ROM (ITALPRESS) – NewAmsterdam Pharma Company N.V., a biopharmaceutical company that deals with advanced clinical development of oral drugs, other than statins, for patients at risk of cardiovascular diseases with high levels of LDL cholesterol, lipoproteins at low density, for which existing therapies are not sufficiently effective or well tolerated, together with the Menarini Group.
“The approval of Ubeslo and Evlarco by the European Commission is a key milestone for NewAmsterdam, constituting the first global regulatory approval of obicetrapib, a new oral therapy, and validation years of work dedicated to offering a potential new therapeutic option to patients who fail to reach the recommended levels of LDL-C despite the available therapies,” said Michael Davidson, M. “This approval of a drug, first of its class, reflects the solidity of clinical evidence in support of obicetrapib, the dedication of our team and our partners and our commitment to address one of the greatest unsatisfied medical needs in cardiovascular medicine. Together with Menarini, we look forward to making Ubeslo and Evlarco available to patients throughout Europe and, starting from this important milestone, carry out our vision of making obicetrapib accessible to patients around the world. ”
The approval of the European Commission follows the positive opinion adopted by the Committee for Human Use Medicines (CHMP) of the European Agency for Medicinal Products (EMA) and is supported by the data of the complete clinical development program of NewAmsterdam of obicetrapib, which includes studies of Phase 3 BROADWAY, BROOKLYN and TANDEM, which have demonstrated statistically significant reductions of LDL-C NewAmsterdam and Menarini continue to advance the clinical development of obicetrapib through several Phase 3 studies in progress, including PREVAIL, a study on cardiovascular events, as well as REMBRANDT and RUBENS studies.
“This approval is an important step forward for patients in Europe who require further LDL-C reduction despite available therapies,” said Elcin Barker Ergun, Chief Executive Officer of the Menarini Group. “We are proud to reach this significant milestone alongside NewAmsterdam and intend to enhance our well-established business structure and our deep cardiovascular competence to put Ubeslo and Evlarco available to healthcare professionals and patients eligible throughout Europe.” Based on the licensing agreement between the parties, Menarini holds exclusive trading rights for obicetrapib in Europe and is responsible for interactions with regulatory authorities and marketing activities throughout the region. NewAmsterdam has the right to royalty as a percentage on net sales in Menarini territory, which has been progressively cut from a minimum of two digits to a share of around 25%, as well as an additional amount of 833 million euros to achieve various clinical, regulatory and commercial goals.
– photos of repertoire press office Menarini Group –
(ITALPRESS).
