Karessa announces that the plan for the two projects K-01 and K-03 remains unchanged
Karessa Pharma Holding AB announces today that the plan presented in December about the development of K-01 and K-03 remains until further notice.
Karessa pledged in December that a revision of the overall development and registration plan should be available in Q1 2017. Newly-appointed CEO Michael Brobjer finds that the plan presented for the two projects remains unchanged until further notice. This means that a Proof of Concept clinical study shall be perform for the projects to obtain initial clinical data before initiating a pivotal clinical programme.
Karessa Pharma's 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 Sildenafil (K-01) or 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 35 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 March 28, 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
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