Cipher Pharmaceuticals Inc., a rapidly growing specialty pharmaceutical dermatology company, has licensed the Canadian distribution rights to CF101, a novel chemical entity being developed by Can-Fite Biopharma (Can-Fite) for moderate to severe plaque psoriasis and rheumatoid arthritis.

CF101 recently completed a phase II/III double-blind, placebo-controlled study, which was designed to test the efficacy of CF101 in patients with moderate to severe plaque psoriasis. Can-Fite enrolled 326 patients through 17 clinical centers in the US, Europe, and Israel. Top-line results from the trial will be published by Can-Fite at the end of March 2015. Interim results from this phase II/III trial and final results from the prior phase II trial in psoriasis were both positive showing that CF101 effectively improved disease symptoms. In addition, at the end of 2013, CF101 completed a phase IIb study for active rheumatoid arthritis, and Can-Fite has completed the study design for a phase III programme.

Approximately 500,000 in Canada people receive treatment for psoriasis. In moderate to severe cases, the most common treatment options are systemic biologic drugs, which are delivered by injection or intravenous (IV) infusion and have well-known shortcomings, including increased risk of infection. CF101 is an oral small molecule drug formulated in a tablet and has an excellent human safety profile, demonstrated in more than 1,000 patients.

"This transaction deepens our Canadian portfolio with a high-potential, novel treatment option for two important indications," said Shawn O'Brien, president & chief executive officer of Cipher. "As an orally bioavailable drug, we believe CF101 has the potential to offer a much-needed treatment alternative to patients living with psoriasis and rheumatoid arthritis. We see CF101 as being complementary to our Beteflam Patch, giving us two products targeting psoriasis, one of the most common autoimmune diseases in Canada."

The timeline to regulatory submissions to Health Canada will be determined by the completion of the remaining clinical trial programme.

Under the terms of the agreement, Can-Fite will receive an upfront payment of CDN$1.65 million and is eligible for milestone payments of up to CDN$2,000,000 and royalties from product sales in Canada. The agreement provides that Can-Fite will deliver finished product to Cipher.

CF101, an A3 adenosine receptor agonist, is a novel, first in class, small molecule, orally bioavailable drug with a favorable therapeutic index demonstrated in phase II clinical studies. CF101 is currently developed for the treatment of autoimmune inflammatory diseases including psoriasis (phase II/III) and rheumatoid arthritis (completed phase II).