3Sbio, Isotechnika Pharma sign development and commercialization agreement for voclosporin inhibitor

Aug 25 2010

Isotechnika Pharma Inc. ("Isotechnika") (TSX: ISA), a biopharmaceutical company focused on the discovery and development of immune modulating therapeutics, and 3SBio Inc. ("3SBio") (NASDAQ: SSRX), a leading China-based biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products, today announced the signing of a development and commercialization agreement for voclosporin, a next generation calcineurin inhibitor being developed for use in the prevention of organ rejection following transplantation and the treatment of autoimmune diseases.

The transaction will provide Isotechnika with proceeds of US$6 million. Isotechnika will receive an upfront non-refundable licensing payment of US$1.5 million with an additional US$4.5 million invested by 3SBio through a convertible debenture.

Under the terms of the agreement, Isotechnika will grant 3SBio exclusive rights to all transplant and autoimmune indications of voclosporin in China, including Hong Kong and Taiwan, excluding ophthalmic indications and medical devices which were previously licensed to Lux Biosciences, Inc. and Atrium Medical Corporation, respectively. 3SBio will be responsible for the clinical development, registration and commercialization of voclosporin in China. Isotechnika will provide, under separate agreement, commercial supply to 3SBio on a cost-plus basis. Isotechnika will also receive ongoing royalties based on sales of voclosporin by 3SBio.

3SBio will invest the US$4.5 million in Isotechnika through a three-year convertible debenture which will pay interest of 7% payable semi-annually. Isotechnika has the option to pay interest in cash or to issue new shares at the prevailing price when the interest is payable. 3SBio has the right to convert the debenture at any time into common equity of Isotechnika at a conversion price of C$0.155 per share. At maturity, any remaining balance will be paid by the issuance of common shares at a price of C$0.155 per share. 3SBio will also nominate one member to Isotechnika's Board of Directors.

"This agreement represents an important milestone for the continued development of voclosporin in transplantation indication worldwide after Isotechnika regained global rights of this product in 2008," commented Dr. Robert Foster, the President and CEO of Isotechnika. He continued, "3SBio's commercial expertise and leading franchise in nephrology in China make the company an ideal partner for the region and provides further validation of voclosporin's market potential. We continue to seek strategic partnerships in other regions."

"Along with Isotechnika, we are committed to bringing this innovative medicine to China's approximately 100,000 transplant recipients, a population which is growing by about 10,000 new patients per year," said Dr Jing Lou, Chief Executive Officer of 3SBio. He continued, "This partnership reinforces our goal of establishing 3SBio as the partner of choice in China for biotechnology companies around the world. We look forward to working with our partners at Isotechnika to prepare and file a dossier for SFDA regulatory approval to begin a phase III trial for voclosporin in China."

In April 2009, voclosporin completed a phase 2b North American trial for the prevention of kidney rejection following transplantation. "New Onset Diabetes After Transplant ("NODAT") is common and has become a major concern in transplantation of all organs. In kidney transplantation, it is shown to be associated with inferior long term graft and patient survival while increasing the cost of patient management. Voclosporin has not only demonstrated equal efficacy with improvements in safety, but is easy to use for clinicians which is a major benefit." stated Suphamai (Michael) Bunnapradist, MD, MS, FACP, FASN, Associate Professor of Medicine, UCLA Medical Center.

"A reduced burden of NODAT in patients on voclosporin at the proposed therapeutic dose was shown in the Phase 2b kidney transplant trial and would represent a significant benefit to patients," added Dr. Foster. "Published literature shows that mean graft survival of 11 years decreases to 8 years with NODAT."

"The worldwide calcineurin inhibitor market in 2009 was at least $3 billion with sales being generated by only two commercially available drugs, cyclosporine and tacrolimus," commented Dr. Foster. "Kidney transplantation represents approximately 60% of all solid organ transplants of which 93% require calcineurin inhibitors as part of their immunosuppressive regimen."