Proving that it is indeed possible to get a new drug past the FDA on the first try, Tercica
Somatuline is a treatment for a rare hormonal disorder called acromegaly. Acromegaly results from excess production of growth hormone in the pituitary gland due to a nonmalignant tumor.
Tercica estimates the current U.S. market for the drug is $160 million, and has guided for $100 million of Somatuline sales by 2011. To get to this goal, Tercica estimates that it will need to have 4,000 of the approximately 15,000 acromegaly sufferers in the U.S. on Somatuline therapy.
There are other compounds that treat the syndrome on the market already, so Tercica will need to convert patients from a similar compound, Sandostatin, marketed by Novartis
Tercica's niche is in treating rare hormone-related disorders and it also has in place a development deal with Genentech
Somatuline is already approved in the European Union, with sales of $108 million last year by European developer Ipsen. Tercica received the U.S. and Canadian rights to Somatuline in a marketing deal with Ipsen last year.
We'll know soon enough how well the Somatuline launch in the U.S. is going, since Tercica plans to have the compound on the market in eight weeks, with a 27-person sales force.
Looking for more Foolish drug stock coverage? Check out the Fool's market-beating Rule Breakers newsletter. You can check out all our recommendations as well as get access to our message boards and exclusive content with a 30-day free trial.