Regeneron and Bayer HealthCare Initiate Phase 3 Global Development Program For VEGF Trap-Eye
`In Wet Age-Related Macular Degeneration (AMD)
`
`August 2, 2007
`Regeneron and Bayer HealthCare Initiate Phase 3 Global Development Program For VEGF Trap-Eye In Wet Age-Related Macular
`Degeneration (AMD)TARRYTOWN, N.Y. & LEVERKUSEN, Germany--(BUSINESS WIRE)--Aug. 2, 2007--Regeneron
`Pharmaceuticals, Inc. (Nasdaq: REGN) and Bayer HealthCare AG (NYSE:BAY) announced today that the companies have
`initiated a Phase 3 study of the VEGF Trap-Eye in the neovascular form of age-related macular degeneration (wet AMD). The
`study will be a non-inferiority comparison of the VEGF Trap-Eye and ranibizumab (Lucentis®, a registered trademark of
`Genentech, Inc.), an anti-angiogenic agent approved for use in wet AMD. The study will be conducted pursuant to a Special
`Protocol Assessment from the U.S. Food and Drug Administration (FDA). This trial, known as VIEW 1 (VEGF Trap: Investigation
`of Efficacy and safety in Wet age-related macular degeneration), is the first study in the companies' Phase 3 global development
`program in wet AMD, which is planned to be carried out in the U.S., Europe, and other parts of the world.
`
`"Age-related macular degeneration continues to be one of the leading causes of blindness in adults, and new therapies are essential to providing
`optimal patient care," stated Jeffrey Heier, M.D., a clinical ophthalmologist at Ophthalmic Consultants of Boston and chair of the steering committee for
`the trial. "The results of early phase studies of VEGF Trap-Eye suggest it has the potential to be a highly efficacious treatment with less frequent
`administration. If these results are confirmed in Phase 3 trials, it would be important for both patients and physicians and would be a significant
`advance in the treatment of these patients."
`
`"The initiation of this Phase 3 trial represents a major milestone in the development of the VEGF Trap-Eye to treat wet AMD," said Avner Ingerman,
`M.D., vice president and ophthalmology team leader for Regeneron. "While this trial enables us to continue in our effort to improve the lives of patients
`suffering from wet AMD, it also signals the beginning of a larger, more global development program investigating the potential of VEGF Trap-Eye for
`the treatment of diabetic eye diseases and other eye diseases and disorders."
`
`The randomized, double-masked Phase 3 study is expected to enroll approximately 1,200 patients in more than 200 centers throughout the United
`States and Canada. The study will evaluate the safety and efficacy of the VEGF Trap-Eye at doses of 0.5 milligrams (mg) and 2.0 mg administered at
`four-week dosing intervals and 2.0 mg at an eight-week dosing interval, compared to 0.5 mg of ranibizumab administered every four weeks, consistent
`with its labeled dosing schedule.
`
`The primary endpoint of the study is the proportion of patients treated with the VEGF Trap-Eye who maintain or improve vision at the end of one year,
`compared to ranibizumab patients. Visual acuity is defined as the total number of letters read correctly on the Early Treatment Diabetic Retinopathy
`Study (ETDRS) chart. Maintenance of vision is defined as losing fewer than three lines (equivalent to 15 letters) on the ETDRS chart. After the first
`year of treatment, patients will continue to be treated and followed for another year.
`
`In an analysis of interim data from the ongoing Phase 2 trial in wet AMD, where patients were treated with the VEGF Trap-Eye either monthly or
`quarterly, combined data for all patients demonstrated a statistically significant reduction in retinal thickness and improvement in visual acuity after 12
`weeks, compared to baseline. There were no drug-related serious adverse events, and treatment with the VEGF Trap-Eye was generally
`well-tolerated. The most common adverse events were those typically associated with intravitreal injections. The interim results of this Phase 2 trial
`were presented at the annual meeting of the Association for Research in Vision and Ophthalmology (ARVO) this past May. The companies expect to
`report final primary endpoint results of the trial at a scientific meeting later this quarter.
`
`Regeneron and Bayer HealthCare are collaborating on the global development of the VEGF Trap-Eye for the treatment of wet AMD, diabetic eye
`diseases, and other eye diseases and disorders. Bayer HealthCare will market the VEGF Trap-Eye outside the United States, where the parties will
`share equally in profits from any future sales of the VEGF Trap-Eye. Regeneron maintains exclusive rights to the VEGF Trap-Eye in the United States.
`
`About the 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, which lead to the development of wet AMD. The 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). The VEGF Trap-Eye is a specific and highly potent blocker of these growth
`factors. Blockade of VEGF, which can prevent abnormal blood vessel formation and vascular leak, has proven beneficial in the treatment of wet AMD.
`Blocking VEGF has been shown to be effective in patients with wet AMD; and a VEGF inhibitor, ranibizumab, has been approved for treatment of
`patients with this condition.
`
`About AMD
`
`Age-related macular degeneration (AMD) is a leading cause of acquired blindness. Patients with this condition can experience a loss of vision due to
`the development of abnormal, fragile blood vessels in the back of the eye. A particular type of AMD, called wet AMD, accounts for approximately 90
`percent of AMD-related blindness. Wet AMD is the leading cause of blindness for people over the age of 65 in the U.S. and Europe.
`
`Macular degeneration is diagnosed as either dry (nonexudative) 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 blind spots in central vision, and it can lead to blindness in wet
`AMD patients.
`
`Mylan Exhibit 1054
`Mylan v. Regeneron, IPR2021-00880
`Page 1
`
`

`

`About Regeneron Pharmaceuticals
`
`Regeneron is a biopharmaceutical company that discovers, develops, and intends to commercialize therapeutic medicines for the treatment of serious
`medical conditions. Regeneron has therapeutic candidates for the potential treatment of cancer, eye diseases, and inflammatory diseases and has
`preclinical programs in other diseases and disorders. Additional information about Regeneron and recent news releases are available on Regeneron's
`worldwide web site at www.regeneron.com.
`
`About Bayer HealthCare
`
`The Bayer Group is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. Bayer HealthCare, a
`subsidiary of Bayer AG, is one of the world's leading, innovative companies in the healthcare and medical products industry and is based in
`Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Diabetes Care and Pharmaceuticals
`divisions. The pharmaceuticals business operates under the name Bayer Schering Pharma AG. Bayer HealthCare's aim is to discover and
`manufacture products that will improve human and animal health worldwide. Find more information at www.bayerhealthcare.com.
`
`Forward Looking Statement - Regeneron
`
`This news release discusses historical information and includes forward-looking statements about Regeneron and its products, programs, finances,
`and business, all of which involve a number of risks and uncertainties, such as risks associated with preclinical and clinical development of our drug
`candidates, determinations by regulatory and administrative governmental authorities which may delay or restrict our ability to continue to develop or
`commercialize our drug candidates, competing drugs that are superior to our product candidates, unanticipated expenses, the availability and cost of
`capital, the costs of developing, producing, and selling products, the potential for any collaboration agreement, including our 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-Q for the quarter ended June 30, 2007. 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.
`
`Forward-Looking Statements - Bayer HealthCare
`
`This news release contains forward-looking statements based on current assumptions and forecasts made by Bayer Group 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 our annual and interim reports to
`the Frankfurt Stock Exchange and in our reports filed with the U.S. Securities and Exchange Commission (including our Form 20-F). The company
`assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
`
` CONTACT: for Regeneron Pharmaceuticals, Inc.(cid:10)
` Charles Poole, 914-345-7640(cid:10)
` Investor Relations(cid:10)
` charles.poole@regeneron.com(cid:10)
` or(cid:10)
` Laura Lindsay, 914-345-7800(cid:10)
` Corporate Communications(cid:10)
` laura.lindsay@regeneron.com(cid:10)
` or(cid:10)
` Lauren Tortorete, 212-845-5609(cid:10)
` Media Relations(cid:10)
` ltortorete@biosector2.com(cid:10)
`
` SOURCE: Regeneron Pharmaceuticals, Inc.(cid:10)
`
`Mylan Exhibit 1054
`Mylan v. Regeneron, IPR2021-00880
`Page 2
`
`