FDA approves Onyx and Bayer colorectal cancer drug

The Food and Drug Administration on Thursday approved a new colorectal cancer pill developed by Onyx Pharmaceuticals Inc. and Bayer HealthCare.

The drug is called Stivarga, and it is designed to block several enzymes that promote cancer growth. The FDA approved Stivarga as a treatment for colorectal cancer that has progressed after treatment and metastasized, or spread to other parts of the body. The agency approved the drug about one month ahead of schedule.

In clinical studies, patients treated with Stivarga and standard treatment had median survival of 6.4 months, compared to 5 months for patients who were received only standard treatment.

The companies will market the drug together. Bayer developed Stivarga, and under an agreement between the companies, Onyx will get royalties on sales of the drug.

Stivarga, which was developed under the name regorafenib, is the second colorectal cancer drug to win FDA approval recently. In August the agency backed Sanofi's drug Zaltrap as a treatment for metastatic colon cancer in combination with chemotherapy.

The FDA says colorectal cancer is the third-most common cancer in the U.S. and the third leading cause of cancer death. It said around 143,460 cases are expected to be diagnosed in 2012, and about 51,690 people will die of the disease.

Onyx and Bayer have also asked the FDA to approve Stivarga as a treatment for gastrointestinal stromal tumors, which mostly occur in the stomach or small intestine.

The drug is approved with a warning connected to sever and sometimes fatal liver toxicity that was observed in some patients in studies.

The most common side effects of Stivarga in clinical trials included weakness or fatigue, loss of appetite, diarrhea, mouth sores, weight loss, infection, high blood pressure, changes in voice volume or quality, and hand-foot syndrome, a condition in which small amounts of the drug leak out of the blood vessels in the palms and the soles of the feet, causing reddened skin, tenderness, and peeling.

Onyx staffs up for pharmaceutical sales of newly approved cancer drug

Onyx Pharmaceuticals has ramped up its team of pharmaceutical sales representatives and marketing professionals after receiving federal approval of its new blood cancer drug Kyprolis.

According to the Maxim Group, Onyx has already hired a 100-people sales force, which will begin calling on doctor in August after the breakthrough treatment was recently cleared for commercialization by the Food and Drug Administration (FDA).

The approval of the multiple myeloma (MM) drug is considered a major victory for Onyx, which up until now has had only one other product on the market, the liver cancer treatment Nexavar, which it sells with Bayer AG.

Federal officials based their approval of Kyprolis on Onyx's Phase 2b safety trial for patients who had received at least two prior unsuccessful MM therapies.

"Today’s approval is a significant milestone for Onyx and, most importantly, for patients with advanced myeloma who have few treatment options available to them," Dr. N. Anthony Coles, president and chief executive officer of Onyx Pharmaceuticals, added. "We are committed to continuing the clinical development of Kyprolis across earlier stages of multiple myeloma treatment.”

Onyx Pharmaceuticals shares jump on reports of potential sale process

Onyx Pharmaceuticals (NASDAQ:ONXX) saw its shares rise over 15 percent Monday on reports the oncology-focused pharmaceutical company is considering a potential sale.Shares of the company, which is responsible for liver and kidney cancer treatment Nexavar, hiked 15.74 percent to $43.61, as of 3:52 pm EDT.Earlier this month, the California-based company released less-than-stellar third quarter results, posting a $36.86 million loss, or $0.58 loss per share, compared to profits of $41.5 million, or $0.66 per share, in the year-ago period.It also reported no revenues from license agreements in the quarter, resulting in a 39 percent decline in revenues, to $75.04 million.President and CEO Dr. N. Anthony Coles said that Onyx would move forward with its oncology platforms - kinase inhibition, and proteasome inhibition.

Onyx Pharmaceuticals Announces Data Presentations Highlighting Carfilzomib at 53rd American Society of Hematology Annual Meeting

Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) today announced the presentation of several studies evaluating carfilzomib, a selective, next-generation proteasome inhibitor, at the American Society of Hematology (ASH) Annual Meeting, December 10-13, 2011, at the San Diego Convention Center in San Diego, CA."The results being presented at ASH demonstrate carfilzomib's potential activity along all lines of multiple myeloma, and we are encouraged by this clinical data ranging from frontline to relapsed and refractory disease," said Ted W. Love, M.D., Executive Vice President and Head of Research and Development and Technical Operations at Onyx Pharmaceuticals. "We are committed to bringing this promising therapy to patients as quickly as possible. We have submitted a new drug application for carfilzomib for the potential treatment of patients with relapsed and refractory multiple myeloma under the accelerated approval pathway, and also have a Phase 3 development program well underway."

Onyx Pharmaceuticals and Bayer Healthcare Restructure Global Oncology Partnership

Today Onyx Pharmaceuticals, Inc. and Bayer HealthCare restructured their partnership for the global development and marketing of Nexavar® (sorafenib) tablets and entered into a new agreement related to regorafenib, a late-stage oncology compound.Under the terms of the agreements, regorafenib is a Bayer compound, and Bayer will have the final decision-making authority for global development and commercialization. Onyx will receive a royalty on any future global net sales of regorafenib in oncology. In addition, Bayer will contract the Onyx sales force to promote regorafenib, along with Bayer sales representatives, in the United States.The status of Nexavar under the revised Collaboration Agreement remains largely unchanged. Onyx and Bayer are free to use their respective Nexavar sales forces to promote regorafenib and additional products outside of the collaboration in the future. Bayer will purchase Onyx's royalty rights for sales of the product in Japan in exchange for a one-time payment to Onyx. Bayer will have no obligation to pay Nexavar royalties to Onyx on Japanese sales after December 31, 2011. Further, in the event of a change of control or acquisition of Onyx, the current profit-sharing, co-development and U.S. co-promotion of Nexavar will be preserved."These new agreements strengthen the collaboration and provide Onyx the opportunity to participate significantly in the market potential of regorafenib," said N. Anthony Coles, M.D., President and Chief Executive Officer of Onyx Pharmaceuticals. "Together we are taking our collaboration to the next level by more effectively structuring our future working relationship. Onyx and Bayer are committed to benefitting patients worldwide and ensuring that the potential of both Nexavar and regorafenib is fully realized.""These agreements set the stage for the next chapter in our successful partnership," said Dr. Joerg Reinhardt, Chairman of the Bayer HealthCare Executive Committee. "Innovation is central to Bayer's mission 'Science for a Better Life,' and our ongoing collaboration with Onyx demonstrates the priority we place on working with partners to identify, develop and commercialize new medicines to meet unmet or under-served medical needs."These agreements also settle and dismiss all claims related to the complaint filed by Onyx against Bayer Corporation and Bayer A.G. in the U.S. District Court (Case No. CV09-2145 MHP).