Apricus Biosciences, Inc. (APRI) recently received a negative opinion from Swissmedic, the Agency for Therapeutic Products in Switzerland. Swissmedic is not in favor of granting marketing approval to Vitaros, indicated for erectile dysfunction, based on some quality related issues.
The pre-clinical and clinical data submitted earlier by Apricus was satisfactory for the approval according to Swissmedic. However, according to Swissmedic the data related to the targeted shelf life of the product's cold chain formulation presented by Apricus was not satisfactory for the approval at present. Apricus plans to submit an appeal regarding this within thirty days.
Vitaros is the only approved product of Apricus. Vitaros is approved in Canada and Europe.
Recently, Apricus got national phase approvals for Vitaros in Ireland, the Netherlands, the UK and Sweden.
The company’s main area of focus this year is the launch of Vitaros and the clinical development of Femprox (female sexual dysfunction treatment). During the first half of 2013, Apricus raised $17.1 million through common stock and warrants. It also divested multiple non-core assets and has streamlined its global operations. This should allow the company to focus on Vitaros and Femprox.
We note that Apricus has several partnership agreements for Vitaros in countries like the U.S., Canada, Germany, UK, Italy, and certain other countries in the Middle East, the Gulf countries, and Israel. The company’s near-term focus is to direct resources toward the commercialization of Vitaros in Europe and Canada with the help of its existing partners in these regions.
Furthermore, Apricus is looking to enter into partnerships in the remaining countries in Europe and global markets. Apricus expects to earn license fees through these partnerships.
Apricus carries a Zacks Rank #3 (Hold). Currently, companies which look attractive include Gilead Sciences Inc. (GILD) and Actelion Ltd. (ALIOF) with a Zacks Rank #1 (Strong Buy), and Jazz Pharmaceuticals (JAZZ) with a Zacks Rank #2 (Buy).
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