PARIS  Flamel Technologies SA, of Vinissieux, near Lyon, has announced an increase in revenues and a reduction in its net loss for the third quarter of 1998, as well as progress in the clinical development of two of its orally administered, controlled-release drugs. Revenues amounted to $1.7 million, up from $1.2 million in the third quarter of 1997, while the net loss was cut to $2.18 million from $2.94 million. The increase in revenue was mostly attributable to contract research payments from Monsanto Co., of St. Louis, and French government programs.

For the first nine months as a whole, revenues were 41.3 percent up at $6.65 million (as compared to $4.7 million in the corresponding period of 1997), while the net loss was reduced to $6.24 million (from $6.86 million). As of Sept. 30, the company¿s financial reserves of cash and investments amounted to $15.1 million, largely thanks to the $10 million it raised in June through the sale of a 14 percent equity stake to the French finance company Financihre et Industrielle Gaz et Eaux. (See BioWorld International, May 20, 1998, p. 2.)

Flamel, which is focused on the development of oral drug delivery systems using advanced polymer technologies for the delivery of controlled-release drugs and biomaterials, is now starting to plan the launch of its first product. A Phase III trial of Genvir, a treatment for acute genital herpes, was completed during the third quarter and the company says initial analyses of resulting data are positive.

Genvir Uses Micropump For Controlled Release

Genvir (formerly known as Viropump) is a controlled-release formulation of acyclovir for twice-daily administration using Flamel¿s Micropump technology, which extends the duration of action of drugs best absorbed in the small intestine. Flamel¿s president and CEO, Girard Soula, said the company is concentrating on bringing Genvir ¿to a market where it could be attractively positioned compared with alternative drugs in terms of patient compliance and price.¿ The plan is to file the product for approval in the European Union in the second half of 1999.

The second product Flamel has in clinical development is Asacard, a controlled-release, Micropump-delivered aspirin which was originally designed to treat cardiovascular diseases but which the company now plans to extend to other traditional indications for aspirin. A Phase I trial of Asacard for cardiovascular use was recently completed in the U.S. and confirmed the results of an earlier trial conducted in Europe. But, because the U.S. cardiovascular market is evolving toward much lower dosage forms, Flamel has decided to defer development of Asacard at a 325 mg dose for that market.

On the other hand, European marketing partner G.D. Searle, a subsidiary of Monsanto, is planning to launch Asacard at 162.5 mg in Europe, following completion of a Phase IV clinical study that has just started. The product has already received marketing approval in the U.K., and the European Union¿s mutual-recognition procedure is being used to extend that to other European countries.

Drawing on the latest clinical data for Asacard, Flamel now intends to develop it for use in analgesic and anti-inflammatory applications. Phase II clinical trials of a high-dosage form are under way to test its efficacy as an analgesic with reduced gastrointestinal side effects compared to conventionally administered aspirin.

In addition to Micropump, Flamel is developing another system for delivering controlled-release drugs and proteins, called Medusa, as well as a proprietary system for the delivery of agrochemical compounds, known as Agsome. It also produces medical devices under the ColCys name and supplies photochromatic materials for eyeglass lenses to Corning.

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