INVESTORS & MEDIA
News Release
Sanofi and Regeneron To Present Alirocumab Clinical Data at the American College of Cardiology's 63rd Annual Scientific Session
"ACC marks the beginning of the presentation of our Phase 3 ODYSSEY data in 2014, with the first full data results from the Phase 3 ODYSSEY MONO study," said
"Despite the availability of lipid-lowering therapies, millions of people worldwide are unable to satisfactorily control their levels of low-density lipoprotein-cholesterol," said
The following data will be presented at ACC on
PHASE 3 ODYSSEY MONO FULL RESULTS:
- Abstract #1183-125: A 24-Week Study of Alirocumab as Monotherapy versus Ezetimibe: The First Phase 3 Data of a Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitor
24-Week Phase 3 ODYSSEY MONO study comparing the LDLc -lowering efficacy and safety of alirocumab vs. ezetimibe in patients not receiving statin or other lipid-lowering therapies1
Eli M. Roth -Sterling Research Group ,Cincinnati, OH , USA
OTHER ALIROCUMAB CLINICAL DATA:
- Abstract #1183-126: One Year Open-Label Treatment with Alirocumab 150 mg Every Two Weeks in Heterozygous Familial Hypercholesterolemic Patients
Phase 2 study assessing initial 52-week safety and efficacy data (as part of a longer term four-year open label treatment extension) in patients taking alirocumab 150 mg every two weeks2
Evan A. Stein -Metabolic and Atherosclerosis Research Center ,Cincinnati, OH , USA
- Abstract #1183-131: Randomized, Partial Blind Study of the Pharmacodynamics, Pharmacokinetics and Safety of Multiple Subcutaneous Doses of Alirocumab, a Fully Human Monoclonal Antibody to Proprotein Convertase Subtilisin/Kexin Type 9, Administered Every 4 Weeks Alone or In Combination with Ezetimibe or Fenofibrate in Healthy Subjects
Partial blind study in three parallel groups of healthy subjects not on lipid-lowering therapy, comparing the efficacy of alirocumab 150 mg Q4W as monotherapy or with ezetimibe or fenofibrate over a four week dosing interval3
Jacques Rey -Sanofi ,Paris, France
- Abstract # 1183-128: Effects of Alirocumab, a Fully Human Monoclonal Antibody to Proprotein Convertase Subtilisin/Kexin Type 9, on Lipoprotein Particle Concentrations Determined by Nuclear Magnetic Resonance: Substudy of a Randomized Double-Blind Phase 2 Clinical Trial
Study determining alirocumab's effect on LDL particle and other lipid particle concentrations versus placebo4
Michael J. Koren -Jacksonville Center for Clinical Research ,Jacksonville, FL , USA
- Abstract #1183-133: A Randomized Study of the Relative Bioavailability, Pharmacodynamics, and Safety of Alirocumab, a Fully Human Monoclonal Antibody to Proprotein Convertase Subtilisin/Kexin Type 9, after
Single Subcutaneous Administration at Three Different Injection Sites in Healthy Subjects
Single-center, open-label, randomized Phase 1 study comparing the bioavailability and adverse events of a single dose of alirocumab in different injection sites (arm, leg, abdomen)5
Catherine Lunven -
Sanofi ,Paris, France
Investor Relations Conference Call on Alirocumab
The companies will host an IR Thematic Conference Call for the financial community focusing on alirocumab during ACC. The conference call will take place on
U.S. +1 866 907 5925
About alirocumab
Alirocumab is an investigational, fully-human monoclonal antibody that targets and blocks PCSK9. It is administered via subcutaneous injection. By inhibiting PCSK9, a determinant of circulating LDL-C levels in the blood, alirocumab has been shown in pre-clinical studies to increase the number of LDL receptors on hepatocytes, thereby lowering LDL-C.
ODYSSEY is the global Phase 3 trial program for investigational compound alirocumab. ODYSSEY currently comprises 14 clinical trials enrolling more than 23,500 patients with hypercholesterolemia in 2,000 study centers across
About
About
Regeneron is a leading science-based biopharmaceutical company based in
References
- Roth E, Taskinen M-R, Ginsberg HN, et al. A 24-week study of alirocumab as monotherapy versus ezetimibe: the first 6-month Phase 3 data of a proprotein convertase subtilisin/kexin type 9 inhibitor. Poster #125 (session #1183) at the
American College of Cardiology's 63rd Annual Scientific Session,March 29-31 . - Stein EA, Bergeron J, Gaudet D, et al. One year open-label treatment with alirocumab 150 mg every two weeks in heterozygous familial hypercholesterolemic patients. Poster #126 (session #1183) at the
American College of Cardiology's 63rd Annual Scientific Session,March 29-31 . - Rey J, Poitiers F, Paehler T, et al. Randomized, partial blind study of the pharmacodynamics, pharmacokinetics and safety of multiple subcutaneous doses of alirocumab, a fully human monoclonal antibody to proprotein convertase subtilisin/kexin type 9, administered every 4 weeks alone or in combination with ezetimibe or fenofibrate in healthy subjects. Poster #131 (session #1183) at the
American College of Cardiology's 63rd Annual Scientific Session,March 29-31 . - Koren MJ, Kereiakes D, Pourfarzib R, et al. Effects of Alirocumab, a Fully Human Monoclonal Antibody to Proprotein Convertase Subtilisin/Kexin Type 9, on Lipoprotein Particle Concentrations Determined by Nuclear Magnetic Resonance: Sub-Study of a Randomized Double-Blind Phase II Clinical Trial. Poster #128 (session #1183) at the
American College of Cardiology's 63rd Annual Scientific Session,March 29-31 . - Lunven C, Paehler T Lewanczyk P, et al. Randomized Study of the Relative Bioavailability, Pharmacodynamics, and Safety of Alirocumab, a Fully Human Monoclonal Antibody to Proprotein Convertase Subtilisin/Kexin Type 9,
After Single Subcutaneous Administration at Three Different Injection Sites in Healthy Subjects. Poster #133 (session #1183) at theAmerican College of Cardiology's 63rd Annual Scientific Session,March 29-31 .
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
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, 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 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, including without limitation the Phase 3 ODYSSEY MONO study and the ODYSSEY global Phase 3 trial program, which may affect the global filing plan for alirocumab; the likelihood and timing of possible regulatory approval and commercial launch of Regeneron's late-stage product candidates; 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
Sanofi Contacts:
Media Relations Tel : +33 (0)1 53 77 94 74
Tel: +1 908-981-5360 Mobile: +1 908-340-7811 |
Investor Relations Sébastien Tel.: +33 (0)1 53 77 45 45 |
Regeneron Contacts:
Media Relations Sandy Sexton Tel: +1 914- 847-3358
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Investor Relations Tel: +1 914-847-5126 manisha.narasimhan@regeneron.com
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