Apricus Biosciences Files Marketing Application for Vitaros

Apricus Biosciences, Inc. recently announced its filing of a marketing application for Vitaros as a treatment for patients with erectile dysfunction (ED) in Switzerland, with Swissmedic, the Swiss Agency for Therapeutic Products.

“We are excited about making our third major filing for our flagship product, Vitaros, for the treatment of ED,” said Dr. Bassam Damaj, Chairman, Chief Executive Officer and President of Apricus Bio.

According to IMS Health data, the annual ED market in Switzerland in 2010 was estimated at EURO27 million. The potential market for a drug approved in Switzerland, however, is much larger than just the Swiss market. Swissmedic approval is relied upon by the regulatory authorities in numerous European countries that are not members of the European Union, as well as by many other countries worldwide. The approval time for Swissmedic is currently approximately 15 months from the time of submission.

The company received marketing approval for Vitaros as a first-line treatment for ED from Health Canada in November 2010, for sales of the product in that country. In April 2011, Apricus Bio filed a marketing application in the European Union, under the Decentralized Procedure (DCP), for Vitaros for the treatment of ED. Under the DCP, approval in a Reference Member State means that a drug may be sold in all of the European Union countries that were filed with the DCP as Concerned Member States.

Switzerland, however, is not part of the European Medicines Agency (EMA). Marketing drugs in Switzerland requires an independent application and approval from Swissmedic.

“Swissmedic is considered one of the most well-respected drug regulatory authorities that is relied on by many countries throughout the world,” said Dr. Damaj. “As we have stated previously, we look forward to applying for approval for this product and for the ED indication in other important international markets in the future.”

The current leading drugs for ED are Viagra, Cialis, and Levitra, which are taken in pill form and work by inhibiting an enzyme called PDE5. There is still a need for new, safe, and effective treatments, however, especially for those patients who cannot or do not respond well to oral medication. Vitaros differs from Viagra, Cialis, and Levitra in two ways. Instead of a pill, it is applied directly to the penis as a cream. The topical application helps to reduce side effects and offers men who do not do well with the existing drugs a patient-friendly alternative. Also, Vitaros operates by a different biochemical mechanism than oral ED medications. It contains a previously marketed ED drug known by the chemical name of alprostadil. When absorbed through the skin, alprostadil directly boosts blood flow, thereby causing an erection within minutes, which the company believes is much faster than the results from the oral treatments.

Alprostadil is currently marketed as an injectable drug or as a suppository inserted into the urethra. The key innovation behind Vitaros is combining alprostadil with Apricus Bio’s NexACT delivery technology, which allows the drug to pass through the skin and makes the treatment much easier to apply. In clinical studies, Vitaros worked in patients suffering from mild to severe ED, including men who did not respond to Viagra. The side effects reported were localized and transient.

Apricus Bio, a San Diego-based, 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. Revenues and growth are driven from out-licensing of this technology for the development and commercialization of such compounds to pharmaceutical and biotechnology companies worldwide. In addition, the company is seeking to monetize its existing product pipeline, including its first product, Vitaros, approved in Canada for the treatment of erectile dysfunction, which is currently expected to be available on the Canadian market in 2011, as well as compounds in development from preclinical through Phase III, currently focused on Sexual Dysfunction, Oncology, Dermatology, Autoimmune, Pain, Anti-Infectives, Diabetes, and Cosmeceuticals among others.