Onyx’s $851 million deal to buy out Proteolix and its potential blockbuster cancer drug is returning some handsome rewards this morning. Ono Pharmaceutical snagged the Japanese rights to the drug–carfilzomib, now in a pivotal Phase III study–for $59 million upfront and up to $280 million in development and sales-based milestones. The pact also covers development rights for ONX 0912.

Onyx sees carfilzomib as a blockbuster-in-the-making, capable of earning the same big bucks as Nexavar. In the Phase IIb data, carfilzomib showed promising response rates and good tolerability with a three-drug combination in patients with relapsed or refractory myeloma. Onyx is gearing up to file its NDA later this year in pursuit of an accelerated approval. And if they get it, Proteolix investors will be in line for a $170 million milestone payment.

“This strategically important transaction underscores the growing interest and excitement surrounding carfilzomib,” said N. Anthony Coles, president and chief executive officer of Onyx. “Ono is an ideal partner in Japan given their focus on highly innovative new pharmaceutical products and their reputation for scientific excellence.”

Source: FierceBiotech

Popularity: 1% [?]

The multiple myeloma therapy carfilzomib registered a response in about one of four drug-resistant patients in a mid-stage trial, reports Onyx Pharmaceuticals, which the biotech believes is solid enough data to win an accelerated approval for a therapy with clear blockbuster potential. Onyx CEO Anthony Coles told reporters that a regulatory filing will be made before the end of this year.

The Phase IIb data on the proteasome inhibitor is a big win for Onyx, which scooped up the therapy when it acquired Proteolix in an $816 million buyout deal–with $276 million up front–just a year ago. And Coles says the drug could be on the market a year from now for the lethal cancer. “The unmet need in the population is so huge and the disease is almost uniformly fatal,” Coles told the San Francisco Business Times.

Researchers recruited 266 patients for the trial and found that 24 percent registered at least a partial response to the therapy. The median duration of response in patients was 7.4 months. But the company declined to say for now just how long patients taking the drug survived, notes the New York Times, waiting for the right scientific conference to detail that data. For now, the company will only say that it believes carfilzomib will prolong survival. Now Onyx’s blockbuster hopes will shift to the Phase III stage. Two late-stage trials are planned for the drug, including one study that will examine the effects of a combination of a low dose of the steroid dexamethasone and Revlimid with and without carfilzomib. A European Phase III study is also planned.

As Forbes’ Robert Langreth notes today, Onyx is anxious to score another blockbuster cancer drug approval to complement its success with Nexavar. Onyx has a unique status as the only sizeable standalone cancer drug developer, he adds, making the company a likely candidate for a rich buyout offer if it can come up with a new blockbuster therapy.

Source: FierceBiotech

Popularity: 3% [?]

When Onyx bought out Proteolix last year for $276 million down and up to $575 million in milestones, both sides highlighted the starring role of the cancer drug carfilzomib in the deal. Emeryville, CA-based Onyx included a $170 million payday if the drug gets an accelerated approval. And the developer sees the therapy as a likely blockbuster able to earn the kind of big bucks that Nexavar is racking up.

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Today, Onyx saw its share price buoyed by its announcement that the FDA had signed off on a key late-stage trial of the blood cancer therapy. The pivotal trial is expected to get underway in the first half of the year. The Phase III is designed to “evaluate the efficacy of carfilzomib in combination with lenalidomide and low dose dexamethasone, versus lenalidomide and low dose dexamethasone alone,” says the company in a release.

“The SPA enables us to initiate this carfilzomib Phase III combination trial in the first half of this year with increased clarity on the full approval pathway,” says Michael Kauffman, M.D., Ph.D., chief medical officer at Onyx. “In the Phase IIb data (from the “006″ trial) reported at the American Society of Hematology meeting last December, carfilzomib showed promising response rates and good tolerability with this three-drug combination in patients with relapsed or refractory myeloma.”

Source: FierceBiotech

Popularity: 3% [?]