Washington Editor

Just months after the FDA approved Nexavar (sorafenib) for advanced kidney cancer, the drug is moving into a pivotal study for non-small-cell lung cancer.

Partners Onyx Pharmaceuticals Inc. and Bayer Pharmaceuticals Corp. have long publicized the multi-kinase inhibitor’s potential in various cancers - Phase IIIs already are under way in liver and skin cancers - so the trial does not come as a surprise. The latest study is being run under a special protocol assessment with the FDA.

Noting Nexavar’s "broad utility" in oncology, Hollings Renton, Onyx’s chairman, president and CEO, said the company expects its research and development investments in the drug "to continue for several more years."

His comments came as part of a conference call in which the company reported a $38.4 million net loss for the quarter ended Dec. 31. That figure was almost triple the amount the company lost in the same year-ago period, attributable to ramping up Nexavar’s early commercialization and its ongoing development.

Onyx, of Emeryville, Calif., posted no revenue in the fourth quarter, although the drug generated "nominal sales" in its few days on the market that were offset by expenses, Renton said.

The company declined to provide financial guidance for the coming year and said that initial sales results will be reported at the end of this quarter. But as Renton noted, the early sales in this first setting represent "a first step" for the drug’s future.

"We do believe Nexavar may change the way cancer is treated," he added.

The latest Phase III program will test 400-mg oral tablets of Nexavar in combination with two chemotherapeutic agents, carboplatin and paclitaxel, vs. the chemo drugs and placebo in a randomized, double-blinded trial. Earlier studies have shown preliminary activity in a small number of non-small-cell lung cancer patients treated with the triple combination, which is the same regimen being tested in the Phase III melanoma trial.

Overall survival is the 900-patient lung cancer study’s primary endpoint, with secondary endpoints measuring progression-free survival, tumor response and safety. The trial is open to patients with all types of the cancer, including those with squamous cell or adeno carcinomas, though it excludes those who have received prior systemic anticancer therapy. Treatment will last for six cycles, after which patients will continue in a maintenance phase with single-agent Nexavar or placebo. It will be conducted at more than 130 sites in North America, South America, Europe and the Asia Pacific region.

Enrollment in the liver and skin cancer studies is expected to close by the end of this year, with 550 and 250 patients being recruited into each, respectively. Nexavar has been studied in more than 20 tumor types and more than 4,000 patients to date through company-sponsored trials and others being conducted by government agencies, cooperative groups and individual investigators.

Nexavar targets members of two classes of kinases known to be involved in both the growth of tumors and the blood supply that feeds them: RAF kinase, VEGFR-2, VEGFR-3, PDGFR-B, KIT and FLT-3. Its approval for kidney cancer came two months ago and generated a $10 million milestone payment from Bayer, of West Haven, Conn. (See BioWorld Today, Dec. 21, 2005.)

Nexavar is under review in numerous other territories around the world, and a European decision is expected in the second half of this year.

With nearly 175,000 new cases of lung cancer diagnosed annually in the U.S., and about 75 percent of them of the non-small-cell variety, the opportunity for Nexavar in this space is quite large. The companies already are charging more than $4,300 for a one-month supply for kidney cancer, which has about 37,000 annual diagnoses in the U.S.

In recent weeks, Nexavar gained a rival in the kidney cancer space, Sutent (sunitinib, from Pfizer Inc.). The multi-tyrosine kinase inhibitor recently received that approval, as well as clearance for gastrointestinal stromal tumors. It also is being studied in non-small-cell lung cancer, as well as breast, colorectal and prostate cancers and neuro-endocrine tumors. (See BioWorld Today, Jan. 30, 2006.)

Onyx closed its fiscal year with $284.7 million in cash, cash equivalents and marketable securities. On Thursday, its shares (NASDAQ:ONXX) traded down 23 cents to $28.53.

Remoxy Also Receives SPA Clearance

In similar news, a special protocol assessment was granted to partners Pain Therapeutics Inc. and King Pharmaceuticals Inc. for Remoxy.

Accrual is expected to begin soon in a pivotal Phase III trial of 400 patients with severe, chronic osteoarthritic pain to test the abuse-resistant version of long-acting oxycodone, a strong opioid painkiller. This will be the only study required to file a new drug application. Following a titration period, patients will be randomized to receive either daily Remoxy doses ranging from 10 mg to 80 mg or placebo for 12 weeks in the double-blinded, multicenter trial.

Its primary endpoint is a reduction in pain scores over three months compared to baseline. Enrollment will continue through the end of the year.

South San Francisco-based Pain Therapeutics’ deal with King, of Bristol, Tenn., is potentially worth up to $400 million. (See BioWorld Today, Nov. 11, 2005.)

On Thursday, shares in Pain Therapeutics (NASDAQ:PTIE) gained 22 cents to $10.61.

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