Lupin launches asthma drug DIFIZMA; stock gains

Shares of Lupin rose over 1% on Thursday, in an otherwise weak broader market, after the drug maker announced the launch of a triple drug combination to treat inadequately controlled asthma. The company has launched a first-of-its-kind novel fixed-dose triple drug combination (FDC) of Indacaterol, Glycopyrronium and Mometasone, under the brand name DIFIZMA in India.

Boosted by the development, Lupin share price gained as much as 1.6% to hit an intraday high of ₹744.60 after opening higher at ₹730 on the BSE. The pharma heavyweight finally settled 1.35% higher at ₹742.95, while the market capitalisation surged to ₹33,786.44 crore. In comparison, the BSE Sensex ended 304 points lower at 60,353 levels, while the BSE healthcare index settled 0.66% higher.

The Mumbai-based healthcare company said in an exchange filing that it is the first company in India to offer this novel FDC dry powder inhalation (DPI) product combining Indacaterol, a long-acting beta-agonist, Glycopyrronium, a long-acting muscarinic receptor antagonist, and Mometasone Furoate, an inhaled corticosteroid.  

“DIFIZMA is the only FDC that has been approved by the Drug Controller General of India (DCGI) for the treatment of inadequately controlled Asthma. DIFIZMA will help in the management of inadequately controlled asthma by improving lung function, providing better symptom control and reducing exacerbations. The drug will be available in one strength with a fixed-dose to be taken once daily,” the company said in a BSE filing today.

As per the release, the estimated national burden of asthma in India is at 1.72 crore with an overall prevalence of 2.05%. Out of this, approximately 30 lakh patients can be classified under “inadequately controlled”, having uncontrolled symptoms and higher chances of exacerbations, which may lead to hospitalisation contributing to higher DALYs (Disability adjusted life years) in most patients.

Commenting on the launch, Mr. Rajeev Sibal, President – India Region Formulations, Lupin said, “We are excited about the launch of DIFIZMA, a first-of-its-kind novel combination product available in India. DIFIZMA is aimed at catering to the unmet need of patients with inadequately controlled asthma and aligns closely with Lupin’s ideology of patient-centricity and enabling accessibility for medicines.”

The launch of DIFIZMA aligns with Lupin’s commitment to introducing novel inhalation products globally. In India, Lupin ranks second in the respiratory therapy area (IQVIA, MAT Nov 2022) and this launch will further reinforce the company’s presence in the segment, the company said.

Lupin is an innovation-led transnational pharmaceutical company which develops and commercialises a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.

Last month, the drug maker’s U.S. arm, Lupin Pharmaceuticals Inc., has voluntarily recalled four lots of its blood pressure tablets in the American market due to the presence of a nitrosamine impurity, which may raise the risk of cancer if people are exposed to them above acceptable levels over long periods of time. “Lupin Pharmaceuticals Inc. is voluntarily recalling four lots of Quinapril Tablets to the patient level due to the presence of a nitrosamine impurity, N-Nitroso-Quinapril, observed in recent testing above the Acceptable Daily Intake (ADI) level,” the company said in a BSE filing on December 23, 2022.

Nitrosamines are common in water and foods, including cured and grilled meats, dairy products and vegetables. Everyone is exposed to some level of nitrosamines, but these impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time.