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news.Tercica and co-plaintiff Genentech have filed for a preliminary injunction against Insmed to prevent it marketing SomatoKine. Bad news for Insmed, which has just received positive data from an ongoing trial of the drug.
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Results from a pivotal phase II clinical trial initiated by Insmed have shown that SomatoKine, a once daily insulin-like growth factor I replacement therapy, can help children with growth hormone insensitivity syndrome.
The therapy, delivered as a proprietary complex of rhIGF-I/rhIGFBP-3, in children with short stature due to growth hormone insensitivity syndrome (GHIS) achieved its primary endpoint of change in height velocity after six months of treatment.
This prospective clinical study was designed to gain FDA approval for the treatment of GHIS with SomatoKine. However, rival pharmaceutical companies Tercica and Genentech have requested the federal court block Insmed from bringing SomatoKine onto the market ahead of a pending patent infringement lawsuit.
Tercica maintains that the SomatoKine compound violates patents it has licensed from Genentech. The patents cover insulin-like growth factor-1 (IGF-1), the same hormone used in SomatoKine. The two companies are seeking an injunction to prevent Insmed from making, using, selling or offering to sell SomatoKine. Further more, if SomatoKine were FDA-approved before Tercia’s IGF-I drug Increlex, the companies hope to force Insmed to share selling rights.
At present both Increlex and SomatoKine are designated as orphan drugs by the FDA
The High Court in London has already ruled in favor of Tercica and Genentech denying the motions brought by Increlex, which sought to attack the validity of Genentech’s patent.