Serono/Alkermes to progress r-hFSH

Switzerland-based Serono and US firm Alkermes intend to proceed with theclinical development of a novel, long-acting formulation of the former's recombinant human follicle stimulating hormone (r-hFSH) for the treatment of infertility.

The new formulation is based on Alkermes' ProLease injectable sustained-release drug delivery technology and is designed to provide patients with a single-injection alternative to multiple daily injections. The decision follows the successful completion and analysis of data from a Phase I trial and triggers an undisclosed milestone payment to the US firm. Under the terms of their original deal, Serono was due to provide Alkermes with development funding and milestones which could exceed $25 million, as well as undisclosed royalties based on the sales of any resulting ProLease products.

Serono's leading reproductive health product is Gonal-F (r-hFSH), which is said to be the most-prescribed gonadotropin and last year achieved sales of $365.9 million.