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Winlevi / Breezula

Cassiopea SpA

Drug Names(s): cortexolone 17alpha-propionate, CB-03-01, Winlevi (acne), Breezula (alopecia)

Description: CB-03-01 is a new androgen antagonist derived from 11-deoxycortisone. It acts at the level of the skin androgen receptor, blocking testosterone and di-hydrotestosterone from binding to the receptor in the cell. The molecule additionally has a moderate anti-inflammatory activity similar to hydrocortisone, and quickly metabolizes to cortexolone, a physiological steroid lacking anti-androgen activity, in blood.

Deal Structure: Intrepid and Cosmo
In March 2012, Intrepid Therapeutics entered into an agreement with Cosmo Pharmaceuticals to conduct the Phase II clinical trials in the US for CB-03-01.

Cosmo and Valeant
In April 2012, Cosmo signed a license agreement with Medicis (now Valeant) granting it exclusive world-wide rights for the development and commercialization of CB-03-01, an investigational anti-androgen drug targeted at certain topical skin applications. 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.

In July 2014, Cosmo and Valeant 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...See full deal structure in Biomedtracker

Partners: Intrepid Therapeutics, Inc. Valeant Pharmaceuticals International, Inc.

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