Isotechnika Inc., an international biopharmaceutical company, announced that the Company had achieved a significant development milestone pursuant to the terms of its collaboration agreement with Roche. In accordance with the agreement, the positive results of the recently completed Phase II clinical trial of ISA247 in patients with moderate to severe psoriasis entitled Isotechnika to receive a milestone payment of $21,900,000 CDN. In April 2002, Isotechnika entered into a collaboration agreement with Roche for the global co-development and commercialization of its lead drug, ISA247.
The milestone payment is comprised of $8,355,000 CDN in cash and $13,545,000 CDN in equity investment.
"The achievement of this drug development endpoint confirms the intrinsic value of our innovative technology, the excellent progress being made in our clinical development program for ISA247 and the inherent strength of our strategic partnership with Roche," commented Dr. Randall Yatscoff, president and COO. "This significant milestone payment enables the Company to preserve its current strong cash position while pursuing its strategy of expanding its drug pipeline through the in-house discovery and development of new and complimentary immunosuppressive compounds and continuing its support of the advancement of ISA247."
Isotechnika's lead drug, ISA247, is currently in Phase II clinical development for two indications; kidney transplantation and psoriasis. The Phase II psoriasis study was completed in November 2002 and the Company released the study results in March 2003. The data showed that ISA247 met or exceeded all of the primary and secondary efficacy and safety endpoints for the study. The Phase IIa trial in kidney transplantation was completed in January 2003 with study results expected by the end of the second quarter.
Under the terms of the global collaboration agreement with Roche, Isotechnika could receive up to $215,000,000 USD in license fees, drug development and commercial milestone payments and equity investment. Roche is also responsible for 70 per cent of the shared development costs of ISA247. The Company will also receive predetermined tiered sales-based royalties at escalating rates upon commercialization of ISA247.
ISA247 is a novel calcineurin inhibitor in Phase II clinical development as immunosuppressive therapy in organ transplantation and in the treatment of autoimmune diseases. Early studies indicate that ISA247 is considerably more potent and less toxic compared to other immunosuppressants, such as cyclosporine A. This powerful combination of reduced toxicity and improved potency should provide a major therapeutic benefit over existing calcineurin based regimens. ISA247 is being developed under a global collaboration agreement with Roche.