Canadian Biotech Merger Puts Focus on Nephrology Drugs

Two Canadian biotechnology firms—the publicly traded Isotechnika Pharma and privately held Aurinia Pharmaceuticals—will combine forces to concentrate on the nephrology therapeutic market. The companies will join together under the Aurinia banner to focus on developing the calcineurin inhibitor voclosporin, an immunosuppressant, for approval.

Although the merger is based in Canada, the deal has international overtones. If approved, the South Korean ILJIN Life Science—which owns the rights to voclosporin—will take a 25 percent ownership stake in the new Aurinia.

Vifor Pharma, the Swiss pharmaceutical company held by the Galenica Group, is also involved. In 2012 it signed a development and commercialization agreement with Isotechnika to market voclosporin for treatment of lupus and all proteinuric nephrology indications in the United States and other countries outside of Canada.

Aurinia itself was spun out from Vifor as a separate entity after the Swiss firm acquired Aspreva in 2008, a company that specialized in immunosuppressive therapies, investigated lupus nephritis treatments, and conducted the Aspreva Lupus Management Study (ALMS).

Previously, voclosporin has been studied in the treatment of chronic noninfectious uveitis. However, the drug was withdrawn from approval for this indication in Europe because of a failure to demonstrate that its benefits outweighed its risks.

Isotechnika recently completed a phase IIb study of voclosporin for use in solid organ transplantation that demonstrated equivalence to tacrolimus in prevention of acute rejection.

“While there have been a number of advances in the treatment of lupus nephritis, there is no question that significant unmet medical need remains,” said Neil Solomons, MD, the new company’s chief medical officer. “To that end, we expect to launch this phase IIB study of voclosporin in lupus nephritis in 2013,” he added.

Based in Edmonton, Alberta, Canada, Isotechnika anticipates completion of the deal by the end of the first quarter of 2013, pending shareholder and regulatory approval.

March 2013 (Vol. 5, Number 3)