Bayer and Regeneron Extend Development Program for VEGF Trap-Eye to Include Central Retinal
`Vein Occlusion
`
`April 30, 2009
`Bayer and Regeneron Extend Development Program for VEGF Trap-Eye to Include Central Retinal Vein OcclusionTwo Phase 3
`studies to start in the second half of this year
`
`BERLIN and TARRYTOWN, N.Y., April 30 /PRNewswire-FirstCall/ -- Bayer HealthCare AG and Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN)
`today announced that the companies are extending their global development program for VEGF Trap-Eye, an investigational agent for the treatment of
`certain eye diseases, to include Central Retinal Vein Occlusion (CRVO). The companies plan to initiate a Phase 3 program evaluating the efficacy and
`safety of VEGF Trap-Eye in the treatment of CRVO in the second half of this year. CRVO is caused by obstruction of the central retinal vein that that
`leads to a back up of blood and fluid in the retina, resulting in retinal injury and loss of vision. The retina can also become "ischemic" (starved for
`oxygen), resulting in the growth of abnormal new blood vessels that can cause further vision loss and more serious complications.
`
`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. Kemal Malik, Head of Global
`Development and member of the Bayer HealthCare Executive Committee. "Since the underlying biology of CRVO is related to edema and the growth
`of abnormal new blood vessels that are mediated by vascular endothelial growth factor (VEGF), we are hopeful that VEGF Trap-Eye may help address
`this significant unmet medical need."
`
`About CRVO
`
`Over 100,000 people in the United States are estimated to suffer from CRVO. CRVO is caused by obstruction of the central retinal vein that leads to a
`back up of blood and fluid in the retina, resulting in retinal injury and loss of vision. The retina can also become "ischemic" (starved for oxygen),
`resulting in the growth of new abnormal blood vessels that can cause further vision loss and more serious complications. Release of VEGF contributes
`to increased vascular permeability in the eye and abnormal new vessel growth. It is believed that anti-VEGF treatment may help decrease vascular
`permeability and edema and prevent the growth of abnormal new blood vessels in the retina in patients with CRVO.
`
`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 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.
`
`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 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
`
`Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals operation of Bayer HealthCare, an affiliate of Bayer AG. One of the world's
`
`Mylan Exhibit 1028
`Mylan v. Regeneron, IPR2021-00880
`Page 1
`
`Joining Petitioner: Apotex
`
`
`Vein Occlusion
`
`April 30, 2009
`Bayer and Regeneron Extend Development Program for VEGF Trap-Eye to Include Central Retinal Vein OcclusionTwo Phase 3
`studies to start in the second half of this year
`
`BERLIN and TARRYTOWN, N.Y., April 30 /PRNewswire-FirstCall/ -- Bayer HealthCare AG and Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN)
`today announced that the companies are extending their global development program for VEGF Trap-Eye, an investigational agent for the treatment of
`certain eye diseases, to include Central Retinal Vein Occlusion (CRVO). The companies plan to initiate a Phase 3 program evaluating the efficacy and
`safety of VEGF Trap-Eye in the treatment of CRVO in the second half of this year. CRVO is caused by obstruction of the central retinal vein that that
`leads to a back up of blood and fluid in the retina, resulting in retinal injury and loss of vision. The retina can also become "ischemic" (starved for
`oxygen), resulting in the growth of abnormal new blood vessels that can cause further vision loss and more serious complications.
`
`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. Kemal Malik, Head of Global
`Development and member of the Bayer HealthCare Executive Committee. "Since the underlying biology of CRVO is related to edema and the growth
`of abnormal new blood vessels that are mediated by vascular endothelial growth factor (VEGF), we are hopeful that VEGF Trap-Eye may help address
`this significant unmet medical need."
`
`About CRVO
`
`Over 100,000 people in the United States are estimated to suffer from CRVO. CRVO is caused by obstruction of the central retinal vein that leads to a
`back up of blood and fluid in the retina, resulting in retinal injury and loss of vision. The retina can also become "ischemic" (starved for oxygen),
`resulting in the growth of new abnormal blood vessels that can cause further vision loss and more serious complications. Release of VEGF contributes
`to increased vascular permeability in the eye and abnormal new vessel growth. It is believed that anti-VEGF treatment may help decrease vascular
`permeability and edema and prevent the growth of abnormal new blood vessels in the retina in patients with CRVO.
`
`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 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.
`
`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 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
`
`Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals operation of Bayer HealthCare, an affiliate of Bayer AG. One of the world's
`
`Mylan Exhibit 1028
`Mylan v. Regeneron, IPR2021-00880
`Page 1
`
`Joining Petitioner: Apotex
`
`
`
`leading, innovative companies in the healthcare and medical products industry, Bayer HealthCare combines the global activities of the Animal Health,
`Consumer Care, Diabetes Care, and Pharmaceuticals divisions. In the United States, Bayer HealthCare Pharmaceuticals comprises the following
`business units: Women's Healthcare, Diagnostic Imaging, General Medicine, Hematology/Neurology, and Oncology. The company's aim is to discover
`and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.
`
`Forward-Looking Statements - Bayer HealthCare AG
`
`This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management.
`Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial
`situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports
`which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking
`statements or to conform them to future events or developments.
`
`Forward Looking Statement -- Regeneron Pharmaceuticals, Inc.
`
`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 United States Securities and Exchange Commission (SEC), including its Form 10-K for the year ended December 31, 2008. 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.
`
`SOURCE Regeneron Pharmaceuticals, Inc.; Bayer HealthCare AG(cid:10)
`
` -0- 04/30/2009
` /CONTACT: Anna Koch, Bayer HealthCare, +49-30-468-15942,(cid:10)
`anna.koch@bayerhealthcare.com, or Rose Talarico, +1-973-305-5302,(cid:10)
`rose.talarico@bayer.com; or Peter Dworkin, Investor Relations,(cid:10)
`+1-914-345-7640, peter.dworkin@regeneron.com, or Laura Lindsay, Media(cid:10)
`Relations, +1-914-345-7800, laura.lindsay@regeneron.com, or Olga Fleming,(cid:10)
`Media Relations, +1-212-845-5636, ofleming@biosector2.com, all of Regeneron(cid:10)
`Pharmaceuticals, Inc./(cid:10)
` /Web Site: http://www.regeneron.com
`
` http://www.bayer.com /(cid:10)
` (REGN)(cid:10)
`
`CO: Regeneron Pharmaceuticals, Inc.; Bayer HealthCare AG; Bayer HealthCare(cid:10)
` Pharmaceuticals Inc.(cid:10)
`
`ST: Germany, New York
`IN: HEA MTC(cid:10)
`SU: TRI JVN(cid:10)
`
`PR(cid:10)
`-- NY08289 --(cid:10)
`8289 04/30/2009 02:00 EDT http://www.prnewswire.com
`
`Mylan Exhibit 1028
`Mylan v. Regeneron, IPR2021-00880
`Page 2
`
`Joining Petitioner: Apotex
`
`
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