PARIS - Flamel Technologies SA has completed the first clinical trial of its controlled-release formulation of human insulin, LABI, for the treatment of Type I and Type II diabetes.

LABI (for long-acting Basulin insulin) is delivered using Flamel's proprietary Medusa system, and the results of the trial have effectively confirmed the validity of the technology. The double-blind Phase I/II clinical trial was carried out in the UK and provided proof of principle of LABI through a 24-hour study on healthy volunteers comparing it with NPH, Novo Nordisk's own prolonged-action insulin.

A few days after the clinical trial started on Dec. 8, Lyon-based Flamel signed a development and licensing agreement covering LABI (then called Basulin) with the Danish pharmaceutical company Novo Nordisk, a world leader in insulin-based products. Under this deal, which could be worth up to $42 million to Flamel, Novo Nordisk has a worldwide exclusive license for developing and commercializing LABI and is financing all further development work carried out by Flamel, including the clinical trials needed to file the product for regulatory approval. For its part, Flamel has undertaken to sell Novo Nordisk the Medusa polymer required for the manufacture of LABI.

The results of this first trial will enable the two companies to produce an optimal formulation of LABI. As Flamel's CEO, Girard Soula, pointed out, Flamel is cooperating with Novo Nordisk "on programs aimed at optimizing the polymer and the formulation before embarking on new clinical trials focusing on this new generation of prolonged-action insulin." He told BioWorld International that a further round of Phase II trials was planned to test the product on patients actually suffering from diabetes, but declined to say when those trials would begin. He similarly declined to confirm or deny analysts' assessments that the product could be on the market by 2004.

Medusa is one of two controlled-release drug delivery systems patented by Flamel, the other being Micropump. Both systems are designed specifically for the delivery of peptides and proteins and incorporate the company's advanced polymer technologies. In addition, Flamel has developed an agrochemical delivery system (Agsome) using these materials, and also produces biomaterials for biomedical devices (under the ColCys name) and photochromic materials for organic ophthalmic lenses (in conjunction with Corning).

Flamel plans to use the Medusa system for delivering other proteins for which the high frequency of injections currently poses a major problem of patient comfort. Soula said research had started on applying the system for the controlled-release administration of alpha interferon and an oral insulin.

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