Regeneron to Webcast Investor Briefing on VEGF Trap-Eye Clinical Program on Sunday, February 13th at 9 am ET
TARRYTOWN, N.Y., Feb. 9, 2011 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) today announced that it will webcast an investor briefing on Sunday, February 13 from 9 a.m. to 10:30 a.m. Eastern Time. At the investor briefing, principal investigators from the VEGF Trap-Eye clinical studies will recap presentations from the Bascom Palmer Eye Institute’s Angiogenesis, Exudation and Degeneration 2011 meeting being held in Miami, Florida on Saturday, February 12.
The investigator presentations will provide additional data from the VIEW 1 and VIEW 2 Phase 3 trials in patients with the neovascular form of age-related macular degeneration (wet AMD), the COPERNICUS Phase 3 trial in macular edema due to central retinal vein occlusion (CRVO), and the DA VINCI Phase 2 trial in diabetic macular edema (DME). Regeneron reported positive top-line results from all these trials in the fourth quarter of 2010.
“It’s a privilege to be able to release this important collection of VEGF Trap-Eye data at the Bascom Palmer Eye Institute’s Eighth Annual Angiogenesis Meeting,” said Philip J. Rosenfeld, M.D., Ph.D., Professor of Ophthalmology, University of Miami Miller School of Medicine and Course Co-Director of the Angiogenesis 2011 Meeting. “In particular, the Phase 3 results in wet AMD suggest that the VEGF Trap-Eye has the potential to address an important unmet need of providing optimal vision gain while reducing the burden of intravitreal injections and office visits for patients and their caregivers.”
The webcast and slides may be accessed through the Company’s web site, www.regeneron.com, on the Investor Relations page (http://investor.regeneron.com). An archived version of the presentation will be available after the live webcast through March 17, 2011.
About VEGF Trap-Eye
VEGF Trap-Eye is a recombinant fusion protein consisting of portions of human VEGF receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1 that binds all forms of VEGF-A along with the related Placental Growth Factor (PlGF). VEGF Trap-Eye is a specific and highly potent blocker of these growth factors. VEGF Trap-Eye is specially purified and contains iso-osmotic buffer concentrations, allowing for injection into the eye.
Regeneron and Bayer HealthCare are collaborating on the global development of VEGF Trap-Eye for the treatment of wet AMD, DME, CRVO, myopic CNV, and other eye diseases and disorders. The companies plan to submit regulatory applications for marketing approval for VEGF Trap-Eye for the treatment of wet AMD in Europe and the U.S. in the first-half of 2011. Bayer HealthCare will market VEGF Trap-Eye outside the United States, where the companies will share equally in profits from any future sales of VEGF Trap-Eye. Regeneron maintains exclusive rights to VEGF Trap-Eye in the United States.
In November 2010, Regeneron and Bayer HealthCare announced positive top-line results from two parallel Phase 3 studies in patients with wet AMD, VIEW 1 and VIEW 2. In these trials, all regimens of VEGF Trap-Eye, including VEGF Trap-Eye dosed every two months, successfully met the primary endpoint compared to the current standard of care, ranibizumab dosed every month. The primary endpoint was statistical non-inferiority in the proportion of patients who maintained (or improved) vision over 52 weeks compared to ranibizumab. A generally favorable safety profile was observed for both VEGF Trap-Eye and ranibizumab. The most frequent ocular adverse events were conjunctival hemorrhage, macular degeneration, eye pain, retinal hemorrhage, and vitreous floaters and were balanced across all treatment groups in both studies. There were no notable differences in non-ocular adverse events among the study arms.
Trials in other indications such as CRVO and DME are currently underway or in preparation.
About Wet Age-Related Macular Degeneration (wet AMD)
Age-related macular degeneration (AMD) is a leading cause of acquired blindness. Macular degeneration is diagnosed as either dry (non-exudative) or wet (exudative). In wet AMD, new blood vessels grow beneath the retina and leak blood and fluid. This leakage causes disruption and dysfunction of the retina creating distortion and/or blind spots in central vision, and it can account for blindness in wet AMD patients. Wet AMD is the leading cause of blindness for people over the age of 65 in the U.S. and Europe. It is estimated that more than 210,000 Americans are newly diagnosed with and treated for wet AMD each year.
About Central Retinal Vein Occlusion (CRVO)
Over 100,000 people in the United States and more than 66,000 people in key European countries are estimated to suffer from central retinal vein occlusion (CRVO). CRVO is caused by obstruction of the central retinal vein that leads to a back up of blood and fluid in the retina. This causes retinal injury and loss of vision. The retina can also become “ischemic” (starved for oxygen), resulting in the growth of new, inappropriate blood vessels that can cause further vision loss and more serious complications. Release of vascular endothelial growth factor (VEGF) contributes to increased vascular permeability in the eye and inappropriate new vessel growth. It is believed that anti-VEGF treatment may help decrease vascular permeability and edema and prevent the inappropriate growth of new blood vessels in the retina in patients with CRVO.
About Diabetic Macular Edema (DME)
Diabetic macular edema (DME) is the most prevalent cause of moderate vision loss in patients with diabetes. DME is a common complication of Diabetic Retinopathy (DR), a disease affecting the blood vessels of the retina. Clinically significant DME is a leading cause of blindness in younger adults (under 50). Clinically significant DME occurs when fluid leaks into the center of the macula, the light-sensitive part of the retina responsible for sharp, direct vision. Fluid in the macula can cause severe vision loss or blindness.
Approximately 370,000 Americans currently suffer from clinically significant DME, with 95,000 new cases arising each year. According to the American Diabetes Association, more than 18 million Americans currently suffer from diabetes, and many other people are at risk for developing diabetes. With the incidence of diabetes steadily climbing, it is projected that up to 10 percent of all patients with diabetes will develop DME during their lifetime.
About Regeneron Pharmaceuticals
Regeneron is a fully integrated biopharmaceutical company that discovers, develops, and commercializes medicines for the treatment of serious medical conditions. In addition to ARCALYSTÃ‚® (rilonacept) Injection for Subcutaneous Use, its first commercialized product, Regeneron has therapeutic candidates in Phase 3 clinical trials for the potential treatment of gout, diseases of the eye (wet age-related macular degeneration and central retinal vein occlusion), and certain cancers. Additional therapeutic candidates developed from proprietary Regeneron technologies for creating fully human monoclonal antibodies are in earlier stage development programs in rheumatoid arthritis and other inflammatory conditions, pain, cholesterol reduction, allergic and immune conditions, and cancer. Additional information about Regeneron and recent news releases are available on Regeneron’s web site at www.regeneron.com.
Regeneron Forward Looking Statement
This news release includes forward-looking statements about Regeneron and its products, development programs, finances, and business, all of which involve a number of risks and uncertainties. These include, among others, risks and timing 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 license or collaboration agreement, including Regeneron’s agreements with the sanofi-aventis Group and Bayer HealthCare, to be canceled or terminated without any product success, and risks associated with third party intellectual property. 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 (SEC), including its Form 10-K for the year ended December 31, 2009 and Form 10-Q for the quarter ended September 30, 2010. 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.
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