Shares of Orchid Pharma have cooled off from the day's high, having gained as much as 11% on Monday, after the company received approval from the United States Food and Drug Administration (USFDA) for a drug used in treating complicated urinary tract infections (UTI) in adults.
The new drug is expected to be launched in the US, the largest pharmaceutical market in the world, within the next couple of quarters. It will be marketed under the brand name Exblifep, with estimated global commercial peak sales projected to reach $150 million - $200 million, Orchid Pharma said in a filing to the stock exchanges.
The approved drug, Enmetazobactam, in combination with cefepime, is indicated for use in adults with complicated urinary tract infections (cUTI) including pyelonephritis, Orchid Pharma informed the bourses.
Enmetazobactam was originally discovered and developed by Orchid Pharma and subsequently licensed to Allecra Therapeutics.
Allecra acquired the global (excluding India) development and commercialisation rights from Orchid.
The USFDA approval follows a positive recommendation for the drug's use in the European Union (EU) from the EU Committee for Medicinal Products for Human Use (CHMP).
Orchid Pharma will receive royalties in the range of 6% - 8% on the sales of Exblifep, translating to peak annual royalties of approximately $12-16 million.
Additionally, the company retains commercialisation rights for Enmetazobactam in India, where it is expected to achieve sales of around ₹ 200 crore, as estimated by Systematix.
Overall, Orchid Pharma's discovery and successful approval of Enmetazobactam represent a significant achievement in the pharmaceutical industry, with promising prospects for both global and domestic markets.
Nuvama estimated potential sales of $40 million in financial year 2025 and $80 million in financial year 2026 of the said drug. The royalty income is anticipated to contribute between 2% - 5% to Orchid Pharma's current core business revenue according to the brokerage which would translate to around $2 million in financial year 2025 and $5 million in financial year 2026.
Shares of Orchid Pharma are trading 2.5% higher currently at ₹1,247. The stock has risen 220% over the last 12 months.
(Edited by : Hormaz Fatakia)
First Published: Feb 26, 2024 1:04 PM IST
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