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 centering on companies that blend scientific rationale, as well as align with the company’s vision of benefitting patients living with a number of different types of cancer. Onyx welcomes the opportunity to explore the possibility of collaborative partnerships with the goal of bringing new, innovative therapies to market. 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, now approved for two types of cancer. Each company funds 50% of the development costs for Nexavar worldwide, excluding Japan, where Bayer funds all product development. Onyx, with Bayer, is co-promoting Nexavar in the United States and sharing equally in any profits or losses. Outside of the U.S., Bayer has exclusive marketing rights and Onyx shares profits 50/50, excluding Japan, where Onyx receives a single-digit royalty on sales.

Pfizer (Warner-Lambert)
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.

S*BIO Pte Ltd.
In 2008, Onyx acquired an option to license rights to SB1518 (ONX 0803), an orally available, selective inhibitor of Janus Kinase (JAK), and SB1578 (ONX 0805), also a JAK inhibitor, for the treatment of hematologic malignancies and myeloproliferative disorders. Under the terms of the agreement, Onyx has option rights to exclusively develop and commercialize ONX 0803 and ONX 0805 for all potential indications in the United States, Canada and Europe. S*BIO retains responsibility for all development costs prior to option exercise, after which Onyx will assume development costs in return for enhanced royalties on any future product sales. Upon option exercise for each compound, S*BIO will receive a one-time fee, milestones upon achievement of certain development and sales triggers and royalties on future product sales.

BTG International
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 several new compounds including carfilzomib, a selective proteasome inhibitor currently in multiple clinical trials to evaluate its efficacy and safety for the treatment of patients with multiple myeloma and solid tumors. The proteasome inhibition program also includes ONX 0912, an oral proteasome inhibitor currently in Phase 1 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 up to $535 million contingent upon the achievement of certain regulatory approvals for carfilzomib in the U.S. and Europe. Of the potential $535 million, a payment of $170 million is based upon the achievement of accelerated approval by the U.S. Food and Drug Administration.

Ono Pharmaceutical
In 2010, Onyx entered into an exclusive agreement with Ono Pharmaceutical Co., Ltd. to develop and commercialize carfilzomib 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.