Has the time come now for this firm to bear the fruit of its long-term efforts? Much has happened for Onyx (ONXX) in one month – all good news and all promising news for a company that is already a member in the club of companies that have important approved drugs, which enabled them to grow and become more achieving. The first good news came when Onyx announced filing NDA with the FDA for the approval of its new generation proteasome inhibitor carfilzomib, for relapsed or relapsed/refractory multiple myeloma and solid tumors. This news was followed by Onyx announcing it has entered into a new agreement with its partner Bayer, upon, which Onyx obtained rights for Bayer’s late-stage cancer compound regorafenib. Yes, a new agreement that gives Onyx royalties on a very important and successful Bayer’s cancer drug sales, in addition to contracting Onyx sales force to promote regorafenib, along with Bayer sales representatives, in the United States.
Guess what? Before the ink used for signing this agreement with Bayer dries, the news announced that Bayer has stopped Phase III trials with regorafenib on metastatic colorectal cancer (mCRC) patients whose cancer had progressed following treatment with approved standard therapies. The reason of stopping the trials is that regorafenib results have met its primary endpoint of statistically significant improvement in overall survival. The Independent Data Monitoring Committee recommended, unblinding the study with regorafenib and giving the drug to patients who were on the placebo arm.
We call It “THE ONYX MONTH”. From one product on the market for two indications, to three products expected to be selling and growing for two important cancers, multiple myeloma and colorectal cancer. The two upcoming drugs are breakthroughs and expected to become blockbusters. This is not all. Onyx’ drugs are also in early and mid-phase trials for other cancers and the pipeline has more drugs for more cancers than many investors are made to believe.
Impresseion: Everybody over 50 years old would love to hear regorafenib’s results. Colorectal cancer CRC is a threat, a serial killer of middle age and older males and females. That’s why colonoscopy is advised to this age group every 5 years, or every 2,5 years if susceptibility for cancer is found in any of the performed colonoscopies. If discovered early, the cancer is treatable, but, unfortunately, in many patients’ colorectal cancer grows and metastasizes before being diagnosed, making colon cancer the third most commonly diagnosed cancer and the third leading cause of cancer death in the United States, in both men and women. It is estimated that more than 140,000 people will be diagnosed with CRC in 2011, and nearly 50,000 people will die from the disease. Approximately 50 percent of colon cancer patients will be diagnosed with metastases, most commonly in the liver.
Onyx’ and Bayer’s news today is offering a new hope for survival from this terrible malignancy. Until the announcement of the stopping of trials because of the successful outcome, no hope existed anywhere for patients who have advanced mCRC. The patients are simply dying, which looks like a non-negotiable fact that has not changed for decades in spite of the introduction of several targeted biological treatments, of new combination treatments, in addition to supplementation with anti-angiogenic drugs that aim at cutting the cancer blood supply and preventing the growth and division of the malignant cells.
Patients with metastatic colorectal cancer are in need for new treatment options, and these data demonstrate that regorafenib has, indeed, increased overall survival," said Ted W. Love, M.D., Executive Vice President, Research and Development and Technical Operations at Onyx Pharmaceuticals. "We look forward to seeing this promising therapy become available to patients as quickly as possible."
Bayer will continue discussions with health authorities worldwide, including the European Medicines Agency (EMA) and the FDA regarding next steps in filing for approval of regorafenib in the treatment of mCRC.
The Drug: Regorafenib is an investigational oral multi-kinase inhibitor of angiogenic, stromal and oncogenic receptor tyrosine kinases (TK) currently being investigated in clinical trials for its potential to treat patients with various tumor types.
Regorafenib was granted orphan drug designation by the FDA for the treatment of patients with gastrointestinal stromal tumors (GIST). Orphan drug designation aims to encourage the development of drugs involved in the diagnosis, prevention or treatment of a medical condition affecting fewer than 200,000 people in the country.Regorafenib was granted Fast Track designation by the FDA for the treatment of patients with metastatic and/or unresectable GIST whose disease has progressed despite at least imatinib and sunitinib as prior treatments, as well as for the treatment of patients with mCRC who have progressed after approved standard therapies. Fast Track is a process designed to facilitate the development, and expedite the review of drugs to treat serious diseases and fill an unmet medical need.
We looked very carefully at all the aspects of the clinical trials and at the results and are convinced more than ever that ONXX has hit the Jackpot this month for a long growth and more achievements in oncology. Even if taken over, this firm will keep its structure and function intact in within the giant buyer, regardless of who it would be. Onyx will never dissolve into inexistency, but will be like Genentech following its acquisition by Roche and like Centocor after becoming the wholly owned subsidiary of Johnson& Johnson. Both remained scientifically independent and extremely productive.
Investors who turned from long-term shareholders to traders have unfortunately missed the rally in the stock, which exceeded 25%. What do we tell these folks? Don’t worry. The best is yet to come.
Those who are still concerned about Sequenom, since it got its Down Syndrome test trisomy 21, will have their questions answered when the firm will report financial results for the third quarter of 2011 after closing of the NASDAQ Global Market on Thursday, November 3, 2011.
A conference call hosted by Harry F. Hixson, Jr., Ph.D., Chairman and CEO, and other members of senior management will take place on the same day at 5:00pm ET (2:00pm PT) and will be webcast live on the Sequenom website.
To access the live teleconference DIAL:
800-860-2442 in the U.S.,
866-605-3852 in Canada (both are toll free),
412-858-4600 for other international callers.
Please specify to the operator that you would like to join the "Sequenom Third Quarter 2011 Earnings Conference Call." If you are unable to listen to the live webcast, a teleconference replay will be available through Friday, November 11, 2011. Interested parties can access the rebroadcast by dialing 877-344-7529 or 412-317-0088 internationally and entering the conference number 10005971. The conference call webcast is accessible through the "Investors" section of the Sequenom website at http://ir.sequenom.com. An online replay will be available following the initial broadcast until Thursday, December 1, 2011.
WE LONG ONXX