Tercica licensed from Ipsen the rights to develop and market Somatuline Autogel in the US and Canada in a transaction that closed on October 13, 2006.
“Ipsen’s submission of the NDA for Somatuline Autogel injection is an important milestone for Tercica as it moves the product closer to potential approval and commercialization in the US,” said John Scarlett, CEO of Tercica.
As of December 31, 2005, Somatuline and Somatuline Autogel had marketing authorizations in over 50 countries for the treatment of acromegaly and neuroendocrine tumors. The product is supplied in pre-filled syringes to be injected subcutaneously.
In July 2006 Health Canada approved Somatuline Autogel for the long-term treatment of patients with acromegaly.
The FDA will determine within 60 days whether the submission will be accepted for filing. Tercica expects to launch Somatuline Autogel in Canada in early 2007.