BioAlliance Pharma SA has confirmed that it will pursue its advanced compound acquisition strategy for European oncology and HIV markets, despite Immtech Pharmaceuticals Inc.’s recently announced discontinuation of its pafuramidine programme.
On Friday February 22, Immtech Pharmaceuticals Inc. informed BioAlliance that the US company “will focus on its novel anti-infectives. It will discontinue all Phase III programs concerning its novel chemical entity, pafuramidine (an investigational therapy for Pneumocystis pneumonia (PCP) in HIV patients and for African sleeping sickness)”.
The decision was made in response to recent reports related to unexpected adverse events (related to liver abnormalities) identified in volunteers in a December 2007 safety study involving the drug in South Africa. This prompted imposition of a clinical hold by the FDA in late December.
In February, Immtech received information on additional events related to abnormal kidney function during the follow-up of the volunteers in the same safety study. The cause of the liver and kidney toxicity has not yet been fully clarified but the decision to discontinue the pafuramidine development programme was taken by Immtech and the independent Data Safety Monitoring Board following a risk-benefit analysis of the compound.
BioAlliance Pharma, based in Paris, signed an exclusive licensing agreement with Immtech Pharmaceuticals for the European sales rights to the new chemical entity pafuramidine on December 5, 2007. The financial exposure on this Phase III product is limited to the $3 million paid on signature of the agreement.
Dominique Costantini, the company’s president and CEO, said:
“Pafuramidine’s Phase II results were promising and did not raise any particular safety concerns; we were thus hopeful that this compound would successfully complete is pivotal Phase III clinical trial in patients with PCP.
“BioAlliance Pharma will actively pursue its product acquisition strategy in order to add complementary compounds to its own portfolio. We are seeking products for treating chemotherapy complications or rare diseases in oncology or HIV, for example.”