BioWorld International Correspondent

Addex Pharmaceuticals SA entered a pact with UK clinical development services outfit Fulcrum Pharma plc that goes well beyond the usual conditions that define such relationships.

During the three-year term of the agreement, Fulcrum will help to build Addex's internal clinical development resource and gradually will work its way out of a job. In addition to receiving fees for the services it will provide, Fulcrum has undertaken to participate in Addex's forthcoming second financing round.

"There is a mechanism in place, which guarantees this is more than a fee-for-service relationship," Addex's CEO and head of research and development, Vincent Mutel, told BioWorld International. Fulcrum's compensation will be based on progress through a defined set of milestones, and an explicit part of its job will be to transfer clinical development knowledge into Addex, of Geneva.

"It's a transition, having their expertise at the beginning gradually being replaced by our expertise," Mutel said. At present, Addex does not have internal toxicology, regulatory or chemistry, manufacturing and controls capabilities.

Addex was formed in May 2002 as a spin-out of a scientific project from London-based GlaxoSmithKline plc, and raised CHF15.75 million (US$12.5 million) in first-round financing shortly afterward. It has had a relationship with Cambridge-based Fulcrum for the past year, during which the latter firm has become acquainted with Addex's pipeline, a factor, Mutel said, that influenced its decision to become an investor as well as a partner. (See BioWorld International, July 17, 2002.)

The company is seeking €25 million to €30 million in a Series B round. "We are in the middle of that process," Mutel said.

Addex's lead compound, ADX-10061, is about to enter a Phase II trial in the U.S. in the first quarter of the new year for treatment of nicotine dependence. The study is expected to involve 120 participants. Addex originally licensed the compound, a selective antagonist of dopamine D1 receptors previously called CEE 03-310, from CeNeS Pharmaceuticals plc, of Cambridge, UK. The company also is negotiating terms with a U.S. firm for a second in-licensing deal. That involves an enzymatic inhibitor, which also would be developed for treatment of addiction. Its internal pipeline is at an earlier stage of development.