Press Releases
SEARLE AND FLAMEL TECHNOLOGIES ANNOUNCE THE UK APPROVAL OF ASACARD™ CONTROLLED-RELEASE CARDIOVASCULAR ASPIRIN
Skokie (IL), Lyon (France), February 2, 1998– Flamel Technologies S.A. (NASDAQ: FLML) and G.D. Searle & Co, a subsidiary of Monsanto Company (NYSE: MTC), today announced that Asacard™ 162.5 mg cardiovascular aspirin has been approved for marketing in the UK for the prophylaxis against myocardial infarction, stroke and vascular death.
Asacard™ is a controlled-release formulation of aspirin tailored specifically for the treatment of cardiovascular diseases. It makes use of Flamel's proprietary Micropump® technology, an innovative oral drug delivery system based on microencapsulation which allows long-lasting activity of the drug. Asacard is protected by patent filings in all major markets; a US patent on Asacard was issued in 1997.
Searle, Flamel's licensee, indicated it expects to begin marketing Asacard 162.5 mg in the UK before the end of 1998. Flamel and Searle also intend to extend the U.K. approval to other countries in Europe in the near future. Upon receipt of such approvals, Asacard 162.5 mg will be marketed in most European countries by Searle.
"We believe Asacard represents a major technical innovation in aspirin," commented Dr. Gérard Soula, Flamel's Chairman and CEO. "We have clinically proven that using our controlled-delivery technology we can maintain aspirin's efficacy as an antiplatelet agent while reducing its gastric side effects. This approval represents the first major validation of our Micropump technology."
In October 1997, Flamel reported the results of an initial endoscopic study which indicated that Asacard at a 325 mg dosage level significantly reduced the incidence of hemorrhagic bleeding versus the comparison aspirin product. Sir John Vane, who received the Nobel Prize of Medicine in 1982 for his work on the mechanism of action of aspirin, commented that "the results clearly show that Asacard is very effective and is much safer than conventional aspirin, even when it is coated. Clearly, Asacard can be taken to prevent heart attacks and strokes without fear of damaging the stomach." Searle and Flamel are now planning to conduct a large study to confirm these initial results.
"In Europe, an estimated 2.5 to 3 billion doses of aspirin are consumed annually for cardiovascular treatment, and 9 billion doses are consumed worldwide" commented Dr. Giorgio Anania, Flamel's Vice President Sales, Marketing and Business Development. "This represents the fastest-growing segment of the aspirin market, and is a medical treatment which nearly everyone can afford. Although we don't expect Asacard sales to make a significant contribution to our 1998 revenues, we believe Asacard's performance advantages will allow it to capture a significant position in this market over the coming years."
Under the licensing terms with Searle, Flamel manufactures and sells controlled-release microparticles containing aspirin to Searle, which manufactures the final product. Flamel also receives royalties on Searle's sales of the product, as well as milestone payments upon approval in the major European countries.
As previously announced, Flamel has also initiated Phase I studies with Asacard 325 mg in the US.
Flamel Technologies is engaged in the development of advanced polymer technologies for unique drug delivery and biomaterial applications. The Company is building on its principal technology platforms – the delivery of active ingredients with its Micropump® and Medusa® drug-delivery systems, its Agsome™ delivery system for agrochemical active ingredients, its ColCys biomaterial-based medical devices, and specialty photochromic materials for ophthalmic lens products – to meet important unmet medical needs and develop other commercially valuable products.
NOTE: This press release contains statements which constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are subject to risks and uncertainties, including but not limited to the risk associated with the Company's limited history of operations and historic and future losses, and the risk 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, reliance on outside parties and the risks associated with key strategic alliances, and other risks detailed in the Company's filings with the Securities and Exchange Commission.
