PARIS ¿ Flamel Technologies and the Danish pharmaceutical company Novo Nordisk signed a development and licensing agreement covering Flamel¿s diabetic treatment Basulin, a controlled-release formulation of insulin for treating Type I and II diabetes.

The agreement gives Novo Nordisk, of Copenhagen, a worldwide exclusive license for developing and commercializing Basulin. In exchange, Lyon, France-based Flamel is receiving an up-front payment of US$5 million, of which $1 million was disbursed at the beginning of December. In the event that Basulin is successfully brought to market, Novo Nordisk could pay Flamel up to $37 million more in milestone payments, as well as royalties on sales of the product.

In addition, Novo Nordisk, a world leader in insulin-based products, will finance all further research and development work carried out by Flamel as well as the clinical trials needed for regulatory approval. The contract also provides for Flamel to sell Novo Nordisk its proprietary Medusa polymer, required for the manufacture of the product.

Flamel¿s chairman, Girard Soula, told BioWorld International that it would take a further four or five years to complete the development and testing of Basulin, and that the aim was to have the product on the market by 2004. Preclinical studies established that Basulin¿s effect lasted twice as long as that of other products on the market (24 hours as opposed to 12 hours). ¿Basulin not only offers the convenience of once-a-day administration, but could also improve the control of glucose levels and thus reduce the long-term complications often associated with diabetes,¿ Flamel¿s medical director, Philippe Vivet, pointed out.

Phase I clinical studies of the product are already under way in the United Kingdom and the first results are expected in the first quarter of 2000. According to Soula, further Phase I tests could be conducted elsewhere. Novo Nordisk will decide where Phase II and III trials are carried out, but Soula stressed that they would be on an international level.

Medusa is the name of one of two controlled-release drug delivery systems patented by Flamel, the other being Micropump. Both systems are specifically designed for the delivery of peptides and proteins, and incorporate advanced polymer technologies developed by Flamel. In addition to Micropump and Medusa, the company 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).