Partnering with Onyx
Onyx's dedicated Corporate Development team looks to build on the core strengths and capabilities that exist within the company's product/pipeline portfolio and experience in oncology. In doing so, Onyx seeks to cultivate strategic alliances with companies that blend scientific rationale with a patient-centered approach to potenitally benefit as many people as possible with various types of cancer.
Onyx welcomes the opportunity to explore the possibility of collaborative partnerships. If you are interested in exploring a partnership opportunity with Onyx, please complete and submit the External Opportunity Submission Form. Onyx’s licensing and partnering activities to-date have covered a wide range of transactions including:
Bayer HealthCare Pharmaceuticals, Inc.
In 1994, Onyx entered into a collaboration agreement with Bayer HealthCare Pharmaceuticals, Inc. to develop and commercialize RAS kinase inhibitors, which led to the discovery of Nexavar® (sorafenib) tablets, now approved for two types of cancer. Nexavar is co-developed by Onyx and Bayer, except in Japan where Bayer manages all development. The companies co-promote Nexavar in the United States. Outside of the U.S. Bayer has exclusive marketing rights, and Bayer and Onyx share profits globally, excluding Japan. In 2011, Bayer entered into an agreement with Onyx, under which Onyx receives a royalty on all global net sales of Stivarga® (regorafenib) tablets in oncology. Stivarga® (regorafenib) is a Bayer compound being developed by Bayer. Onyx receives a 20% royalty on all global net sales in approved markets. Bayer and Onyx are jointly promoting Stivarga in the U.S.
In 1995, Onyx entered into a research collaboration agreement with Warner-Lambert, now Pfizer, to develop PD 0332991, an oral, small molecule cyclin-dependent kinase 4/6 inhibitor. Pfizer is responsible for all product development activities and costs, and Onyx receives certain milestone payments. If Pfizer commercializes this product, Onyx will receive royalties on worldwide sales.
In 2008, Onyx in-licensed ONX 0801(BGC 945), a novel targeted oncology compound for the potential treatment of solid tumors, including lung cancer and ovarian cancer. Under the terms of the agreement, Onyx obtained a worldwide license for ONX 0801 and all of its related patents. Onyx received exclusive worldwide marketing rights and is responsible for all product development and commercialization activities.
In 2009, Onyx acquired Proteolix, a privately-held biopharmaceutical company. The acquisition resulted in the addition of new proteasome inhibitor compounds to Onyx’s development pipeline, including Kyprolis® (carfilzomib) for Injection. KYPROLIS was approved in 2012 for the treatment of patients with multiple myeloma who have received at least two prior therapies including bortezomib and an immunomodulatory agent (IMiD), and have demonstrated disease progression on or within 60 days of completion of the last therapy. Approval was based on response rate. Clinical benefit, such as improvement in survival or symptoms, has not been verified. Carfilzomib is currently being evaluated in a number of clinical trials for its efficacy and safety across all lines of multiple myeloma therapy, as well as in solid tumors. The proteasome inhibition program also includes oprozomib, an oral proteasome inhibitor currently in Phase 1b/2 clinical testing, and ONX 0914, an immunoproteasome inhibitor. Under the terms of the transaction, Onyx made a $276 million cash payment upon closing of the transaction. Additional payments included $40 million paid in 2010, based on the achievement of a development milestone and $80 million was paid in a combination of cash and stock in 2012, based upon the achievement of KYPROLIS accelerated approval by the U.S. Food and Drug Administration. Up to an additional $365 million is contingent upon the achievement of certain regulatory approvals for KYPROLIS in the U.S. and Europe.
In 2010, Onyx entered into an exclusive agreement with Ono Pharmaceutical Co., Ltd. to develop and commercialize Kyprolis and ONX 0912 in Japan. Under the terms of the agreement, Ono has exclusive rights to develop and commercialize both compounds for all oncology indications in Japan. Onyx retains commercialization rights in other countries in the Asia Pacific region, as well as in all other regions of the world, including the U.S. and Europe. The potential value of the transaction, which includes rights to all oncology indications for the two molecules, is estimated to exceed $300 million, plus royalties. Ono paid Onyx an upfront payment of approximately ¥5 billion (Japanese yen, approximately $59 million at current exchange rates). In addition, Onyx will receive development and sales-based payments related to the compounds.
Important Safety Information for Kyprolis® (carfilzomib) for Injection
Safety data have been evaluated in 526 patients with relapsed and/or refractory multiple myeloma who received single-agent KYPROLIS. There were 37 deaths in the Phase 2 studies, or 7% of patients. The most common causes of death, other than disease progression, were cardiac (5 patients), end-organ failure (4 patients), and infection (4 patients). Important warnings and precautions include cardiac arrest, congestive heart failure, myocardial ischemia; pulmonary hypertension, pulmonary complications, infusion reactions, tumor lysis syndrome, thrombocytopenia, hepatic toxicity and embryo-fetal toxicity.
Death due to cardiac arrest has occurred within a day of KYPROLIS administration. Patients with New York Heart Association Class III and IV heart failure, myocardial infarction in the preceding 6 months, and conduction abnormalities uncontrolled by medications were not eligible for the clinical trials. These patients may be at greater risk for cardiac complications.
Pulmonary arterial hypertension (PAH) was reported in 2% of patients treated with KYPROLIS and was Grade 3 or greater in less than 1% of patients. Dyspnea was reported in 35% of patients enrolled in clinical trials. Grade 3 dyspnea occurred in 5%; no Grade 4 events, and 1 death (Grade 5) was reported.
Infusion reactions, characterized by a spectrum of systemic symptoms including fever, chills, arthralgia, myalgia, facial flushing, facial edema, vomiting, weakness, shortness of breath, hypotension, syncope, chest tightness, or angina can occur immediately following or up to 24 hours after administration of KYPROLIS. Administration of dexamethasone prior to KYPROLIS reduces the incidence and severity of reactions. Tumor lysis syndrome (TLS) occurred following KYPROLIS administration in < 1% of patients. Patients with multiple myeloma and a high tumor burden should be considered to be at greater risk for TLS.
Thrombocytopenia following KYPROLIS administration resulted in a dose reduction in 1% of patients and discontinuation of treatment with Kyprolis in < 1% of patients.
Cases of hepatic failure, including fatal cases, have been reported (< 1%). KYPROLIS can cause elevations of serum transaminases and bilirubin.
There are no adequate and well-controlled studies in pregnant women using KYPROLIS. Females of reproductive potential should be advised to avoid becoming pregnant while being treated with KYPROLIS.
The most common serious adverse reactions were pneumonia, acute renal failure, pyrexia, and congestive heart failure. The most common adverse reactions (incidence of 30% or greater) observed in clinical trials of patients with multiple myeloma were fatigue, anemia, nausea, thrombocytopenia, dyspnea, diarrhea, and pyrexia. Serious adverse reactions were reported in 45% of patients.
Full prescribing information is available at http://www.kyprolis.com.