Mylan starts Ph III trials for generics of Advair Diskus and insulin analog to Lantus
US generic drugs major Mylan (Nasdaq: MYL) says it is initiating Phase III clinical trials for its generic version of GlaxoSmithKline's (LSE: GSK) Advair Diskus (salmeterol and fluticasone propionate combination) and its insulin analog to Sanofi's (Euronext: SAN) Lantus (insulin glargine).
In October, Mylan will commence a Phase III clinical trial to evaluate the equivalence of its product to Advair Diskus when administered by inhalation in adult asthma patients. The Seretide/Advair (salmeterol and fluticasone) franchise generated second-quarter sales of £1,095 million ($1.78 billion) for GSK, down 12% year-on-year.
Two Phase III clinical trials for Mylan's insulin analog program already are underway. In August, 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. Sanofi’s second-quarter sales of Lantus were up 16.3% to 1.56 billion euros ($2.02 billion).
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