Roche and Isotechnika Inc. have changed their licensing deal for ISA247 in transplantation, restructuring the collaboration to make Isotechnika solely responsible for Phase II studies of a trans isomer discovered as part of the agreement.
"We're the ones who instigated this," said Joseph Koziak, vice president of Edmonton, Alberta-based Isotechnika. The company's stock (TSE:ISA) fell C45 cents, or 15.3 percent, to close Tuesday at C$2.50 (US$1.84).
Under the terms, Isotechnika will manage and fund the clinical development of transISA247 (the trans isomer of ISA247) - including the single-ascending-dose and multiple-ascending-dose clinical trials, which are bridging studies - without help from Basel, Switzerland-based F. Hoffmann-La Roche Ltd.
When those are finished, Isotechnika will conduct a Phase II study in renal transplantation and Phase III studies in psoriasis at its own expense. Roche can opt back into the deal for transplant indications up to the end of the Phase II renal trial, but Isotechnika keeps all other rights.
"We negotiated with Roche the rights to psoriasis, but instead of paying them a check for the drug, we have to pay for the Phase IIb trials [in renal transplant]," Koziak said. "After those results are done, then we go back to our original agreement."
If Roche exercises its option to develop and commercialize transISA247 for transplants worldwide, it would pay a fee plus milestones, and provide 70 percent of development costs. The royalty structure from the original deal stays the same. Roche and Isotechnika entered the original deal, then valued at more than $215 million, two years ago. (See BioWorld Today, April 10, 2002.)
The immunosuppressant ISA247 has completed a Phase II trial for psoriasis and a Phase IIa trial for kidney transplant. The main Phase IIb trial in kidney transplant is due to begin within the next year.
"When we first developed the drug, we developed it as a mixture [of the cis and trans isomers]," Koziak told BioWorld Today. "With Roche's involvement, when we were going through the nuances of optimizing manufacturing, we found the trans [version alone] was one-third the cost of producing the mixture, and the trans is considerably more potent."
The trans version also provides more predictability, he said, noting that with such drugs as cyclosporine - which would be the main competitor for ISA247 - "if you had two people of the same weight, same height and same sex, they would require totally different dosages to work."
With ISA247 as a mixture, "you could get an inference by weight of how much drug to use, and the trans [version] is even tighter," he said. "Really, this is just tweaking the formulation and it's normally done at Phase II anyway."
Isotechnika originally developed the drug for psoriasis, Koziak pointed out, and it will enter Phase III trials in the latter part of this year or early next.
"It's a molecule we can get through Phase III with minimal costs," he said, adding that would-be partners already are expressing interest.
"The competitors are biologics, and it's questionable how effective they will be in these disease states," he said, noting that "very few late-stage products [such as ISA247] are still available for licensing. We're open to options. We can't say that we're going to take one direction or another."