BioWorld International Correspondent

PARIS - BioAlliance Pharma SA and Immtech Pharmaceuticals Inc. signed an exclusive licensing agreement granting the French company European commercialization rights to pafuramidine maleate.

Immtech Pharmaceuticals, of New York, is developing this orally administered drug for the treatment of pneumocystis pneumonia (PCP) in AIDS patients and human African trypanosomiasis, also known as African sleeping sickness, and the drug is currently in Phase III clinical trials in the U.S. in both indications. In addition to those two indications, Paris-based BioAlliance Pharma has an option to market pafuramidine in Europe for the prevention and treatment of malaria in travelers.

Under the agreement, Immtech is to receive an initial license fee of $3 million and stands to earn a further $13 million in milestone payments if pafuramidine obtains regulatory approval in Europe. In addition, the U.S. company will receive "significant" royalties on sales and also may earn two additional milestone payments linked to the value of sales.

Furthermore, if BioAlliance elects to exercise its option to commercialize pafuramidine for malaria prophylaxis, the French company will start to share the clinical development costs of a Phase III trial that is due to start shortly.

Marketing approval in malaria will trigger the payment of additional regulatory and sales-related milestones to Immtech, plus royalties on sales.

Pointing out that the deal marks another step in BioAlliance's strategy of in-licensing "advanced products to complement our own portfolio," the CEO of BioAlliance Pharma, Dominique Costantini, said that "pafuramidine, with its attractive activity on resistant strains, is the first strategic product that perfectly complements our portfolio of products to treat cancer and AIDS patients."

Pafuramidine has been granted orphan drug designation in the U.S. for the treatment of PCP, a deadly fungal infection of the lungs that is the most common opportunistic infection in people living with HIV. It also affects people with severely compromised immune systems due to cancer or immunosuppressive therapy.

Currently available treatments for PCP are not very satisfactory, according to Immtech, since adverse events associated with them result in 20 percent to 57 percent of patients being switched to alternative therapies.