Mylan and Biocon Present Clinical Data on Insulin Glargine at the American Diabetes Association's 77th ...
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`Mylan and Biocon Present Clinical Data on Insulin
`Glargine at the American Diabetes Association's 77th
`Scientific Sessions
`
`Print
`
`Data Show Comparable Efficacy, Safety and Immunogenicity to Lantus® in Type 1 and Type 2
`Diabetes Patients
`
`HERTFORDSHIRE, England and PITTSBURGH and BENGALURU, India, June 10,
`2017 /PRNewswire/ -- Mylan N.V. (NASDAQ, TASE: MYL) and Biocon Ltd. (BSE code: 532523, NSE:
`BIOCON) today announced the presentation of new data from the insulin glargine clinical program,
`including the INSTRIDE studies at the American Diabetes Association's 77th Scientific Sessions in San
`Diego. The studies confirmed the efficacy, safety and immunogenicity of MYL-1501D, insulin glargine,
`in comparison to Lantus® in patients with Type 1 and Type 2 diabetes. Data demonstrating
`pharmacokinetic and pharmacodynamic equivalence also was presented.
`
`Insulin glargine is a long-acting insulin used to treat adults with Type 2 diabetes, as well as adults and
`pediatric patients with Type 1 diabetes, for the control of high blood sugar.
`
`Mylan President Rajiv Malik commented, "With more than 29 million Americans living with diabetes*
`and the cost of insulin products on the rise, there's a clear unmet need for more-affordable treatment
`options for insulin glargine. We are pleased with the positive results of the INSTRIDE clinical program,
`which demonstrate comparable clinical efficacy and safety of our insulin glargine to Lantus. We have
`long been deeply committed to supporting this community and advancing treatment for patients as the
`leading producer of oral diabetes medications in the U.S., and now we are continuing to deliver on our
`mission through our insulin programs."
`
`Arun Chandavarkar, CEO & Joint Managing Director, Biocon, added, "We are pleased with the
`outcome of these global clinical studies confirming the safety, efficacy and immunogenicity of our
`insulin glargine in comparison to the reference product in Type 1 and Type 2 diabetes. This is an
`important milestone in our development of a more affordable insulin glargine and furthers our mission
`of enabling access by addressing the needs of diabetes patients globally."
`
`Data will be presented during the poster session at 11:30 a.m. PT today.
`• Comparative Pharmacokinetics (PK) and Pharmacodynamics (PD) of a Proposed Biosimilar
`Insulin Glargine and Lantus in Patients with Type 1 diabetes (T1D) (Poster #1019-P)
`
`http://newsroom.mylan.com/2017-06-10-Mylan-and-Biocon-Present-Clinical-Data-on-Insulin-Glargine-at...
`
`12/27/2018
`
`Sanofi Exhibit 2003.001
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`Mylan and Biocon Present Clinical Data on Insulin Glargine at the American Diabetes Association's 77th ...
`• Efficacy and safety of MYL-1501D (Mylan's insulin glargine) compared with Lantus®
`(Sanofi's insulin glargine) in patients with Type 1 diabetes after 52 weeks: The INSTRIDE 1
`study (Poster #1018-P)
`• Efficacy and safety of MYL-1501D (Mylan's insulin glargine) compared with Lantus®
`(Sanofi's insulin glargine) in patients with Type 2 diabetes after 24 weeks: The INSTRIDE 2
`study (Poster #1017-P)
`• Comparable Immunogenicity between MYL-1501D (Mylan's insulin glargine) and Lantus®
`(Sanofi's insulin glargine) in Patients with Type 1 and 2 Diabetes Mellitus: The Phase 3
`INSTRIDE studies (Poster #1028-P)
`
`Full session details and abstracts for the 2017 Scientific Sessions can be found on the American
`Diabetes Association's website at professional.diabetes.org/meeting/scientific-sessions/77th-scientific-
`sessions.
`
`*Centers for Disease Control and Prevention. National Diabetes Statistics Report: Estimates of
`Diabetes and Its Burden in the United States, 2014. Atlanta, GA: U.S. Department of Health and
`Human Services; 2014.
`About the INSTRIDE Studies
`The two INSTRIDE studies were randomized, confirmatory clinical trials designed to evaluate
`comparative efficacy and safety of Mylan's proposed insulin glargine, MYL-1501D versus branded
`insulin glargine, Lantus®. INSTRIDE1 was a 52-week study in 558 T1DM patients, while INSTRIDE 2
`was a 24-week study in 560 T2DM (including insulin-naïve) patients. In both studies, patients were
`randomized to receive either once daily MYL-1501D or Lantus® and the primary endpoint was change
`from baseline in HbA1c after 24 weeks. Secondary endpoints included glycemic endpoints like change
`from baseline in fasting plasma glucose and insulin dose, as well as safety endpoints like systemic
`reactions, device-related safety issues and immunogenicity.
`About the Mylan and Biocon Collaboration
`Biocon and Mylan are exclusive partners on a broad portfolio of biosimilars and insulin analogs.
`Glargine is one of the three insulin analogs being co-developed by Mylan and Biocon for the global
`marketplace. Mylan has exclusive commercialization rights for insulin glargine in the U.S., Canada,
`Australia, New Zealand, the European Union and European Free Trade Association countries. Biocon
`has exclusive rights for Japan and a few emerging markets, and co-exclusive commercialization rights
`with Mylan in the rest of the world.
`About Mylan
`Mylan is a global pharmaceutical company committed to setting new standards in healthcare. Working
`together around the world to provide 7 billion people access to high quality medicine, we innovate to
`satisfy unmet needs; make reliability and service excellence a habit; do what's right, not what's easy;
`and impact the future through passionate global leadership. We market a growing portfolio of more
`than 7,500 products around the world, including antiretroviral therapies on which approximately 50% of
`people being treated for HIV/AIDS in the developing world depend. We market our products in more
`than 165 countries and territories. We are one of the world's largest producers of active pharmaceutical
`ingredients. Every member of our more than 35,000-strong workforce is dedicated to creating better
`health for a better world, one person at a time. Learn more at mylan.com.
`About Biocon
`Biocon Limited, publicly listed in 2004, (BSE code: 532523, NSE Id: BIOCON, ISIN Id: INE376G01013)
`is India's largest and fully-integrated, innovation-led biopharmaceutical company. As an emerging
`global biopharmaceutical enterprise serving customers in over 120 countries, it is committed to reduce
`therapy costs of chronic diseases like diabetes, autoimmune and cancer. Through innovative products
`and research services it is enabling access to affordable healthcare for patients, partners and
`http://newsroom.mylan.com/2017-06-10-Mylan-and-Biocon-Present-Clinical-Data-on-Insulin-Glargine-at...
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`12/27/2018
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`Sanofi Exhibit 2003.002
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

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`Mylan and Biocon Present Clinical Data on Insulin Glargine at the American Diabetes Association's 77th ...
`healthcare systems across the globe. It has successfully developed and taken a range of Novel
`Biologics, Biosimilars, differentiated Small Molecules and affordable Recombinant Human Insulin and
`Analogs from 'Lab to Market'. Some of its key brands are INSUGEN® (rh-insulin), BASALOG®
`(Glargine), CANMAb™ (Trastuzumab), BIOMAb-EGFR™ (Nimotuzumab) and ALZUMAb™ (Itolizumab), a
`'first in class' anti-CD6 monoclonal antibody. It has a rich pipeline of Biosimilars and Novel Biologics at
`various stages of development including Insulin Tregopil, a high potential oral insulin analog.
`Visit: www.biocon.com
`Forward-Looking Statement: Mylan
`This press release includes statements that constitute "forward-looking statements," including with
`regard to the presentation of data, future plans and expectations and product development. These
`statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform
`Act of 1995. Because such statements inherently involve risks and uncertainties, actual future results
`may differ materially from those expressed or implied by such forward-looking statements. Factors that
`could cause or contribute to such differences include, but are not limited to: any changes in or
`difficulties with Mylan's or its partners' ability to develop, manufacture, and commercialize products; any
`regulatory, legal, or other impediments to Mylan's or its partners' ability to bring products to market;
`Mylan's and its partners' ability to protect intellectual property and preserve intellectual property rights;
`the effect of any changes in Mylan's or its partners' customer and supplier relationships and customer
`purchasing patterns; other changes in third-party relationships; the impact of competition; changes in
`the economic and financial conditions of the businesses of Mylan or its partners; the scope, timing, and
`outcome of any ongoing legal proceedings and the impact of any such proceedings on Mylan's or its
`partners' business; actions and decisions of healthcare and pharmaceutical regulators, and changes in
`healthcare and pharmaceutical laws and regulations, in the United States and abroad; risks associated
`with international operations; other uncertainties and matters beyond the control of management; and
`the other risks detailed in Mylan's filings with the Securities and Exchange Commission. Mylan
`undertakes no obligation to update these statements for revisions or changes after the date of this
`release.
`Forward-Looking Statement: Biocon
`This press release may include statements of future expectations and other forward-looking statements
`based on management's current expectations and beliefs concerning future developments and their
`potential effects upon Biocon and its subsidiaries/associates. These forward-looking statements involve
`known or unknown risks and uncertainties that could cause actual results, performance or events to
`differ materially from those expressed or implied in such statements. Important factors that could cause
`actual results to differ materially from our expectations include, amongst other: general economic and
`business conditions in India and overseas, our ability to successfully implement our strategy, our
`research and development efforts, our growth and expansion plans and technological changes,
`changes in the value of the Rupee and other currency changes, changes in the Indian and international
`interest rates, change in laws and regulations that apply to the Indian and global biotechnology and
`pharmaceuticals industries, increasing competition in and the conditions of the Indian and global
`biotechnology and pharmaceuticals industries, changes in political conditions in India and changes in
`the foreign exchange control regulations in India. Neither Biocon, nor our Directors, or any of our
`subsidiaries/associates assume any obligation to update any particular forward-looking statement
`contained in this release.
`
`SOURCE Mylan N.V.
`
`For further information: MYLAN: Nina Devlin (Media), 724.514.1968, Email: Nina.Devlin@mylan.com;
`Melissa Trombetta (Investors), 724.514.1813, Email: Melissa.Trombetta@mylan.com; BIOCON:
`Seema Ahuja (Media), +91-80-2808-2222, M:+919972317792, Email: seema.ahuja@biocon.com;
`
`http://newsroom.mylan.com/2017-06-10-Mylan-and-Biocon-Present-Clinical-Data-on-Insulin-Glargine-at...
`
`12/27/2018
`
`Sanofi Exhibit 2003.003
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`Mylan and Biocon Present Clinical Data on Insulin Glargine at the American Diabetes Association's 77th ...
`Saurabh Paliwal (Investors), +91 80 6775 2040; M:+91 95383 80801, Email:
`saurabh.paliwal@biocon.com
`
`Page 4 of 4
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`http://newsroom.mylan.com/2017-06-10-Mylan-and-Biocon-Present-Clinical-Data-on-Insulin-Glargine-at...
`
`12/27/2018
`
`Sanofi Exhibit 2003.004
`Mylan v. Sanofi
`IPR2018-01676
`
`