Immtech Pharmaceuticals has announced that the Company has granted an exclusive license to BioAlliance Pharma SA to commercialize Immtech's oral drug, pafuramidine maleate (pafuramidine), in Europe for the treatment of pneumocystis pneumonia (PCP) in AIDS patients and for the treatment of Human African trypanosomiasis, also known as African sleeping sickness.
Pafuramidine is currently in Phase III clinical trials for these two indications. Immtech also granted to BioAlliance an option to commercialize pafuramidine in Europe for prevention and treatment of malaria in travelers.
Pursuant to the agreement, Immtech will receive an initial payment of $3 million from BioAlliance. An additional $13 million will be paid to Immtech as pafuramidine advances through European regulatory approval and pricing. Immtech will also receive additional payments based on sales milestones and significant double-digit royalties on sales. BioAlliance has an option to commercialize pafuramidine for malaria prophylaxis in Europe, and BioAlliance would contribute to funding clinical development costs. Additional regulatory, pricing, and sales milestone payments to Immtech and royalty payments based on sales would also be paid by BioAlliance.
"We are delighted to be collaborating with BioAlliance to launch pafuramidine in Europe," said Eric L. Sorkin, Chairman and Chief Executive Officer of Immtech. "BioAlliance's development and marketing expertise, as evidenced by the recent launch of Loramyc(R) in Europe for the treatment of HIV and cancer, demonstrate BioAlliance's proven capabilities in this market. We believe BioAlliance's valuable experience in working with patients and healthcare providers will be a vital asset supporting the success of pafuramidine in Europe."
PCP is a deadly fungal infection of the lungs and the most common opportunistic infection in people living with HIV, the virus that causes AIDS. It also affects people with severely compromised immune systems due to cancer or immunosuppressive therapy (e.g., chemotherapy or following organ transplantation).
Dominique Costantini, Chief Executive Officer of BioAlliance, said, "We are excited to be teaming up with Immtech and we will work together to have a significant impact on PCP, a devastating disease. As represented to our investors last July, we are adding advanced products to complement our own portfolio. Considering the franchise we are building in products to treat cancer and AIDS patients, pafuramidine, with its attractive activity on resistant strains, is the first ideal strategic product complementing perfectly our portfolio: Loramyc, doxorubicin Transdrug and acyclovir Lauriad, all of which are either already approved or in phase 3 for oncology or infectious disease indications."
Current treatment options for PCP include Trimethoprim-sulfamethoxazole (TMP-SMX), primaquine plus clindamycin, trimetrexate (with or without dapsone) plus leucovorin, atovaquone, and pentamidine. The adverse events associated with currently available treatment options for PCP leads to between 20-57% of all patients being switched to better tolerated regimens during their course of care.
The development of pafuramidine for the treatment of PCP was sponsored in part by a National Cooperative Drug Discovery Groups grant from the National Institutes of Health, U.S. Department of Health and Human Services, to the University of North Carolina at Chapel Hill. Pafuramidine was initially synthesized at Georgia State University, which is a member of Immtech's Scientific Consortium.