Teijin Limited has signed an exclusive license and supply agreement with Versartis, Inc. for the development and marketing of Somavaratan (VRS-317), a novel, potential long-acting form of recombinant growth hormone (rhGH), in Japan. Versartis is an endocrine-focused biopharmaceutical company developing Somavaratan for the treatment of growth hormone deficiency (GHD).
Versartis is currently conducting clinical trials of Somavaratan in Japan for the indication of paediatric GHD (PGHD). Versartis will be responsible for completing and funding the Phase II/III trial of Somavaratan in paediatric GHD already under way in Japan.
Teijin Pharma Limited, the core company of the Teijin Group’s healthcare business, will be solely responsible for executing and funding regulatory and commercialization activities for Somavaratan in Japan, in all indications including adult growth hormone deficiency (AGHD), a condition with symptoms including increased abdominal fat, reduced vitality and decreased concentration, and Turner’s syndrome, a genetic condition caused by the complete or partial absence of one of the sex chromosomes.
Teijin Pharma is committed to pursuing continuous improvement of the quality of life (QOL) of patients, by adding this innovative product to the lineup and by leveraging its experience obtained from its own drugs for endocrine and children’s diseases.
Somavaratan is Versartis’ investigational, novel, long-acting form of rhGH. From the result of a Phase II trial in the US, Somavaratan is expected to provide a twice-monthly therapy, which will be a significant therapeutic benefit to Japanese patients currently being treated with the PGHD products that require a daily injection. Somavaratan is currently in a Phase II/III trial in Japan as the longest acting growth hormone for the indication of PGHD. Versartis is also conducting a Phase III trial of Somavaratan for PGHD and a Phase II trial for AGHD in the US and Europe.
Teijin Limited will pay $40 million upfront to Versartis, and $100 million or more in potential development, regulatory and sales milestones.
PGHD occurs when the pituitary gland does not produce sufficient growth hormone during childhood, resulting in symptoms such as dwarfism. PGHD is generally treated through growth hormone replacement therapy involving a daily injection which imposes heavy strains on patients. Teijin Pharma estimates the market size of the existing growth hormone products in Japan for PGHD at ¥60 billion ($580 million).