Esperion Therapeutics Inc's Comment on Supply Chain
The company does not own manufacturing facilities and relies on contract manufacturers to produce drug substances and products for commercial supply and clinical studies, all in compliance with current Good Manufacturing Practices (cGMP). It plans to continue using contract manufacturers and collaboration partners, including DSE, for manufacturing bempedoic acid and its combination tablet in the United States, Europe, and other territories. The company acquired intellectual property related to bempedoic acid from Pfizer in 2008 and holds license agreements with Pfizer that permit development, manufacturing, and commercialization of bempedoic acid without royalty obligations. In 2019, the company entered into a license and collaboration agreement with DSE, granting DSE exclusive commercialization rights in the European Economic Area, Switzerland, and later Turkey. Under this agreement, DSE is responsible for regulatory matters and manufacturing in these territories. In 2024, DSE assumed sole responsibility for manufacturing NILEMDO and NUSTENDI in the DSE Territory and obtained exclusive rights for clinical development, regulatory activities, manufacture, and commercialization of a triple combination pill. Additionally, in 2020, the company entered into a license and collaboration agreement with Otsuka, granting Otsuka exclusive development and commercialization rights in Japan, with Otsuka responsible for all development activities.
Esperion Therapeutics Inc's Comment on Supply Chain
The company does not own manufacturing facilities and relies on contract manufacturers to produce drug substances and products for commercial supply and clinical studies, all in compliance with current Good Manufacturing Practices (cGMP). It plans to continue using contract manufacturers and collaboration partners, including DSE, for manufacturing bempedoic acid and its combination tablet in the United States, Europe, and other territories. The company acquired intellectual property related to bempedoic acid from Pfizer in 2008 and holds license agreements with Pfizer that permit development, manufacturing, and commercialization of bempedoic acid without royalty obligations. In 2019, the company entered into a license and collaboration agreement with DSE, granting DSE exclusive commercialization rights in the European Economic Area, Switzerland, and later Turkey. Under this agreement, DSE is responsible for regulatory matters and manufacturing in these territories. In 2024, DSE assumed sole responsibility for manufacturing NILEMDO and NUSTENDI in the DSE Territory and obtained exclusive rights for clinical development, regulatory activities, manufacture, and commercialization of a triple combination pill. Additionally, in 2020, the company entered into a license and collaboration agreement with Otsuka, granting Otsuka exclusive development and commercialization rights in Japan, with Otsuka responsible for all development activities.
Sources:
Esperion Therapeutics Inc 's official press releases and regulatory filings; CSIMarket.com's supply-chain research; and the financial filings and press releases of other companies cited in this report.
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