BioAlliance Pharma SA said it has entered into an exclusive licensing agreement with Immtech Pharmaceuticals Inc. covering the European commercialisation rights to pafuramidine maleate.
This patented, orally administered new chemical entity is currently in phase III clinical trials in the USA for two indications: the treatment of Pneumocystis Pneumonia (PCP) in AIDS patients and human African trypanosomiasis (also known as sleeping sickness). Pafuramidine has orphan designation in the United States. BioAlliance has also negotiated the grant of an option to sell pafuramidine in Europe for the prevention and treatment of malaria in travellers.
In return, Immtech will receive an initial license fee of $3 million and up to an additional $13 million if pafuramidine achieves European regulatory approval and pricing milestones. Immtech will receive significant royalties on sales and may also earn two additional milestone payments linked to the turnover generated. Furthermore, if BioAlliance elects to exercise the option to commercialise pafuramidine for malaria prophylaxis, it will start to share the clinical development costs for a phase III trial which is due to start shortly. Marketing approval in malaria will trigger the payment of additional regulatory, pricing and sales milestones to Immtech, plus royalties on sales.
Dominique Costantini, chief executive officer, BioAlliance, said, "We are very keen to gain access to pafuramidine and work closely with Immtech in order to make a significant impact on PCP, a very serious disease. She added that "We are pursuing the European growth strategy presented at the time of our fund raising by private placement in July, with the acquisition of late-stage development products such as pafuramidine. The compound displays particularly valuable activity in resistant strains and constitutes our first strategic acquisition - one that fits perfectly with our existing portfolio of Loramyc, Doxorubicin Transdrug, and Acyclovir Lauriad, since all these products are either already approved for marketing or in phase III trials in oncology or infectious diseases".
PCP is a deadly fungal infection of the lungs and is the most common opportunistic infection in people living with HIV (the virus that causes AIDS). The pathogen also affects people whose immune system has been severely compromised by cancer chemotherapy or immunosuppressive therapy following organ transplantation.
"We are delighted to be collaborating with BioAlliance on launching pafuramidine in Europe" said Eric L. Sorkin, CEO and chairman, Immtech Pharmaceutical Inc. "With the recent European launch of Loramyc, in HIV or cancer patients, BioAlliance has demonstrated its development expertise and marketing capabilities in this market. The company's understanding of both patients and healthcare providers will be key to the success of pafuramidine".
Current treatment options for PCP include trimethoprim-sulfamethoxazole, primaquine plus clindamycin, trimetrexate (with or without dapsone) plus leucovirin, atovaquone and pentamidine. The risk of adverse events associated with the currently available treatment options for PCP requires between 20-57 per cent of all patients to be switched to better tolerated regimens during their course of care.
The development of pafuramidine for the treatment of PCP was funded in part by a National Cooperative Drug Discovery Groups grant from the National Institutes of Health, Department of Health and Human Services, to the University of North Carolina at Chapel Hill. Pafuramidine was initially synthesized at Georgia State University, a member of Immtech's Scientific Consortium.
BioAlliance Pharma SA is a specialty pharmaceutical company focused on the treatment of opportunistic infections in cancer and HIV. The company has launched its first portfolio product (Loramyc) in France and the compound is currently in phase III clinical development in oropharyngeal candidiasis in the USA.
Immtech Pharmaceuticals, Inc. is focused on developing and commercialising drugs to treat infectious diseases. Immtech has advanced clinical programs that include new oral treatments for Pneumocystis pneumonia (PCP), malaria and trypanosomiasis (African sleeping sickness) and has developed a well-defined, expanding library of compounds targeting hepatitis C, fungal infections and bacterial infections.