Our goal is to become a fully integrated medical dermatology-focused specialty pharmaceutical company, recognized for novel, differentiated products for the treatment of skin diseases. The key components of our strategy are:
Rapidly complete the development and seek regulatory approval for Winlevi™
We are in the advanced stages of our development process of Winlevi™ for the topical treatment of acne. We expect to initiate the first of two U.S. and European Phase III pivotal clinical trials in the second half of 2015. We submitted a SPA to the FDA on April 3, 2015. We expect to file for regulatory approval of Winlevi™ for the treatment of acne in the United States by the end of 2017.
Build our own sales and marketing capabilities to commercialize Winlevi™ and our other product candidates in the United States and partner with other companies in the rest of the World
If Winlevi™ is approved for the treatment of acne by the FDA, we intend to build our own sales force and commercial organization to launch Winlevi™ in the United States with anticipated commercial launch in 2018. Specifically, we plan to build a focused, specialized sales force to target key dermatologists. This market is characterized by a large patient population that is served to a large extent by a relatively small, and therefore accessible, number of treating physicians, principally dermatologists and pediatricians. We chose to focus on this market initially not only because of its size and growth potential but also because this market can be easily accessed by a small specialty sales force and because acne treatments have a strong track record of achieving eligibility for reimbursement in the United States. This sales force would also market our other product candidates following their approval. We intend to partner with third parties to help us reach European and other geographic markets or therapeutic specialties.
Continue the development of our mid-stage product candidates and advance them through Phase III clinical trials to approval
Breezula™, our topical treatment for AGA, is currently undergoing a Phase II proof-of-concept clinical trial in the United States. The treatment is expected to be completed by end of 2015 and clinical data is expected to be released in the first half of 2016. CB-06-02, our topical treatment for genital warts, is currently undergoing a Phase II proof-of-concept clinical trial in Israel. The trial completion is expected in the first half of 2016. CB-06-01, our antibiotic for treatment of severe acne, is currently undergoing a Phase II proof-of-concept clinical trial in Slovakia. The trial completion is expected in the first half of 2016. We expect to progress these programs through Phase III trials to approval and to build a commercial organization.
In-License and Acquire New Product Candidates and, Potentially, Commercial-Stage Products
Our immediate focus is on our four product candidates. While Winlevi™ and Breezula™ were developed in-house at Cosmo Pharmaceuticals, we have entered into licensing agreements with BioMAS and Naincon, respectively, granting us licenses to the intellectual property rights pertaining to the active pharmaceutical ingredients, or APIs, of CB-06-01 and CB-06-20. See "Material agreements". We may also consider in-licensing and acquiring additional product candidates from a number of sources should attractive opportunities emerge. Our objective is to maintain a well-balanced portfolio of product candidates across various stages of development. We intend to leverage the insights, network and experience of our management team.
We intend to focus on product candidates that we believe have expeditious clinical development and regulatory pathways, including product candidates that we believe have demonstrated attractive profiles in early clinical testing and that we can advance into late-stage development, as well as earlier-stage product candidates targeting substantial commercial opportunities that we can quickly and efficiently advance through proof-of-concept studies. We may also seek to in-license and acquire dermatology products that have received regulatory approval for marketing in order to accelerate our entry into the market or expand the portfolio of products we can market to dermatologists.