Tercica Seeks to Block Insmed Drug
Tuesday May 31, 5:17 pm ET
Tercica Seeks Court Injunction Barring Insmed's SomatoKine Drug Pending Patent Trial
SOUTH SAN FRANCISCO, Calif. (AP) -- Drug makers Tercica Inc. and Genentech Inc. said Tuesday they asked a federal court to block Insmed Inc. from bringing its SomatoKine growth therapy to market ahead of a pending patent infringement lawsuit.
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Insmed and the Tercica-Genentech team are both awaiting approval from the Food and Drug Administration for drugs that treat extreme short stature caused by a rare genetic hormone deficiency. The agency has granted an accelerated priority review of both therapies, with a ruling expected on SomatoKine by July 3 and on Tercica's Increlex by Aug. 31.
Tercica maintains that Insmed's SomatoKine violates patents it has licensed from Genentech for a hormone called Insulin-like Growth Factor-1, or IGF-1. The injunction seeks to keep Insmed from making, using, selling or offering to sell SomatoKine and to force Insmed to share exclusive selling rights if SomatoKine is approved before Increlex.
The FDA has designated both Increlex and SomatoKine as "orphan" drugs -- a label that is reserved for new treatments for rare diseases and includes such benefits as seven years of marketing exclusivity after approval.
Tercica's president and chief executive, John A. Scarlett, said in an interview that the injunction, if granted, could make it less likely the FDA would award exclusive selling rights to Insmed.
"In order for someone to assert orphan drug exclusivity you have to be able to supply this drug to the marketplace," Scarlett said. However, he noted that the two therapies could get approved for slightly different indications and each receive exclusive selling rights for their respective niches.
If the injunction is granted, it would last until the trial, Tercica said. The lawsuit already went to trial once, in April, but the U.S. District Court for the Northern District of California dismissed the litigation on what Tercica said were procedural grounds, and the companies filed an amended complaint.
Children who fail to grow at a normal rate are currently treated with a different but related therapy called Human Growth Hormone. This hormone actually prompts the production of IGF-1, which then "actually causes the bones and cartilage to grow," Scarlett said. Both Increlex and SomatoKine are geared toward a subset of children who have trouble producing IGF-1, even with the prompting of Human Growth Hormone therapy. Scarlett estimates that there are about 30,000 children in the United States with a primary IGF-1 deficiency.
Tercica and Genentech also are pursuing patent litigation against Insmed in England, where a court recently rejected a motion filed by Insmed and its contract manufacturer that would have effectively nullified Tercica's patent claims.
Separately Tuesday, Insmed released more detailed results from its late stage trial of SomatoKine, showing that its therapy -- a combination of IGF-1 and insulin-like growth factor binding protein-3 -- significantly improved height growth rates in children after six months.
Tercica shares closed unchanged at $7.98 on the Nasdaq, then slid 30 cents, or 3.7 percent, to $7.68 in aftermarket activity. Genentech shares fell 1 cent to $79.25 on the New York Stock Exchange, then slid 20 cents to $79.05 in aftermarket activity. Meanwhile, Insmed shares slipped 4 cents, or 3 percent, to close at $1.27 on the Nasdaq, and then rose 20 cents, or 15.7 percent, to $1.47 in aftermarket activity. |
