fosun pharma granted exclusive license by tb alliance for tb cure
23 april 2014, shanghai fosun pharmaceutical (group) co., ltd. ("fosun pharma" or the “company”; stock code: 600196-sh, 02196-hk), a leading healthcare company in the prc announces that the company has reached an agreement with tb alliance after one year of negotiation and has been granted an exclusive license to develop, register, produce and market pamz, a novel tb drug regimen developed by tb alliance in china (including hong kong, macau and taiwan area) (licensed territory). 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 ds-tb and mdr-tb. the regimen has completed phase 2 clinical trial and is now ready to enter a global phase 3 clinical trial.
pursuant to the agreement, fosun pharma’s shanghai fosun pharmaceutical industrial development company limited and shenyang hongqi pharmaceuticals co., ltd. will carry out the development, registration, production and marketing of the drug in china. as a wholly-owned subsidiary of fosun pharma, shenyang hongqi pharmaceuticals co., ltd. operates the largest tb drug r&d and manufacturing base in china and is the only producer of 3 kinds of independently developed group 1 anti-tb fdc (ethambutol hydrochloride, pyrazinamide, rifampicin and isoniazid tablets; ethambutol hydrochloride, rifampicin and isoniazid tablets; rifampicin and isoniazid tablets) available in china. it is also a drafter of quality standards and owns proprietary intellectual property rights.
under this agreement, fosun pharma will support research sites in 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. meanwhile, fosun pharma 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.”
“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 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 thousands of costly pills and daily injections for the first 6 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 ds-tb 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.
if successful, the regimen would eliminate the need for injectable drugs and significantly reduce the cost of mdr-tb therapy. 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 good health , fosun pharma aims to become the first-tier enterprise in the global mainstream pharmaceutical and healthcare market. shenyang hongqi pharmaceuticals co. ltd., a wholly-owned subsidiary of fosun pharma, has been the largest manufacturer and distributor of tb treatments for over 30 years in china. for more information on fosun pharma, please visit www.fosunpharma.com .
about tb alliance
the global alliance for tb drug development (tb alliance) is a not-for-profit organization dedicated to finding faster-acting and affordable drug regimens to fight tuberculosis. through innovative science and with partners around the globe, we aim to ensure equitable access to faster, better tb cures that will advance global health and prosperity. tb alliance operates with the support of the bill & melinda gates foundation, aids clinical trial group, uk aid, irish aid, unitaid, the united states agency for international development (usaid), australian department of foreign affairs and trade (dfat), european commission, global health innovative technology (ghit) fund, national institute of allergy and infectious diseases (niaid), and the united states food and drug administration (fda). for more information on tb drug development and tb alliance, please visit www.tballiance.org.