Sun Pharmaceutical Industries’s ophthalmic business in the US has received a boost, with the US Food and Drug Administration (USFDA) accepting the company’s application for a novel medicine to treat dry-eye disease.
Investors cheered the development and the company stock gained 6.89 per cent to close at Rs 577.70 on the BSE on Wednesday.
Sun Pharma is building its specialty drugs business in the US through acquisitions, increased spending on research and development, and dedicated sales teams.
Currently, the company markets four specialty drugs in the US, and overall the market contributed about 30 per cent to the company’s revenue in Q2FY18.
On Wednesday, the drugmaker announced that the USFDA had accepted its new drug application for OTX-101, drops to treat dry-eye disease. The drug made its way into Sun Pharma’s portfolio following its $40-million acquisition of Ocular Technologies last December.
Currently the US market for dry-eye disease medicine is valued at about $2.4 billion, and drugmakers Allergan and Shire are the key players. Competition is expected to intensify, with Allergan losing patent for its Retasis eye drops in October.
Sun Pharma, however, is optimistic about its product, as there are over 16 million patients suffering from dry eye disease in the US alone. The company will develop the drug for global market.
In a statement, Sun Pharma Managing Director Dilip Shanghvi said: “Dry-eye disease is a complex, chronic condition that affects patient quality of life, often significantly. OTX-101, a novel formulation of cyclosporine, will allow us to participate in the rapidly growing underserved and dynamic dry eye market. When approved, it will be a milestone for millions of dry-eye patients across the globe, who are yet to find relief for their condition.”
Last November the drugmaker launched Bromsite, its first branded ophthalmic product in the US. Bromsite, which is indicated for treatment of post-operative inflammation, has been developed by InSite Vision. Sun Pharma acquired the firm in 2015.
However, the approval for its anti-glaucoma eye drop Xelpros is stuck due to lingering compliance issues at its Halol plant. The drug has been developed by Sun Pharma Advanced Research Company.