BioWorld International Correspondent

LONDON - CeNeS Pharmaceuticals plc and Elan Corporation plc, of Dublin, will form a new company to develop pain control products based on CeNeS's M6G morphine metabolite and Elan's MediPad subcutaneous drug delivery system. Elan is to loan Cambridge-based CeNeS $18.5 million to fund the venture, and will invest £4.2 million in CeNeS once the deal is approved, followed by a further £1.4 million on achievement of an agreed clinical milestone.

Neil Clark, CeNeS finance director, told BioWorld International, "This deal, along with Elan"s direct investment [in CeNeS], is a strong tie-up. We have a lot of synergy with Elan, and they will appoint a non-executive director to our board, which we believe will be important in terms of wider contacts."

The new venture will have a budget of $6 million over the next two years to develop a product based on CeNeS's morphine-6-glucuronide (M6G) painkiller and Elan"s MediPad subcutaneous delivery system, which is worn like a transdermal patch. "This will be aimed at pain control generally, but in the first case will be developed for cancer pain," Clark said. "We believe a product could be launched in 2005. Obviously, we need a significant budget to get to that point, but the two-year first phase should enable us to reach the end of Phase II."

The venture will be 80 percent owned by CeNeS and will operate as a CeNeS subsidiary. CeNeS will grant it an exclusive license to certain M6G rights, while Elan will grant exclusive rights to MediPad with M6G, in return for a license payment of $15 million. CeNeS will fund the venture through two convertible loans from Elan, one for $12 million, the second for $6.4 million. The new venture must be approved by CeNeS shareholders at an extraordinary general meeting set for June 25.

Morphine is broken down to two metabolites in the body: M6G, which is responsible for pain relief, and M4G, which causes nausea, and is linked to the drug's addictive effects. In January, CeNeS published Phase II data in more than 140 post-operative pain patients showing that while M6G had an equivalent analgesic effect, the incidence of nausea and vomiting was reduced by more than 50 percent.

CeNeS is now conducting a trial to compare M6G with morphine for pain relief after hip replacement surgery.

As a natural metabolite, there is a lower risk of M6G failing in development. The compound itself is not patentable, but CeNeS has a patent on the manufacturing process.