Karessa Pharma in final negotiations with manufacturing company regarding start of manufacturing of the drug candidate Vigressa™
Karessa Pharma announces today that the company has entered into final negotiations with Laboratories Plasto Santé (PlastoPharma) regarding the manufacturing of pharmaceuticals for the upcoming clinical trial of Vigressa™ - a drug candidate with the potential to improve the treatment of impotence. The ambition for the cooperation with PlastoPharma is also to ensure a well-functioning and cost-effective manufacturing of Vigressa™ on a commercial scale for future market launch.
PlastoPharma is a privately owned contract manufacturer with more than 20 years of experience in transdermal, film-based drugs. The company has its headquarters in Paris and research and manufacturing facilities in Chenôve, France.
"We think there is good opportunities to complete the negotiations with PlastoPharma shortly and begin preparations for the manufacturing of drugs for the pivotal clinical programme with Vigressa™. PlastoPharma has also the knowledge and capacity to handle the future manufacturing of Vigressa™ on a commercial scale, which is important to strength Karessa's offer to potential partners for product launch" says Torbjörn Kemper, CEO, Karessa Pharma AB.
Vigressa™ is a drug candidate based on a unique and patented bioorganic film with the active substance in the impotence drug Viagra. Vigressa™ is delivered directly into the bloodstream via the oral mucosa, which means that the effect of the drug is not depending on food intake or degradation in the liver. By this way a quick and reliable onset is achieved for patients with impotence problems. A pivotal clinical programme is scheduled to start during 2016 and the company estimates that an application for approval can be submitted already at the beginning of 2017.
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. 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.
FOR MORE INFORMATION, PLEASE CONTACT:
Torbjörn Kemper, CEO, Karessa Pharma Holding AB (publ)
Tel: +46 8-768 22 33
About Karessa Pharma Holding AB
Karessa's unique technology allows pharmaceuticals to take a shortcut to the right place in the body. The goal of the company's most advanced project - Vigressa™ - is to offer men with impotence problems a fast and more reliable effect. A pivotal clinical programme is 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