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that is designed to work against the same molecular target as carfilzomib, which is known as a proteasome inhibitor. The oral drug, now called ONX 0912, was an important piece of the package in this deal with Ono, Coles says. Both drugs are being designed to treat multiple myeloma patients, with the IV version for use in hospitals, and the oral pill able to be taken when patients are sent home.
“We believe these two products can co-exist nicely inside and outside the hospital,” Coles says.
Ono isn’t exactly the first company that jumps to mind when I think of Japanese pharma companies, but Coles says he’s confident they will be a good partner. The company currently markets a drug for cancer patients in Japan called aprepitant (Emend) that was originally discovered by Merck. Ono also has oncology R&D programs, and a specialty sales force of 960 people, Onyx says.
While the folks at Ono get up to speed on the new compounds for the Japan market, Onyx is continuing to push ahead on its own in the U.S. and Europe. The company is focusing on getting its carfilzomib application together for the FDA by year’s end, with a goal of winning approval and starting U.S. sales as soon as possible.
Coles noted that the combination of safety, effectiveness, and a clear patient population in need puts his company in a strong position to have a second cancer drug on the U.S. market. But as all biotechies know, nothing can ever be certain when it comes to getting permission from the FDA. And Coles wanted to make sure he mentioned that before hanging up the phone yesterday. “Ultimately it’s the FDA’s call,” he says.
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