Davanat is in Phase II studies for treating colorectal, gall bladder, and bile duct cancers.

Pro-Pharmaceuticals granted Procaps exclusive rights to market and sell Davanat in Colombia. The drug is being tested in Phase II trials as a treatment for late-stage colorectal cancer as well as gall bladder and bile duct cancers.

Procaps is responsible for obtaining regulatory and pricing approval in Colombia. Pro-Pharmaceuticals will retain all intellectual property rights. Procaps has first right of negotiation to other countries in South and Central America and the Caribbean. Based on approval in Colombia, Procaps may then obtain marketing authorization in more than 10 countries in Latin America.

“This is a very significant milestone in our Latin American business development initiative,” notes Theodore D. Zucconi, Ph.D., CEO, Pro-Pharmaceuticals. “Procaps operates directly in 10 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 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.

Davanat is a polysaccharide polymer that targets Galectin receptors on cancer cells. Peer-reviewed studies have demonstrated that Galectins affect cell development and play important enabling roles in cancer, including tumor cell survival, angiogenesis, and tumor metastasis.

To date Davanat has been administered to approximately 100 cancer patients. The gall bladder/bile duct cancer trial is currently enrolling patients. The Phase II trial for end-stage colorectal cancer patients has showed that in combination with 5-FU, Davanat extended median survival by 46% over the standard of care as determined by the patients’ physicians. Clinical trial results also showed that patients experienced substantially fewer serious adverse side effects from the chemotherapy including 100% elimination of sores in the mouth and throughout the colon.

Procaps will also take care of vial filling, packaging, marketing, and distribution of Davanat in the region. Procaps will purchase an initial minimum order of the therapy from Pro-Pharmaceuticals to qualify its vial-filling process and to replicate Pro-Pharmaceuticals’ stability study.

Pro-Pharmaceuticals will receive a transfer payment for each dose of Davanat shipped to Procaps in addition to a royalty above a minimum annual sales threshold.

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