By Proactive Investors
It has been a busy summer for Apricus Biosciences (NASDAQ:APRI).
The San Diego-based pharmaceutical company has five approved products internationally, covering erectile dysfunction (Vitaros), side effects of cancer therapy (Totect and Granisol), coronary artery disease (Nitromist), and dry mouth (Aquoral). After a series of successes in strategic partnerships, acquisitions, peer review, and clinical data in Q3, the company is garnering some serious attention.
Of particular note are Apricus' two most recent announcements, coming just four days apart in the past week. On Sept. 13, the company announced an exclusive licensing agreement with Takeda Pharmaceuticals International GmbH for the marketing of Vitaros in the United Kingdom. Takeda will pay NexMed (U.S.) -- a wholly owned subsidiary of Apricus Bio -- an undisclosed upfront payment and milestone payments of up to €35 million.
According to IMS Health, the United Kingdom represents the second-largest erectile dysfunction market in Europe, affecting 2.3 million men. It is estimated the ED market was worth over €200MM in 2011, and the number of cases worldwide is expected to double in a decade.
Vitaros is an alprostadil topical cream, which, when combined with the company’s NexACT DDAIP, provides a rapid onset with "significant efficacy, tolerability, and favorable safety profile." Vitaros may be considered a more favorable option to pills, as it causes increased blood-flow when applied to the skin and erections are obtained much quicker. Vitaros has been shown to be a viable treatment for erectile dysfunction in the patient population medically ineligible for leading oral medication.
Vitaros received market approval in Canada in late 2010, and in January 2012 the company announced a marketing agreement with Abbott Laboratories (NYSE:ABT). Sales are expected in late 2012 or early 2013. The marketing authorization application for Vitaros was accepted by the European Medicines Agency for review in June 2011 and marketing license is anticipated in 2013, according to the company -- Vitaros is also partnered in Germany and Italy, and is currently exploring Switzerland.
In addition, Vitaros is partnered with Warner Chilcott in the U.S., where NDA is pending, and is in registration in other parts of the world. The worldwide market opportunity is estimated to be $4 billion.
Apricus' NexACT drug delivery technology allows for the development of more effective treatments across a broad pipeline, as the company can explore the effect of NexACT -- and the platform’s underlying agent, pharmaceutical ingredient DDAIP -- on compounds already accepted by the medical community and regulatory bodies. Such is the case with Vitaros -- alprostadil is sold in the United States as urethral suppositories and in injection form. NexACT uses novel excipients, or "penetration enhancers," to dramatically improve absorption -- overcoming the body’s natural barrier properties and allowing more permeation.
Such is also the case for Apricus' anti-fungal Tolnaftate-D, an FDA-compliant OTC for athlete's foot. Tolnaftate is already approved and commonly used (it is the active ingredient in Novartis' Lamisil and Merck's Tinactin). Apricus, however, has shown NexACT significantly enhances permeation and effectiveness of the antifungal. In summer 2011, the FDA deemed Tolnaftate-D compliant, and listed DDAIP as part of the OTC drug monograph. NexACT can now be formulated with other drugs listed in this monograph and marketed without formal drug approval or clearance.
The FDA recognized DDAIP as a drug excipient, meaning NexACT may be used with other generally recognized as safe and effective (GRASE) active ingredients listed in final FDA OTC monographs. Examples of proprietary formulations drawn from these monographs are the company's Hydrocortisone-D and Diphenhydramine-D, deemed compliant in summer 2011.
On Sept. 17, Apricus announced publication of an article in the Journal of Pharmaceutics and Drug Delivery Research featuring Tolnaftate-D. Data in this article demonstrates that the company’s formulation of tolnaftate 1% delivered using 0.5% DDAIP resulted in a 57% increase in penetration over a 24-hour period, as compared to non-DDAIP tolnaftate formulations. The paper is entitled "Enhancing the Skin Flux of Tolnaftate Utilizing the Novel Excipient, Dodecyl-2-N,N-Dimethylaminopropionate (DDAIP)."
The company cited this paper as "yet another example of the broadly applicable nature of our NexACT drug delivery technology." This publication is significant as the company continues to develop a broad and robust pipeline of OTC and pharmaceuticals.
Apricus Bio is in clinical phases with Femprox (Phase III), an alprostadil formulation to treat female sexual arousal disorder, and MycoVa (Phase III), a topical terbinafine hydrogen chloride formulation for the treatment of fungal nail infection. The company is also in IND stage for a number of oncology indications, and in preclinical stages for a number of anti-inflammatory conditions.