Press Releases
FLAMEL TECHNOLOGIES S.A. ANNOUNCES INITIAL CLINICAL RESULTS ON ITS ASACARD CARDIOVASCULAR ASPIRIN
LYON, FRANCE, OCTOBER 23, 1997 – Flamel Technologies S.A. (NASDAQ: FLML) today announced initial clinical results on its Asacard controlled-release cardiovascular aspirin indicating that Asacard causes less endoscopic damage than conventional aspirin. These data have been presented yesterday at the 6th European Gastroenterology Meeting in Birmingham, U.K., by a group led by Professor Hawkey, of the gastroenterology division of University Hospital, Nottingham (UK), who conducted the study.
Asacard is licensed to Searle for marketing in most countries in Europe and is currently under registration in the UK. It is also undergoing Phase I studies in the US.
The endoscopic study performed on volunteers observed incidences of gastric ulcers, erosions and other signs of gastric bleeding during a 3-week treatment with either Asacard 325mg or with a currently marketed coated aspirin product of the same dose.
The study indicated that significantly fewer gastric lesions were observed in patients taking Asacard 325 than in patients taking the same dose of the coated aspirin product. Gastric erosions per patient were 1.57 with Asacard 325 compared to 5.48 with the comparison coated aspirin product, or a reduction of over 70% (p < 0.001). 3.09 petechiae per person were observed with Asacard 325 compared to 7.35 with the comparison aspirin product (p < 0.001).
Asacard makes use of Flamel's Micropump™ technology, an oral drug delivery system based on microencapsulation which enables controlled-delivery and long-lasting absorption in the small intestine.
The company believes that these very positive results for Asacard may be explained by the biochemical selectivity of Asacard, which inhibits thromboxane (TXB2), the platelet aggregant prostanoids, while sparing Prostacyclin (PGI2), the systemic cytoprotective prostaglandin. This objective has been identified by Sir John Vane in a scientific paper published in Nature ("Towards a better aspirin," Nature, 1995). Sir John Vane received the Nobel Prize of Medicine in 1982 for his discovery of prostaglandins and for his work on the mechanism of action of aspirin.
Sir John Vane was in Birmingham this week for the meeting giving a plenary lecture entitled "100 Years of Aspirin". He commented: "The Nottingham clinical group's results clearly show that Asacard is very effective in inhibiting platelet clumping, the cause of heart attacks and strokes. At the same time, it is much safer than conventional aspirin, even when it is coated. Clearly, Asacard is much kinder to the lining of the stomach, which is well known to be damaged by ordinary preparations of aspirin, and can be taken to prevent heart attacks and strokes without fear of damaging the stomach."
"Aspirin is recognized as probably the best all-round treatment for preventing re-occurrences of stroke and myocardial infarction, and gastro-intestinal side effects are the single major issue with its widespread use," commented Dr. Soula, CEO of Flamel Technologies. "For this type of disease where patients have to take aspirin for the rest of their life, we believe the safety improvement brought by Asacard will represent a major advantage. We are encouraged to conduct a larger clinical trial, in collaboration with Searle, to confirm this safety improvement. If confirmed, physicians prescribing aspirin for the prevention of myocardial infarction and stroke may not need to choose between proven efficacy (high doses) and gastric safety (low doses)."
It is estimated that more than 6 billion doses of aspirin are consumed worldwide every year for cardiovascular treatment, a number that is growing steadily.
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 – through programs including Micropump™ and Medusa® in drug-delivery, ColCys in biomaterial-based medical devices, and new materials for ophthalmic lens products – to meet important unmet medical needs and develop other commercially valuable products. In June 1996, Flamel completed its initial public offering in the U.S.
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.
