Press Releases
FLAMEL TECHNOLOGIES FILES IND IN U.S. FOR ASACARD
Reports on Progress to Investors at Alex. Brown Healthcare Conference
LYON, FRANCE, MAY 5, 1997 -- Flamel Technologies S.A. (NASDAQ:FLML) said today it has filed an IND in the U.S. on its Asacard cardiovascular aspirin product. Flamel's president and chief executive officer, Dr. Gérard Soula, reported the filing as part of an update of the Company's progress over the last few months, in a presentation at the Alex. Brown Health Care Conference today in Baltimore.
Asacard, based on Flamel's MicropumpTM technology for oral delivery to the small intestine, is a controlled-release formulation of aspirin for cardiovascular treatment designed to maintain the efficacy of aspirin while reducing its well-known gastric side effects.
Dr. Soula also said the Company is also preparing to file an IND in the U.S. on Viropump, its controlled-release formulation of acicylovir for the treatment of chronic genital herpes. In January 1997, the Company commenced a Phase III study of Viropump in France, targeting the treatment of acute genital herpes.
Concerning the Company's MedusaTM technology for the delivery of proteins and peptides, Dr. Soula reported that Flamel has achieved significant progress in the development of a long-acting formulation of insulin for the treatment of diabetes. Preclinical studies on fasted dogs indicate that the Medusa insulin formulation, named BasulinTM, maintains a flat insulin profile for over two days, compared to less than one full day for leading long-acting formulations currently on the market. Dr. Soula said, "We believe a twice-weekly formulation of insulin should be obtainable. The longer we can extend the delivery of insulin, the fewer injections will be required to provide base insulin levels for diabetic patients."
Dr. Soula said the Company expects to start human studies of Basulin™ before the end of the calendar year. The technology is protected by three international patents. Dr. Soula commented that data from the insulin studies show the potential of Flamel's Medusa technology for the delivery of a wide range of proteins and peptides.
In addition, the Company disclosed that it is developing a polymer-based photochromic material under terms of its collaborative agreement with Corning Incorporated. During 1996 Flamel manufactured and delivered to Corning initial production quantities of this material.
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.
