Can-Fite BioPharma Ltd (PETACH TIKVA, Israel), a clinical-stage drug development company focused on a portfolio of orally bioavailable, highly selective, small-molecule A(3) adenosine receptor (A3AR) agonists with potent activities in inflammation and cancer, announced that it has signed an exclusive license agreement with a Japanese research-based pharmaceutical company, Seikagaku Corporation, to develop and market its lead orally bioavailable A3AR agonist, CF101 (1-deoxy-1-(6-[([3-iodophenyl] methyl) amino]-9H-purin-9-yl)-N-methyl-β-d-ribofuranuronamide), in Japan for the treatment of inflammatory indications including rheumatoid arthritis (RA) but not including ophthalmic indications. As previously announced, Can-Fite has received approval from the Israeli Ministry of Health to conduct a phase IIa clinical trial with CF101 for the treatment of dry eye syndrome (keratoconjunctivitis sicca).
Under the terms of the agreement, Can-Fite is eligible to receive up to US $19.5 million should all specified milestones be achieved, and royalties from the sales of CF101 in Japan. Can-Fite will immediately receive a US $3.5 million payment and a further US $1.5 million during the course of the coming year, contingent on achieving progress-related milestones in its 250-patient phase IIb RA trial ongoing in United States, Europe, and Israel, which is due for completion in 2007. The Company will also receive annual license fees up to a total of US$2.5 million. Can-Fite will receive the remainder of the consideration, US $12 million, contingent on achieving milestones set forth in the agreement and based on Seikagaku Corporation's progress in developing CF101 for RA in Japan. Additional income will be received from the sale to Seikagaku Corporation of the active pharmaceutical ingredient needed to manufacture the drug for marketing in Japan.
Can-Fite recently also announced its intention to initiate a phase II trial of CF101 in psoriasis.
Seikagaku Corporation (TOKYO, Japan) is a pioneer and leader in the field of glycoscience and therapeutics for joint diseases such as arthritis. It has developed sodium hyaluronate injection (trade named: SupartzR, Artz®, or Artzal®), its first specialty product for osteoarthritis, and has obtained regulatory marketing approval for the product in 23 countries, including the United States.
— A. Techman
E-mail any comments to .