AsianScientist (May 7, 2014) – Shanghai Fosun Pharmaceutical (Group) Co., Ltd. has been granted an exclusive license to develop, register, produce and market PaMZ, a novel tuberculosis (TB) drug regimen developed by TB Alliance in China. The Bill & Melinda Gates Foundation will contribute funds to continue supporting the global development and clinical research on the drug.
The Global Alliance for TB Drug Development (TB Alliance) is a not-for-profit organization dedicated to finding drug regimens to fight tuberculosis. PaMZ, on which the cooperation is centered, is a novel TB drug regimen and shows the potential to be a shorter, simpler, safer, and affordable treatment for both drug sensitive and multi-drug resistant (MDR) TB. The regimen has completed a Phase II clinical trial and is now ready to enter a global Phase III clinical trial.
Under this agreement, Fosun Pharma will support research sites in China as part of the Phase III STAND (Shortening TB Treatment by Advancing Novel Drugs) trial and will conduct any additional studies required for regulatory approval of PaMZ in China. If the regimen is successful, Fosun Pharma will commercialize the PaMZ regimen. Meanwhile, Fosun Pharma has committed to the principles of affordability and accessibility for the treatment.
According to a report from the National Health and Family Planning Commission of the People’s Republic of China, the country has the world’s second largest TB epidemic and MDR-TB posses the largest challenge. Each year, approximately one million people in the country contract the disease, with 50,000 of those cases estimated to be MDR-TB. Currently, people with MDR-TB require a minimum of 18 to 24 months of treatment, with costly pills and daily injections for the first six months of therapy. As such, new TB treatments are urgently needed.
PaMZ consists of two new drug candidates, PA-824 and moxifloxacin, and pyrazinamide, which is part of the current first-line treatment. Earlier study results show PaMZ’s potential to treat both drug sensitive and MDR-TB patients with the same oral therapy, and to dramatically shorten treatment times, especially for those patients with MDR-TB.
In July 2012, a study published in the Lancet showed that PaMZ could kill more than 99 percent of patients’ TB bacteria within two weeks. Findings from a subsequent two-month study are expected to be published later this year.
“This collaboration is emblematic of the type of innovative partnerships needed to truly advance global health technologies,” said Dr. Mel Spigelman, President and CEO of TB Alliance.
“Through this partnership, Fosun Pharma will both help support the global registration of urgently needed new tools for TB, while also retaining the benefits of a traditional product developer within their core market; this is the sort of agreement that Product Development Partnerships are able to achieve to benefit the millions of patients needlessly dying from neglected diseases of poverty such as TB.”
Source: Fosun Pharma.
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