Press Releases
Lyon, France, August 27, 2003 – Bristol-Myers Squibb Company (NYSE: BMY) and Flamel Technologies S.A. (NASDAQ:FLML) today announced that the companies have entered into a licensing and commercialization agreement to develop and market Basulin®, the first controlled release, unmodified human insulin to be developed as a once-daily injection for patients with type 1 or type 2 diabetes. The agreement is subject to clearance under the Hart Scott Rodino Antitrust Improvements Act of 1976.
"As a leader in the field of diabetes treatment, Bristol-Myers Squibb is committed to bringing new therapeutic options to physicians and patients," said Peter R. Dolan, chairman and chief executive officer, Bristol-Myers Squibb. "We are pleased to have the opportunity to work with our partners at Flamel Technologies S.A. to continue the development of Basulin. It is our hope that this first-in-class product may offer an important new long acting option for patients with type 1 and type 2 diabetes."
Basulin is now entering Phase II clinical development. Under the terms of the agreement, Bristol-Myers Squibb will lead, and assume the cost of, the future development and manufacturing efforts for Basulin® and will have worldwide exclusive rights to the product. Flamel will continue to provide additional support for certain activities as the product moves forward in development. Bristol-Myers Squibb will pay Flamel Technologies S.A. a $20 million up-front payment and $145 million in additional milestone payments for a total of $165 million. Bristol-Myers Squibb will also pay double-digit royalties to Flamel on sales.
Basulin is the first controlled release insulin that uses recombinant human insulin, rather than an insulin analog. Basulin is delivered via Medusa®, a unique nanoparticulate technology that was developed by Flamel.
"Flamel Technologies S.A. has chosen to partner with Bristol-Myers Squibb based on the company's leadership in diabetes disease treatment," said Dr. Gerard Soula, president and chief executive officer, Flamel Technologies S.A. "I look forward to combining our partner's development and commercialization expertise with Flamel's innovation experience to develop Basulin, our flagship Medusa project."
According to the World Health Organization, approximately 177 million people worldwide suffer from diabetes, and that number may double by 2025. Nearly 40% of people with diabetes require insulin injections.
Bristol-Myers Squibb is a global pharmaceutical and related healthcare products company whose mission is to extend and enhance human life.
Flamel Technologies, S.A. is a biopharmaceutical company principally engaged in the development of two unique polymer-based delivery technologies for medical applications. Micropump® is a controlled release and taste- masking technology for the oral administration of small molecule drugs. Flamel's Medusa® technology is designed to deliver controlled-release formulations of therapeutic proteins.
For further information on the Company, please review Flamel's Annual Report on the Securities and Exchange Commission Form 20-F for the year ended December 31, 2002.
Visit Bristol-Myers Squibb on the World Wide Web at www.bms.com
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations and involve significant risks and uncertainties that may cause results to differ materially from those set forth in the statements. Among other risks, there can be no guarantee that the product described in this release will receive regulatory approval, or that it will prove to be commercially successful. This and other risk factors are discussed in the company's 2002 Annual Report on Form 10-K and in the company's periodic reports on Form 10-Q. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.
