Pro-Pharmaceuticals, Inc, a developer of therapeutics that target Galectin receptors to treat cancer and fibrosis, has granted Procaps S.A. exclusive rights to market and sell Davanat to treat cancer in Colombia, South America. Phase-ll clinical trial results for late-stage colorectal cancer patients demonstrate that when Davanat is co-administered with the chemotherapy drug 5-FU, survival increased by 46 per cent over the best standard of care and reduced serious adverse events associated with chemotherapy. Procaps S.A. is a large, international, privately held pharmaceutical company based in Barranquilla, Colombia.
Under terms of the agreement, Procaps S.A. is responsible for obtaining regulatory and pricing approval in Colombia, South America. Procaps S.A. also will be responsible for the vial filling, packaging, marketing and distribution of Davanat in the region. Pro-Pharmaceuticals will receive a transfer payment for each dose of Davanat shipped to Procaps S.A., in addition to a royalty above a minimum annual sales threshold. Procaps S.A. will purchase an initial minimum order of Davanat from Pro-Pharmaceuticals to qualify their vial-filling process and to replicate Pro-Pharmaceuticals’ stability study. Pro- Pharmaceuticals retains all intellectual property rights and is the owner of the regulatory approval of Davanat in the region.
Procaps S.A. has first negotiation rights to other countries in South and Central America and the Caribbean. Based on approval in Colombia, Procaps S.A. may then obtain the marketing authorization in more than 10 countries in Latin America. According to the World Health Organization, there were approximately 24,000 new cases of colorectal cancer in 2007 in Colombia.
“This is a very significant milestone in our Latin American business development initiative. We believe Procaps S.A. is an excellent partner to commercialize Davanat in Colombia as well as other countries in Latin America,” said Theodore D Zucconi, chief executive officer, Pro-Pharmaceuticals. “Procaps S.A. operates directly in ten Latin America countries, reaching more than 30 countries worldwide exporting pharmaceutical and supplement products and has a record of success launching new products in its territories, including oncolytics. Procaps S.A. has a dedicated sales force with an increasing focus on cancer and a record of collaborating with pharmaceutical companies, such as Wyeth, Merck, GSK and Sanofi.
“Procaps S.A. brings to the relationship experience with the US FDA and in obtaining approval for new medicines throughout the America's. Procaps S.A. will efficiently obtain approval for Davanat in Colombia and other countries in Latin America. Additional near-term plans for Pro-Pharmaceuticals include initiating a phase-lll trial in the US and seeking out licensing and partnering opportunities with pharmaceutical companies to commercialize Davanat domestically and internationally,” stated Zucconi.
"We are pleased to collaborate with Pro-Pharmaceuticals to commercialize Davanat to treat cancer patients in Colombia,” said Ruben Minski, president of Procaps S.A. “Davanat will give physicians and patients a new treatment option that we believe will increase survival and improve quality of life. Davanat has the potential to assist a large number of cancer patients in Colombia who cannot afford many current cancer treatments. We believe this new treatment option may give them the hope of continuing to live a normal life during treatment since Davanat has been shown to minimize the side effects of chemotherapy drugs. With Pro- Pharmaceuticals’ advanced technology and our manufacturing and marketing expertise, together we can have a positive impact on cancer patients in Colombia."
Davanat, the company's lead product candidate, is a polysaccharide polymer that targets Galectin receptors on cancer cells.
Pro-Pharmaceuticals is a leader in the field of Galectin therapeutics and is engaged in the discovery, development and commercialization of therapeutics that target Galectin receptors for advanced treatment of cancer and fibrosis.
Procaps S.A. is a pharmaceutical manufacturing and distribution company located in Barranquilla, Colombia.