Lupin, TB Alliance join hands for new therapy for drug-resistant Tuberculosis

INDIA – Non-profit drug developer TB Alliance has granted Lupin Pharmaceuticals a non-exclusive license to manufacture anti-TB drug pretomanid as part of the three-drug BPaL regimen.

The Mumbai-based company said it intends to commercialise the medicine in around 140 countries and territories, including many of the highest TB burden nations around the world.

“As a global leader in anti-TB medicines, Lupin is committed to enhancing access to bridge unmet needs in countries where it is needed the most. This collaboration with TB Alliance leverages our strength and expertise to contribute to better global health,” Lupin Managing Director Nilesh Gupta said in a statement.

TB Alliance President and CEO Mel Spigelman said that partnering with Lupin, a well-established manufacturer with experience delivering high-quality TB therapies, will help further enable widespread access to the novel regimen while promoting a competitive market to drive affordability.

Tuberculosis is one of humanity’s oldest, deadliest, and most persistent diseases. The BPaL regimen offers the TB community the first all-oral, six-month treatment for highly resistant forms of drug resistant-TB.

Worldwide, TB is one of the top 10 causes of death and the leading cause from a single infectious agent (above HIV/AIDS), according to data by WHO.

In 2019, an estimated 10 million people fell ill with tuberculosis (TB) worldwide. 5.6 million men, 3.2 million women and 1.2 million children. TB is present in all countries and age groups.

Of the estimated 480,000 cases of multidrug-resistant (MDR) TB, approximately 10% are either extensively drug-resistant (XDR)—with additional resistance to second-line drugs—or totally drug resistant.

While TB is curable when patients adhere to the treatment regimen, MDR- and XDR-TB are more problematic. Lupin is the largest supplier of first-line anti-TB drugs in the world, the drug maker stated.

This is a worthwhile investment for Lupin, as the global tuberculosis drugs/therapeutics (TB) market size is expected to reach US$1.38 billion by 2025, according to a new report by Grand View Research, Inc., registering a CAGR of 5.2% during the forecast period.

High incidence of drug susceptible (DS) tuberculosis (TB), rise in multi-drug resistant (MDR) TB cases, and increase in R&D efforts toward drug development are some of the factors anticipated to fuel market growth.

Globally, low patient adherence to medication remains a concern underlying the occurrence of MDR TB, with few effective drug alternatives in the market.

This wave of antimicrobial drug resistance in Mycobacterium TB strains has prompted a worldwide initiative through WHO-led programs such as Directly Observed Therapy (DOT).

Moreover, collaborations among international organizations, such as Unitaid, WHO, UNICEF, and TB Alliance focused on development of shorter treatment regimens to fight drug resistance is addressing unmet medical needs, is expected to drive market growth.