Since the beginning of this year, Apricus Biosciences has made significant progress towards achieving its key corporate objectives, the sustained growth of our flagship product Vitaros® in Europe, the advancement of our clinical pipeline with RayVa™ and fispemifene, and improving our financial position, with the following accomplishments:
Vitaros launched by Recordati in Spain, which marks the fifth launch in Europe in one of the largest EU markets;
Strengthened our balance sheet by closing an $11 million registered direct offering led by Sarissa Capital Management LP in February 2015;
Received clear guidance from the U.S. Food and Drug Administration (“FDA”) regarding the design of the Phase 2 clinical trial for fispemifene in our lead indication for the treatment of symptomatic secondary hypogonadism;
Expanded our exclusive license agreement with Sandoz to market Vitaros in select Asia-Pacific countries; and
Extended exclusivity for RayVa out to 2032 with the issuance of a U.S. patent for methods for treating Raynaud’s phenomenon that is secondary to systemic sclerosis.
We are excited to have two highly differentiated product candidates in RayVa and fispemifene, which we believe have significant clinical and commercial value in large, underserved markets. Fispemifene is the first tissue-specific selective estrogen receptor modulator, or SERM, designed specifically for use in men in multiple urologic indications and RayVa has the potential to be a first in class treatment for Raynaud’s phenomenon secondary to systemic scleroderma.
Importantly, we expect to report on several important clinical development milestones this year, including a go/no go decision for RayVa in Raynaud’s phenomenon and the commencement of enrollment in our Phase 2b clinical trial for fispemifene in men with symptomatic secondary hypogonadism, both expected in June. Finally, given the potential value in fispemifene as a multi-indication opportunity in male urological conditions, we plan to initiate an additional clinical study to further explore one of these indications in the second half of this year. We believe that this multi-indication strategy enhances the clinical and commercial benefit-risk profile of fispemifene.
We continue to be pleased with our commercial partners’ efforts to establish Vitaros as the erectile dysfunction treatment of choice in Europe. Vitaros was recently launched in Spain by our partner Recordati and we expect additional launches throughout 2015 in multiple important markets, such as France, the largest ED market in Europe, by our partner Laboratoires Majorelle, as soon as final pricing is granted by the French authorities, and in Italy by our partner Bracco. We regard Vitaros as a strategic asset with the potential to generate meaningful long-term revenue for the Company.
In summary, while we have made significant progress since the beginning of 2015, I believe the coming months will be even more exciting as we look forward to establishing proof-of-concept with RayVa, we enroll our first patients in the fispemifene Phase 2b program, and we continue to leverage our flagship product Vitaros for the benefit of shareholders.
As always, thank you for your continued support and interest in Apricus Biosciences.