Date: 2012-10-05
Type of information: Distribution agreement
Compound: LCP-Tacro™
Company: Veloxis Pharmaceuticals (Denmark) Chiesi Farmaceutici (italy)
Therapeutic area: Transplantation
Type agreement: distribution
Action mechanism:
Disease:
Details: Veloxis Pharmaceuticals has entered into an exclusive distribution agreement with Chiesi Farmaceutici S.p.A, a fully integrated European Pharmaceutical company focused on respiratory disease and special care products, for the commercialization and distribution of its novel formulation immunosuppressant drug candidate LCP-Tacro in certain countries, including Europe, Turkey and CIS countries.
Veloxis is completing two Phase III studies of LCP-Tacro™ in kidney transplant recipients as the basis for its development program for LCP-Tacro™ as a once-daily agent for the prophylaxis of organ rejection in kidney transplantation. The first of these studies, the 3001 Study was a non-inferiority study performed in 326 stable kidney transplant recipients, and this study was successfully completed in 2011, meeting its primary efficacy and safety endpoints when compared to Prograf® (tacrolimus, Astellas Pharma Inc.). The second study, Study 3002 is being undertaken in de novo kidney transplant recipients.
Financial terms: Under the terms of the agreement, Veloxis will receive up-front and milestone payments of up to $ 47.5 million (in aggregate). The milestone payments are subject to the achievement of certain regulatory milestones and sales targets. Veloxis will supply product to Chiesi for sale in the Territory at a transfer price at a pre-agreed double-digit percentage of the product\'s sales price. In addition, Chiesi is committed to certain minimum purchases during the term of the agreement. The agreement will extend through expiry of product patents in the territory of the agreement.
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