Karessa has signed an agreement for manufacturing of clinical trial material for the project K-03
Karessa Pharma Holding AB announces today that an agreement for manufacture of clinical trial material has been signed between Karessa and Recipharm. The intention is to manufacture clinical trial material that will be used for Proof of Concept studies later this year.
Manufacturing of clinical trial materials is a prerequisite to be able to perform clinical trials on humans. The manufacturing is performed according to GMP (Good Manufacturing Practice) to ensure that the material to be used for clinical trials have the quality required to complete the study.
Karessa Pharma's 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. The development of formulation, analytical methods and manufacturing methods has been ongoing during the year and is now available for tech transfer to the CDMO (Contract Development and Manufacturing Organization) for the manufacturing of GMP material.
The development of Karessa's other projects within the therapeutic area erectile dysfunction, K-01 (Sildenafil) continues according to plan.
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 Vardenafil (K-03). 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 many middle-aged men and has an increased prevalence of age. The global market for impotence drugs is estimated to a value of approximately SEK 40 billion.
This information is such information that Karessa Pharma Holding AB (publ) 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 April 25, 09.00 CET.
FOR MORE INFORMATION, PLEASE CONTACT:
Michael Brobjer, CEO, Karessa Pharma Holding AB (publ)
Tel: +46 8-768 22 33
Email: michael.brobjer@karessa.se
About Karessa Pharma Holding AB
Karessa develops new pharmaceuticals based on a patented drug delivery technology and proven pharmaceutical substances in order to offer men with impotence problems a fast and more reliable effect. Karessa is listed on Nasdaq First North. For more information, please visit karessa.se
About Recipharm
Recipharm is a leading CDMO (Contract Development and Manufacturing Organization) company in the pharmaceutical industry and has approximately 5,000 employees. Recipharm offers manufacturing services of pharmaceuticals in various forms, production of materials for clinical trials and APIs, as well as pharmaceutical product development. Recipharm manufactures several hundred different products for big pharmaceutical companies as well as small development companies. The company has a turnover of approximately SEK 5.3 billion and has development and manufacturing facilities in France, India, Israel, Italy, Portugal, Spain, UK, Sweden, Germany and in the United States, headquartered in Stockholm, Sweden. Recipharm B share (RECI B) is listed on Nasdaq Stockholm. For more information, please visit www.recipharm.com
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