Announce 18,000-Patient ODYSSEY OUTCOMES Trial of Praluent® Injection Fully Enrolled
TARRYTOWN, New York and PARIS, Nov. 24, 2015 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the companies have completed enrollment in the global Phase 3 ODYSSEY OUTCOMES trial, which is prospectively evaluating the potential cardiovascular (CV) benefits of Praluent® (alirocumab) Injection after an acute coronary syndrome (ACS). The 18,000-patient OUTCOMES trial is expected to be completed in 2017.

ODYSSEY OUTCOMES is designed to determine whether the addition of Praluent to intensive statin therapy reduces major adverse cardiac events among patients who had previously experienced an ACS, such as a heart attack or unstable angina. The primary endpoint evaluates the time to first occurrence of coronary heart disease death, acute myocardial infarction, hospitalization for unstable angina, or fatal and non-fatal ischemic stroke. Patients with recent ACS were selected as the study population because they face a higher risk of recurrent events than patients with stable cardiovascular disease.

Praluent is currently approved in the U.S. and EU to reduce bad (LDL) cholesterol in some patients with significant unmet need, including those with established cardiovascular disease, or an inherited form of high cholesterol, called heterozygous familial hypercholesterolemia (HeFH). The effect of Praluent on CV morbidity and mortality has not yet been determined.

The global ODYSSEY program includes 16 Phase 3 trials conducted at more than 2,000 study centers, around the world, and once complete will evaluate more than 25,000 patients. Data from this program helped form one of the most comprehensive data sets ever used for the initial regulatory filing of a cholesterol-lowering therapy. In completed trials, Praluent reduced LDL cholesterol by up to an additional 62 percent versus placebo, and was generally well-tolerated with an acceptable safety profile.

The ODYSSEY OUTCOMES trial design was published in the American Heart Journal in November 2014.
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Source: press release, 11/24/15. http://investor.regeneron.com/releaseDetail.cfm?ReleaseID=944167

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July 30, 2014
Regeneron and Sanofi Report Positive Top-Line Results from Nine Phase 3 Trials of Alirocumab in People with Hypercholesterolemia
Primary efficacy endpoints met in all nine new trials of investigational PCSK9 inhibitor
TARRYTOWN, N.Y. and PARIS, July 30, 2014 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi (EURONEXT: SAN and NYSE: SNY) today announced that nine new Phase 3 ODYSSEY trials of alirocumab in people with hypercholesterolemia met their primary efficacy endpoint of a greater percent reduction from baseline in low-density lipoprotein cholesterol (LDL-C) at 24 weeks compared to placebo or active comparator. Alirocumab is an investigational monoclonal antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9).

In the nine ODYSSEY trials, the mean percent reduction in LDL-C from baseline at 24 weeks in alirocumab-treated patients was consistent with results seen in previous alirocumab trials. The nine trials included ODYSSEY LONG TERM, FH I, FH II, HIGH FH, COMBO I, COMBO II, OPTIONS I, OPTIONS II and ALTERNATIVE. All patients received alirocumab in addition to standard-of-care lipid-lowering therapy, with the exception of some patients in ODYSSEY ALTERNATIVE.

The 2,341-patient ongoing ODYSSEY LONG TERM trial evaluated the long-term safety and efficacy of alirocumab compared to placebo. Both treatment groups received statins and some patients also received additional lipid-lowering therapies. The trial met its primary efficacy endpoint at 24 weeks. A pre-specified interim safety analysis was performed when all patients reached one year and approximately 25 percent of patients reached 18 months of treatment. A lower rate of adjudicated major cardiovascular events (cardiac death, myocardial infarction, stroke, and unstable angina requiring hospitalization) was observed in the alirocumab arm compared to placebo in a post-hoc analysis (p-value of less than 0.05). The potential of alirocumab to demonstrate cardiovascular benefit is being prospectively assessed in an ongoing 18,000-patient ODYSSEY OUTCOMES trial.

Alirocumab was generally well tolerated in the 9 ODYSSEY trials. The most common adverse events were nasopharyngitis and upper respiratory tract infections, which were generally balanced between treatment groups. Injection site reactions occurred more often in the alirocumab group compared to placebo. Serious adverse events and deaths were generally balanced between treatment groups as were other key adverse events including musculoskeletal, neurocognitive and liver-related events.

"Clinical data to date show consistent, positive results in LDL-C lowering, with an encouraging safety and tolerability profile across all Phase 3 alirocumab trials that we have reported," said George D. Yancopoulos, M.D., Ph.D., Chief Scientific Officer of Regeneron and President of Regeneron Laboratories. "Importantly, in the trials that used an individualized approach with 75 mg and 150 mg doses, the majority of patients reached their LDL-C goal while remaining on a 75 mg dose. This dosing approach was designed to provide physicians and patients with the flexibility to tailor therapy to patients' lipid-lowering needs."

The ODYSSEY ALTERNATIVE trial evaluated patients with a history of intolerance to two or more statins, who were randomized to receive alirocumab, ezetimibe or atorvastatin 20 mg (a calibrator arm). This trial met its primary efficacy endpoint of a greater percent reduction from baseline in LDL-C at 24 weeks with alirocumab compared to ezetimibe. In the ALTERNATIVE trial, rates of discontinuation due to adverse events were 25 percent for atorvastatin, 25 percent for ezetimibe and 18 percent for alirocumab; these differences between treatment groups were not statistically significant.

"The robust data from these studies in more than 5,000 patients is the basis of our global regulatory submissions, which we expect in the U.S. and EU by year end," said Elias Zerhouni, M.D., President, Global R&D, Sanofi. "We look forward to potentially providing a new treatment option for patients who may need a more aggressive cholesterol-lowering treatment on top of standard of care."

More detailed data will be presented at upcoming medical congresses.

The ODYSSEY trials assessed the potential of subcutaneous alirocumab in one or more patient groups where there is high unmet need:

Heterozygous Familial hypercholesterolemia (HeFH), an inherited form of high cholesterol: ODYSSEY FH I, FH II and HIGH FH focused solely on patients in this group. HeFH is an inherited disorder of lipid metabolism that predisposes a person to high LDL-C and premature severe cardiovascular disease (CVD).
High or very high cardiovascular (CV) risk: ODYSSEY COMBO I, COMBO II, OPTIONS I, OPTIONS II and LONG TERM.
Patients with a history of statin-intolerance: ODYSSEY ALTERNATIVE included patients who had a history of being intolerant to statins and at moderate- to very-high CV risk.
The 9 ODYSSEY trials reported today, along with the previously announced MONO trial, encompass over 5,000 patients studied in double-blind trials for 24-104 weeks. ODYSSEY MONO reported positive results in October 2013. All trials included patients with LDL-C not at goal with or without a documented history of CVD. ODYSSEY OPTIONS I, OPTIONS II, COMBO II, MONO and ALTERNATIVE included at least one active comparator (e.g., ezetimibe). The trials evaluated two distinct dosing regimens: 150 milligrams (mg) every two weeks or 75 mg every two weeks increasing to 150 mg if needed to reach protocol-specified LDL-C targets. The 75 mg and the 150 mg dose were delivered with a single, self-administered one-milliliter (mL) injection.

The ODYSSEY clinical trial program remains ongoing. This includes three additional studies, CHOICE I, CHOICE II (both evaluating monthly doses of alirocumab) and OUTCOMES, which are expected to report primary endpoints in 2015 and beyond. Click here for more information on the ODYSSEY program, alirocumab, PCSK9, and LDL-C. Alirocumab is currently under clinical development and its safety and efficacy have not been fully evaluated by any regulatory authority.
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Source: press release, 7/30/14. http://investor.regeneron.com/releaseDetail.cfm?ReleaseID=862926

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ODYSSEY OUTCOMES - A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Effect of Alirocumab (SAR236553/REGN727) on the Occurrence of Cardiovascular Events in Patients Who Have Recently Experienced an Acute Coronary Syndrome
Estimated Enrollment: 18600
Study Start Date: October 2012
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
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Source: clinical trials.gov. http://clinicaltrials.gov/ct2/show/NCT01663402?term=OUTCOMES&intr=Aliroc...

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
Alirocumab (REGN727/SAR236553)CardiovascularAtherosclerosisPCSK9 inhibitorPCSK9

Mechanism of action: Alirocumab (REGN727/SAR236553) is the first fully human monoclonal antibody directed against proprotein convertase subtilisin/kexin type 9 (PCSK9). REGN727/SAR236553 is a high affinity, sub-cutaneously delivered, specific inhibitor of PCSK9. It blocks the binding of PCSK9 to the low density lipoprotein (LDL) receptor and interrupts the resultant internalization and degradation of the LDL receptor.

Phase of Development: III

Event Type: Data: Phase III trial results

Dates: 2017-10-01 - 2017-12-31

Results: Pending