Sanofi and Regeneron to present new data from investigational agent Praluent™ (alirocumab) phase 3 program at ACC.15
Bridgewater, NJ, and Tarrytown, NY - Sanofi and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) will present Phase 3 data from the PraluentTM (alirocumab) clinical program at the American College of Cardiology’s 64th Annual Scientific Session & Expo (ACC.15), being held March 14-16 in San Diego. Data includes detailed results from two new Phase 3 trials evaluating monthly dosing of Praluent in patients with hypercholesterolemia, as well as pooled safety analyses of up to nine Praluent trials.
Praluent is an investigational fully human monoclonal antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9) that is being studied for lowering low-density lipoprotein cholesterol (LDL-C, or “bad” cholesterol).
Data to be presented at ACC.15 includes:
- Saturday, March 14, 10:00 to 10:45 a.m. PT (Poster Hall B1)
Efficacy and Safety of Different Dosing Regimens of Alirocumab (Starting Doses of
75 mg Every Two Weeks and 150 mg Every Four Weeks) Versus Placebo in Patients with Hypercholesterolemia Not Treated Using Statins: The ODYSSEY CHOICE II Study
Abstract #1107-105, Poster Presentations
ODYSSEY CHOICE I and II evaluated the efficacy and safety of monthly (every four weeks) dosing of Praluent in patients with hypercholesterolemia and with moderate to high cardiovascular (CV) risk.
- Saturday, March 14, 4:00 to 4:10 p.m. PT (Poster Hall B1)
Adverse Events in Patients with Low-Density Lipoprotein Cholesterol Levels <25 or <15 mg/dL on at Least Two Consecutive Visits in Fourteen Randomized, Controlled, Clinical Trials of Alirocumab
Abstract #1164M-05, Poster Presentations
- Sunday, March 15, 9:45 to 10:30 a.m. (Poster Hall, B1)
Cardiovascular Event Rates in a High-Risk Managed Care Population in the United States
Abstract #1195-378, Poster Presentations
- Monday, March 16, 11:30 to 11:42 a.m. (Room 62B)
Pooled Safety and Adverse Events in Nine Randomized, Placebo-Controlled, Phase 2 and 3 Clinical Trials of Alirocumab
Abstract #914-08, Oral Contributions
Additional information on ACC.15 is available on the ACC website.
Earlier this year, the companies announced that the U.S. Food and Drug Administration (FDA) accepted for priority review the Biologics License Application for Praluent. Under the Prescription Drug User Fee Act (PDUFA), the goal for a priority review is six months, for a target action date of July 24, 2015. Additionally, the European Medicines Agency (EMA) accepted for review the Marketing Authorization Application for Praluent in the European Union. The EMA and FDA have conditionally accepted Praluent as the trade name for alirocumab. The safety and efficacy of Praluent have not been fully evaluated by any regulatory authority.
About Sanofi
Sanofi, an integrated global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new 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, colorectal cancer, 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 atoic dermatitis. For additional information about the company, please visit www.regeneron.com.
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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; 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, such as the ODYSSEY global trial program evaluating Praluent; the likelihood and timing of possible regulatory approval and commercial launch of Regeneron's late-stage product candidates, including without limitation Praluent; ongoing regulatory obligations and oversight impacting Regeneron's 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, 2013 and its Form 10-Q for the quarter ended September 30, 2014. 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.