Orchid Pharma - Enmetazobactam, First Indian NCE Gets U.S. FDA Nod: Systematix

Systematix Research Report

On February 22, 2024, U.S. Food and Drug Administration approved novel drug Enmetazobactam in combination with cefepime for use in adults with cUTI including pyelonephritis.

Enmetazobactam which has been discovered / innovated by Orchid Pharma Ltd. (out licensed to Allecra therapeutics) is the first ever new chemical entity discovered by an Indian company to have received U.S. FDA nod.

Allecra therapeutics had acquired global (excluding India) development / commercial rights from Orchid Pharma. The approval by the U.S. FDA follows the recent positive recommendation received for European Markets from EU CHMP.

Enmetazobactam is expected to be launched within the next couple of quarters in the U.S. market and will be marketed under the brand Exblifep.

We estimate global commercial peak sales for Exblifep to be in the $150 to $200 million range. Exblifep will be positioned as a carbpanem sparing option in the fight against cUTI caused by ESBL producing gram negative bacteria.

Revise our price target and retain Hold rating –

We revise our target price on Orchid pharma at Rs. 1,057 as we raise our target price-to-earnings multiple from 30 times to 33 times.

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