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`Bayer HealthCare and Regeneron to Collaborate on VEGF Trap
` for the Treatment of Eye Diseases
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`Regeneron Retains U.S. Commercialization Rights, Receives
`$75 Million Upfront, and Eligible for up to $245 Million of Milestone Payments
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`Leverkusen, Germany and Tarrytown, NY (October 18, 2006) -- Bayer HealthCare (NYSE: BAY)
`and Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) today announced that the companies have
`entered into a collaboration agreement for the global development, and commercialization outside the
`U.S., of the VEGF Trap for the treatment of eye disease by local administration (VEGF Trap-Eye). The
`VEGF Trap-Eye, currently in Phase I and Phase II clinical trials, is a protein that binds to or traps
`vascular endothelial growth factor (VEGF) and blocks its activity. VEGF is thought to play a critical
`role in certain eye diseases.
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`The VEGF Trap is an excellent strategic fit for Bayer, which underscores our commitment to specialty
`pharmaceuticals, said Arthur Higgins, Chairman of the Board of Management, Bayer HealthCare. "We
`are encouraged by the early clinical data we ve seen and believe the VEGF Trap has the potential to
`further transform the treatment paradigm for patients suffering from diseases of the eye."
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`Under the agreement, Bayer and Regeneron will collaborate on the development of the VEGF Trap-
`Eye through an integrated global plan that encompasses the neovascular form of age-related macular
`degeneration (wet AMD), diabetic eye diseases, and other eye diseases and disorders. The
`companies will jointly commercialize the VEGF Trap-Eye outside the U.S and will share equally in
`profits from ex-U.S. sales. Within the U.S., Regeneron has exclusive commercialization rights in all
`indications and will retain 100% of all profits from any such sales.
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`Principal financial terms of the agreement include:
` Bayer will make an upfront payment of $75 million to Regeneron.
` Bayer and Regeneron will share initial global development costs (totaling over $250 million
`over the next several years) as follows:
`o 2007-2008: According to a formula based on total development costs
`o 2009 and thereafter: All expenses shared equally.
`If a VEGF Trap-Eye product is granted marketing authorization in a major market country
`outside the U.S., Regeneron, from its 50% share of VEGF Trap-Eye profits outside the U.S.,
`will reimburse Bayer for 50% of the development costs that Bayer has incurred.
` Regeneron can earn up to $110 million in total development and regulatory milestones related
`to the development of the VEGF Trap-Eye for wet AMD and DME (or other major eye
`indications) and marketing approvals in a major market countries outside the U.S. A total of
`$40 million of these milestone payments are due upon the initiation of Phase 3 clinical trials in
`wet AMD and diabetic macular edema (DME).
` Regeneron can earn up to $135 million in sales milestones when total annual sales of the
`VEGF Trap-Eye outside the U.S. achieve certain specified levels starting at $200 million.
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`Samsung et al. v. Regeneron IPR2023-00884
`Regeneron Pharmaceuticals, Inc. Exhibit 2068 Page 1
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`As an established leader in specialty pharmaceutical products, Bayer is an ideal partner to help
`develop and commercialize the VEGF Trap outside the U.S. for eye disease, said Leonard S.
`Schleifer, M.D., Ph.D., president and chief executive officer of Regeneron. In recent years there have
`been important advances in the treatment of serious eye diseases such as wet AMD, which is the
`leading cause of vision loss and blindness among people over age 65. However, there continues to be
`a need for additional treatment options. We look forward to working together with Bayer to
`aggressively develop the VEGF Trap-Eye for wet AMD, diabetic eye disease, and other eye diseases
`with unmet medical needs.
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`About Wet AMD and the VEGF Trap-Eye
`Age-related Macular Degeneration (AMD) and diabetes are the leading non-infectious causes of
`acquired blindness. Patients with these conditions can experience a gradual loss of vision due to the
`development of abnormal, fragile new blood vessels in the back of the eye. There is a particular type
`of AMD called wet AMD which accounts for approximately 90% of AMD-related blindness, despite
`constituting only 10% of cases of AMD. Approximately 1.5 million people are affected with wet AMD in
`the United States and at least an equal number in the rest of the world.
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`The development of the blood vessels which contribute to these conditions is in part due to a secreted
`protein called Vascular Endothelial Growth Factor, or VEGF. 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 a number of eye diseases,
`such as wet AMD.
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`The VEGF Trap-Eye is a fully human, soluble VEGF receptor fusion protein that binds all forms of
`VEGF-A and related placental growth factor (PlGF). The VEGF Trap-Eye is designed to block the
`interaction of these growth factors with cell-surface receptors, thereby preventing the subsequent
`formation of the new blood vessels that play an important role in the development of eye diseases
`such as wet AMD. Currently the VEGF Trap is in a Phase II clinical trial for the treatment of patients
`with wet AMD and a Phase I trial for the treatment of patients with diabetic macular edema (DME).
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`About Regeneron Pharmaceuticals
`Regeneron Pharmaceuticals, Inc. is a biopharmaceutical company that discovers, develops, and
`intends to commercialize therapeutic medicines for the treatment of serious medical conditions.
`Regeneron has therapeutic candidates in clinical trials for the potential treatment of cancer, eye
`diseases, and inflammatory diseases, and has preclinical programs in other diseases and disorders.
`For more information on Regeneron, visit the Company s web site at www.regeneron.com.
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`About Bayer HealthCare
`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. Bayer HealthCare
`generated sales amounting to some 9.4 billion euros and employed 33.800 people worldwide in 2005.
`The company combines the global activities of the Animal Health, Consumer Care, Diabetes Care,
`Diagnostics and Pharmaceuticals divisions. The new Pharmaceuticals division was established on
`January 1, 2006, and comprises the former Biological Products and Pharmaceutical divisions. Bayer
`Pharmaceuticals now has three business units: Hematology/Cardiology, Oncology and Primary Care.
`Bayer HealthCare s aim is to discover and manufacture products that will improve human and animal
`health worldwide. The products enhance well-being and quality of life by diagnosing, preventing and
`treating diseases.
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`Samsung et al. v. Regeneron IPR2023-00884
`Regeneron Pharmaceuticals, Inc. Exhibit 2068 Page 2
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`Forward Looking Statements
`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 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 Regenerons filings with the United States Securities and Exchange Commission (SEC),
`including its Form 10-K for the year ended December 31, 2005 and its Form 10-Q for the quarter ended June 30, 2006.
`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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`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 public reports filed with the Frankfurt Stock Exchange and 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.
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`Media Contacts:
`Lauren Tortorete
`Regeneron
`1.212.845.5609
`Investor Relations:
`Charles Poole
`Regeneron
`1.914.345.7640
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`Dr. Michael Diehl
`Bayer HealthCare
`+ 49 214 30 58532
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`Mark Bennett
`Bayer HealthCare
`1.203.812.2160
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`Samsung et al. v. Regeneron IPR2023-00884
`Regeneron Pharmaceuticals, Inc. Exhibit 2068 Page 3
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