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In November 2010, Health Canada gave marketing approval for Vitaros, Apricus Bio’s (NASDAQ:APRI) first line therapy for erectile dysfunction (ED). Vitaros is an easy-to-use topical treatment that has been clinically approved and also proven to work faster, have a more attractive safety profile, and to work on a wider population compared to leading ED drugs, such as Viagra.
Partnerships for Vitaros have been announced for the Middle East and Gulf region, Israel, and Italy. A partnership for the Canadian market where the drug is approved, and potentially Europe, is expected in the near term.
Late last year, Apricus Bio announced that the company had selected Therapex, a division of Bracco Pharma, as the centralized manufacturer of Vitaros.
“Getting the manufacturing facility ready to produce is an important step in bringing Vitaros to market,” explained Apricus Bio CEO Bassam Damaj, in an exclusive interview. “We want to be as close to production as possible when we sign our Canadian partner,” he said.
According to the company, the new manufacturing facility is producing its first three batches of Vitaros. The analytical data from those batches will be submitted to Health Canada for inspection to approve the manufacturer before the drug becomes available to Canadian patients.
“Having the manufacturing facility prepared for production will cut the lag time between signing a partnership agreement and beginning production,” said Dr. Damaj. Because of the advanced stage of the manufacturing facility’s development, an announcement of a partnership will likely translate directly into sales, royalties, and revenues within a shorter period of time than without such development. Apricus Bio believes production of Vitaros could begin as early as October, with revenues coming in potentially by the end of the year.
In addition, the newly produced Vitaros samples will also allow Apricus Bio to issue the Certificate of Pharmaceutical Product (CPP) from Health Canada, which it plans to do in the coming months. The key here is that presenting a CPP with actual drug samples is usually sufficient for drug approval in many places around the world, such as the Middle East, the Gulf Countries and Israel where Apricus Bio has already established partnerships. A CPP may also help facilitate approval in developed countries with more stringent regulations. With partners already established in some of these geographies, revenue from these partnerships could be realized sooner.
The company is currently negotiating an agreement for a Canadian partner and aims to have a deal worked out in the near future. An agreement will likely have traditional structure, with upfront and milestone payments, royalties, as well as health agency filing reimbursements.
In an additional positive turn of events, the company indicated that it now believes a partnership could include both the Canadian and the European markets, which make up a combined billion-dollar-plus ED market. Dr. Damaj stated that “We received increased interest after filing for approval in Europe. The advantage for our commercial partner is that Vitaros can be sold in Canada, while we are waiting for European approval,” he explained. This development could result in a larger partnering deal for Apricus Bio. It appears that the terms in a European agreement may be at the level they would be if Vitaros was already approved on the continent.
But the company also sees further opportunities. “Within our Vitaros partnership discussions, there is interest in the use of the NexACT technology and building long term relationships,” Dr. Damaj noted. In fact, Apricus Bio is already in advanced discussions with companies for the use of its NexACT technology. NexACT allows for a more effective absorption of drug compounds into the body. Many companies have carried out studies with NexACT®, with some coming back to negotiate a license for the use of the technology within their own compounds. Apricus Bio believes that it may secure its first NexACT® license by year end.
The company also continues to work on a room temperature Vitaros® product. The new variation, which is currently undergoing stability testing, could create several exciting opportunities for the company.
“We believe our room temperature version of the product would likely be the only viable ED drug able to go from prescription-only to being available over-the-counter,” Dr. Damaj explained. The possibility of being the first and only OTC erectile dysfunction drug is a very exciting development. The hope is that no clinical data will be required for approval due to the similar properties that the new formulation shares with the original version of Vitaros. More importantly, Apricus Bio owns the full rights to this product’s dispenser, even in the United States.
The company also recently appointed an in-house general counsel. According to Apricus Bio, the move will help the companytransition into a commercial stage biopharmaceutical company and pursue numerous commercial partnership discussions and negotiations.”
The need for an in-house counsel is a response to the growing interest in the company’s products and technology. It is also indicative of the developments ongoing behind the scenes. The near-term looks full of positive events for this transitioning company, with its first approved drug set to hit shelves this year and significant revenues following. In addition, with the Vitaros manufacturing facility now producing the first batches of the drug, a pivotal Canadian and potentially European partnership should be announced in the near future.
Source: Apricus Bio Moves Forward With Viagra Competitor Vitaros