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Orchid Pharma aims to launch its new drug, Enmetazobactum, by next quarter. The company received approval from the Drug Controller General of India last week, allowing it to manufacture and market the product in India.
The company has since applied to the Tamil Nadu Government for permission to manufacture the drug at its Chennai plant, the company’s Director, Mridul Dhanuka, told businessline.
Enmetazobactum was discovered by Orchid in 2008, when the company was under the previous management. Because of financial difficulties, it entered into an agreement with Allecra of Germany in 2013, under which the German company would do all the clinical trials and have the right to manufacture and market the drug everywhere in the world, except India. Orchid would get royalty, estimated at 6-8 per cent.
Allecra has since completed all three phases of clinical trials and has secured US FDA approval — making enmetazobactum the first India-discovered drug to get the US regulator’s nod. It will start selling the drug in a year.
Since the drug has been approved by the US, the DCGI has exempted Orchid from the need to do clinical trials in India.
The drug can fight anti-microbial resistance (AMR) -- the immunity that bacteria sometimes develop against antibiotics, making the antibiotics ineffective. Enmetazobactum will be administered along with Cefepime, an antibiotic of the Cephalosporin class.
In a recent press release, Orchid Pharma said the drug controller had granted permission “to manufacture and market Finished Dosage Form (FDF) of Cefepime and Enmetazobactam as a dry powder injectable.’
This formulation is indicated for the treatment of complicated Urinary Tract Infections (cUTI), including acute Pyelonephritis, HospitalAcquired Pneumonia (HAP), including Ventilator-associated pneumonia (VAP), and Bacteremia, when it is associated or suspected to be associated with either complicated urinary tract infections or hospital-acquired pneumonia.
“With this approval, Orchid Pharma intends to improve the treatment landscape for serious infections in India, providing patients with access to advanced and effective therapy options,” the release said.
On the BSE today, shares of the Rs 819-crore Orchid Pharma closed at ₹1,045.15, which was ₹1.7 (0.16 per cent) lower than the previous close.
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