Investors and Media


RHEI Pharmaceuticals Licenses Flamel's Asacard® (controlled-release aspirin) For China and Taiwan.

NEW HAVEN, Conn. -- RHEI Pharmaceuticals, Inc. and Flamel Technologies, S.A. (Nasdaq:FLML) today announced that RHEI has licensed from Flamel the exclusive right to market Asacard® in the Greater China region (including China, Taiwan, Hong Kong and Macau). Asacard® is a controlled release formulation of aspirin. Flamel will manufacture commercial supply of the product at its facilities in Pessac, France. Financial terms were not disclosed.

"We believe Asacard® represents a technical innovation in aspirin and we are excited to bring Flamel's unique formulation of low dose aspirin to the China market," said Dr. Sylvia He, Chief Executive Officer of RHEI Pharmaceuticals. "Cardiovascular disease accounts for more deaths in China than any other single disease state. The market is growing by more than 20% each year as the availability of treatment regimens come closer to those seen in the United States."

Stephen H. Willard, Flamel's Chief Executive Officer, stated, "We are pleased that we have been able to reach this agreement with RHEI Pharmaceuticals for Asacard®. We have long maintained that Asacard® is an excellent product that offers all of aspirin's therapeutic benefits while strongly limiting the side-effects that often accompany chronic use of this otherwise well-tolerated molecule. We are pleased to avail ourselves of RHEI's expertise in developing and commercializing drugs for the Chinese market, offering us an excellent opportunity to access an area of strong demographic potential."

About Asacard®
Asacard® is a controlled release formulation of aspirin for prophylactic cardiovascular indications. Using the Flamel's Micropump® technology platform, Asacard® is designed to provide effective and safe therapy for cardiovascular treatment. Its safety and efficacy for this indication comes from controlling the release of aspirin while providing cardiovascular benefits similar to conventional aspirin formulations. Asacard® is differentiated from conventional aspirin in that it reduces gastrointestinal side effects. Asacard® is the only aspirin formulation that significantly controls the rate of release of aspirin in the systemic circulation system, thus avoiding Cox 1 inhibition, the major cause of gastrointestinal problems. Additionally, its microparticle coating protects the stomach and intestine linings from direct contact with the aspirin. Asacard® is currently approved for marketing in 11 countries including France and the United Kingdom.

According to the World Health Organization, cardiovascular disease is one of the leading causes of mortality in Southeast Asia. In China alone, more than a quarter (27.4%) of all deaths are due to cardiovascular disease and there are currently more than 120 million adults with hypertension in China.

About Flamel Technologies
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.

About RHEI Pharmaceuticals
RHEI Pharmaceuticals is a venture backed specialty pharmaceutical company with operations in the US and in China that acquires, licenses, develops and commercializes in China proprietary drug therapies based upon the unmet needs of the emerging China pharmaceuticals market. RHEI leverages its proprietary and extensive network of experienced clinical development and regulatory professionals in China to obtain accelerated approvals for pharmaceuticals new to the China market. RHEI's growing sales and marketing capabilities then provide broad patient access in China to these new and critically necessary therapeutics. RHEI specializes in hospital-based proprietary products with a therapeutic focus on urgent unmet needs in the areas of cancer, cardiovascular disease, pulmonary disease, pain, anti-infective, and other life threatening conditions.

This document contains a number of matters, particularly as related to financial projections and the status of various research projects and technology platforms, that constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The presentation reflects the current view of management with respect to future events and is subject to risks and uncertainties that could cause actual results to differ materially from those contemplated in such forward-looking statements. These risks include risks that products in the development stage may not achieve scientific objectives or milestones or meet stringent regulatory requirements, uncertainties regarding market acceptance of products in development, the impact of competitive products and pricing, and the risks associated with Flamel's reliance on outside parties and key strategic alliances. These and other risks are described more fully in Flamel's Annual Report on the Securities and Exchange Commission Form 20-F for the year ended December 31, 2004