Sanofi announced that Elias Zerhouni, the company’s Head of Global R&D, is retiring and will be succeeded by John Reed, the former Global Head of Roche Pharma Research & Early Development.
Oramed has initiated a Ph2b dose ranging study evaluating its oral insulin (ORMD-0801) in T2DM subjects (CT.gov record). According to the press release, the trial is a “prerequisite to Phase 3 confirmatory studies under FDA’s BLA.”
Mylan hosted its Investor Day and provided updates on biosimilar Lantus and Novolog, as well as disclosing for the first time its intentions to develop biosimilar versions of Toujeo, Victoza, and Saxenda. Below, FENIX provides analysis and market implications for each of the biosimilar programs.
AZ has announced FDA approval of Bydureon as an add-on to basal insulin for T2DM based on the results of the DURATION-7 study. The corresponding label update may help strengthen a Bydureon message of broad use including first-injectable therapy and treatment intensification.
Biocon has reported that FDA issued a form 483 with six observations for its Malaysian facility. Recall, this facility is primarily responsible for the manufacturing of insulins including its biosimilar glargine. Biocon did not provide further details into the FDA observations.
Biocon hosted its CY Q4 ’17 (FY Q3 ’18) earnings call and provided updates on its insulin portfolio including bs-glargine regulatory status, bs-aspart Ph1 initiation, and Tregopil (oral insulin) Ph2/3 initiation in India. Below are highlights from the call.
Sanofi has reportedly announced a round of 400 layoffs for the diabetes and cardiovascular business unit sales team. In a separate news release, it was also announced that Sanofi has appointed Dominique Carouge, former VP of Administration & Management for Global R&D, as a new EVP Head of Business Transformation.
Lilly disclosed major announcements about its diabetes connected care strategy, including intentions to develop an in-house automated insulin-delivery (AID) device as well as a wireless smart pen injection device. As a part of this endeavor, Lilly has engaged in collaborations with Deka R&D Corp., CGM-manufacturer Dexcom, and acquired Montreal-based algorithm startup Class AP. In light of these developments, Lilly has indicated plans to initiate trials by YE 2017 and has suggested it will take 2-3 years for these new devices to reach the market.
On May 10th, Mylan hosted its Q1 2017 earnings call and briefly discussed its insulin glargine development program.
Lilly has announced intentions to invest $850M in its US operations in 2017 including $85M to expand the Trulicity device assembly operations. Additionally, Lilly announced the dedication of a $140M insulin cartridge facility.