Bristol-Myers Squibb Company (NYSE:BMY) 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. "With its novel mechanism of action, ALD518 has the potential to offer an exciting new option for patients with rheumatoid arthritis," said Brian Daniels, M.D., senior vice president, Global Development & Medical Affairs, Bristol-Myers Squibb. "We are pleased to have the opportunity to develop this novel monoclonal antibody. As part of our String of Pearls strategy, this transaction provides Bristol-Myers Squibb with the opportunity to strengthen our immunoscience pipeline, and leverage our company's experience in developing and delivering novel biologics to help patients prevail over rheumatoid arthritis and, potentially, other autoimmune diseases."
"Bristol-Myers Squibb and Alder share the vision that ALD518 could become an important part of treating patients with rheumatoid arthritis," said Randall C. Schatzman, Ph.D., president and chief executive officer of Alder Biopharmaceuticals. "Bristol-Myers Squibb's extensive development and commercial experience in immunology translate into an exceptionally good fit for Alder, especially at this stage of our corporate development."
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.
About ALD518
ALD518 is a humanized, monoclonal antibody, designed to block a pro-inflammatory molecule called interleukin-6 (IL-6), which plays a key role in the inflammatory cascade leading to the inflammation, swelling, pain, and destruction of large and small joints associated with rheumatoid arthritis. Based on the strong association of IL-6 with inflammatory disease, inhibition of IL-6 with ALD518 represents a promising new anti-inflammatory mechanism that could result in bone and joint preservation. ALD518 has completed Phase IIa development for rheumatoid arthritis. ALD518 is also being studied by Alder for the treatment of cancer and in cancer supportive care.
About Rheumatoid Arthritis
Rheumatoid arthritis (RA) is a systemic,(1) chronic, autoimmune disease characterized by inflammation in the lining of joints (or synovium), causing joint damage with chronic pain, stiffness, swelling and fatigue.(2) RA causes limited range of motion and decreased function as a result of affected joints losing their shape and alignment.(3)
RA affects about one percent of the world's population,(4) including more than one million people in the United States.1 The condition is more common in women than in men, who account for 75 percent of patients diagnosed with RA.(2)
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company committed to discovering, developing and delivering innovative medicines that help patients prevail over serious diseases. For more information, please visit www.bms.com.
About Alder
Alder Biopharmaceuticals, Inc. uniquely identifies, develops, and manufactures novel antibody therapeutics to alleviate human suffering in the autoimmune and inflammatory disease areas. Alder's management team combines decades of industry experience with a proven track record for identifying and developing novel antibody therapeutics and enabling partners through the out-licensing of its technologies. In addition to Bristol-Myers Squibb, partners include Schering-Plough, Seattle Genetics, Genmab, and two non-disclosed large pharmaceutical companies. For more information, visit www.alderbio.com.
1. Helmick CG, Felson DT, Lawrence RC, Gabriel S, Hirsch R, Kwoh CK, Liang MH, Kremers HM, Mayes MD, Merkel PA, Pillemer SR, Reveille JD, Stone JH; National Arthritis Data Workgroup. Estimates of the prevalence of arthritis and other rheumatic conditions in the United States. Part I. Arthritis Rheum. 2008;Jan;58(1):15-25.
2. American College of Rheumatology, Patient Education, Rheumatoid Arthritis. Available at: http://www.rheumatology.org/public/factsheets/ra_new.asp?aud=pat2. Accessed May 2006.
3. National Institute of Arthritis and Musculoskeletal and Skin Diseases. National Institutes of Health. U.S. Department of Health and Human Services. Rheumatoid Arthritis. May 2004.
4. Lee DM, Weinblatt ME. Rheumatoid Arthritis. The Lancet. 2001;358:903-11.