Karessa changes its development strategy to facilitate the commercialization of new pharmaceuticals for impotence
Karessa Pharma AB announces today that the company has decided that the next step for the drug candidates K-01 and K-03 is to perform Proof of Concept clinical studies before pivotal studies for the projects. This is considered to facilitate the process of finding suitable commercial partners for future market launches. Because of the changed strategy, the company will present a revised overall development and registration plan for the projects concerned in the first quarter of 2017.
Karessa develops new pharmaceuticals based on proven pharmaceutical substances in order to offer men with erectile dysfunction a fast and more reliable effect. The company intends to sign commercial cooperation agreements for its drug candidates based on results from pivotal studies. However, partnership negotiations are usually prolix, and it may be an advantage to initiate them even before the results from the pivotal studies are available. The company therefore intends to perform Proof of Concept clinical studies for the pharmaceutical projects K-01 and K-03 as the next development step, with the aim of being able to demonstrate robust clinical data as early as possible. Provided no obstacles arise during the ongoing development activities, Proof of Concept clinical studies are expected to be initiated during 2017. A revised development and registration plan, based on the updated strategy, will be presented in the first quarter of 2017.
"We look forward to perform time and cost-effective Proof of Concept clinical studies with our most advanced drug candidates for impotence, in order to further visualize the values in our product portfolio for potential partners as well as for the stock market" says Torbjörn Kemper, CEO, Karessa Pharma AB.
Karessa Pharma's most advanced project K-01 is based on Sildenafil, the active substance in Viagra. The sale of Sildenafil amounted to approximately SEK 14 billion in 2015. The pharmaceutical project K-03 is based on the drug molecule Vardenafil, which is the active substance in the impotence drug Levitra. The sale of Levitra, marketed as Staxyn in the United States, amounted to approximately SEK 2.4 billion in 2015.
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.
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 below for publication on 21 December 2016, 09.25 CET.
FOR MORE INFORMATION, PLEASE CONTACT:
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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