Bayer buys exclusive marketing rights for cardiology drug Acoramidis in Europe
Under the terms of the agreement, BridgeBio and the affiliates will receive up to USD 310 million in upfront and near-term milestone payments and are eligible to receive additional undisclosed sales milestone payments and tiered-royalties beginning in the low-thirties percent.;
Berlin: Bayer has acquired the exclusive marketing rights for acoramidis in Europe from Eidos Therapeutics Inc., BridgeBio International GmbH and BridgeBio Europe B.V..
Acoramidis is a highly potent and selective small molecule, orally administered transthyretin (TTR) stabilizer for the treatment of patients suffering from ATTR CM, a progressive fatal disease presenting as an infiltrative, restrictive cardiomyopathy resulting in heart failure. In a placebo-controlled Phase III study in ATTR CM, acoramidis met all clinical endpoints by significantly reducing hospitalization burden, improved survival and preserved functional capacity and quality of life for patients in need.
Marketing authorization application (MAA) with the European Medicines Agency (EMA) was filed in January 2024, after announcing that acoramidis successfully met the primary endpoint in the pivotal Phase III trial, confirming highly statistically significant efficacy and good tolerability in the trial population. New Drug Application (NDA) for acoramidis has also been submitted to U.S. Food and Drug Administration (FDA) and accepted with Prescription Drug User Fee Act (PDUFA) action date of November 29, 2024.
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.