TB Alliance, an international non-profit drug development organization that develops better, faster-acting, and affordable tuberculosis (TB) drugs, has announced that it is collaborating with, and has granted an exclusive license to, the Shanghai Fosun Pharmaceutical Development Co., Ltd., and its subsidiary Shenyang Hongqi Pharmaceutical Co., Ltd. (Fosun Pharma), to develop and commercialize the first-ever regimen designed to treat both drug-sensitive TB (DS-TB) and multi-drug resistant TB (MDR-TB) for use within People’s Republic of China, Taiwan, Hong Kong and Macau (Licensed Territory).
PaMZ, a novel TB drug regimen, shows the potential to be a shorter, simpler, safer and affordable treatment for both DS-TB and some forms of MDR-TB. The regimen has reached a major milestone and is now ready to enter a global Phase 3 clinical trial. Shenyang Hongqi Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Fosun Pharma, is the largest manufacturer and distributor of TB treatments in China. The collaboration, announced today at the Global Health Product Development Forum, organized by the Bill & Melinda Gates Foundation, in Seattle, Washington, is important to help expedite the final stage of clinical development and, if successful, ensure that the promising PaMZ treatment is made available in the Licensed Territory to the people who need it.
“This collaboration is emblematic of the type of innovative partnerships needed to truly advance global health technologies,” said Mel Spigelman, MD, 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.”
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, including MDR-TB, as each year, approximately one million people in the country contract the disease, with 50,000 of those cases estimated to be MDR-TB. New TB treatments are urgently needed. Currently, people with MDR-TB require a minimum of 18 to 24 months of treatment, with thousands of costly pills and daily injections for the first six months of therapy. MDR-TB treatment is cost-prohibitive for many MDR-TB patients and health systems, severely limiting the number of patients who even receive any treatment.
Under this agreement, Fosun Pharma will support research sites in the People’s Republic of China as part of the newly announced Phase 3 STAND (Shortening TB Treatment by Advancing Novel Drugs) trial and will conduct any additional studies required for regulatory approval of PaMZ in the Licensed Territory. If the regimen is successful, Fosun Pharma will commercialize the PaMZ regimen in the Licensed Territory. As part of the terms of the agreement, the company has committed to the principles of affordability and accessibility for the treatment.
“TB is a significant issue in our country and there remains a critical need for new and improved tools to overcome the disease,” said Mr. Qiyu Chen, chairman of Fosun Pharma. “We are proud to take a lead role in the fight against TB and contribute to the development of this promising new treatment.”
PaMZ consists of two new drug candidates, PA-824 and moxifloxacin, and pyrazinamide, part of the current first-line treatment. Earlier studies show PaMZ’s potential to treat both DS-TB and MDR-TB patients with the same oral therapy, and to shorten treatment, especially for those with MDR-TB. The development of PaMZ is projected to save years of time by testing new drugs simultaneously as a “drug regimen,” instead of one-by-one. In July 2012, a two-week study published in The Lancet showed that PaMZ appeared to kill patients’ bacteria more quickly than standard therapy after starting treatment.
If successful, the regimen would eliminate the need for injectable drugs and significantly reduce the cost of MDR-TB therapy, in some countries by more than 90 percent, in those patients whose TB organisms are sensitive to the three drugs. It also promises to be compatible with commonly used HIV drugs, helping the millions of people co-infected with TB/HIV.
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About Fosun Pharma
Established in 1994, Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (Fosun Pharma) is a leading healthcare company in China, which was listed on Shanghai Stock Exchange in August 1998 and on the Main Board of the Stock Exchange of Hong Kong Limited in October 2012 (stock code: 600196-SH, 02196-HK). Specializing in modern biopharmaceutical and healthcare industry, our main businesses include pharmaceutical manufacturing, pharmaceutical distribution and retail, healthcare services, medical diagnosis and medical devices. With its commitment to innovation for