HQ Team
October 5, 2024: Italy’s Recordati will acquire global rights for Sanofi’s drug Enjaymo, used in the treatment of a rare autoimmune disease that causes the body’s immune system to attack red blood cells, for an upfront $825 million.
Recordati will additional commercial milestone payments of up to $250 million, if net sales reach certain thresholds at or above the top end of peak year sales expectations, according to a company statement.
The transaction is expected to close by the end of 2024 and the deal will be funded by existing cash and new committed bank debt facilities.
“This transaction is in line with our broader strategy and reaffirms our commitment to the rare diseases space and is complementary to our oncology portfolio,” said Rob Koremans, Chief Executive Officer of Recordati.
“Enjaymo further expands our rare diseases footprint in theUS, Japan and Europe, and will contribute positively to both our top and bottom lines. Most importantly, with a strong clinical profile and as the only product approved for the treatment of cold agglutinin disease,” he said.
“Enjaymo addresses a serious unmet medical need for patients living with this debilitating disease.”
According to Recordati Enjaymo generated approximately 100 million euros in revenue over the last 12 months as of August 2024.
It is expected to generate revenue of over 150 million euros in the financial year ending 2025, with a peak sales potential of 250-300 million euros, more than double the current levels.
Cold agglutinin disease is a rare blood condition that occurs when the immune system attacks red blood cells. The immune system makes proteins called antibodies that destroy harmful germs that enter your body.
Cold conditions activate the immune system to make an autoantibody that flags your red blood cells for destruction. The red blood cells clump together (agglutinate) in response.
The clumped cells make an easy target for another part of the immune system, called macrophages, to destroy.
Cold agglutinin disease is a type of hemolytic anaemia that involves not having enough red blood cells because they break down or die faster than your body can replace them, according to the Cleveland Clinic.
Disease prevalence in the US, Japan and Europe is approximately 11,000 patients, and while median age of onset is approximately 60 years, the disease has been diagnosed in patients as young as 30.
Enjaymo was approved by the US Food and Drug Administration in February 2022 as the first and only treatment indicated to decrease the need for red blood cell transfusion due to hemolysis in adults with the disease.
The Japanese Ministry of Health, Labor and Welfare approved Enjaymo in June 2022. The European Medicines Agency also decided to maintain the orphan designation.
