Nippon Shinyaku (TYO: 4516) has been granted the right to co-promote Gonal-f (follitropin alfa) in Japan by Merck Serono, a unit of Germany’s Merck KGaA (MRK: DE), and has commenced the promotion and information gathering activities of Gonal-f as of July 1. Financial terms of the accord were not disclosed.
The drug is intended for the treatment of the induction of ovulation in the oligo-anovulatory infertile patients due to functional disorders in hypothalamus and pituitary or polycystic ovary syndrome (OI) and the induction of sperm formation in male hypogonadotropic hypogonadism (MHH).
In Japan, Serono Japan launched Gonal-f for the treatment of MHH in 2006 and Merck Serono Japan (MSJ) launched it for OI in 2009 and has been marketing Gonal-f for both indications since then. Outside Japan, Gonal-f is approved for the treatment of OI and MHH in 103 countries and 92 countries, respectively, and is marketed by Merck Serono worldwide, only in the US and Canada it is sold by EMD Serono.
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