OrchidPharma's 'Exblifep' Gets European Medicines Agency Approval

OrchidPharma Ltd.'s 'Exblifep' got approval from the European Medicines Agency.

The drug is used to treat urinary tract infections, pneumonia, and bacteremia due to ESBL-producing pathogens. The EMA authorised the marketing of 'Exblifep' on Monday.

The primary novel invention component of Exblifep, Enmetazobactam, is the first drug invented in India to get approval.

During clinical trials, 'Exblifeb' exhibited superior performance compared to the current go-to drug, Piperacillin +Tazobactam. It has been positioned as a potent, cost-effective, and Carbapenem-sparing therapy, offering a viable solution in the fight against rising AMR, an exchange filing said.

Enmetazobactam, in combination with the fourth-generation cephalosporin antibiotic Cefepime, has been proven to overcome antimicrobial resistance produced by extended-spectrum beta-lactamase-producing bacteria, said Systematix Institutional Equities.

OrchidPharma created the salt in India and then granted an out-licencing agreement to Allecra Therapeutics GmbH for further development. Allecra Therapeutics has completed phase-3 trials of Enmetazobactam in the U.S. and the EU and is awaiting approvals from regulators (expected in H1 CY24), according to Systematix.

Enmetazobactam may see global commercialisation in FY25, which would be positioned in a Rs 20 billion market. A quick ramp-up is possible due to its superior efficacy and the rising resistance of infections to conventional antibiotics, according to the research firm.

This could translate into a meaningful royalty stream for OrchidPharma and flow straight into the company’s profit before tax. The company holds the marketing rights for Enmetazobactam in India and expects to get a 6-8% royalty on its ex-India sales, Systematix said.

Shares of the company jumped 20%, compared to a 0.43% decline in the benchmark Nifty 50 as of 2:12 p.m.