TB Alliance and Mylan Announce Global Collaboration to Commercialize Investigational Drug Pretomanid as Part of Two Regimens to Treat Tuberculosis (TB)
TB is a global epidemic responsible for 1.6 million deaths in 2017(1)Regimens under clinical development include treatment options for drug-resistant forms of TB
NEW YORK and HERTFORDSHIRE, England and PITTSBURGH, April 18, 2019? Non-profit drug developer, TB Alliance, and pharmaceutical company, Mylan N.V.(NASDAQ: MYL), today announced a global collaboration to make the experimental drug pretomanid accessible for use in two investigational drug regimens for pulmonary tuberculosis (TB).
TB, a bacterial infection transmitted through the air, is a challenging disease to treat, often requiring treatment through a combination of antibiotics. It also is the leading cause of death among people with HIV/AIDS2?and accounts for more than 1 in 4 fatalities from antimicrobial resistance annually.3?TB occurs in every part of the world. In 2017, the largest number of new TB cases occurred in the?Southeast Asia?and?Western Pacific?regions, followed by the African region. There is a growing resistance to available drugs, which means the disease is becoming deadlier and more difficult to treat. There were 558,000 cases of drug resistant TB in 2017.1
Multidrug resistant- (MDR) and extensively drug resistant- (XDR) TB are forms of the disease caused by bacteria that do not respond to first-line anti-TB drugs. Current treatments, therefore, consist of combinations of many different drugs, which may need to be taken for up to two years. Patients may take as many as 20 pills a day, resulting in numerous side-effects and often creating a significant economic burden.4?Drug sensitive- (DS) TB treatment, which consists of treatment with up to four drugs daily for six to nine months, has traditionally fared better with a global treatment success rate of approximately 82%; however, rising rates of resistance are complicating treatment and necessitating different options.1
"The TB drug pipeline is showing significant promise as we progress in our goal to provide transformative benefit to people with TB," said?Mel Spigelman, President and CEO of?TB Alliance. "We are determined to take steps now to ensure that pretomanid, if approved, will be able to reach patients in need as part of an appropriate treatment regimen."
Mylan CEO?Heather Bresch?added, "For more than a decade, Mylan has led the charge in accelerating access to high quality and affordable antiretrovirals for people living with HIV all over the world. We look forward to collaborating with?TB Alliance?to bring that same level of commitment and innovation to the millions of people suffering from tuberculosis, many of whom also have HIV. The drug regimens under development represent an important step in transforming the TB treatment landscape."
Advancing Treatment for Patients
Pretomanid is a new chemical entity and a member of a class of compounds known as nitroimidazooxazines.?TB Alliance?began preclinical development of pretomanid in 2002, and it has since studied pretomanid in 20 clinical trials alone or in combination with other anti-TB drugs. Pretomanid has been administered in a clinical trial setting to more than 1,200 people in 14 countries.
The two pretomanid-based regimens under development include:
- For XDR-TB and MDR-TB that is treatment-intolerant or non-responsive: All oral, six- to nine-month treatment regimen consisting of bedaquiline, pretomanid and linezolid ("BPaL" regimen)
- For DS-TB and MDR-TB: All oral, four- and six-month treatments, respectively, consisting of bedaquiline, pretomanid, moxifloxacin and pyrazinamide ("BPaMZ" regimen)
- As part of the BPaL regimen,?TB Alliance?has granted a license to Mylan to manufacture and commercialize pretomanid, pending regulatory approval, for XDR-TB and treatment-intolerant or non-responsive MDR-TB. The BPaL regimen includes bedaquiline, which is exclusively manufactured and marketed by the Janssen Pharmaceutical Companies of?Johnson & Johnson?(Janssen) outside of DS-TB, and linezolid, which is available from multiple manufacturers, including Mylan. A New Drug Application for pretomanid as part of the BPaL regimen is currently under Priority Review by the?U.S. Food and Drug Administration.7?In addition, a marketing authorization application for pretomanid as part of the BPaL regimen is under review by the?European Medicines Agency. Janssen will retain the exclusive rights to market bedaquiline including as part of any combination therapy for the treatment of MDR-TB for the term of its patents.
- As part of the BPaMZ regimen,?TB Alliance?has licensed pretomanid to Mylan for DS- and MDR-TB, and has granted a sublicense for bedaquiline to Mylan, for its development and commercialization for use in DS-TB only, under its license agreement with?Janssen Pharmaceutica N.V., one of the Janssen Pharmaceutical Companies of?Johnson & Johnson. Janssen has granted its consent to this sublicense. If the BPaMZ regimen is proven successful in the SimpliciTB trial, Mylan will seek regulatory approval of pretomanid as part of the BPaMZ regimen in DS-TB and MDR-TB as well as bedaquiline as part of the regimen in DS-TB. As with the BPaL regimen, Janssen will retain the exclusive rights to market bedaquiline as part of the combination therapy for the treatment of MDR-TB for the term of its patents.