Press Release: Novacea Receives $60 Million Under Schering-Plough Corporation Agreement for Asentar
Novacea Receives $60 Million Under Schering-Plough Corporation Agreement for Asentar SOUTH SAN FRANCISCO, CA -- Jul 11, 2007 -- Novacea, Inc., today announced that it has received $60 million from Schering-Plough Corporation under the terms of the previously announced worldwide development and commercialization agreement for Asentar(TM) (DN-101). The payment from the closing of this transaction follows the early termination by the United States Federal Trade Commission of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. Under the terms of the development and commercialization agreement, Novacea received an upfront payment of $60 million, including $35 million as reimbursement for past research and development expenses and a license fee of $25 million. In addition, pursuant to a related stock purchase agreement, Schering-Plough purchased $12 million of Novacea common stock. The development and commercialization agreement provides Novacea with potential pre-commercial milestone payments of up to $380 million, and royalties on worldwide sales of Asentar based on tiered royalty percentage rates. Schering-Plough also will be responsible for all forward development costs in exploring indications for earlier stages of prostate cancer, such as androgen-dependent prostate cancer and adjuvant therapy and will lead all global commercialization efforts for Asentar. Novacea will provide medical support to Schering-Plough's commercial operations for Asentar in the United States, including deployment of their Medical Science Liaisons, which will be funded by Schering-Plough. About Asentar Asentar is currently being developed as an oral treatment in combination with TaxotereÃ‚Â®(docetaxel) for the treatment of AIPC. Prostate cancer is the second leading cause of cancer death in men with approximately 232,000 new cases and 30,000 deaths in the U.S. in 2005. AIPC is an advanced disease state of prostate cancer. Based on results of Novacea's completed Phase 2 clinical trial, known as ASCENT, the use of weekly Asentar in combination with weekly Taxotere may provide AIPC patients with an innovative cancer therapy that may prolong survival with the potential in reducing some of the toxicities and complications normally associated with chemotherapy. Novacea is now evaluating the benefits of Asentar in a 900-patient Phase 3 trial, known as ASCENT-2, which uses overall survival as the primary endpoint and compares weekly Asentar plus Taxotere to the current standard of care in the treatment of AIPC. About Novacea Novacea, Inc. is a biopharmaceutical company focused on in-licensing, developing and commercializing novel cancer therapies. Novacea has two novel oncology product candidates in clinical trials. Asentar(TM), which is partnered with Schering-Plough Corporation, currently is in a Phase 3 clinical trial for androgen-independent prostate cancer (AIPC). Novacea's second product candidate, AQ4N, is a hypoxia-activated prodrug that is currently in a Phase 1b/2a clinical trial in glioblastoma multiforme. More information on any of Novacea's trials can be found at www.ClinicalTrials.gov. Note: Except for the historical information contained herein, the matters set forth in this press release, including statements as to financial guidance, development, clinical studies, regulatory review and approval, and commercialization of products, are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements speak only as of the date the statements are made and are based on information available at the time those statements are made and/or management's good faith belief as of that time with respect to future events. You should not put undue reliance on any forward-looking statements. Important factors that could cause actual performance and results to differ materially from the forward-looking statements we make include: early stage of development; the focus, conduct, enrollment and timing of our clinical trials; regulatory review and approval of product candidates; commercialization of products; developments relating to our licensing and collaboration agreements; market acceptance of products; funding requirements; intellectual property protection for our product candidates; competing products and other risks detailed from time to time under the heading "Risk Factors" in our most recent Quarterly Report on Form 10-Q or Annual Report on Form 10-K, as may be updated from time to time by our future filings under the Securities Exchange Act. 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