Investor News 2008 - Bayer Investor Relations
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`Investor News 2008
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`April 28, 2008
`
`Bayer HealthCare and
`Regeneron Announce
`Encouraging 32-week
`Follow-Up Results from a
`Phase 2 Study of VEGF
`Trap-Eye in Age-related
`Macular Degeneration
`
`Gains in visual acuity achieved in initial 12-week fixed dosing phase
`of study maintained in PRN (as-needed) dosing phase
`
`Leverkusen, Germany and Tarrytown, NY, April 28, 2008 - Bayer HealthCare AG
`and development partner Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN)
`today announced that VEGF Trap-Eye dosed on a PRN (as-needed) dosing
`schedule maintained the statistically significant gain in visual acuity achieved
`after an initial, 12-week, fixed-dosing phase of a Phase 2 study in the
`neovascular form of Age-related Macular Degeneration (wet AMD). A full analysis
`of the 32-week results of the Phase 2 study will be presented today at the 2008
`Association for Research in Vision and Ophthalmology (ARVO) meeting in Fort
`
`https://www.investor.bayer.com/en/nc/news/archive/investor-news-2008/investor-news-2008/bayer-healthcare-and-regeneron-announce-encouraging-32-w...
`
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`Mylan v. Regeneron, IPR2021-00880
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`Investor News 2008 - Bayer Investor Relations
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`Lauderdale, Florida. The data being reported at the meeting are available on the
`Regeneron website (www.regeneron.com on the Investor Relations page, under
`the Presentations heading).
`
`Study results showed that across all dose groups in the study population, the
`6.6 mean letter gain in visual acuity achieved versus baseline at the week 16
`evaluation visit, following 12 weeks of fixed dosing, was maintained out to week
`32 (a 6.7 mean letter gain versus baseline; p< 0.0001) using a PRN dosing
`schedule (where dosing frequency was determined by the physician's
`assessment of pre-specified criteria). The decrease in retinal thickness, an
`anatomical measure of treatment effect achieved with a fixed-dose schedule was
`also maintained for all dose groups combined at week 32 (a 137 micron mean
`decrease versus baseline, p<0.0001).
`
`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 for 12 weeks 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-dose 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 week 32 analysis from the 52-week study, which is
`continuing to follow patients.
`
`Patients receiving monthly doses of VEGF Trap-Eye, either 0.5 or 2.0 mg, for 12
`weeks followed by PRN dosing thereafter achieved mean improvements in visual
`acuity of 8.0 (p<0.01 versus baseline) and 10.1 letters (p<0.0001 versus
`baseline), respectively, and mean decreases in retinal thickness of 141
`(p<0.0001 versus baseline) and 162 microns (p<0.0001 versus baseline) at week
`32, respectively. While PRN dosing also maintained the improvements in retinal
`thickness and visual acuity achieved versus baseline following a fixed dosing
`regimen utilizing quarterly dosing at baseline and week 12, the results achieved
`with a quarterly fixed dosing regimen were generally not as robust as obtained
`
`https://www.investor.bayer.com/en/nc/news/archive/investor-news-2008/investor-news-2008/bayer-healthcare-and-regeneron-announce-encouraging-32-w...
`
`Mylan Exhibit 1067
`Mylan v. Regeneron, IPR2021-00880
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`Investor News 2008 - Bayer Investor Relations
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`with initial fixed monthly dosing.
`
`VEGF Trap-Eye was generally safe and 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, which was deemed not to be drug-
`related. The most common adverse events were those typically associated with
`intravitreal injections.
`
`After the last fixed-dose administration at week 12, patients from all dose groups
`combined required, on average, only one additional injection over the following
`20 weeks to maintain the visual acuity gain established during the fixed-dosing
`period. Notably, 55 percent of the patients who received 2.0 mg monthly for 12
`weeks did not require any additional treatment throughout the next 20-week
`PRN dosing period. Moreover, 97 percent of the patients who received 2.0 mg
`monthly for 12 weeks did not require re-dosing at the week 16 evaluation visit,
`indicating that an 8-week dosing schedule may be feasible.
`
`"Due to its high affinity for all isoforms of VEGF-A and PlGF, potent mediators of
`blood vessel overgrowth in wet AMD, as well as its long residence time in the
`eye, it is anticipated that VEGF Trap-Eye may be able to be dosed at a frequency
`less than once monthly, especially on a chronic basis, without compromising
`visual acuity," stated Quan Dong Nguyen, M.D., M.Sc.,* Assistant Professor of
`Ophthalmology, Wilmer Ophthalmological Institute, the Johns Hopkins University
`School of Medicine, Baltimore, MD and a primary investigator in the Phase 2
`study. "These emerging Phase 2 clinical data seem to support the concept of
`durability of VEGF Trap-Eye."
`
`In this study, treatment with VEGF Trap-Eye was associated with a reduction in
`the size of the choroidal neovascular membrane (CNV), the lesion that is the
`underlying cause of vision loss due to wet AMD. Patients initially treated with a
`0.5 mg or 2.0 mg monthly fixed dose for 12 weeks, followed by PRN dosing
`thereafter, experienced 1.55 mm2 and 2.52 mm2 reductions in mean CNV size at
`24 weeks (the most recently available analysis from the independent reading
`center) versus baseline, respectively. Patients treated initially with fixed quarterly
`dosing also experienced an overall reduction in CNV size.
`
`https://www.investor.bayer.com/en/nc/news/archive/investor-news-2008/investor-news-2008/bayer-healthcare-and-regeneron-announce-encouraging-32-w...
`
`Mylan Exhibit 1067
`Mylan v. Regeneron, IPR2021-00880
`Page 3
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`Investor News 2008 - Bayer Investor Relations
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`"Regression in CNV size is generally not seen when treating wet AMD patients.
`The reduction in CNV size achieved thus far with VEGF Trap-Eye treatment
`highlights the potential clinical utility of this investigational treatment in patients
`suffering from this devastating condition," stated Jason Slakter, M.D., Clinical
`Professor of Ophthalmology, New York University School of Medicine, New York.
`
`"These additional results underline that VEGF Trap-Eye has the potential to
`significantly reduce retinal thickness and improve vision," said Dr. Gunnar
`Riemann, member of Bayer HealthCare's Executive Committee. "The further
`development of this compound is important for millions of people worldwide,
`who suffer from this devastating ocular disease."
`
`About the Phase 3 Program in Wet AMD
`Bayer HealthCare and Regeneron initiated a Phase 3 global development
`program for VEGF Trap-Eye in wet AMD in August 2007. In two Phase 3 trials,
`the companies are evaluating VEGF Trap-Eye using four- and eight-week dosing
`intervals in direct comparison with ranibizumab (Lucentis®, a registered
`trademark of Genentech, Inc.) administered every four weeks according to its
`label during the first year of the studies. PRN dosing will be evaluated during the
`second year of each study. The VIEW1 study is currently enrolling patients in the
`United States and Canada. The VIEW2 study has recently been initiated and will
`enroll patients in up to 200 centers in Europe, Asia Pacific, Japan, and Latin
`America. The companies are collaborating on the global development of VEGF
`Trap-Eye 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
`
`https://www.investor.bayer.com/en/nc/news/archive/investor-news-2008/investor-news-2008/bayer-healthcare-and-regeneron-announce-encouraging-32-w...
`
`Mylan Exhibit 1067
`Mylan v. Regeneron, IPR2021-00880
`Page 4
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`Investor News 2008 - Bayer Investor Relations
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`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 and a VEGF inhibitor,
`ranibizumab, has been approved for treatment of patients with this condition.
`
`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 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, Consumer Care,
`Diabetes Care and Pharmaceuticals divisions. The pharmaceuticals business
`operates under the name Bayer Schering Pharma AG. 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, Hematology/Cardiology, Oncology, Primary Care,
`Specialized Therapeutics 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
`
`https://www.investor.bayer.com/en/nc/news/archive/investor-news-2008/investor-news-2008/bayer-healthcare-and-regeneron-announce-encouraging-32-w...
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`Investor News 2008 - Bayer Investor Relations
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`more information at www.bayerscheringpharma.de.
`
`Forward-looking statements<br/>Bayer AG
`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.
`
`(*) The assessment made by Dr. Nguyen does not necessarily imply endorsement
`by the Johns Hopkins University, the Johns Hopkins Hospital, or the Johns
`Hopkins Medical Institutions.
`
`<br/>
`
`16. Januar 2019  17:29 Uhr MEZ
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`Last updated: November 05, 2013
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