Tercica begins dosing in Ph II IGF-1 deficiency trial

California, USA-based biopharmaceutical firm Tercica says it has initiated dosing in a Phase II trial evaluation of its insulin-like growth factor product Increlex (mecasemin [rDNA] origin) in combination with Genentech's recombinant human growth hormone Nutropin AQ (somatropin [rDNA] origin). The regimen, which is covered by an R&D agreement signed by the firms last year (Marketletter July 16, 2007), is being assessed as a treatment for short stature associated with IGF-1 deficiency.

Under the terms of the accord, Genentech has the right to opt-in to the development of both products until the completion of Phase II. If it does exercise this option, the San Francisco-headquartered firm will reimburse certain R&D costs. However, if these rights are not activated, Tercica will pay royalties on sales of the combination product if it gains regulatory approval.

Comparative study in IGF-1 deficiency