New Delhi: A molecule developed fully in India, enmetazobactam, which has gone on to become the first-ever internationally approved “new drug” from the country as part of an antibiotic fixed dose combination (FDC), is set for a local launch.
The combination of enmetazobactam — invented by scientists associated with Chennai-based pharma firm Orchid Pharma in 2008 — and cefipime, a fourth generation cephalosporin antibiotic, is used in cases of various moderate to severe bacterial infection, and was approved in the US and European Union earlier this year.
In the US, the FDC is being marketed under the brand name Exblifep.
The launch of this antibiotic FDC has been indicated for serious infections such as complicated Urinary Tract Infections (cUTI) including acute pyelonephritis, when UTI leads to kidney infection and hospital-acquired pneumonia. The drug, which will be available in powdered form, to be administered intravenously, could hit the Indian market in a few weeks.
It has also been indicated for bacteremia, or bacterial infection of the blood. The launch of the antibiotic drug combination, Orchid Pharma said, will improve the treatment landscape for serious infections in India, providing patients with access to advanced and effective therapy options.
The development is particularly significant for India, which is grappling with the growing burden of antimicrobial resistance (AMR) or cases where disease-causing pathogens are becoming resistant to existing therapies, pointed out a Central Drugs Standard Control Organisation (CDSCO) official.
Speaking to ThePrint, Manish Dhanuka, managing director, Orchid Pharma, explained that though cefipime is a powerful antibiotic, several superbugs are now becoming increasingly resistant to it, limiting the choice of drugs that effectively combat them.
“In simplified terms, the addition of enmetazobactam enhances cefepime’s efficacy by inhibiting beta-lactamases, enzymes that could degrade cefepime,” Dhanuka said.
Dhanuka said the price of the drug is yet to be decided, though it will be a “cost-effective” medicine compared to similar therapeutic options.
Also Read: Superbugs behind fatal blood infections in India rapidly growing resistant to last-resort antibiotics
Critical to combatting AMR
AMR has been declared as the silent pandemic by the United Nations and the World Health Organisation. According to a University of Washington paper, it contributed to nearly 5 million deaths in 2019.
In addition to causing death and disability, AMR has significant economic costs. The World Bank estimates that AMR could result in USD 1 trillion additional healthcare costs by 2050, and USD 1 trillion to USD 3.4 trillion gross domestic product (GDP) losses per year by 2030.
In India, in 2019, it was estimated that there were 2,97,000 deaths attributable to AMR and 10,42,500 deaths associated with it. It was also found that in the country, deaths due to AMR were higher than deaths from cancers, respiratory infections and tuberculosis, enteric infections, diabetes and kidney diseases, and maternal and neonatal disorders.
In particular, the pathogens associated with the highest number of AMR deaths in the country included Escherichia coli (1,52,700), Klebsiella pneumoniae (1,23,200), Staphylococcus aureus (1,11,400), Acinetobacter baumannii (1,03,500), and Mycobacterium tuberculosis (98,600). These pathogens commonly cause tuberculosis, peritoneal and intra-abdominal infections, lower respiratory infections and all related infections in the thorax, diarrhea, UTIs and pyelonephritis.
In this context, Orchid Pharma said the combination drug provides a powerful treatment option against a range of severe infections caused by resistant bacteria, addressing a critical need in combating AMR.
“Enmetazobactam’s approval in India is personally fulfilling as being an Indian company, we wanted to expand access to advanced and affordable treatment options for patients in India,” Dhanuka said.
ThePrint had earlier reported that an analysis of data obtained from the Antimicrobial Resistance Surveillance Network (IAMRSN) under the Indian Council of Medical Research (ICMR) had shown that resistance to last-resort antibiotics used for treating bloodstream infections was seeing a significant monthly increase.
First new chemical entity from India
The Chennai-based drugmaker which specialises in manufacturing antibiotic active pharmaceutical ingredients (APIs) says it is the only Indian pharmaceutical company to ever have invented a New Chemical Entity (NCE), a novel small molecule drug.
Dhauka said that following development by Orchid Pharma’s research and development team, enmetazobactam was out-licensed to a German biotech company for in-vitro studies and later clinical trials.
“After the drug demonstrated its safety and efficacy in the large-scale clinical trials that took place across several countries and was approved in the US and EU, the CDSCO has given a waiver for the drug’s clinical trial in India,” the company MD said.
However, he said, the firm has been asked to present safety and efficacy data through post-marketing analysis in the country.
(Edited by Gitanjali Das)
Also Read: 57% antibiotics prescribed in India have potential to cause high antimicrobial resistance, govt survey finds