homemarket NewsOrchid Pharma hits 20% upper circuit after its new antibiotic drug gets EMA authorisation
Orchid Pharma hits 20% upper circuit after its new antibiotic drug gets EMA authorisation
Orchid Pharma Share Price | The drug which is expected to have demonstrated superior efficacy compared to regularly used antibiotic Piptaz in clinical trials is expected to be the first Indian-invented drug to reach this advanced stage of clinical development
Orchid Pharma has received approval of its novel antibiotic drug, Exblifeb, by the European drug regulator the European Medicines Agency. The antibiotic, incorporating Emmetazobactum, is aimed at treating complicated Urinary Tract Infections, Pneumonia, and infections caused by Extended Spectrum Beta-lactamase (ESBL) Producing Pathogens.
The antibiotic is expected to focus on the market of anti-microbial resistance or AMR, which led to the direct death of 1.27 million people globally in 2019.
The drug which is expected to have demonstrated superior efficacy compared to regularly used antibiotic Piptaz in clinical trials is expected to be the first Indian-invented drug to reach this advanced stage of clinical development.
Background
Orchid Pharma began with the development of Cefepime Enmetazobactum (OCID 5090). In 2013, the global rights, excluding India, were outlicensed to Allecra Therapeutics. Subsequently, Allecra further outlicensed the drug, selling China rights to Shanghai Haini for $78 million in 2020 and European rights to Advanz Pharma.
Orchid Pharma first started the development of the molecule in 2006. It undertook ideation, invention, pre-clinical studies and out licensed the molecule to Allecra which then undertook Phase 1-3 of the molecule. Allecra further outlicensed the drug. Orchid has however retained the India rights of the drug.
It has filed the drug with the DCGI, the admin review of which is almost completed. Orchid Pharma will receive royalty sales from all global sales of the drug. For the USFDA – approval pending – the drug has received the Qualified Infectious Disease Product Designation (QIDP) status.
Market Impact and Potential
The drug which is awaiting approval from other geographies such as China & US is estimated to generate global sales of Exblifeb of around $200-300 million annually. Orchid is entitled to a 6-8% royalty on worldwide sales with estimates that the company could make approximately $16-25 million annually.
Nuvama estimates potential sales of $40 million in FY25 and $80 million in FY26 of the drug. The royalty income is anticipated to contribute 2-5% to Orchid Pharma's current core business revenue according to the brokerage which would translate to around $2 million in FY25 and $5 million in FY26.
During a conversation with CNBC-TV18, Manish Dhanuka, Managing Director of Orchid Pharma, talked about the recent approval from the European Medicines Agency (EMA) for the company's latest antibiotic medication, Exblifeb.
The Orchid Pharma stock is up 159% in the past one year from Rs 334 to Rs 863. The stock was up 20% at Rs 863.85 apiece at 1.20pm on January 30.
(Edited by : Shloka Badkar)
First Published: Jan 30, 2024 10:52 AM IST
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