Investor News 2008 - Bayer Investor Relations
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`Page 1 of 6
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`Investor News 2008
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`August 19, 2008
`
`Bayer HealthCare and
`Regeneron Announce VEGF
`Trap-Eye Achieved Durable
`Improvement in Vision over
`52 Weeks in a Phase 2
`Study in Patients with Age-
`related Macular
`Degeneration
`
`Study patients, on average, received only two additional doses
`following a 12-week fixed dosing period
`
`Leverkusen, Germany and Tarrytown, NY, August 19, 2008 - Bayer HealthCare
`AG and Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) today announced that
`patients with wet age-related macular degeneration (AMD) receiving VEGF Trap-
`Eye in a Phase 2 extension study on a PRN (as needed) dosing schedule
`continued to show highly significant improvements at 52 weeks in the primary
`and key secondary endpoints of retinal thickness (an anatomic measure of
`
`https://www.investor.bayer.com/en/nc/news/archive/investor-news-2008/investor-news-2008/bayer-healthcare-and-regeneron-announce-vegf-trap-eye-achi...
`
`Mylan Exhibit 1092
`Mylan v. Regeneron, IPR2021-00881
`Page 1
`
`Joining Petitioner: Apotex
`
`

`

`Investor News 2008 - Bayer Investor Relations
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`Page 2 of 6
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`treatment effect) and vision gain. The 12-week primary endpoint results from the
`fixed-dosing period of the study were presented at the 2007 Retina Society
`conference in September 2007. The 32-week results of the Phase 2 study were
`presented at the 2008 Association for Research in Vision and Ophthalmology
`(ARVO) meeting in Fort Lauderdale, Florida. A full analysis of the 52-week results
`of the Phase 2 study will be presented at the 2008 meeting of the Retina Society
`on September 26-28, 2008 in Scottsdale, Arizona.
`
`In this double-masked, prospective, randomized, multi-center Phase 2 trial, 157
`patients were randomized to five dose groups and treated with VEGF Trap-Eye in
`one eye. Two groups initially received monthly doses of 0.5 or 2.0 milligrams
`(mg) of VEGF Trap-Eye (at weeks 0, 4, 8, and 12) and three groups received
`quarterly doses of 0.5, 2.0, or 4.0 mg of VEGF Trap-Eye (at baseline and week
`12). Following the initial 12-week fixed-dosing phase of the trial, patients
`continued to receive therapy at the same dose on a PRN dosing schedule based
`upon the physician assessment of the need for re-treatment in accordance with
`pre-specified criteria. Patients were monitored for safety, retinal thickness, and
`visual acuity. These data represent the final one-year analysis from the 52-week
`study.
`
`Patients receiving four monthly doses of VEGF Trap-Eye, either 2.0 or 0.5 mg,
`for 12 weeks followed by PRN dosing thereafter, achieved mean improvements
`in visual acuity versus baseline of 9.0 letters (p<0.0001) and 5.4 letters
`(p=0.085), respectively, and mean decreases in retinal thickness versus baseline
`of 143 microns (p<0.0001) and 125 microns (p<0.0001) at week 52, respectively.
`During the subsequent PRN dosing phase, patients initially dosed on a 2.0 mg
`monthly schedule received, on average, only 1.6 additional injections and those
`initially dosed on a 0.5 mg monthly schedule received, on average, 2.5
`injections.
`
`For all dose cohorts combined, there was a 5.3 mean letter gain in visual acuity
`versus baseline at the week 52 evaluation visit (p<0.0001). The mean decrease in
`retinal thickness for all dose groups combined at week 52 was 130 microns
`versus baseline (p<0.0001). During the week 12 to week 52 PRN dosing period,
`patients from all dose groups combined received, on average, only two
`
`https://www.investor.bayer.com/en/nc/news/archive/investor-news-2008/investor-news-2008/bayer-healthcare-and-regeneron-announce-vegf-trap-eye-achi...
`
`Mylan Exhibit 1092
`Mylan v. Regeneron, IPR2021-00881
`Page 2
`
`Joining Petitioner: Apotex
`
`

`

`Investor News 2008 - Bayer Investor Relations
`
`Page 3 of 6
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`additional injections.
`
`VEGF Trap-Eye was generally well tolerated and there were no drug-related
`serious adverse events. There was one reported case of culture-negative
`endophthalmitis/uveitis in the study eye and one arterial thrombotic event,
`neither of which was deemed to be drug-related. The most common adverse
`events were those typically associated with intravitreal injections.
`
`"The 52-week results underline that VEGF Trap-Eye has the potential to
`significantly
`reduce retinal thickness and improve vision," said Dr. Kemal Malik, member of
`the Bayer HealthCare Executive Committee responsible for product
`development. "The further development of this compound is important for
`millions of people worldwide who suffer from this devastating ocular disease."
`
`"Based upon retinal physicians' feedback, there remains a significant unmet
`medical need for a treatment for wet AMD that can reliably improve visual acuity
`over time without the need for monthly intravitreal injections," said George D.
`Yancopoulos, M.D., Ph.D., President of Regeneron Research Laboratories. "We
`are excited about these study findings and the potential for VEGF Trap-Eye to
`fulfill this need pending the results of our ongoing Phase 3 clinical studies."
`About the Phase 3 Program in Wet AMD
`Regeneron and Bayer HealthCare initiated a Phase 3 global development
`program for VEGF Trap-Eye in wet AMD in August 2007. In two Phase 3 trials
`VIEW 1 and VIEW 2 (VEGF Trap-Eye: Investigation of Efficacy and Safety in Wet
`age related macular degeneration), the companies are evaluating VEGF Trap-Eye
`dosed 0.5 mg every 4 weeks, 2 mg every 4 weeks, or 2 mg every 8 weeks
`(following three monthly doses) in direct comparison with ranibizumab
`(Lucentis®, a registered trademark of Genentech, Inc.) administered 0.5 mg
`every four weeks according to its U.S. label during the first year of the studies.
`PRN dosing will be evaluated during the second year of each study. The VIEW1
`study (www.regeneron.com/vegftrap_eye.html) is currently enrolling patients in
`the United States and Canada and the VIEW2 study (www.view2study.com) is
`currently enrolling patients in Europe, Asia Pacific, Japan, and Latin America.
`The companies are collaborating on the global development of VEGF Trap-Eye
`
`https://www.investor.bayer.com/en/nc/news/archive/investor-news-2008/investor-news-2008/bayer-healthcare-and-regeneron-announce-vegf-trap-eye-achi...
`
`Mylan Exhibit 1092
`Mylan v. Regeneron, IPR2021-00881
`Page 3
`
`Joining Petitioner: Apotex
`
`

`

`Investor News 2008 - Bayer Investor Relations
`
`Page 4 of 6
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`for the treatment of wet AMD, diabetic eye diseases, and other eye diseases and
`disorders. Bayer HealthCare will market VEGF Trap-Eye outside the United
`States, where the companies will share equally in profits from any future sales of
`VEGF Trap-Eye. Regeneron maintains exclusive rights to VEGF Trap-Eye in the
`United States.
`
`About 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). 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.
`
`About Wet AMD
`Age-related Macular Degeneration (AMD) is a leading cause of acquired
`blindness. 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 account for blindness in
`wet AMD patients. Wet AMD is the leading cause of blindness for people over
`the age of 65 in the U.S. and Europe.
`
`About Bayer
`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
`
`https://www.investor.bayer.com/en/nc/news/archive/investor-news-2008/investor-news-2008/bayer-healthcare-and-regeneron-announce-vegf-trap-eye-achi...
`
`Mylan Exhibit 1092
`Mylan v. Regeneron, IPR2021-00881
`Page 4
`
`Joining Petitioner: Apotex
`
`

`

`Investor News 2008 - Bayer Investor Relations
`
`Page 5 of 6
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`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
`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.
`
`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.
`
`<br/>
`
`January 16, 2019  17:29 CET
`
`64.95
`-0.11 %
`
`January 16, 2019  17:45 CET
`
`10,931.24
`0.36 %
`
`https://www.investor.bayer.com/en/nc/news/archive/investor-news-2008/investor-news-2008/bayer-healthcare-and-regeneron-announce-vegf-trap-eye-achi...
`
`Mylan Exhibit 1092
`Mylan v. Regeneron, IPR2021-00881
`Page 5
`
`Joining Petitioner: Apotex
`
`

`

`Investor News 2008 - Bayer Investor Relations
`
`Page 6 of 6
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`
`Last updated: November 05, 2013
`
`https://www.investor.bayer.com/en/nc/news/archive/investor-news-2008/investor-news-2008/bayer-healthcare-and-regeneron-announce-vegf-trap-eye-achi...
`
`Mylan Exhibit 1092
`Mylan v. Regeneron, IPR2021-00881
`Page 6
`
`Joining Petitioner: Apotex
`
`