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news.Eli Lilly and Company and United Therapeutics, a biotechnology company, have entered into a license and a supply agreement related to the US commercialization rights for the pulmonary arterial hypertension indication of Lilly's molecule, tadalafil. The PAH indication is currently under regulatory review in the US, Canada, Mexico, Japan and the EU.
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Under the terms of the agreements, United Therapeutics will make an upfront payment of $150 million to Lilly for the exclusive rights to commercialize tadalafil for pulmonary arterial hypertension (PAH) in the US, as well as for a product manufacturing and supply arrangement.
Lilly will manufacture and supply tadalafil to United Therapeutics and will retain authority globally for all regulatory, development, intellectual property and manufacturing aspects of the tadalafil molecule for all potential indications.
Lilly will also retain commercialization rights to tadalafil for PAH outside of the US. In addition, Lilly will purchase $150 million of common stock from United Therapeutics. The transaction is subject to clearance of the stock purchase under the Hart-Scott-Rodino Antitrust Improvements Act and other customary closing conditions.
Martine Rothblatt, chairman and CEO of United Therapeutics, said: “The addition of tadalafil for PAH expands our portfolio and strengthens United Therapeutics’s position in the area of cardiovascular disease. Building upon the success of Remodulin, we are committed to addressing the unmet medical needs of patients. We also welcome the support and confidence expressed by Lilly through their financial investment in our company.”