Bayer HealthCare AG And Regeneron Pharmaceuticals, Inc. To Collaborate On VEGF Trap For The Treatment Of Eye Diseases; Regeneron Retains U.S. Commercialization Right…
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`Bayer HealthCare AG And
`Regeneron Pharmaceuticals,
`Inc. To Collaborate On VEGF
`Trap For The Treatment Of Eye
`Diseases; Regeneron Retains
`U.S. Commercialization Rights,
`Receives $75 Million Upfront,
`And Eligible For Up To $245
`Million Of Milestone Payments
`
`Published: Oct 19, 2006
`
`LEVERKUSEN, Germany and TARRYTOWN, N.Y., Oct. 18 /PRNewswire-
`FirstCall/ -- Bayer HealthCare (NYSE: BAY - News) and Regeneron
`Pharmaceuticals, Inc. (Nasdaq: REGN - News) 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.
`
`https://www.biospace.com/article/releases/bayer-healthcare-ag-and-regeneron-pharmaceuticals-inc-to-collaborate-on-vegf-trap-for-the-treatment-of-eye-diseases-b-regeneron-b-retains-u-s-c/
`
`1/9
`
`Mylan Exhibit 1172
`Mylan v. Regeneron, IPR2021-00881
`Page 1
`
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`Bayer HealthCare AG And
`Regeneron Pharmaceuticals,
`Inc. To Collaborate On VEGF
`Trap For The Treatment Of Eye
`Diseases; Regeneron Retains
`U.S. Commercialization Rights,
`Receives $75 Million Upfront,
`And Eligible For Up To $245
`Million Of Milestone Payments
`
`Published: Oct 19, 2006
`
`LEVERKUSEN, Germany and TARRYTOWN, N.Y., Oct. 18 /PRNewswire-
`FirstCall/ -- Bayer HealthCare (NYSE: BAY - News) and Regeneron
`Pharmaceuticals, Inc. (Nasdaq: REGN - News) 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.
`
`https://www.biospace.com/article/releases/bayer-healthcare-ag-and-regeneron-pharmaceuticals-inc-to-collaborate-on-vegf-trap-for-the-treatment-of-eye-diseases-b-regeneron-b-retains-u-s-c/
`
`1/9
`
`Mylan Exhibit 1172
`Mylan v. Regeneron, IPR2021-00881
`Page 1
`
`
`
`Bayer HealthCare AG And Regeneron Pharmaceuticals, Inc. To Collaborate On VEGF Trap For The Treatment Of Eye Diseases; Regeneron Retains U.S. Commercialization Right…
`"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."
`
`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.
`
`Principal financial terms of the agreement include:
`
`* Bayer will make an upfront payment of $75 million to
`Regeneron.
`
`https://www.biospace.com/article/releases/bayer-healthcare-ag-and-regeneron-pharmaceuticals-inc-to-collaborate-on-vegf-trap-for-the-treatment-of-eye-diseases-b-regeneron-b-retains-u-s-c/
`
`2/9
`
`Mylan Exhibit 1172
`Mylan v. Regeneron, IPR2021-00881
`Page 2
`
`
`
`Bayer HealthCare AG And Regeneron Pharmaceuticals, Inc. To Collaborate On VEGF Trap For The Treatment Of Eye Diseases; Regeneron Retains U.S. Commercialization Right…
`* Bayer and Regeneron will share initial global development
`costs (totaling over $250 million over the next several years) as
`follows:
`
`-- 2007-2008: According to a formula based on total
`development costs
`
`-- 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.
`
`https://www.biospace.com/article/releases/bayer-healthcare-ag-and-regeneron-pharmaceuticals-inc-to-collaborate-on-vegf-trap-for-the-treatment-of-eye-diseases-b-regeneron-b-retains-u-s-c/
`
`3/9
`
`Mylan Exhibit 1172
`Mylan v. Regeneron, IPR2021-00881
`Page 3
`
`
`
`Bayer HealthCare AG And Regeneron Pharmaceuticals, Inc. To Collaborate On VEGF Trap For The Treatment Of Eye Diseases; Regeneron Retains U.S. Commercialization Right…
`"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."
`
`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
`
`https://www.biospace.com/article/releases/bayer-healthcare-ag-and-regeneron-pharmaceuticals-inc-to-collaborate-on-vegf-trap-for-the-treatment-of-eye-diseases-b-regeneron-b-retains-u-s-c/
`
`4/9
`
`Mylan Exhibit 1172
`Mylan v. Regeneron, IPR2021-00881
`Page 4
`
`
`
`Bayer HealthCare AG And Regeneron Pharmaceuticals, Inc. To Collaborate On VEGF Trap For The Treatment Of Eye Diseases; Regeneron Retains U.S. Commercialization Right…
`AMD in the United States and at least an equal number in the
`rest of the world.
`
`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.
`
`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).
`
`About Regeneron Pharmaceuticals
`
`https://www.biospace.com/article/releases/bayer-healthcare-ag-and-regeneron-pharmaceuticals-inc-to-collaborate-on-vegf-trap-for-the-treatment-of-eye-diseases-b-regeneron-b-retains-u-s-c/
`
`5/9
`
`Mylan Exhibit 1172
`Mylan v. Regeneron, IPR2021-00881
`Page 5
`
`
`
`Bayer HealthCare AG And Regeneron Pharmaceuticals, Inc. To Collaborate On VEGF Trap For The Treatment Of Eye Diseases; Regeneron Retains U.S. Commercialization Right…
`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.
`
`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
`
`https://www.biospace.com/article/releases/bayer-healthcare-ag-and-regeneron-pharmaceuticals-inc-to-collaborate-on-vegf-trap-for-the-treatment-of-eye-diseases-b-regeneron-b-retains-u-s-c/
`
`6/9
`
`Mylan Exhibit 1172
`Mylan v. Regeneron, IPR2021-00881
`Page 6
`
`
`
`Bayer HealthCare AG And Regeneron Pharmaceuticals, Inc. To Collaborate On VEGF Trap For The Treatment Of Eye Diseases; Regeneron Retains U.S. Commercialization Right…
`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.
`
`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
`
`https://www.biospace.com/article/releases/bayer-healthcare-ag-and-regeneron-pharmaceuticals-inc-to-collaborate-on-vegf-trap-for-the-treatment-of-eye-diseases-b-regeneron-b-retains-u-s-c/
`
`7/9
`
`Mylan Exhibit 1172
`Mylan v. Regeneron, IPR2021-00881
`Page 7
`
`
`
`Bayer HealthCare AG And Regeneron Pharmaceuticals, Inc. To Collaborate On VEGF Trap For The Treatment Of Eye Diseases; Regeneron Retains U.S. Commercialization Right…
`Regeneron's 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.
`
`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.
`
`Source: Bayer HealthCare
`
` >>> Discuss This Story
`
`https://www.biospace.com/article/releases/bayer-healthcare-ag-and-regeneron-pharmaceuticals-inc-to-collaborate-on-vegf-trap-for-the-treatment-of-eye-diseases-b-regeneron-b-retains-u-s-c/
`
`8/9
`
`Mylan Exhibit 1172
`Mylan v. Regeneron, IPR2021-00881
`Page 8
`
`
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`Bayer HealthCare AG And Regeneron Pharmaceuticals, Inc. To Collaborate On VEGF Trap For The Treatment Of Eye Diseases; Regeneron Retains U.S. Commercialization Right…
`Related links
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`https://www.biospace.com/article/releases/bayer-healthcare-ag-and-regeneron-pharmaceuticals-inc-to-collaborate-on-vegf-trap-for-the-treatment-of-eye-diseases-b-regeneron-b-retains-u-s-c/
`
`9/9
`
`Mylan Exhibit 1172
`Mylan v. Regeneron, IPR2021-00881
`Page 9
`
`
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