Apricus Biosciences (Nasdaq: APRI) and Stellar Pharmaceuticals Announce Exclusive License Agreement

Tallahassee, FL 1/3/12 (StreetBeat) -- Apricus Biosciences, Inc. (Nasdaq:APRI) and Stellar Pharmaceuticals Inc. (Pink Sheets:SLXCF), a Canadian public company, announced today the signing of an exclusive license agreement. Under the agreement, Stellar Pharma has the exclusive right to sell Apricus Bio's MycoVa(TM) product for the treatment of onychomycosis (nail fungus) in Canada, following receipt of Canadian regulatory approval for such product. The exclusive license agreement provides for an upfront payment, regulatory approval milestone, sales achievement milestones and royalty payments during the term of the agreement.

Onychomycosis is a chronic persistent fungal infection of the nail bed resulting in thickening and discoloration of the nail, which sometimes can be accompanied by serious pain and disability. According to the Merck Manual, the worldwide incidence rate of onychomycosis is approximately 10%. As described by Iorizzo and Piraccini (2007), the incidence has been increasing due to diabetes, immunosuppression and an aging population. While occurring in approximately 2.6% of children younger than 18 years, it occurs in as much as 90% of the elderly population (eMedicine.medscape.com). As of 2008, Thomson Reuters Pharma had stated that the worldwide market was approximately $2.8 billion in size and is expected to grow to approximately $2.9 billion by 2014.

The advantage of Apricus Bio's MycoVa(TM) product is that it is easy to apply, and is therefore believed to improve patient compliance. MycoVa(TM) is applied to the infected nails, typically at bedtime, with minimal preparation, such as simply washing with soap and water. The formulation allows significant amounts of the drug to penetrate through the nail plate to the nail bed and surrounding area where fungus is located without significant systemic exposure.

Dr. Bassam Damaj, Chairman, President and Chief Executive Officer of Apricus Bio commented, "We are very pleased with our exclusive license agreement with Stellar Pharma and we look forward to the future commercialization in the Canadian market of MycoVa(TM), our second major product utilizing our proprietary NexACT(R) technology. We are very impressed with the experience of Rob Harris and his team at Stellar Pharma, and we are very excited about this first potential launch of this important drug in that market. We also hope that our partnership with Stellar Pharma will produce additional collaborations among multiple NexACT(R) products in the future."

Rob Harris, President and Chief Executive Officer of Stellar Pharma stated, "We are excited about this opportunity and are very pleased to be able to strengthen our dermatology portfolio in Canada. I would like to thank Bassam and his excellent team at Apricus Bio for providing us with this opportunity to launch MycoVa(TM) in the Canadian market. We will be assisting Apricus Bio in the filing of a New Drug Submission for MycoVa(TM) for onychomycosis and look forward to its commercial launch in Canada following Canadian regulatory approval."

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Viagra Cream Sends Apricus Bio (NASDAQ:APRI) UP +20%

Viagra and Cialis are cornerstones in the multi-billion dollar erectile dysfunction market. Today, another company hoping to capitalize on some of this popular pie made good headway with its approval in Canada for a “Viagra cream” so to speak. Shares of Apricus Biosciences (NASDAQ:APRI) spiked more than 20 percent in late trading after announcing the good news. As I write, the stock is up 18 percent at $2.46 per share on heavy volume of nearly 2.3 million shares compared to its average daily volume of only 130,000 shares. Apricus Biosciences has a market cap of $43 million and a 52-week range between $1.60 and $12.60 per share.

Apricus Biosciences announced that Health Canada has granted marketing approval for Vitaros as a first-line therapy for erectile dysfunction. Vitaros is Apricus Bio’s proprietary, topically-applied, on-demand treatment for erectile dysfunction.

Commenting on today’s news, Bassam Damaj, Ph.D., President and Chief Executive Officer of Apricus Bio, stated, “We at Apricus Bio are thrilled to have received this approval from Health Canada. The achievement of this milestone is a testament to the focus and dedication of the Apricus Bio team and our success in executing on our stated growth strategy.”

Dr. Damaj continued, “Data from our clinical trials showed that patients responded to treatment within minutes of applying Vitaros. Now, for the first time, men suffering from erectile dysfunction will have access to a patient-friendly, on-demand topical treatment. We view this Canadian approval as a validation of the NexACT technology as a transdermal delivery mechanism that is safe and effective. We intend to quickly finalize our marketing strategy to bring the product to the Canadian patient population. In addition, we will use this approval as the basis for seeking registration of the product for marketing in over 100 international markets.”

Vitaros incorporates alprostadil, a well-recognized vasodilator that is currently marketed as an injectable product or an intra-urethral insert product for patients with erectile dysfunction. Apricus Bio incorporated its proprietary NexACT drug delivery technology in the development of Vitaros as a patient-friendly topically-applied treatment for erectile dysfunction.

The product has been studied in over 3,300 patients including difficult to treat populations (diabetes, cardiac problems, sildenafil (Viagra) failures and post prostatectomy patients). Vitaros demonstrated clinical efficacy and excellent safety profile versus the currently approved oral therapies, and is not contraindicated for patients taking alpha blockers or nitrate medication. Viagra is a registered trademark of Pfizer.

Backed by NexMed, USA and Bio-Quant, Inc., its revenue generating CRO business, Apricus Bio has leveraged the flexibility of its proven NexACT drug delivery technology to enable multi-route administration of new and improved compounds across numerous therapeutic classes. Future growth is expected to be driven primarily through out-licensing of this technology for the development and commercialization of such compounds to pharmaceutical and biotechnology companies, worldwide. Concurrently, the Company is seeking to monetize its existing product pipeline, including its approved drug erectile dysfunction treatment, Vitaros, as well as compounds in development from pre-clinical through Phase 3, currently focused on dermatology, sexual dysfunction and cancer.

For further information on Apricus Bio and its subsidiaries, visit http://www.apricusbio.com.