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Perrigo has signed an exclusive licensing agreement that allows it to seek regulatory approval to sell an over-the-counter nasal spray.
The Dublin-based drug maker — which has its North American headquarters in Allegan — announced the news Thursday in conjunction with its second-quarter 2018 earnings report.
The agreement with a subsidiary of Kenilworth, New Jersey-based Merck & Co. grants Perrigo the exclusive rights to pursue regulatory approval in the U.S. for a non-prescription, over-the-counter (OTC) Nasonex nasal spray, which is currently available by prescription only.
It will allow Perrigo to market, sell and distribute the product following receipt of all necessary regulatory approvals.
Financial terms of the licensing agreement were not disclosed.
Uwe Roehrhoff, president and CEO of Perrigo, said the decision to form the agreement will help Perrigo expand its “OTC self-care market” while growing its U.S. consumer business.
Jeff Needham, executive vice president and president of Consumer Healthcare Americas for Perrigo, said the company hopes to streamline the Rx-OTC-switch process.
“As with other similar products that have previously switched from prescription to OTC status, we are working diligently to bring this important product to consumers and customers more quickly than the average five-year OTC switch timeframe,” he said. “We expect to execute the Rx-OTC-switch, fully penetrate this market with a branded offering and provide a future store brand alternative.”
Annual prescription brand and generic market sales for Nasonex during the 12 months ending June 2018 were about $214 million, according to clinical research consulting firm IQVIA.
This licensing agreement comes as Perrigo also on Thursday announced its plans to separate its prescription, or Rx, business unit from the company following an 8 percent drop in net sales for first-half 2018 compared to the same period last year.
Perrigo Company (NYSE: PRGO), a global over-the-counter consumer goods and pharmaceutical company, was founded in Allegan in 1887 as a packager of generic home remedies.
Now headquartered in Dublin, the company makes OTC products and supplies infant formulas and topical medications across a variety of product categories and geographies in North America, Europe and Australia, as well as Israel and China.
The company reported net revenue of $4.9 billion in 2017.