Apricus Biosciences, Inc. announced that the Korean Patent Office recently issued a notice of allowance to grant a patent for the company's development of a topical cream utilizing vasoactive prostaglandin E to treat premature ejaculation (PE), When issued, the patent, entitled, “Compositions and Methods for the Treatment of Premature Ejaculation,” will provide Korean patent protection until March 2024. It is one in a series of issued patents and pending applications that Apricus Bio owns in the male sexual dysfunction field utilizing its proprietary NexACT technology, which includes its Vitaros product to treat erectile dysfunction (ED), among others in research and development.

Commenting on the news, Dr Bassam Damaj, president and chief executive officer of Apricus Bio, commented, “We are very pleased with this patent allowance in South Korea for the use of vasoactive prostaglandin E to treat PE. This allowed patent includes the same pharmaceutical composition as Vitaros, combined with a local anaesthetic. We are aggressively seeking marketing approval from various regulatory authorities and pursuing partnership transaction applications for Vitaros for erectile dysfunction, and are also developing related products utilizing our NexACT technology that may add to the value of our existing portfolio of drugs to treat various types of sexual dysfunction. In addition to the issuance of this new Korean patent, we are actively seeking patent protection for this PE application in the U.S. and in other key countries.”

Vitaros has been approved by Health Canada for marketing and sales for patients with ED and the Company has filed for marketing approval for the drug for this indication in the European Union and Switzerland. Vitaros is a topical cream that incorporates alprostadil, a well-recognized vasodilator currently marketed by other companies as an injectable product or an intra-urethral insert. The drug has been studied in over 3,300 patients, including difficult to treat populations, such as those with diabetes, cardiac problems, sildenafil (Viagra) failures and post prostatectomy patients. Vitaros has demonstrated clinical efficacy and an 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, Inc.

Apricus Bio is currently studying the use of vasoactive prostaglandin E, combined with and without local anaesthetics, to develop a topical cream to treat PE. To date, the Company has completed three clinical studies for this application, including two single-blind studies and one double-blind study.

The company's PE patent portfolio currently consists of four issued patents (Australia, Singapore, Japan and soon-to-be Korea) and eight pending applications (the US, Canada, Europe, Mexico, Brazil, China, Hong Kong and Israel).

According to Datamonitor 2010, “PE is a commonly yet poorly understood and defined male condition. Prevalence estimates vary greatly from 4% to 29% as stated by a study done by Simons and Carey (2001), according to the different definitions used. The disorder is currently severely undertreated and off-label prescription of selective serontonin reuptake inhibitors (SSRIs) is the most common treatment pathway in the seven major markets.”

Apricus Bio, a revenue-generating, biopharmaceutical company, has leveraged the flexibility of its clinically-validated NexACT drug delivery technology to enable multi-route administration of new and improved compounds across numerous therapeutic classes.