West Coast Editor
With early work under way trying the first of a new class of selective estrogen receptor modulators against hot flashes and osteoporosis in menopausal women, Radius has licensed exclusive worldwide rights (except Japan) to the bundle from Eisai Co. Ltd.
"It's a new class because within the central nervous system it functions as an agonist as opposed to an antagonist, and that's really what you want to treat vasomotor symptoms [such as hot flashes]," said Richard Lyttle, president and CEO of Cambridge, Mass.-based Radius, formerly known as Nuvios Inc.
Terms of the deal were not disclosed.
As for filing an investigational new drug application, "our target is about a year from now," he said. Raloxifene (branded Evista, from Indianapolis-based Eli Lilly and Co.) and other SERMs in development do not reduce hot flashes and may even exacerbate them, he said.
"They're very good at doing the bone protection," Lyttle conceded, adding that all research is preclinical with RAD 1901, the first compound from Tokyo-based Eisai's portfolio, "but it looks as good or better than those in that aspect."
Each tissue requires something different from a SERM, and the one to be advanced by Radius could be the first to "thread the needle" and provide just the right mix of attributes - relieving hot flashes and preventing bone loss without uterine and breast stimulation, he said.
The balance is tricky. In the treatment of breast cancer, for example, the estrogen receptor antagonist tamoxifen (available under various brand names from London-based AstraZeneca plc) is widely used, but causes hot flashes, which afflict 75 percent of menopausal women and represent one of the main reasons they go to the doctor for a prescription, Lyttle said.
He could not comment in detail on whether Radius might become entangled in the ongoing legal battle between Ariad Pharmaceuticals Inc. and Lilly. The patent dispute yielded a $65.2 million victory for Ariad, also of Cambridge, in early May, regarding Evista and Xigris (drotrecogin alfa), the only approved therapy for septic shock, which sold $215 million for Lilly last year. (See BioWorld Today, May 5, 2006.)
The dispute involved Ariad's U.S. patent covering methods of treating disease by regulating NF-kappa B cell-signaling activity, and jurors awarded damages to Ariad and its co-plaintiffs based on a royalty rate of 2.3 percent, to be paid in accordance with U.S. sales of Evista and Xigris from June 25, 2002 (when the lawsuit was filed), through Feb. 28, 2006. Lilly plans first to ask the judge to set aside the jury's verdict regarding Evista and Xigris and then to appeal, if necessary.
"We don't think we hit that [NF-kappa B] area at all," Lyttle said. "Certainly we haven't looked at any of those mechanisms."
Radius, founded in November 2003 with $24 million in institutional financing, has nine full-time employees and a total of 21 workers.
In December, the firm licensed from Paris-based Ipsen SA exclusive rights to develop, manufacture and distribute the molecule BA058 and its analogues for osteoporosis. The license is worldwide, except for Japan, where Ipsen previously granted a license to Tokyo-based Teijin Ltd.
Lyttle said the Phase Ib trial with BA058 is finishing up, with data expected at the end of July, and a Phase II study is expected to begin at the end of this year or early next.