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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Onyx Pharma shares soar on report of its hunt for options, acquirers

Posted under Bayer Healthcare, Blog, carfilzomib, Companies, Diagnostics, Funding, Medical Devices, Medical Supply, Mergers and Acquisitions, Nexavar, Onyx Pharmaceuticals, Pharmaceuticals, regorafenib, Startups, Universities, Videos by Ryan McBride

A report about Onyx Pharmaceuticals' ($ONXX) search for business alternatives such as a company sale has generated buzz in the biotech world. Bloomberg reported Monday afternoon that the South San Francisco cancer drug developer has hired Centerview Partners to aid its exploration for options, but neither the company nor the firm would comment.

With even the possibility of a merger-and-acquisition event, investors seem to get jazzed. Onyx's shares jumped more than 20% on Monday, Reuters reported.

Onyx, which developed the kidney cancer drug Nexavar, has another potential drug in its pipeline in carfilzomib, which could be just months from an FDA decision on its use for treating multiple myeloma. The company also recently settled its dispute with Bayer Healthcare, its partner for marketing Nexavar. The companies' deal lets Onyx off the hook for funding development of regorafenib, and the partners amended the terms of their Nexavar collaboration, Bloomberg reported.

"I would think that any potential acquirer would want to see the outcome of carfilzomib regulatory review," Howard Liang, an analyst at Leerink Swann, told Bloomberg. "We are only a few months away."

Bloomberg cited two unnamed sources familiar with Onyx's plans in its report, which was met with some skepticism among industry commentators such as TheStreet.com's Adam Feuerstein on Twitter on Monday. With large drugmakers starved for new products, drug developers with a commercial asset or two like Onyx's Nexavar are often discussed as buyout targets. Even companies without marketed drugs, like Pharmasset ($VRUS), which Gilead ($GILD) aims to buy for $11 billion, have wet the appetites of acquisition-minded drugmakers.

- check out Bloomberg's report
- and the Reuters article

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FDA pins approval on Regeneron eye drug Eylea

Posted under Avastin, Bayer Healthcare, Blog, Companies, Diagnostics, Eylea, Funding, Lucentis, Medical Devices, Medical Supply, Pharmaceuticals, Regeneron Pharmaceuticals, Startups, Universities, Videos by Ryan McBride

Regeneron ($REGN) is wrapping up the week with a big victory. U.S. regulators have given market approval to the Tarrytown, NY-based company's Eylea for treating a neurovascular form of wet age-related macular degeneration, the most common cause of blindness in adults older than 65 in the U.S. and Europe. It's an approval that was highly expected after an FDA advisory committee unanimously backed the drug in June.

The drug, also called VEGF Trap-Eye, was approved for use every month for the first three months of treatment followed by injections every 8 weeks. This makes the drug the first FDA-approved treatment for wet-AMD that can be given less frequently than once per month, according to the company. The less frequent dosing is expected to be a competitive advantage over Roche's existing therapy, Lucentis, which is recommended for use once every month. Eylea's big competition, however, is another Roche product, the cancer drug Avastin, which is used off-label in small doses to treat AMD and has been a more popular option than the more expensive Lucentis. The Wall Street Journal cited analysts who estimated Avastin is used to treat more than two-thirds of AMD cases.

Eylea showed in two late-stage clinical trials that its efficacy in patients getting injections of the drug every 8 weeks was clinically equivalent to patients getting Lucentis in the more frequent monthly doses. The drug blocks the new blood vessel formation observed in patients with wet AMD by inhibiting a vascular growth factor know as VEGF-A. The most common side effects of the drug included conjunctival hemorrhage, eye pain and intraocular pressure, according to the company.

"This approval is an important step forward for Regeneron and for patients suffering with wet AMD,"  Regeneron CEO Leonard Schleifer said in a statement. "Now that Eylea is approved, we plan to make Eylea available to patients within the next few days."

Regeneron controls exclusive rights to Eylea in the U.S. and has partnered with Bayer Healthcare, which will handle marketing of the drug in the rest of the world. Bayer filed paperwork for approval of the drug in Europe in June.

- here's the release
- get more from the FDA's statement
- see the Wall Street Journal's coverage

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