Mylan Inc. announced it is initiating Phase 3 clinical trials for its generic version of GlaxoSmithKline’s Advair Diskus and its insulin analog to Sanofi’s Lantus.
In October 2014, Mylan will commence a Phase 3 clinical trial to evaluate the equivalence of its product to Advair Diskus when administered by inhalation in adult asthma patients.
Two Phase 3 clinical trials for Mylan’s insulin analog program already are underway. In August 2014, the company initiated INSTRIDE 1 and INSTRIDE 2 to compare the efficacy and safety of Mylan’s insulin Glargine with that of Lantus in both Type 1 and Type 2 diabetes mellitus patients.
Mylan CEO Heather Bresch said: “The commencement of Phase 3 clinical trials for Mylan’s generic Advair Diskus and insulin Glargine programs are important milestones in the progress of two of our strategic growth drivers, demonstrating our strong capabilities in developing complex, difficult-to-manufacture products. We look forward to providing patients with access to high quality, more affordable versions of these medications upon final FDA approval.”
Mylan President Rajiv Malik added: “These noteworthy clinical trial developments, combined with the significant strides we have made in advancing our production scale manufacturing, reinforce our continued belief that Mylan will be the first to bring to market an AB-rated, substitutable generic form of Advair Diskus and one of the first to bring to market an interchangeable insulin analog to Lantus. These products, in addition to the hundreds of others in our pipeline, will continue to expand and diversify our portfolio and further differentiate Mylan with its customers.”
Date: September 16, 2014