Somatuline(R) Depot Receives FDA Marketing Approval for the Treatment of Acromegaly
Tercica Management Will Hold a Conference Call on August 31st at 9:00 a.m. EDT/ 6:00 a.m. PDT
Tercica, Inc. (NASDAQ:TRCA) today announced that its partner Ipsen (Euronext:IPN) has received notice of approval from the U.S. Food and Drug Administration (FDA) for marketing Somatuline® Depot (lanreotide) injection 60, 90 and 120 mg/ml in the United States.
Somatuline® Depot is indicated for the long-term treatment of acromegaly in patients who have had an inadequate response to surgery and/or radiotherapy, or for whom surgery and/or radiotherapy is not an option. Somatuline® Depot will be available in a pre-filled syringe eliminating any need for reconstitution and thus enabling freedom of easy administration to patients. The FDA has also designated Somatuline® Depot as an orphan drug for acromegaly. The Orphan Drug Act provides a seven-year period of exclusive marketing to the first manufacturer who obtains marketing approval for a designated orphan product.
In October 2006, Ipsen granted to Tercica the development and commercialization rights for Somatuline® Depot in the United States and Canada. At the same time, Ipsen acquired a 25% stake in Tercica on a non-diluted basis. According to the terms of the agreement, the FDA approval of Somatuline® Depot triggers a €30 million (approximately $41 million) milestone payment that Tercica will pay to Ipsen by issuing a convertible bond (converted into Tercica common stock at a conversion price of €5.92). Tercica will simultaneously issue an additional $15 million convertible bond to Ipsen (converted into Tercica common stock at a conversion price of $7.41), which will be paid in cash to Tercica.
“We are delighted with the approval of Somatuline Depot. Somatuline Depot is the only long-acting acromegaly therapy available in a pre-filled syringe, and the only long-acting somatostatin analogue that does not require reconstitution prior to injection. Somatuline Depot provides a significant medical advance for the treatment of acromegaly by offering physicians, nurses, and patients the freedom of easy injections and ready-to-go simplicity. We expect to launch Somatuline Depot in the U.S. in approximately eight weeks,” said John A. Scarlett, M.D., Tercica’s President and Chief Executive Officer. “The approval of Somatuline Depot represents a major step in our goal of establishing Tercica as the leading U.S. endocrine and metabolic company. This will be the second market introduction of an important endocrine product made by Tercica within a two-year period. Tercica has now become a well balanced biotechnology company with two commercial products and an exciting pipeline that includes our next generation growth hormone products targeting existing billion dollar market opportunities,” added Dr. Scarlett.
About Acromegaly
Acromegaly is a disorder caused by the over-production of growth hormone usually by a benign tumor of the anterior pituitary gland. Acromegaly occurs in approximately 60 people per million of population. In acromegaly patients, the pituitary gland releases too much growth hormone into the bloodstream, the growth hormone then triggers the liver to produce IGF-1, which in turn directly stimulates bone and tissue growth. The most common signs and symptoms of this serious condition include: enlarged hands, feet, and head; facial changes such as bulging forehead, enlarged lower jaw, tongue and lips; wider spacing between teeth; enlarged heart, liver, kidneys, spleen and other organs; joint pain and fatigue; reduced sex drive; and loss of concentration.
About the Marketing Approval
This decision follows the filing by Ipsen of a New Drug Application (NDA) for Somatuline® Depot in the United States in December 2006. The effect of Somatuline® Depot on reducing growth hormone and IGF-levels and control of symptoms in patients with acromegaly was studied in two long-term, multiple-dose, randomized multicenter studies performed in the United States and in Europe. Somatuline® Depot demonstrated its ability to decrease the levels of growth hormone and IGF-1 in the majority of patients over a one-year period.
About Somatuline® Depot
Somatuline® Depot (also marketed as Somatuline® Autogel® outside the United States) is a sustained-release formulation for injection containing lanreotide, a somatostatin analogue (a hormone that inhibits the release of growth hormone). Somatuline® Depot was initially developed and continues to be used mainly in the treatment of acromegaly, a disorder caused by the over-production of growth hormone or prolactin due to a benign tumor of the anterior pituitary gland. This product subsequently underwent further development in Europe in the treatment of symptoms associated with neuroendocrine tumors (particularly of a carcinoid type). Ipsen believes that the Somatuline® Depot formulation, to which it holds the patent, represents a major technological advance. As far as Ipsen is aware, this represents the first semi-solid formulation for injection without any excipient, since the active substance itself controls the sustained release. Somatuline® Depot releases the active substance with no excipient other than water over a period of at least 28 days, thus requiring just one injection per month, compared with the two or three injections previously necessary. This product is presented in a pre-filled syringe for easier administration.
Active Substance
The active substance in Somatuline® Depot is lanreotide, which inhibits the growth and secretion of several endocrine, exocrine and paracrine functions. It is particularly effective in inhibiting the secretion of growth hormone.
Indications
Somatuline® Depot is indicated for the treatment of acromegaly when circulating levels of growth hormone remain high despite surgery or radiotherapy. Somatuline® inhibits growth hormone release and thus controls the therapeutic and relieves the symptoms associated with elevated levels of this hormone.
surf's up......crikey
