Orchid Pharma gets USFDA nod, to market its new drug in US soon

Chennai, Feb 23: Vertically integrated pharma player Orchid Pharma Ltd said on Friday that it will launch its Enmetazobactam drug in the US in the next couple of quarters.

The company has received approval from the United States Food and Drug Administration (USFDA) for its invention Enmetaobactam, a Beta Lactamase Inhibitor.

The company shares went up to Rs 1,217.20 on Friday at the BSE after closing at Rs 1,150.95 on Thursday.

According to the company, the USFDA approval paves the way for the introduction of Enmetazobactam in the United States, the largest pharmaceutical market in the world.

The product is expected to be launched within the next couple of quarters in the US market.

This development comes in close succession to the recent recommendation for approval by the European Medicines Agency (EMA).

This New Drug Approval (NDA) allows the use of Exblifep (Cefepime and Enmetazobactam) as an injection for the treatment of patients 18 years and older with complicated urinary tract infections (cUTI), including pyelonephritis caused by the following susceptible microorganisms -- Escherichia coli (E. coli), Klebsiella pneumoniae, Pseudomonas aeruginosa, Proteus mirabilis, and Enterobacter cloacae complex.

“While the EMA recommendation for grant of marketing authorisation last month was a big achievement, the USFDA approval reinforces Orchid’s position on the safety of the drug and its innate need in the times of increasing Antimicrobial resistance,” said Manish Dhanuka, Managing Director, Orchid Pharma.

Enmetazobactam was invented in India by Orchid Pharma and then out licensed to Allecra Therapeutics for further development.

Dhanuka Group acquired Orchid Pharma through CIRP (Corporate Insolvency Resolution Process) under IBC (Insolvency and Bankruptcy Code) on March 31, 2020.