Shares of Aurobindo Pharma climbed over 2% in early trade on Wednesday after the drug maker informed exchanges that it has received US Food & Drug Administration (USFDA) approval for nasal spray. The Hyderabad-based pharma company will manufacture and market Mometasone Furoate Monohydrate Nasal Spray 50 mcg, which will be launched in the first quarter of the financial year 2024-25.
“It has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Mometasone Furoate Monohydrate Nasal Spray, 50 mcg/spray, which is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Nasonex Nasal Spray, 50 mcg/spray of Organon LLC,” Aurobindo Pharma said in an exchange filing on March 19.
Mometasone Furoate Monohydrate Nasal Spray, 50 mcg/spray, is used for the treatment of the nasal symptoms of seasonal allergic and perennial allergic rhinitis, in adults and paediatric patients 2 years of age and older. The product has an estimated market size of $44.5 million for the twelve months ending January 2024, according to IQVIA, a global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry.
With this approval, Aurobindo now has a total of 507 abbreviated new drug application (ANDA) approvals (488 final approvals and 19 tentative approvals) from the USFDA.
Boosted by the development, Aurobindo Pharma shares opened higher at ₹1,006.45, up 1.7% against the previous closing price of ₹989.40 on the BSE. On Tuesday, the pharma stock ended 2.6% lower.
In the first hour of trade so far, shares of Aurobindo Pharma gained as much as 2.5% to hit a high of ₹1,013.90, while the market capitalisation rose to ₹58,715 crore.
The stock price of Aurobindo Pharma touched its 52-week high of ₹1,177 on January 30, 2024, and a 52-week low of ₹466 on March 21, 2023. The counter has given 111% returns in the last one year and 12.6% in six months. The counter lost more than 7% in the calendar year 2024 as investors booked some profit after it scaled record high levels in January.
Last week, Aurobindo Pharma’s subsidiary, CuraTeQ Biologics Private Limited, completed the phase 1 clinical study outcome of their Omalizumab biosimilar candidate BP11 product, which can be used for the treatment of chronic spontaneous or idiopathic urticaria. The trial was conducted in 165 healthy volunteers in Australia and New Zealand.
“CuraTeQ Biologics Private Limited, a wholly owned subsidiary of Aurobindo Pharma Ltd, announced that their Omalizumab biosimilar candidate BP11 has met the Phase 1 trial end points vis-à-vis the EU and US sourced reference product Xolair,” it said in an exchange filing on March 15.
“We have initiated a Phase 3 study of our Omalizumab candidate BP11 for the treatment of chronic spontaneous or idiopathic urticaria, which is a presence of hives that are itchy and can last for a number of weeks with no apparent external trigger,” said Disha Dadke, Associate President and Head R&D.
As per the company, the Phase 3 efficacy and safety study is being conducted across multiple sites in seven European countries and in 600 patients with chronic spontaneous urticaria. Additionally, a separate Phase 3 trial in asthma patients is being carried out in the Indian population. CuraTeQ intends to file the Omalizumab biosimilar product in India in 2024 and is on track to file the product in regulated markets in 2025, the release noted.
Aurobindo Pharma, which manufactures and sells pharmaceuticals globally in over 150 countries, has 25 manufacturing and packaging facilities that are approved by leading regulatory agencies including USFDA, UK MHRA, EDQM, Japan PMDA, WHO, Health Canada, South Africa MCC, Brazil ANVISA. The company’s product portfolio is spread over 7 major therapeutic/product areas encompassing CNS, AntiRetroviral, CVS, Antibiotics, Gastroenterological, Anti-Diabetics and Anti-Allergic, supported by a strong R&D set-up.
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