Tokyo, Japan, Aug 10, 2016--- Teijin Limited announced today that it 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 pediatric GHD (PGHD). Versartis will be responsible for completing and funding the Phase 2/3 trial of Somavaratan in pediatric GHD already underway 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 2 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 2/3 trial in Japan as the longest acting growth hormone for the indication of PGHD. Versartis is also conducting a Phase 3 trial of Somavaratan for PGHD and a Phase 2 trial for AGHD in the US and Europe.
Teijin Limited will pay USD 40 million upfront to Versartis, and USD 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 JPY 60 billion (USD 580 million).
About the Teijin Group
Teijin (TSE: 3401) is a technology-driven global group offering advanced solutions in the areas of sustainable transportation, information and electronics, safety and protection, environment and energy, and healthcare. Its main fields of operation are high-performance fibers such as aramid, carbon fibers & composites, healthcare, films, resin & plastic processing, polyester fibers, products converting and IT. The group has some 150 companies and around 16,000 employees spread out over 20 countries worldwide. It posted consolidated sales of JPY790.7 billion (USD 7.4 billion) and total assets of JPY 823.4 billion (USD 7.7 billion) in the fiscal year ending March 31, 2016.
About Versartis, Inc.
Versartis, Inc. is an endocrine-focused biopharmaceutical company initially developing somavaratan, a novel, long-acting form of recombinant human growth hormone in late-stage clinical trials for the treatment of GHD in children and adults. Somavaratan is intended to reduce the burden of daily injection therapy by requiring significantly fewer injections, potentially improving compliance and, therefore, treatment outcomes.
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