Recordati Strengthens Rare Disease Portfolio with Global Rights

Recordati Expands Rare Disease Commitment with Ejaimo® Acquisition

Recordati is excited to announce its recent agreement to acquire the global rights to Ejaimo® (stimulimab) from Sanofi. This pivotal move underscores Recordati’s unwavering dedication to advancing treatments in the rare disease sector. Ejaimo® is the only approved biological treatment for Cold Agglutinin Disease (CAD), a rare condition characterized by the abnormal buildup of antibodies that leads to the destruction of red blood cells.

Understanding Cold Agglutinin Disease (CAD)

Cold Agglutinin Disease (CAD) is classified as an autoimmune hemolytic anemia and is categorized among rare B-cell lymphoproliferative disorders. In CAD, autoantibodies produced by B-cells attach to red blood cells at temperatures below 37°C, resulting in the breakdown of these cells. The symptoms of CAD can significantly impair quality of life, presenting debilitating fatigue and other anemia-related issues such as joint pain and muscle weakness. It is estimated that there are around 11,000 affected patients across various regions.

The Impact of Ejaimo® on Treatment Options

Ejaimo® (stimulimab) is a humanized monoclonal antibody specifically designed to target and inhibit C1s in the classical complement pathway. By blocking C1s, the treatment aims to prevent the activation of the complement cascade, which is responsible for C1-dependent hemolysis in CAD patients. Approved by the FDA in early 2022, Ejaimo® has emerged as the first and only medication to decrease the necessity for blood transfusions in adults suffering from hemolytic conditions related to CAD.

Financial Highlights of the Acquisition

The acquisition of Ejaimo® is anticipated to significantly impact Recordati's financial performance. For the 12 months leading up to August 2024, Ejaimo® generated approximately €100 million in revenue, with projections exceeding €150 million for the upcoming fiscal year. Expected peak sales could range between €250 million and €300 million, promising to more than double current revenues. Although the revenue impact for 2024 is expected to be minimal, this acquisition is set to contribute positively to the company’s EBITDA from 2025 onwards.

The Transaction Details

Under the contract, Recordati will make an upfront payment of $825 million, with an additional $250 million in commercial milestone payments if peak sales exceed projections. The transaction is expected to be completed by the end of 2024, pending regulatory approvals. Funding for this acquisition will be sourced through existing cash reserves and a new credit line, ensuring a stable financial structure moving forward.

Comments from Recordati’s Leadership

Rob Koremans, CEO of Recordati, expressed enthusiasm for the acquisition, stating, “This agreement aligns with our comprehensive strategy and reaffirms our commitment to the rare disease segment, particularly enhancing our oncology portfolio.” He emphasized that Ejaimo® will bolster the company’s rare disease efforts in the US, Japan, and Europe, yielding positive contributions to both revenue and profits, ultimately addressing significant unmet patient needs for those suffering from debilitating conditions.

Recordati: A Leader in Rare Disease Treatments

Founded in 1926, Recordati is a globally recognized pharmaceutical group publicly traded on the Milan Stock Exchange (Ticker: REC), dedicated to providing specialized healthcare and primary care solutions along with rare disease treatments. The company believes that health is a right for all individuals, enabling everyone to live life to the fullest. With integrated operations spanning research and development, manufacturing, and commercialization, Recordati is active in approximately 150 countries and employs over 4,450 staff. In 2023, Recordati achieved consolidated revenues of €2.082 billion.

Frequently Asked Questions

What is the significance of Recordati acquiring Ejaimo®?

The acquisition enhances Recordati's rare disease portfolio, providing a crucial treatment for patients with Cold Agglutinin Disease.

How does Ejaimo® function in treating CAD?

Ejaimo® targets and inhibits the C1s complement protein, reducing hemolysis and the need for blood transfusions in patients.

What are the financial expectations from the Ejaimo® acquisition?

Recordati anticipates revenues exceeding €150 million for the upcoming fiscal year and potential peak sales reaching between €250 million and €300 million.

How does Recordati support rare disease patients?

Recordati is committed to developing specialized treatments and ensuring access to therapies that address the unique needs of rare disease patients.

Where can I find more information about Recordati?

For more details on Recordati’s initiatives and products, please visit their official website.

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