Bristol-Myers Squibb Co. - Conference Presentation Calls

Bristol-Myers Squibb Co. and Alder Biopharmaceuticals Inc. announced a global agreement for the development and commercialization of ALD518, a novel biologic that has completed Phase IIa development for the treatment of rheumatoid arthritis. Under the terms of the collaboration agreement, Alder will grant to Bristol-Myers Squibb worldwide exclusive rights to develop and commercialize ALD518 for all potential indications except cancer, for which Alder will retain rights and grant Bristol-Myers Squibb an option to co-develop and commercialize outside the United States. An upfront cash payment of $85 million, potential development-based and regulatory-based milestone payments of up to $764 million across a range of indications, potential sales-based milestones which, under certain circumstances, may exceed $200 million, and royalties on net sales are payable to Alder by Bristol-Myers Squibb. Alder has an option to require Bristol-Myers Squibb to make an equity investment of up to $20 million in Alder during an initial public offering. The effectiveness of the collaboration agreement is subject to antitrust clearance by the United States Federal Trade Commission and Department of Justice, under the provisions of the Hart-Scott-Rodino Antitrust Improvements Act of 1976, and other customary regulatory approvals.

Bristol-Myers Squibb Co. announced that the U.S. Food and Drug Administration (FDA) has approved a labeling update for REYATAZ(R) to include long-term data from the CASTLE Study. The CASTLE Study assessed a once-daily REYATAZ/ritonavir (REYATAZ/r)-based regimen versus a twice-daily lopinavir/ritonavir (LPV/r)-based regimen in previously untreated adult patients infected with HIV-1. Data from the study demonstrate enduring virologic response through 96 weeks of treatment with REYATAZ/r as part of combination therapy. According to the most recent report from the Centers for Disease Control and Prevention, more than one million people are living with HIV and the annual incidence of new infections was 56,300 in the U.S.1 It is critical that effective and tolerable medicines are available to patients initiating antiretroviral therapy. Long-term data from the CASTLE Study demonstrate that treatment with REYATAZ/r can effectively suppress HIV viral load over 96 weeks in treatment-naive patients.