Partnerships
Hoffman La Roche
On April 9, 2002 the Company entered into a strategic collaboration with F. Hoffmann-La Roche and Hoffmann-La Roche Inc. (hereinafter collectively referred to as "Roche") for the global co-development and commercialization of voclosporin. This agreement represented the largest Canadian early clinical trial drug development deal between a large pharmaceutical company and a biotech company.
Under the terms of the original agreement:
- Roche would contribute 70% of the development cost of voclosporin;
- Roche would make "up-front" and "milestone payments" to Isotechnika. Assuming all development milestones were achieved, the total amount of upfront and milestone payments would be $215 million USD dollars;
- Roche would pay Isotechnika a percentage of gross profits; and
- Roche had exclusive world-wide marketing rights to voclosporin. Isotechnika had retained the rights to the use of voclosporin for the purposes of diagnostic assays and in the use of medical devices such as stents. Isotechnika had the right of first refusal to distribute voclosporin in certain key markets, in the event that Roche desired to enter into a distribution agreement with a third party.
The agreement further included the establishment of a joint decision-making governance structure with equal representation from both organizations. In compliance with the agreement, two decision-making committees were formed, a joint development committee and a joint steering committee. The committees meet once every quarter to oversee and guide the future development of voclosporin.
On April 19, 2004, Isotechnika and Roche amended the collaboration agreement for the development and commercialization of voclosporin in transplantation.
Under the amended terms of the collaboration agreement:
- Isotechnika regains the world-wide rights for all non-transplant indications, including psoriasis.
- Isotechnika has control over clinical development, manufacturing and regulatory affairs.
- Isotechnika is responsible for all development costs.
- Isotechnika will pay all R&D costs until the completion of the Phase 2b renal transplantation trial.
- Upon successful completion of the Phase 2b renal transplant trial, Roche has the option to continue joint development in transplantation.
- Upon exercise of the option, the original agreement with 70%-30% split of R&D expenditures will be in effect.
- Other milestone payments based on commencement, successful completion and NDA filing for the first three (3) transplant indications.
- Isotechnika is free to market or license any of the non-transplant indications with a third party.
- The total amount of upfront and milestone payments have increased to $242 million US dollars from $215 million US dollars.
- Upon commercialization, there is no change to the royalty structure from the original agreement
As of December 31st, 2003, the total financial contribution from Roche amounted to $67.4 million, comprised of development, milestone and option fee revenues of $25.6 million, $9.9 million in voclosporin development cost recoveries, and $32.0 million in equity investment.