Fosun medicine is authorized exclusively by pamz, a new tuberculosis drug in Greater China

At present, Fosun medicine has completed the second phase of clinical treatment and is ready to enter the third phase of global clinical trials According to the agreement, Fosun Pharmaceutical will support the R & D pilot of phase III trial in China and carry out all relevant research required to obtain regulatory approval from pamz If the treatment is successful, Fosun will put pamz into commercial operation in the authorized area Pamz is a composition of three active ingredients, of which PA-824 is a nitroimidazolium pyran derivative (nature 2000, 405, 962-966) reported in 2000 Moxifloxacin and pyrazinamide are both old drugs Phase II clinical trial (Lancet 2012, 380, 986-993.) compared bedaquiline (n = 15), bedaquiline + pyrazinamide (n = 15), PA-824 + pyrazinamide (n = 15), bedaquiline + PA-824 (n = 15), pamz (PA-824 + moxifloxacin + pyrazinamide, n = 15), riffour e-275 (rifampin + isoniazid + pyrazinamide + ethambutol, n = 10) The figure shows the decline curve of the average log 10 CFU (CFU = colony forming unit) Pamz is superior to rifafour e-275 In pamz group, one patient was stopped because of QT interval extension, but not in other groups; another patient was stopped because of ALT elevation, two patients in bedaquiline + PA-824 group had ALT elevation, one patient in PA-824 + pyrazinamide group had ALT elevation, and no ALT elevation was found in the group without PA-824, which may mean that PA-824 has damage to liver At present, the first-line treatment plan for tuberculosis is to take rifampin + isoniazid + pyrazinamide + ethambutol for 2 months, and then continue to take rifampin + isoniazid for 4 months 95% of the patients recovered after 6 months of treatment However, 5% of patients will be resistant to rifampin and isoniazid At this time, they need to use other drugs, and the cure rate is only 50-70% Pamz has a short treatment cycle, and does not contain rifampicin and isoniazid It is effective for drug sensitive and multi drug resistant tuberculosis However, PA-824 and moxifloxacin may cause arrhythmia, and PA-824 may also have a lot of hepatotoxicity At present, only two weeks' data are published, and the longer-term safety remains to be studied TB alliance is carrying out a phase II trial (nct01498419) for 8 weeks This batch of data should be able to complete the conceptual verification Fosun needs to carry out a phase III stand (shortening TB treatment by promoting new drugs) trial in China, proving that pamz can replace the existing treatment and shorten the treatment course Tuberculosis is a fatal infectious disease China has implemented the policy of free treatment In 1990, the number of deaths was 169000, and in 2010, it had been reduced to 44700 The research and development of new drugs for tuberculosis is very cold On the one hand, old drugs are too cheap to be cheaper On the other hand, it is difficult to prove that new drugs have better curative effect It is unrealistic to expect to generate a large amount of profits on pamz Even if the phase III trial proves that pamz can shorten the treatment course, it is difficult to compare the safety with the old drug that has been used for decades The biggest possibility is that as a second-line drug, the country is not willing to increase unnecessary expenditure on tuberculosis The price is not allowed to be too high, only a good charity Tuberculosis drugs have not been updated for decades New drugs are life-saving drugs for a few patients News extension: the global TB Alliance announced on April 23 that based on the positive data of early research, it will promote the new TB treatment program pamz to the milestone phase III clinical in the world The announcement was announced by Bill Gates, co-founder of Microsoft and co chairman of the Bill & Melinda Gates Foundation Pamz is composed of a new TB drug, PA-824, moxifloxacin and pyrazinamide The aim of this therapy is to shorten and simplify the treatment of drug-sensitive and drug-resistant TB Early stage studies have shown that pamz regimens have shorter cure times, are simpler, safer, and are cheaper than current MDR-TB drugs The global alliance for TB drug research and development predicts that the pamz program is expected to significantly shorten the time to cure MDR-TB, from two years to just six months Meanwhile, it will eliminate the use of injection and reduce the cost of MDR-TB treatment by up to 90% In addition, the pamz program is expected to be compatible with commonly used HIV drugs and help millions of TB / HIV co infected people Mel spigelman, President and CEO of TB alliance, pointed out that TB patients, especially drug-resistant TB patients, urgently need a treatment scheme without injection, less medication, less toxicity, simpler administration and much lower cost The phase III stand study will be conducted in 50 research sites across Africa, Asia, Eastern Europe and Latin America to test the new three in one program pamz as a shorter, simpler and safer treatment for drug sensitive and drug-resistant tuberculosis A phase II study published in the lancet in July 2012 showed that the pamz regimen could kill more than 99% of TB in patients within two weeks Early studies of the pamz programme were provided by the bill and Melinda Gates Foundation (bmgf), DFID, DFAT, USAID, Irish aid and DGIS Globally, tuberculosis is the second largest adult killer after AIDS, with nearly 2 million deaths each year New Tuberculosis Drug Regimen Will Move to Landmark Phase 3 Trial APRIL 28, 2014 Based on positive results from earlier clinical studies, TB Alliance is advancing the first-ever drug regimen designed to treat both drug-sensitive and some forms of multi-drug resistant tuberculosis (TB) to a global Phase 3 clinical trial The landmark trial, funded by the Bill & Melinda Gates Foundation, will determine the safety and efficacy of the new drug regimen, which is known as PaMZ Bill Gates called on other organizations to support the effort to develop new treatments for TB, a disease that kills an estimated 1.3 million people annually and remains a leading cause of death globally, especially among people who are co-infected with HIV “The results from early phase research suggest that this new drug regimen could provide the breakthrough we need to accelerate progress against this deadly and dangerous disease, ” said Mr Gates “PaMZ could dramatically reduce the time required to cure drug-resistant TB from two years to just six months, and it could cut the cost of curing drug-resistant TB in low-income countries from thousands of dollars to just a fraction of that cost Now we need funders to step forward to make next-generation TB drugs like PaMZ a reality.” 18-24 Months for Traditional MDR-TB Treatments Limitations in standard treatment for TB remain a strong barrier to TB control The treatment and cure of a typical case of drug-sensitive TB currently takes between six and nine months and the drug therapy is long, complicated, and can cause severe side effects Currently, people with drug-resistant TB require a minimum of 18 to 24 months of treatment This more extensive therapy requires more than 12,000 pills and daily injections for at least 6 months The long duration of MDR-TB treatment, combined with the pain and side effects that treatment causes, help to explain why only just over half (53 percent) of patients who currently enter therapy for MDR-TB complete their full course of medicines STAND – Shortening Treatments by Advancing Novel Drugs The PaMZ regimen shows promise to significantly shorten therapy, particularly for some forms of MDR-TB It will be tested in a Phase 3 clinical trial named STAND (Shortening Treatments by Advancing Novel Drugs) If successful, the regimen would eliminate the need for injectable drugs and 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 “TB patients, especially those with drug-resistant TB, urgently need cures  that eliminate the need for injectable therapies, require taking fewer pills for a shorter period of time, are less toxic, simpler to administer and cost much less money,” said Dr Mel Spigelman, president and CEO of TB Alliance, an international non-profit working to develop improved TB treatments “The STAND trial brings us closer to an era of high-impact drug regimens instead of where we are today, relying on the relics of the mid-20th century.” Novel Three-Drug Regimen The STAND trial will span some 50 study sites across Africa, Asia, Eastern Europe and Latin America It will test the novel three-drug regimen PaMZ as a shorter, simpler and safer treatment for drug-sensitive and drug-resistant TB The development of the PaMZ regimen is projected to save years of time by having tested new drugs simultaneously as a “drug regimen” instead of one-by-one PaMZ is a three-drug regimen comprised of two candidate drugs that are not yet licensed for use against TB: PA-824 (Pa) and moxifloxacin (M), and one existing antibiotic used in TB treatment today, pyrazinamide (Z) Earlier study results show PaMZ’s potential to treat both drug-sensitive and drug-resistant patients with the same oral therapy, and to dramatically shorten treatment times for some patients In July 2012, a two-week study published in The Lancet showed that PaMZ appeared to kill the patients’ bacteria more quickly than standard therapy after starting treatment Findings from a subsequent two-month study are expected to be published later this year Support for earlier research of the PaMZ regimen was provided by the Bill & Melinda Gates Foundation (BMGF), the United Kingdom Department for International Development (DFID), the Australia Department for Foreign Affairs (DFAT), US Agency for International Development (USAID), Irish Aid, and the Directorate-General for International Cooperation (DGIS) While the TB Alliance hopes to launch the STAND trial by the end of this year, Spigelman noted the date will be subject to obtaining adequate funding commitments “We thank all our supporters to date, as without their investment, the highly promising PaMZ regimen would not have reached this critical stage,” said Spigelman “We need new and expanded commitments for the STAND trial, however, if we are to realize the significant potential of this treat