Pafuramidine on Clinical Hold
Loramyc(R) Completes Patient Enrollment Ahead of Schedule
Zensana(TM) Reformulation Complete, Resubmission on Target
WOODCLIFF LAKE, N.J., Dec. 28 /PRNewswire-FirstCall/ -- Par Pharmaceutical Companies, Inc. (NYSE: PRX) today provided an update on the development status of its three, in-licensed, proprietary pipeline products: pafuramidine, Loramyc(R) (miconazole Lauriad(R)), and Zensana(TM) (ondansetron). These three products represent the current product pipeline of Strativa Pharmaceuticals, Par's proprietary products division.
Pafuramidine maleate for pneumocystis pneumonia (PCP) in AIDS patients:
In June 2007, Par Pharmaceutical, Inc. 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 (PCP) 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
|SOURCE Par Pharmaceutical Companies, Inc.|
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