Lupin UK subsidiary gets MHRA nod for COPD treatment drug

The pharma major on Friday announced that its UK subsidiary, Lupin Healthcare has received approval from Medicines and Healthcare products Regulatory Agency (MHRA) for Lutio (Tiotropium bromide inhalation powder).

The company said that the drug is generic version of Spiriva. Lutio has the potential to offer significant cost savings when available to UK patients, it added.

Thierry Volle, President, EMEA, Lupin, said, We are pleased to have received the approval of Lutio from the MHRA for the treatment of chronic obstructive pulmonary disease (COPD), providing an effective and high-quality treatment option to patients in UK.

Tiotropium is used to relieve wheezing, shortness of breath, coughing, and chest tightness in patients with chronic obstructive pulmonary disease (COPD), a group of diseases that affect the lungs and airways) such as chronic bronchitis and emphysema.

This is the second inhalation product by Lupin Healthcare for the UK market after Luforbec pressurised metered dose inhaler (pMDI), the company stated.

Meanwhile, on 25 August 2022, Lupin said that it has entered into an exclusive licensing agreement with I'rom Group Co (I'rom), a leading pharmaceutical company in Japan. Under the terms of the agreement, I'rom will conduct clinical trials along with Lupin, register, distribute and market biosimilar Denosumab in Japan on an exclusive basis.

Denosumab is indicated for the treatment of postmenopausal women with osteoporosis at high risk of fracture and prevention of skeletal-related events in patients with bone metastases from solid tumors among other indications.

Following the completion of the clinical trial and receipt of marketing authorization from Pharmaceuticals and Medical Devices Agency (PMDA) in Japan, I'rom will exclusively commercialize the product in Japan. As part of the agreement, Lupin will receive multiple milestone payments. Currently, Denosumab is available under two brands, Pralia and Ranmark, with a market size of approximately $500 million in Japan, the drug major said in the press release.

Lupin is an innovation-led transnational pharmaceutical company. The company develops and commercializes 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.

The drug maker reported a net loss of Rs 89.1 crore in Q1 FY23 as against a net profit of Rs 542.5 crore in Q1 FY22. Total revenue from operations declined 12.3% YoY to Rs 3,743.8 crore during the quarter.

Shares of Lupin were down 1.20% to Rs 657 on the BSE.

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