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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.
`
`Regeneron Exhibit 1179.001
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
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`(656,720)
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`(3,655)
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`(115)
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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.
`
`Regeneron Exhibit 1179.001
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`VEGF is thought to play a critical role in certain eye
`diseases.
`
`"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.
`
`Regeneron Exhibit 1179.002
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`* 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.
`
`Regeneron Exhibit 1179.003
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`"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 AMD in the United States and at least
`an equal number in the rest of the world.
`
`Regeneron Exhibit 1179.004
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`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
`
`Regeneron Pharmaceuticals, Inc. is a
`biopharmaceutical company that discovers,
`develops, and intends to commercialize
`
`Regeneron Exhibit 1179.005
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`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 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.
`
`Regeneron Exhibit 1179.006
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`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
`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
`
`Regeneron Exhibit 1179.007
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`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
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`Related links
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`✉ F T L 𝓟 r
`
`Regeneron Exhibit 1179.008
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`◄ Back to news
`< Back to news
`
`Regeneron Exhibit 1179.009
`Regeneron Exhibit 1179.009
`Regeneron v. Novartis
`Regeneronv. Novartis
`IPR2021-00816
`IPR2021-00816
`
`
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