Pro-Pharmaceuticals Grants Procaps Exclusive Rights To Commercialize Davanat

Under terms of the agreement, Procaps will be responsible for obtaining regulatory and pricing approval in Colombia, South America. Procaps 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, in addition to a royalty above a minimum annual sales threshold. Procaps will purchase an initial minimum order of Davanat to qualify their vial-filling process and to replicate Pro-Pharmaceuticals’ stability study.

Pro-Pharmaceuticals will retain all intellectual property rights and is the owner of the regulatory approval of Davanat in the region.

Procaps has negotiation rights to other countries in South and Central America and the Caribbean. Based on approval in Colombia, it may then obtain the marketing authorization in more than 10 countries in Latin America.

As per the study, 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% over the standard of care and reduced serious adverse events associated with chemotherapy.

Theodore Zucconi, chief executive officer of Pro-Pharmaceuticals, said: “This is a significant milestone in our Latin American business development initiative. We believe Procaps is an excellent partner to commercialize Davanat in Colombia as well as other countries in Latin America.

“Procaps brings to the relationship experience with the FDA and in obtaining approval for new medicines throughout the America’s. Procaps 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.”

Ruben Minski, president of Procaps, said: “We are pleased to collaborate with Pro-Pharmaceuticals to commercialize Davanat to treat cancer patients in Colombia. 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.”