Mylan and Biocon Present Clinical Data on Insulin Glargine at the American Diabetes Association’s 77th Scientific Sessions

Data Show Comparable Efficacy, Safety and Immunogenicity to Lantus® in Type 1 and Type 2 Diabetes Patients

Bengaluru, June 17, 2017: 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)
• 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.

Corporate Comm India(CCI Newswire)