Investor News 2010 - Bayer Investor Relations
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`Investor News 2010
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`February 18, 2010
`
`VEGF Trap-Eye Shows
`Positive Results in Phase II
`Study in Patients with
`Diabetic Macular Edema
`
`Statistically significant improvement in vision achieved over 24
`weeks / Results to be presented at the Angiogenesis 2010 - Clinical
`Trials meeting in Miami, Florida on February 20, 2010
`
`Leverkusen, Germany and Tarrytown, NY, USA, February 18, 2010 - Bayer
`HealthCare AG and Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) today
`announced that VEGF Trap-Eye showed positive results in a Phase II study in
`patients with Diabetic Macular Edema (DME). The primary endpoint of the study,
`a statistically significant improvement in visual acuity over 24 weeks compared
`to the standard of care in DME, macular laser treatment, was met. Visual acuity
`improvement was measured by the mean number of letters gained over the initial
`24 weeks of the study.
`
`"The ability of VEGF Trap-Eye to significantly improve vision in patients with
`DME in this initial Phase II study is encouraging," said Kemal Malik, MD, Head of
`Global Development and member of the Bayer HealthCare Executive Committee.
`"Bayer and Regeneron will discuss the next steps in further developing VEGF
`Trap-Eye in this indication."
`
`https://www.investor.bayer.com/en/nc/news/archive/investor-news-2010/investor-news-2010/vegf-trap-eye-shows-positive-results-in-phase-ii-study-in-pat...
`
`Mylan Exhibit 1066
`Mylan v. Regeneron, IPR2021-00880
`Page 1
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`

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`Investor News 2010 - Bayer Investor Relations
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`"The magnitude of the gain in visual acuity achieved with VEGF Trap-Eye in this
`Phase II study demonstrates the biologic activity of VEGF Trap-Eye in treating
`diabetic macular edema, a disease in which high levels of vascular endothelial
`growth factor (VEGF) are present," said Diana Do, MD, the Principal Investigator
`for the study and Assistant Professor of Ophthalmology and Assistant Head of
`the Retina Fellowship Training Program at the Wilmer Eye Institute, The Johns
`Hopkins University School of Medicine in Baltimore, Maryland.
`
`Patients in each of the four dosing groups receiving VEGF Trap-Eye achieved
`statistically significantly greater mean improvements in visual acuity (8.5 to 11.4
`letters of vision gained) compared to patients receiving laser therapy (2.5 letters
`gained) at week 24 (p< 0.01 for each VEGF Trap-Eye group versus laser). VEGF
`Trap-Eye was generally well tolerated, and there were no drug-related serious
`adverse events.
`
`A full analysis of the primary endpoint results of the Phase II study will be
`presented at the Angiogenesis 2010 - Clinical Trials meeting on February 20,
`2010 in Miami, Florida. Slides presented will be made available at that time on
`the Regeneron website (www.regeneron.com on the Presentations Page, under
`the Investor Relations section).
`
`About the Phase II study
`In this double-masked, prospective, randomized, multi-center Phase II trial,
`entitled DA VINCI (DME And VEGF Trap-Eye: INvestigation of Clinical Impact),
`219 patients with clinically significant DME with central macular involvement
`were randomized to five groups. The control group received macular laser
`treatment at week one and patients were eligible for repeat laser treatments, but
`no more frequently than at 16 week intervals. Two groups received monthly
`doses of 0.5 or 2.0 milligrams (mg) of VEGF Trap-Eye throughout the 6-month
`dosing period. Two groups received three initial monthly doses of 2.0 mg of
`VEGF Trap-Eye (at baseline and weeks 4 and 8), followed through week 24 by
`either every 8-week dosing or as-needed (PRN) dosing with specific repeat
`dosing criteria. The following summarizes the mean gain in visual acuity at week
`24 by dosing arm and the mean number of treatments received by patients over
`
`https://www.investor.bayer.com/en/nc/news/archive/investor-news-2010/investor-news-2010/vegf-trap-eye-shows-positive-results-in-phase-ii-study-in-pat...
`
`Mylan Exhibit 1066
`Mylan v. Regeneron, IPR2021-00880
`Page 2
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`Investor News 2010 - Bayer Investor Relations
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`Page 3 of 8
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`the first six monthly visits:
`
`- Standard-of-care macular laser treatment (n=44; 1.7 treatments): +2.5 letters
`gained
`
`- VEGF Trap-Eye 0.5 mg monthly (n=44; 5.6 injections): +8.6 letters gained
`
`- VEGF Trap-Eye 2 mg monthly (n=44; 5.5 injections): +11.4 letters gained
`
`- VEGF Trap-Eye 2 mg every other month, following 3 monthly injections (n=42;
`3.8 injections): +8.5 letters gained
`
`- VEGF Trap-Eye 2 mg as-needed, following 3 monthly injections (n=45; 4.4
`injections): +10.3 letters gained
`
`The study was not designed to evaluate statistical differences among the results
`achieved in each of the VEGF Trap-Eye groups and no significant differences
`were observed. Over 90 percent of the VEGF Trap-Eye patients and the control
`patients remained in the study at the 6-month primary endpoint evaluation.
`
`VEGF Trap-Eye was generally well-tolerated and there were no ocular or non-
`ocular drug-related serious adverse events reported in the study. The adverse
`events reported were those typically associated with intravitreal injections or the
`underlying disease. The most frequent adverse events reported among the
`patients receiving VEGF Trap-Eye included conjunctival hemorrhage, eye pain,
`floaters (myodesopsia), ocular redness (hyperemia), and increased intraocular
`pressure. There were three deaths among the 175 patients treated with VEGF
`Trap-Eye and none in the 44 patients treated with laser over 6 months. All three
`patients had underlying risk factors for their cause of death and the cases were
`not reported to be drug-related.
`
`Following the initial 24 weeks of treatment, patients continue to be treated for
`another 24 weeks on the same dosing regimens. Initial one-year results will be
`available later this year. Regeneron and Bayer HealthCare are sponsors of the
`
`https://www.investor.bayer.com/en/nc/news/archive/investor-news-2010/investor-news-2010/vegf-trap-eye-shows-positive-results-in-phase-ii-study-in-pat...
`
`Mylan Exhibit 1066
`Mylan v. Regeneron, IPR2021-00880
`Page 3
`
`

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`Investor News 2010 - Bayer Investor Relations
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`DA VINCI study.
`
`About Diabetic Macular Edema (DME)
`Diabetic Macular Edema is the most prevalent cause of moderate vision loss in
`patients with diabetes. DME is a common complication of Diabetic Retinopathy,
`a disease affecting the blood vessels of the retina. Clinically significant DME is a
`leading cause of blindness in younger adults (under 50). Clinically significant
`DME occurs when fluid leaks into the center of the macula, the light-sensitive
`part of the retina responsible for sharp, direct vision. Fluid in the macula can
`cause severe vision loss or blindness.
`
`Approximately 370,000 Americans currently suffer from clinically significant
`DME, with 95,000 new cases arising each year. According to the American
`Diabetes Association, more than 18 million Americans currently suffer from
`diabetes and many other people are at risk for developing diabetes. With the
`incidence of diabetes steadily climbing, it is projected that up to 10 percent of all
`patients with diabetes will develop DME during their lifetime.
`
`About VEGF Trap-Eye
`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). VEGF
`Trap-Eye is a specific and highly potent blocker of these growth factors.
`
`VEGF Trap-Eye is currently in Phase III development in wet (age-related) macular
`degeneration (AMD). The VIEW 1 (VEGF Trap-Eye: Investigation of Efficacy and
`Safety in Wet AMD) study is being conducted in the United States and Canada
`by Regeneron and the VIEW 2 study is being conducted in Europe, Asia Pacific,
`Japan, and Latin America by Bayer HealthCare. The primary endpoint of these
`non-inferiority studies is the proportion of patients treated with VEGF Trap-Eye
`who maintain vision at the end of one year, compared to ranibizumab patients.
`Patient enrollment has been completed in both studies with initial year-one
`primary endpoint data expected in the second half of 2010.
`
`VEGF Trap-Eye is also in Phase III development for the treatment of Central
`Retinal Vein Occlusion (CRVO), another major cause of blindness. The
`
`https://www.investor.bayer.com/en/nc/news/archive/investor-news-2010/investor-news-2010/vegf-trap-eye-shows-positive-results-in-phase-ii-study-in-pat...
`
`Mylan Exhibit 1066
`Mylan v. Regeneron, IPR2021-00880
`Page 4
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`Investor News 2010 - Bayer Investor Relations
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`COPERNICUS (COntrolled Phase III Evaluation of Repeated iNtravitreal
`administration of VEGF Trap-Eye In Central retinal vein occlusion: Utility and
`Safety) study is being led by Regeneron and the GALILEO (General Assessment
`Limiting InfiLtration of Exudates in central retinal vein Occlusion with VEGF Trap-
`Eye) study is being led by Bayer HealthCare. The primary endpoint of both
`studies is improvement in visual acuity versus baseline after six months of
`treatment. Initial data from the CRVO program are anticipated in early 2011.
`
`About Regeneron Pharmaceuticals, Inc.
`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
`Phase III clinical trials for the potential treatment of cancer, eye diseases, and
`gout. Additional therapeutic candidates are in earlier stage development
`programs in rheumatoid arthritis and other inflammatory conditions, pain,
`cholesterol reduction, allergic conditions, and cancer. Additional information
`about Regeneron and recent news releases are available on Regeneron's 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, Bayer Schering
`Pharma, Consumer Care and Medical Care divisions. 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.
`
`About Bayer Schering Pharma
`Bayer Schering Pharma is a worldwide leading specialty pharmaceutical
`company. Its research and business activities are focused on the following
`areas: Diagnostic Imaging, General Medicine, Specialty Medicine and Women's
`Healthcare. With innovative products, Bayer Schering Pharma aims for leading
`
`https://www.investor.bayer.com/en/nc/news/archive/investor-news-2010/investor-news-2010/vegf-trap-eye-shows-positive-results-in-phase-ii-study-in-pat...
`
`Mylan Exhibit 1066
`Mylan v. Regeneron, IPR2021-00880
`Page 5
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`Investor News 2010 - Bayer Investor Relations
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`positions in specialized markets worldwide. Using new ideas, Bayer Schering
`Pharma aims to make a contribution to medical progress and strives to improve
`the quality of life. Find more information at www.bayerscheringpharma.de.
`
`Bayer HealthCare
`Forward-looking statements<br/>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.
`
`Regeneron Forward-Looking Statement
`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 and Form 10-Q for the quarter
`
`https://www.investor.bayer.com/en/nc/news/archive/investor-news-2010/investor-news-2010/vegf-trap-eye-shows-positive-results-in-phase-ii-study-in-pat...
`
`Mylan Exhibit 1066
`Mylan v. Regeneron, IPR2021-00880
`Page 6
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`

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`Investor News 2010 - Bayer Investor Relations
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`ending September 30, 2009. 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.
`
`<br/>
`
`January 16, 2019  17:29 CET
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`January 16, 2019  17:45 CET
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`Last updated: September 30, 2013
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`https://www.investor.bayer.com/en/nc/news/archive/investor-news-2010/investor-news-2010/vegf-trap-eye-shows-positive-results-in-phase-ii-study-in-pat...
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`Mylan v. Regeneron, IPR2021-00880
`Page 7
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`Investor News 2010 - Bayer Investor Relations
`
`Page 8 of 8
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`https://www.investor.bayer.com/en/nc/news/archive/investor-news-2010/investor-news-2010/vegf-trap-eye-shows-positive-results-in-phase-ii-study-in-pat...
`
`Mylan Exhibit 1066
`Mylan v. Regeneron, IPR2021-00880
`Page 8
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`