TB Alliance and Mylan Announce Global Collaboration

Saturday, April 20, 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.

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.

"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."

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