Somatuline Autogel To Be Promoted By Tercica
This article was originally published in The Pink Sheet Daily
Executive Summary
Tercica gains the rights to the acromegaly treatment in the U.S. and Canada through a cross-licensing agreement with Ipsen, which receives European rights to Increlex.
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Tercica will commercialize Ipsen's Somatuline Autogel in the U.S. after the treatment for acromegaly gains regulatory approval. Ipsen plans to file an NDA for the sustained-release formulation of lanreotide with FDA before year-end for acromegaly, a disorder caused by the over-production of growth hormone secondary to a pituitary tumor. U.S. sales of Somatuline Autogel are expected to reach approximately $125 mil.-$150 mil. by 2011, Tercica predicted. The company announced it had gained the rights to market Somatuline Autogel in the U.S. and Canada through a cross-licensing deal with Ipsen July 18. "By gaining the rights to Somatuline Autogel in the U.S., Tercica will not only gain a second endocrine product, but one that will be squarely in our strategic area of expertise around the growth hormone IGF-1 excess," CEO John Scarlett stated during a July 19 conference call. Tercica plans to leverage its existing 40-person commercial organization for Increlex , its Primary IGF-1 deficiency treatment for short stature, to target the 500 adult endocrinologists who write the majority of scripts for somatostatin analogs used to treat acromegaly. Acromegaly affects approximately 15,000 people in the U.S. and Canada, and if the elevated growth hormone caused by the tumor goes untreated, it is estimated to result in a more than two-fold increase in mortality and a five- to 10-year reduction in life expectancy, Scarlett said. Novartis markets a long-acting treatment, Sandostatin LAR (octreotide). However, Scarlett said Somatuline Autogel offers benefits over Sandostatin LAR, including dosing and administration advantages. Ipsen currently markets Somatuline Autogel in Europe, where it is also approved for the treatment of neuroendocrine tumors; the drug was approved by Canadian regulatory authorities July 17. Tercica said it expects to launch Somatuline Autogel in Canada in 2007. In exchange, Tercica granted Ipsen exclusive rights to sell Increlex in all regions of the world outside the U.S., Canada, Japan, Taiwan and the Middle East. The companies will also grant each other product development rights and share the costs for improvements to or new indications for Somatuline Autogel and Increlex. In addition, they gain the rights to first negotiation for their respective endocrine pipelines. As part of the partnership, Ipsen will acquire newly issued shares of Tercica common stock representing a 25% stake, with the opportunity to increase its stake to 40%. The deal also includes upfront and milestone payments and royalty fees. "Tercica also gains access to Ipsen's proprietary technology and expertise in developing long-acting formulations of peptide and protein products," Scarlett pointed out. He said the firm will seek to tap Ipsen's expertise in the area to develop a sustained-release formulation of Increlex. In the U.S., however, Tercica is facing a patent dispute with Insmed over Increlex and Insmed's growth hormone iPlex . The two companies are scheduled to go to court in November (1 (Also see "Insmed, Tercica Head To Court Over Growth Hormone Patents" - Pink Sheet, 5 Jul, 2006.)). Both pediatric products were granted orphan drug designation by FDA. Despite their similarities, FDA determined they were each separate new molecular entities. Increlex launched in January followed by iPlex in May (2 (Also see "Insmed Growth Treatment iPlex Enters Market" - Pink Sheet, 25 May, 2006.)). -Jessica Merrill |