Date: 2014-07-08
Type of information: Licensing agreement
Compound: CB-03-01
Company: Cosmo Pharmaceuticals (Italy) undisclosed US public pharmaceutical company (USA)
Therapeutic area: Dermatological diseases
Type agreement: licensing
Action mechanism: CB-03-01 is a molecule that acts at the level of the skin androgen receptor, blocking testosterone and dihydrotestosterone from binding to the receptor in the cell. The molecule has a unique mechanism that acts at the skin surface, and is quickly metabolized to free inactive cortexolone, a substance naturally found in the body. The molecule has been evaluated in a variety of animal models as well as initial human trials in Europe for acne and androgenic alopecia. The results of these studies demonstrate that CB-03-01 appears to have potent anti-androgenic activity without significant local or systemic side effects.
Disease: undisclosed skin disorders
Details: Cosmo Pharmaceuticals has signed a license agreement with a leading U.S. public pharmaceutical company granting it exclusive world-wide rights for the development and commercialization of Cosmo’s new chemical entity CB-03-01, an investigational anti-androgen drug targeted at certain topical skin applications.
Financial terms: The license agreement provides for the payment of $25 million up-front, regulatory and commercial milestones and royalties on sales averaging those of other commercial transactions.
Latest news: * On July 8, 2014, Cosmo Pharmaceuticals announced that it had successfully concluded the phase II acne trials of CB-03-01 and that, prior to the upcoming end of phase II meeting with the FDA, both Cosmo and Valeant Pharmaceuticals International, the licensee, had agreed that it was preferable for both parties for Cosmo to continue developing the drug. Consequently both Cosmo and Valeant agreed to unwind the present agreement and replace it with an agreement granting Valeant a right of first refusal should Cosmo decide to license out the drug after completing its development.
