Karessa starts new pharmaceutical project with the opportunity to reach clinical phase during 2017 and re-prioritize the project portfolio

Karessa Pharma AB announces today that the company initiated a new pharmaceutical project, K-03, based on the approved and well proven drug molecule Vardenafil. Vardenafil is the active substance in the impotence drug Levitra, whose patent expires in 2018. The sale of Levitra, marketed as Staxyn in the United States, amounted to approximately SEK 2.1 billion in 2015. Based on new promising research results and the possibility to start clinical trials with K-03 already in 2017, a down-prioritization of the company's preclinical project K-02 is being made.

Recent laboratory tests show that the characteristics of Vardenafil molecules are significantly better adapted to Karessa's drug delivery technology than Tadalafil, the substance included in the company's pre-clinical project K-02. This is expected to enable fast and cost-effective pre-clinical development prior to the start of clinical trials. In addition, the patent expiries for Vardenafil in the USA is approximately two years earlier than for Tadalafil, which could lead to a faster market introduction of K-03. In order to secure sufficient operational and financial resources for the new pharmaceutical project K-03, Karessa has decided to down-prioritize the development of K-02.

"Recent successful pre-clinical work has resulted in the integration of another impotency drug, Vardenafil, for Karessa's unique transmucosal film. This in order to enable the absorption of the drug through the oral mucosa to provide practical and clinical benefits for the patients. Our current assessment is that the project can reach clinical phase already during next year" says Torbjörn Kemper, CEO, Karessa Pharma AB.

The company's most advanced project, based on the active substance in Viagra, is not affected by the re-prioritization of resources currently being implemented. Production development is currently ongoing with the French PlastoPharma, with the aim to starting clinical studies in the end of the year.

About Karessa's pharmaceutical projects for treatment of erectile dysfunction
Current treatment of impotence is well proven and has a favorable safety profile, but many patients are bothered by the delayed onset and that it may vary depending on food intake. These problems are a consequence of the drug being given as tablets and thus has to pass the stomach and liver before reaching the right place in the body.

Karessa has developed a buccal film with the active substance in Viagra (Sildenafil) or Levitra (Vardenafil). The film is small and is placed on the inside of the chin where it dissolves as the drug is delivered directly into the bloodstream via the oral mucosa. By this way the drug is delivered into the body and a quick and reliable onset is achieved. Karessa's most advanced pharmaceutical project is based on Sildenafil and will be evaluated in two pivotal clinical programmes, which are expected to start in the second half of 2016.

Impotence affects about half of all men over 40 years and the global market for impotence drugs is estimated to a value of approximately SEK 35 billion.

This information is such information that Karessa Pharma Holding AB is obliged to disclose public according to the European Union's Market Abuse Regulation. The information was provided by the contact person above for publication on 18 August 2016, 09.00 CET.

Torbjörn Kemper, CEO, Karessa Pharma Holding AB (publ) 
Tel: +46 8-768 22 33
Email: torbjorn.kemper@karessa.se

About Karessa Pharma Holding AB
Karessa's unique technology allows pharmaceuticals to take a shortcut to the right place in the body. Karessa develops new pharmaceuticals based on proven pharmaceutical substances in order to offer men with impotence problems a fast and more reliable effect. Two pivotal clinical programmes with Karessa's most advanced projects, based on the active substance in Viagra, are expected to be initiated during 2016. Karessa is listed on Nasdaq First North and has Remium as Certified Advisor. For more information, please visit karessa.se


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