Orchid Pharma new antibiotic drug gets EMA approval; stock surges 20%

Orchid Pharma shares hit a 20% upper circuit limit of ₹859.40 on Tuesday after the company’s new antibiotic drug ‘Exblifeb’ received the European Medicines Agency's (EMA) approval. The pharma company announced in a filing that the primary novel invention component of ‘Exblifep’ – Enmetazobactam is the first drug invented in India to secure EMA approval.

Enmetazobactam was invented in India by Orchid and then out-licensed to Allecra Therapeutics for further development, the company says in a filing.

‘Exblifep’ obtained marketing authorisation from the EMA for the treatment of complex urinary tract infections, pneumonia, and bacteremia caused by ESBL-producing pathogens, the company states.

Manish Dhanuka, Managing Director, Orchid Pharma, said, “With the potential to save thousands of lives globally, this approval by EMA is a testament to Indian ingenuity. It is also a matter of great pride that as the pharmacy of the world, India has now developed a new drug for the first time.”

“According to the Global Burden of Disease Study, infections caused by antimicrobial-resistant bacteria led to the direct death of 1.27 million people in 2019,” the pharma company adds.

The company said that 'Exblifeb' has the capacity to emerge as a global standard of care in addressing the ongoing global health crisis.

In Q2FY24, the company reported revenue of ₹199 crore, from ₹165.2 crore in the same quarter last year. The quarterly net profit surged to ₹19.80 crore, up from ₹5.39 crore in September 2022.

In another development in November last year, the company stated that it had been selected through a global tender for the manufacture of Cefidorocol. Cefidorocol is employed in the treatment of complex urinary tract infections (including pyelonephritis) in patients with restricted or no alternative treatment alternatives. 

Manish Dhanuka, the Managing Director of the company, stated that the ability to manufacture this essential product has been made possible through the sublicensing agreement with Shionogi, Japan, facilitated by GARDP (Global Antibiotic Research and Development Partnership).