Pafuramidine

From WikiCover

Pafuramidine maleate is for pneumocystis pneumonia in AIDS patients.

In June 2007, Par Pharmaceutical entered into an exclusive licensing agreement under which Par received commercialization rights in the U.S. to Immtech Pharmaceuticals' Phase III lead oral drug candidate, pafuramidine maleate, for the treatment of pneumocystis pneumonia in AIDS patients.

Earlier this week, Immtech Pharmaceuticals, Inc. announced that after discussion with the U.S. Food and Drug Administration (FDA), the pafuramidine program has been placed on clinical hold. In preliminary findings from an in- progress safety study at a South African site, abnormal laboratory values were found in several volunteers following treatment with pafuramidine.

In this South African safety study volunteers were dosed with pafuramidine 100 mg or placebo twice daily for 14 days. The subjects are undergoing close monitoring for any changes in the status of their liver function. No subject has required any treatment or hospitalization for the abnormalities to date. This evaluation will continue until patients stabilize or return to baseline status. At that time, Immtech and the independent experts in liver toxicity will prepare a summary of the available safety data and recommendations for presentation to the FDA. The clinical hold may be released after FDA has received satisfactory data regarding the safety of pafuramidine.

In return for the commercialization rights to pafuramidine, Par paid Immtech an initial payment of $3 million, which Par incurred as Research & Development (R&D) expense in 2007. Should pafuramidine advance through its ongoing Phase III clinical trials and U.S. regulatory review and approval, Par will pay Immtech up to $29 million in development milestones.