HQ Team
March 4, 2024: Bayer AG, a German multinational pharmaceutical and biotechnology company, has bought the marketing rights in Europe for a heart drug for $310 million to expand its cardiology portfolio.
The exclusive rights to market acoramidis in Europe were acquired from Eidos Therapeutics Inc., BridgeBio International GmbH and BridgeBio Europe BV, according to a Bayer statement.
Acoramidis is a potent and selective small molecule, orally administered transthyretin stabilizer for the treatment of patients suffering from ATTR CM — a progressive fatal disease presenting as infiltrative, restrictive cardiomyopathy resulting in heart failure.
A buildup of faulty proteins called fibrils causes transthyretin amyloidosis (ATTR-CM). These protein deposits stiffen and weaken your heart chambers, leading to cardiomyopathy.
Up to half of all patients with cardiac amyloidosis die suddenly. Seventy-five per cent of those deaths are due to heart failure. Ventricular arrhythmia is also associated with cardiac amyloidosis and unexpected death.
‘Glove and stocking neuropathy’
Symptoms of the disease include worsening kidney function, protein in the urine, swollen ankle, shortness of breath on exertion, fainting, and tingling, pain and altered sensation in the hands and feet- “glove and stocking neuropathy.”
Once diagnosed, ATTR CM patients have a median survival of 3-5 years if left untreated.
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 per cent.
During a last-stage clinical trial, acoramidis met all clinical endpoints by “significantly reducing the hospitalisation burden, improving survival and preserving functional capacity and quality of life for patients,” according to the statement.
NDA application
A marketing authorisation application (MAA) was filed with the European Medicines Agency in January 2024. The regulator has accepted the MAA for acoramidis with potential EU approval planned for 2025.
A New Drug Application for acoramidis was also submitted to the US Food and Drug Administration and accepted with a Prescription Drug User Fee Act action date of November 29, 2024.
“Bayer has a clear vision to transform cardiovascular care for patients and acoramidis complements our portfolio in speciality cardiology,” said Juergen Eckhardt, MD, Member of the Executive Committee of Bayer’s Pharmaceuticals Division and Head of Business Development, Licensing & Open Innovation.
“As a leading player in the field of cardiovascular diseases, we will work to make this new treatment available to patients as soon as possible, after a positive decision by the European authorities.”
Ananth Sridhar, Senior Vice President of Corporate Development, BridgeBio Cardiorenal said: “This partnership leverages Bayer’s established European cardiovascular infrastructure and enables us, via substantial cost savings, to focus our resources on our wholly-owned geographies for acoramidis, including preparing for the US launch.”
