Tercica Stock Gets Growth Boost

Tercica(TRCA Quote) shares climbed 5% in recent trading Friday on a positive recommendation in Europe for its growth-failure treatment Increlex.

The Brisbane, Calif., biopharmaceutical company said the Committee for Medicinal Products for Human Use of the European Medicines Agency -- the EU's equivalent of the U.S.' Food and Drug Administration -- offered a positive opinion on recommending marketing authorization for Increlex. The recommendation was based on clinical data from 76 patients who were treated with Increlex for up to 12.5 years.

Tercica said the indication is recommended for long-term treatment of growth failure in children and adolescents with severe primary insulin-like growth factor-1 deficiency (IGFD) and in children with growth-hormone gene deletion who have developed neutralizing antibodies to GH.

The company expects to receive marketing authorization in two to three months, based on the European Commission's acceptance of the CHMP positive opinion. Also, because the drug has received orphan drug designation in the EU, Tercica expects 10 years of marketing exclusivity for the treatment of severe primary IGFD.

Tercica markets Increlex in the EU with France's Ipsen, and if it receives marketing authorization, it expects a milestone payment of around $20 million from Ipsen under their licensing agreement. Following pricing reviews, Ipsen would then launch Increlex in the EU.

"Our collaboration with Ipsen provides us with a very strong partner to commercialize Increlex in the European Union, and represents an important step in our joint efforts to develop a worldwide leadership position in the field of endocrinology," said Tercica CEO John A. Scarlett.

After hitting a 52-week high of $7.43 earlier in the morning, Tercica shares were lately up 38 cents at $6.97.