Archive for the ‘Onyx Pharmaceuticals’ Category

Apr
25

Buzz: Is Bayer looking to buy Onyx Pharma?

Posted under Bayer, Blog, carfilzomib, Companies, Diagnostics, Funding, M&A, Medical Devices, Medical Supply, Nexavar, Onyx Pharmaceuticals, Pharmaceuticals, regorafenib, Startups, Universities, Videos by john

Reuters reported today that Bayer is looking to close a multibillion-euro acquisition deal, quoting sources who say that an announcement could be "imminent." And investors took one look at the news and started to bid up the share price of Onyx Pharmaceuticals--a close partner of Bayer's on Nexavar with a big stake in some promising late-stage cancer drugs.

San Francisco-based Onyx ($ONXX) has been at the center of persistent buyout rumors since last fall, when it reportedly brought in bankers to scout a strategic deal. And it would be a perfect fit for Bayer, which would like to have carfilzomib in its portfolio when the FDA hits the July 27 PDUFA date on the potential blockbuster multiple myeloma drug. Bayer also was forced to settle up with Onyx on regorafenib, a close cousin to Nexavar that Onyx now has a 20% stake in.

It's pure speculation, of course, but it's a sensible enough theory to investors, who bid up Onyx shares 8.5% today.

Bayer CEO Marijn Dekkers has done nothing to squelch the buyout rumors in recent months. "Every company of our size is looking for acquisition opportunities," he told reporters recently. "You have to do it to remain competitive."

M&A has been a key theme in the past few weeks, with GlaxoSmithKline ($GSK) looking to acquire Human Genome Sciences ($HGSI), Roche ($RHHBY) wrestling with a frustrated bid for Illumina ($ILMN), a much discussed but never confirmed attempt by Bristol-Myers Squibb to acquire Amylin and AstraZeneca's ($AZN) move to snap up Ardea Biosciences ($RDEA) in a scramble for new drug programs. There's no sign of the wave evaporating anytime soon.

Carfilzomib has an interesting history. Originally developed at Proteolix, a biotech run by Susan Molineaux, Onyx acquired it in an $851 million deal. Onyx also lists PD 0332991, a mid-stage drug, in its pipeline.

- here's the story from Reuters

Special Report: Carfilzomib – Top 10 Late-Stage Cancer Drugs – 2012

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Apr
03

Bayer bolsters blockbuster case for regorafenib with new PhIII data

Posted under Bayer, Blog, Cancer, Clinical Trials, colorectal cancer, Companies, Diagnostics, Funding, gastrointestinal tumors, Medical Devices, Medical Supply, Nexavar, Onyx Pharmaceuticals, Pharmaceuticals, Phase III, Pipeline, regorafenib, Startups, Universities, Videos by john

Bayer has racked up a fresh set of preliminary late-stage data that will bolster its plans to market regorafenib for a range of cancers. The treatment, which bears a striking resemblance to sorafenib (Nexavar), registered a successful response for gastrointestinal stromal tumors in Phase III, adding to the positive data already gathered on colorectal cancer.

Just a few months ago Bayer agreed to pay Onyx ($ONXX) $160 million and a hefty royalty slice on regorafenib to settle the biotech's claim that Bayer scientists had secretly created an analog closely matched to sorafenib, their blockbuster cancer medication. Now that that dispute has been replaced by a partnership, Bayer is eager to move ahead on a new drug program that promises to deliver more than a billion dollars a year in new revenue. Bayer has set its sights on applying for an approval on colorectal cancer with plans to expand its use for other cancers.

In this latest trial Dana-Farber's George Demetri studied regorafenib in advanced cancer patients who weren't responding to existing medications. Bayer says the treatment hit its primary endpoint on progression-free survival. The data will be detailed at an upcoming scientific meeting.

About 200 patients were enrolled in the study, with a 2-to-1 mix getting 160 mg of regorafenib daily, three weeks on and one week off. And patients in the control arm whose disease progressed were offered regorafenib.

"GIST is a difficult disease to treat. Patients treated with currently available therapies have a high likelihood that their disease will progress, and there are no remaining treatment options for those patients whose prior therapies have failed," said Ted W. Love, the EVP for R&D at Onyx. "These clinical data will show regorafenib's activity in patients with previously treated GIST."

- get the press release
- here's the story from Bloomberg

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Jan
18

Bayer details positive PhIII data on cancer blockbuster hopeful regorafenib

Posted under Bayer Healthcare, Blog, Cancer Drugs, Companies, Diagnostics, Funding, Medical Devices, Medical Supply, Nexavar, Onyx Pharmaceuticals, Pharmaceuticals, regorafenib, Startups, Universities, Videos by John Carroll

Bayer HealthCare took another step toward a planned marketing application for the cancer drug regorafenib today as it unveiled the late-stage colorectal cancer data that it plans to take to regulators later this year. Late last year Bayer tapped regorafenib--sometimes referred to by industry wags as the "son of Nexavar"--as one of the pharma company's top four blockbuster contenders, as CEO Marijn Dekkers vowed to stand by its multibillion-dollar strategy on drug development.

Investigators report that the treatment improved the median overall survival rate of metastatic patients by 29%, with the drug arm demonstrating a 6.4 month overall survival rate while advanced patients who had already failed standard therapy survived a median average of 5 months on a placebo. Metastatic patients in the drug arm also experienced high rates of fatigue, skin reactions and diarrhea, according to Bayer.

Bayer already knew it had a positive batch of data coming late last year when researchers unblinded the Phase III CORRECT study on the advice of the monitoring committee so they could give regorafenib to the placebo arm.

Today's news is likely to inspire some smiles at Onyx ($ONXX) as well. The biotech landed a $160 million payday and won a 20% royalty stake in the drug last fall after prevailing in a bitter dispute over the rights to regorafenib, which bears a close resemblance to the jointly-owned Nexavar. Onyx had accused Bayer researchers of secretly developing analogs of Nexavar before the two partners finally managed to reach an agreement on ownership.

"It will be very likely that they'll grant approval because there's nothing else like it," Axel Grothey, a professor of oncology at the Mayo Clinic, tells Bloomberg. The next hurdle will be payers, who have been frowning over expensive new cancer drugs that offer only marginal improvements in median survival.

- read the press release
- here's the report from Bloomberg

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Jan
13

Onyx Pharma CFO plugs cancer pipeline amid rumored sales process

Posted under Big Pharma, Blog, Cancer Drugs, carfilzomib, Companies, Diagnostics, Funding, Medical Devices, Medical Supply, Nexavar, Onyx Pharmaceuticals, Pharmaceuticals, regorafenib, Startups, Universities, Videos by Ryan McBride

Onyx Pharmaceuticals' ($ONXX) financial chief rattled off the reasons why the cancer drug company would make a nice buyout option in an interview with Bloomberg, walking a fine line by declining to confirm whether Onyx is seeking a sale of the company as two sources have told the news service.

Bloomberg first reported the sale talk back in November, and while some analysts agree that Onyx's marketed cancer drug Nexavar and the firm's late-stage pipeline fit the bill for a takeover, no offers have been made public. Pfizer ($PFE) and Takeda, two drug powerhouses aspiring to build their oncology franchises, have been identified as the kind of companies that would be interested in Onyx.

"We could have data or regulatory approval for three different products and as many as seven different indications," Onyx CFO Matt Fust told Bloomberg on Thursday. "Those are very large populations of patients with significant unmet need, which is inherently attractive to other interested parties."

South San Francisco-based Onyx is expected to have several significant data readouts and a regulatory decision in 2012. For starters, the FDA is expected to make a decision in July about the company's bid for approval of carfilzomib for treating relapsed multiple myeloma. And it's completed pivotal studies of its drug regorafenib, partnered with German drug giant Bayer, for treating colorectal cancer. Nexavar, also partnered with Bayer and approved for treating kidney cancers, is in development for combating breast, lung and thyroid cancers, Bloomberg reported.

It's an open question whether 2012 will be a big year for M&A activity in biopharma, but there's no doubt that many Big Pharma outfits are jonesing new products in areas where the medical need is high, like oncology. Onyx definitely appears to have all those attributes.

- get more in the Bloomberg article

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Archive for the ‘Onyx Pharmaceuticals’ Category

Buzz: Is Bayer looking to buy Onyx Pharma?

Bayer bolsters blockbuster case for regorafenib with new PhIII data

Bayer details positive PhIII data on cancer blockbuster hopeful regorafenib

Onyx Pharma CFO plugs cancer pipeline amid rumored sales process