Evaluation of the drug by Canadian regulatory authorities is under way.

Paladin Labs will take over distribution of BTG’s treatment for digoxin toxicity or overdose in Canada. DigiFab™ is currently under review at Health Canada. The therapy was developed by Protherics, which was acquired by BTG in September 2008 for roughly £218.1 million (about $333 million).

Digoxin (also known as digitalis) is a drug used to treat congestive heart failure and to slow heart rate in some cardiac disturbances. It has a narrow therapeutic window, making it easy to move from therapeutic levels to toxic levels as a result of excessive dosing, slow elimination, or interaction with other drugs.

The treatment has been on the U.S. market since 2001. It is marketed by Nycomed, but BTG will take over sales in the U.S. by October 1.

On February 4, DigiFab was approved in Switzerland, making it the first European country to sanction the treatment. BTG has licensing agreements with Beacon Pharmaceuticals for marketing the drug in Europe. Beacon sublicensed distribution in Switzerland to Proreo Pharma.

“DigiFab provides an important opportunity to grow Paladin’s specialty and orphan franchise, which includes Replagal, Elaprase, and Antizol,” says Jonathan Ross Goodman, president and CEO of Paladin Labs.

Paladin concentrates on acquiring or in-licensing pharmaceutical products for world markets. Replagal and Elaprase were developed by Shire Biologics for Fabry disease and Hunter syndrome, respectively, both orphan indications. Antizol was developed by Jazz Pharmaceuticals for ethylene glycol and methanol poisoning. Paladin’s product portfolio broadly includes treatments for CNS-related disorders, and dermatology, endocrinology, pain, urology, and women’s health.

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