Navigation Links
Regeneron Announces Data Publication and Presentations with Potential First-in-Class Lipid-Lowering PCSK9 Antibody

TARRYTOWN, N.Y., March 21, 2012 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that results of the Phase 1 clinical program with their investigational product REGN727/SAR236553, a novel, high-affinity, subcutaneously administered, fully-human antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9 serine protease) were published in the March 22, 2012 issue of the New England Journal of Medicine.  The primary author of the article, entitled "Effect of a Monoclonal Antibody to PCSK9 on LDL Cholesterol," was Evan A. Stein, M.D., Ph.D., Director of the Metabolic and Atherosclerosis Research Center in Cincinnati, Ohio, and Principal Investigator of one of the REGN727/SAR236553 Phase 1 clinical trials. 

Additionally, results of two of three completed Phase 2 studies of REGN727/SAR236553 will be presented at oral sessions at the American College of Cardiology (ACC) annual meeting.  The presentations are:

  • "A Randomized, Double-Blind, Placebo-Controlled Trial Of The Safety And Efficacy of a Monoclonal Antibody To Proprotein Convertase Subtilisin/Kexin Type 9 Serine Protease, REGN727/SAR236553, in Patients With Primary Hypercholesterolemia" will be presented by James M. McKenney, Pharm.D, Professor Emeritus, Virginia Commonwealth University School of Medicine, during a Late-Breaking Clinical Trial session on Monday, March 26 at 11:14 AM.
  • "The Effects of Co-administering a Monoclonal Antibody to Proprotein Convertase Subtilisin/Kexin Type 9 Serine Protease, REGN727/SAR236553, with 10 and 80 mg Atorvastatin Compared to 80 mg Atorvastatin Alone in Patients With Primary Hypercholesterolemia" will be presented by Eli M. Roth, M.D., Professor of Clinical Medicine and Director of Preventive Cardiology for the Division of Cardiology, University of Cincinnati College of Medicine, on Sunday, March 25 at 8:25 AM.
  • About PCSK9
    PCSK9 is known to be a determinant of circulating LDL levels, as it binds to LDL receptors resulting in their degradation so that fewer are available on liver cells to remove excess LDL-cholesterol from the blood.  Moreover, traditional LDL-lowering therapies such as statins actually stimulate the production of PCSK9, which may limit their ability to lower LDL-cholesterol.  Blocking the PCSK9 pathway is therefore a potentially novel mechanism for lowering LDL-cholesterol.

    About REGN727
    REGN727/SAR236553 is a fully-human monoclonal antibody directed against PCSK9, administered via subcutaneous injection.  By inhibiting PCSK9, a determinant of circulating LDL-cholesterol levels in the blood, REGN727 increases the number of free LDL receptors which can bind to circulating LDL and clear it from the bloodstream.  REGN727 was created using Regeneron's pioneering VelocImmune® technology and is being developed by Regeneron in collaboration with Sanofi.

    About Regeneron Pharmaceuticals
    Regeneron is a fully integrated biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions.  Regeneron markets two products in the United States, one for the treatment of neovascular (wet) age-related macular degeneration and another for the treatment of a rare inflammatory condition.  Additionally, Regeneron has three regulatory applications pending before the U.S. Food and Drug Administration (FDA) and 10 drug candidates in clinical development.  More information and recent news releases are available on the Regeneron web site at

    Regeneron Forward-Looking Statement
    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.  These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of Regeneron's product candidates and research and clinical programs now underway or planned, including without limitation REGN727/SAR236553, unforeseen safety issues resulting from the administration of products and product candidates in patients, 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 drug candidates, competing drugs that may be superior to Regeneron's products and drug candidates, uncertainty of market acceptance of Regeneron's products and drug candidates, unanticipated expenses, the costs of developing, producing, and selling products, the potential for any license or collaboration agreement, including Regeneron's agreements with the Sanofi Group and Bayer HealthCare, to be canceled or terminated without any product success, and risks associated with third party intellectual property 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, 2011.  Regeneron does not undertake any obligation to update publicly any forward-looking statement, whether as a result of new information, future events, or otherwise, unless required by law.

    Contact Information:Media RelationsInvestor RelationsPeter DworkinManisha Narasimhan,


    SOURCE Regeneron Pharmaceuticals, Inc.
    Copyright©2010 PR Newswire.
    All rights reserved

    Related medicine technology :

    1. Bayer and Regeneron Dose First Patient in Second Phase 3 Study for VEGF Trap-Eye in Wet Age-Related Macular Degeneration
    2. Bayer and Regeneron Extend Development Program for VEGF Trap-Eye to Include Central Retinal Vein Occlusion
    3. Enrollment Completed in Regeneron and Bayer HealthCare Phase 3 Studies of VEGF Trap-Eye in Neovascular Age-Related Macular Degeneration (Wet AMD)
    4. Regeneron Announces Presentation at the 18th Annual Credit Suisse Healthcare Conference
    5. Regeneron Reports Third Quarter 2009 Financial and Operating Results
    6. Sanofi-aventis and Regeneron Expand Strategic Antibody Collaboration
    7. Regeneron Announces Presentation at the Deutsche Bank 2009 Biotech Boston Confab
    8. BioMed Realty Trust Signs New Lease With Regeneron Pharmaceuticals for 131,000 Square Feet at Landmark
    9. Regeneron Announces Presentation at the Morgan Stanley Global Healthcare Conference
    10. Regeneron Announces Presentation at the UBS Global Life Sciences Conference
    11. Regeneron Announces Panel Discussion at Citis 5th Annual Biotech Day
    Post Your Comments:
    (Date:12/1/2015)... Breg, Inc ., a premier provider ... it has been awarded three contracts by Novation, a ... will have access to improved pricing for Breg,s portfolio ... goods dedicated to advancing orthopedic care.  ... population, rising prevalence of chronic conditions and the health ...
    (Date:12/1/2015)... 2015 During the recent 2015 Transcatheter ... Francisco, CA , Medinol Ltd. continued to ... During a satellite symposium, "The BioNIR eDES: The ... Restenosis", a renowned physician panel discussed the key ... Coronary Stent System and the Medinol eDES Coronary ...
    (Date:12/1/2015)... 2015 ... of the "2016 Europe Enteric ... Coli, Enterovirus, Rhinovirus, Rotavirus, Salmonella, Shigella, ... offering. --> ) ... "2016 Europe Enteric Disease Testing ...
    Breaking Medicine Technology:
    (Date:12/1/2015)... , ... December 01, 2015 , ... ... leadless pacemakers in the U.S. and is the only hospital in the region ... largest clinical data presentation of transcatheter pacing patients were revealed recently at a ...
    (Date:12/1/2015)... ... December 01, 2015 , ... Growth in medical payments per workers’ compensation claim ... of hospital and nonhospital care, according to a recent study by the Workers Compensation ... Edition , found medical payments per claim with more than seven days of lost ...
    (Date:12/1/2015)... ... 01, 2015 , ... It’s official: Tattoo taboo is a thing of the ... among Millennials (a whopping one in three aged 18 to 25 is inked). As ... with their ink. In fact, RealSelf , the world’s largest community for learning ...
    (Date:12/1/2015)... ... December 01, 2015 , ... For many X-rays taken at ... accurate interpretation by the radiologist. The marking utensils are so small, however, they ... found a way to alleviate this problem. , He developed the patent-pending MARK ...
    (Date:12/1/2015)... ... December 01, 2015 , ... ... been selected as a finalist in this year’s Fierce Innovation Awards: Healthcare Edition, ... Healthcare was recognized as a finalist in the category of Digital Solutions for ...
    Breaking Medicine News(10 mins):