ProMetic Life Sciences Inc. has licensed its biologics manufacturing technologies to Kedrion SpA for use with two plasma-derived protein products.
Montreal-based ProMetic expects the deal to bring $2 million (US$2.04 million) in service fees, up-front payments and milestone payments over the next 12 months. Company spokesperson Anne Leduc declined to specify how the payments break down.
In exchange, Lucca, Italy-based Kedrion will gain the right to use ProMetic's Mimetic Ligand purification technology, which has the potential to increase the production yield and purity of biologics. Kedrion will fund and manage clinical trials of the resulting purified protein products. Kedrion also will market the products in Europe and pay a royalty to ProMetic, while ProMetic will manage marketing in North America and pay a royalty to Kedrion.
The first product covered under the deal is an intravenous immunoglobulin (IVIG) for treating acute exposure to blood infected with the hepatitis B virus and for preventing reinfection with HBV following liver transplant.
In the U.S., hepatitis B immune globulin is approved for preventing infection after accidental exposure to HBV and is used off-label as the standard of care in liver transplant patients at risk for HBV reinfection.
Nabi Biopharmaceuticals was pursuing FDA approval of Nabi-HB [hepatitis B immune globulin (human)] in the liver transplant indication, but the FDA had asked for additional data. Last fall, Nabi sold Nabi-HB and the rest of its biologics unit to Biotest AG. (See BioWorld Today, Sept. 12, 1007.)
Assuming successful clinical development and approval, ProMetic said it expects annual revenues of $30 million from its HBV product beginning in 2011.
The focus of the second program has not been disclosed.
Last spring, ProMetic and Kedrion began working together on purified plasma products, and in the fall, they entered a deal for the use of ProMetic's technology in manufacturing for European markets. At the time, terms were not disclosed.
Shares of ProMetic (TSX:PLI) lost C1 cent to close at C47 cents on Tuesday.