West Coast Editor
With positive preliminary Phase III data from its lead product for psoriasis, ISA247, Isotechnika Inc. has entered a licensing deal with device-focused Atrium Medical Corp. for that compound and another, earlier-stage drug candidate.
"We have a marriage here, essentially, that's made in heaven," Robert Foster, chairman and CEO of Isotechnika, told investors during a conference call.
Edmonton, Alberta-based Isotechnika's stock (TSE:ISA) closed Friday at C$2.20 (US$1.89), unchanged.
Under the terms, Hudson, N.H.-based Atrium - which is getting rights to the cyclosporine derivative ISA247 and the other drug, TAFA93, for use in devices only - will provide an up-front licensing fee of $3 million, plus milestone payments and royalties on any products that incorporate the drugs separately or in combination.
TAFA93 is a prodrug of the mTOR inhibitor rapamycin (mTOR stands for "mammalian target of rapamycin," the latter being a kinase involved in cell-cycle regulation), and applications being studied for TAFA93 include uses in stents, oncology and transplants.
Randall Yatscoff, president and chief operating officer of Isotechnika, explained that the "long and short [of an mTOR inhibitor] is that it makes cells resistant to growth factors such as IL-2 and other immune mediators," thus offering potential uses in transplants, autoimmune disease and oncology, among other settings. "Today [with the Atrium deal], we're dealing with stent technology," he said.
In 1999, the FDA approved the first in the mTOR class, the immunosuppressant Rapamune (sirolimus), from Madison, N.J.-based Wyeth Pharmaceuticals Inc., to prevent rejection of renal transplants.
Foster said Isotechnika's "strategy is not to invent drugs on a lark. We take existing drugs and try to make [them] better." Cyclosporine "had a lot of difficulties associated with its safety profile," and Isotechnika sought improvements with ISA247. "It appears we've done that," he said. Rapamune also "has certain limitations in its use. We wanted to take rapamycin and make it better," Foster said.
ISA247 is expected to enter "in the very near future" a Phase IIb study to evaluate its ability to block rejection in kidney transplant patients, as part of a collaborative effort with F. Hoffmann-La Roche Ltd., of Basel, Switzerland, Foster said.
Last spring, Isotechnika retooled its deal with Roche, taking over sole responsibility for Phase II studies of the ISA247 trans-isomer discovered in the agreement. (See BioWorld Today, April 21, 2004.)
As part of the Atrium deal, Isotechnika is required to complete a Phase Ib trial with TAFA93, but Atrium will conduct and pay development costs of the medical-device program, with Isotechnika making both drugs for use in trials and after commercialization.
Steve Herweck, founder and CEO of Atrium, said the company sees promise in the two drugs for use with his firm's coronary-stent platform and with balloon catheters.
Early animal results with TAFA93 showed cell proliferation was reduced after stent implants, and inflammation went down thanks to Atrium's oil coating. ISA247, for its part, is believed to reduce inflammation as a result of tissue trauma when hernia mesh is placed into a patient.
Atrium hopes to begin more extensive trials late next year or in early 2007, Herweck said.
"The biggest market application is for drug-eluting stents," he said, noting that the risk of both subacute thrombosis and restenosis is believed to lessen after stent implants, when TAFA93 is used with the omega-3 oil coating.
Marketing of products from the deal will be handled entirely by Atrium, which makes and sells devices for use in open-heart surgery, emergency chest trauma, thoracic drainage and surgical repair of diseased blood vessels. The arrangement with Isotechnika is for drug-eluting tools only in those areas, and Isotechnika keeps all rights for oral and topical indications.
Last month, Isotechnika reported ISA247 met all primary and secondary endpoints in preliminary data from the psoriasis Phase III trial in Canada with ISA247, to which the firm owns all rights in that indication. Foster said the firm hopes to begin a Phase III study in psoriasis in the U.S. shortly. (See BioWorld Today, Sept. 22, 2005.)