The $2 billion pharma giant, Lupin, has been slowly building a strong portfolio of inhalation products to tap the complex generics respiratory products market globally. The firm is looking for manufacturing partners to enter the Chinese market with a handful of respiratory products that it has either commercialised in other regulated markets or is in the pipeline.
Vinita Gupta, chief executive officer (CEO), Lupin, said it has been working on building a complex generics respiratory portfolio with focus on inhalation products for the last five-six years. The firm has been utilising around 10 per cent of its research and development (R&D) spend on inhalation products.
Gupta elaborated that Lupin is looking for a partner in China for a manufacturing facility. “To make it big in China, one would need to have a local manufacturing facility. So, we are looking for partners who either have a local manufacturing facility or are willing to invest in a manufacturing facility there,” she said. She added that Lupin expects to have its first products in the Chinese market in the next four-five years. It has identified products like generic Luforbec (already approved in the UK) and generic Spiriva (a pipeline product for Europe, Australia, Japan and the US) for entry into the Chinese market.
Inhalation products present a big opportunity with a global market size of $38 billion. Lupin’s portfolio and pipeline addresses 70 per cent of the entire market. The US is the largest part of the respiratory market, constituting 75 per cent of global revenues. Apart from China, Gupta outlined Lupin’s global plans to encash the inhalation portfolio it has built. “We have identified geography-specific portfolios and will now work towards launching products. Apart from the US, which is the largest opportunity for respiratory products, we see significant opportunities in Europe, Canada, Australia and China,” she said. For Albuterol, a product in which Lupin enjoys a 12-13 per cent share in the US market and aims for 20 per cent by the end of this year, it is not looking beyond the US immediately.
“Albuterol is not a big opportunity outside the US,” Gupta said. Focus on the US market would continue with products like Brovana, which it launched in June and now enjoys a 50 per cent market share.
For the UK, it expects to launch Luforbec this month and does not expect any competition for the next 12 months. Spiriva, an inhaler used by patients with chronic obstructive pulmonary disorder (COPD) patients, is the next big opportunity for multiple geographies.
Gupta said, “We have the first-to-file (FTF) for Spiriva in the US, and it is also a large opportunity in Europe, Australia, Japan, and China.” For Spiriva, Lupin has even developed an in-house device called Lupinhaler. “We can leverage this platform for other products in other markets,” Gupta added. Since it is focusing on inhalation products, Lupin has also been working on developing devices – for example the Ellipta device, a multi-dose dry powder inhaler (DPI). Lupin’s Florida R&D unit has developed an in-house Ellipta device and is now working on individual products that can go with this platform.
However, the global launch plans would be contingent to regulatory clearances for its sites. Kunal Randeria, analyst with Edelweiss, said there are no regulatory overhangs for Lupin’s inhalation portfolio, but clearances would be a relief nonetheless.
Gupta added: “We have built flexibility in manufacturing between our Pithampur site and the US site (Florida). Inhalation products are made at Pithampur site 3, which is already cleared by the USFDA (US Food and Drug Administration).”