Lupin hits 52-wk high; rallies 7% on US FDA nod for key respiratory drug

Lupin has received US FDA nod for Tiotropium Bromide Inhalation Powder in the strength of 18 mcg per capsule. The drug is a generic equivalent of Spiriva HandiHaler, used for pulmonary patients

Shares of Lupin rallied 7 per cent to hit a fresh 52-week high of Rs 885 on the BSE in Wednesday’s intra-day trade on heavy volumes after the company recieved US FDA approval for a key inhaler drug. The stock of the drug maker surpassed its previous high of Rs 843.40, touched on June 16, 2023.

The average trading volumes on the counter jumped seven-fold today. A combined 3.9 million shares, representing nearly 1 per cent of total equity, had changed hands on the NSE and BSE till 01:47 pm.

In a filing today, Lupin announced that it has received US FDA nod for Tiotropium Bromide Inhalation Powder in the strength of 18 mcg per capsule. The drug is a generic equivalent of Spiriva HandiHaler owned by Boehringer Ingelheim Pharmaceuticals and is indicated to reduce exacerbations in chronic obstructive pulmonary disease (COPD) patients.

This generic approval given to Lupin for Spiriva HandiHaler is the first in the US, and is also the first dry powder inhalation product from India for the US, the company said. 

Spiriva HandiHaler had estimated annual sales of $1,264 million in the US on a MAT basis as of Mar 2023, as per IQVIA. This product will be manufactured at Lupin’s Pithampur facility in India.

Besides on Tuesday, the company had said that its corporate social responsibility (CSR) arm, Lupin Human Welfare and Research Foundation (LHWRF) has signed a Memorandum of Understanding (MoU) with the Maharashtra government to address the growing prevalence of Cardiovascular Diseases (CVD) and COPD in the Palghar district of Maharashtra.

The partnership aims to prioritize the diagnosis and treatment of these diseases while working to reducing their long-term prevalence. The program will be implemented over the next five years, initially focusing on two blocks, Palghar and Dahanu, the company said.

Lupin develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the US, India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.

The company enjoys a leadership position in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastrointestinal, central nervous system, and women’s health areas.