Two Phase 3 studies to start in the second half of this year
The Phase 3 program in CRVO will consist of two, multinational, one-year clinical studies which have been reviewed with regulatory authorities. These studies will expand the companies' global development collaboration for VEGF Trap-Eye, which already includes two ongoing Phase 3 studies in patients with the neovascular form of Age-related Macular Degeneration (wet AMD) and a Phase 2 study in patients with Diabetic Macular Edema (DME). Enrollment in the wet AMD and DME studies is expected to be completed later this year.
"Although CRVO is a leading cause of blindness, there is currently no
treatment available that can be universally considered to be the standard of
care, and there is no approved treatment to prevent the loss of vision or
improve vision once it is lost," said Dr.
Over 100,000 people in the
About the Phase 3 CRVO Program
In the Phase 3 CRVO program for VEGF Trap-Eye, Regeneron and Bayer HealthCare will conduct two identical multinational clinical studies: COPERNICUS (COntrolled Phase 3 Evaluation of Repeated iNtravitreal administration of VEGF Trap-Eye In Central retinal vein occlusion: Utility and Safety) will be led by Regeneron and GALILEO (General Assessment Limiting InfiLtration of Exudates in central retinal vein Occlusion with VEGF Trap-Eye) will be led by Bayer HealthCare. Enrollment will be initiated later in 2009.
Patients in both studies will receive 6 monthly intravitreal injections of either VEGF Trap-Eye at a dose of 2 milligrams (mg) or sham control injections. The primary endpoint of both studies is improvement in visual acuity versus baseline after 6 months of treatment. At the end of the initial 6 months, all patients will be dosed on a PRN (as needed) basis for another 6 months. All patients will be eligible for rescue laser treatment.
About VEGF Trap-Eye
Vascular Endothelial Growth Factor (VEGF) is a naturally occurring protein in the body whose normal role is to trigger formation of new blood vessels (angiogenesis) to support the growth of the body's tissues and organs. It has also been associated with the abnormal growth and fragility of new blood vessels in the eye and vascular permeability and edema. VEGF Trap-Eye is a fully human, soluble VEGF receptor fusion protein that binds all forms of VEGF-A along with the related Placental Growth Factor (PlGF). Investigational VEGF Trap-Eye is a specific blocker of VEGF-A and PlGF that has been demonstrated in preclinical models to bind these growth factors with greater affinity than their natural receptors.
Regeneron and Bayer HealthCare are collaborating on the global development
of VEGF Trap-Eye for the treatment of wet AMD, DME, CRVO, and other eye
diseases and disorders. Bayer HealthCare will market VEGF Trap-Eye outside the
Regeneron is a fully integrated biopharmaceutical company that discovers, develops, and commercializes medicines for the treatment of serious medical conditions. In addition to ARCALYST® (rilonacept) Injection for Subcutaneous Use, its first commercialized product, Regeneron has therapeutic candidates in clinical trials for the potential treatment of cancer, eye diseases, inflammatory diseases, and pain and has preclinical programs in other diseases and disorders. Additional information about Regeneron and recent news releases are available on Regeneron's web site at www.regeneron.com.
About Bayer HealthCare Pharmaceuticals
Forward-Looking Statements - Bayer HealthCare AG
This release may contain forward-looking statements based on current
assumptions and forecasts made by
Forward Looking Statement --
This news release discusses historical information and includes
forward-looking statements about Regeneron and its products, development
programs, finances, and business, all of which involve a number of risks and
uncertainties, such as risks associated with preclinical and clinical
development of Regeneron's drug candidates, determinations by regulatory and
administrative governmental authorities which may delay or restrict
Regeneron's ability to continue to develop or commercialize its product and
drug candidates, competing drugs that are superior to Regeneron's product and
drug candidates, uncertainty of market acceptance of Regeneron's product and
drug candidates, unanticipated expenses, the availability and cost of capital,
the costs of developing, producing, and selling products, the potential for
any collaboration agreement, including Regeneron's agreements with the
sanofi-aventis Group and Bayer HealthCare, to be canceled or to terminate
without any product success, risks associated with third party intellectual
property, and other material risks. A more complete description of these and
other material risks can be found in Regeneron's filings with the
Regeneron Pharmaceuticals, Inc.; Bayer HealthCare AG-0- 04/30/2009/CONTACT: Anna Koch, Bayer HealthCare, +49-30-468-15942, firstname.lastname@example.org, or Rose Talarico, +1-973-305-5302, email@example.com; or Peter Dworkin, Investor Relations, +1-914-345-7640, firstname.lastname@example.org, or Laura Lindsay, Media Relations, +1-914-345-7800, email@example.com, or Olga Fleming, Media Relations, +1-212-845-5636, firstname.lastname@example.org, all of Regeneron Pharmaceuticals, Inc./ /Web Site: http://www.regeneron.com http://www.bayer.com / (REGN) CO: Regeneron Pharmaceuticals, Inc.; Bayer HealthCare AG; Bayer HealthCare Pharmaceuticals Inc.ST: Germany, New YorkIN: HEA MTC SU: TRI JVN PR -- NY08289 -- 8289 04/30/2009 02:00 EDThttp://www.prnewswire.com