Rare Daily Staff

Sanofi has entered into a definitive merger agreement with Kadmon Holdings as part of its strategy to grow core assets and immediately add Kadmon’s approved therapeutic to its transplant portfolio.

The U.S. Food and Drug Administration recently approved Kadmon’s Rezurock, a first-in-class therapy, for the treatment of chronic graft-versus-host disease (cGVHD) for adult and pediatric patients 12 years and older who have failed at least two prior lines of systemic therapy.

Graft versus Host Disease (GVHD) is a rare disorder that can strike persons whose immune system is deficient or suppressed and who have received a bone marrow transplant or a nonirradiated blood transfusion.

Shareholders of Kadmon common stock will receive $9.50 per share in cash, which represents a total equity value of approximately $1.9 billion (on a fully diluted basis). The offer price represents a premium of 79 percent over the closing price on September 7, 2021 and a premium of approximately 113 percent over the 60 trading days volume weighted average price. The Sanofi and Kadmon Boards of Directors unanimously approved the transaction.

“We are transforming and simplifying our General Medicines business and have shifted our focus on differentiated core assets in key markets,” said Olivier Charmeil, executive vice president of General Medicines for Sanofi. “Our existing scale, expertise, and relationships in transplant create an ideal platform to achieve the full potential of Rezurock, which will address the significant unmet medical needs of patients with chronic graft-versus-host disease around the world.”

Sanofi’s transplant business mainly consists of Thymoglobulin, a polyclonal, anti-human thymocyte antibody preparation that acts as a broad immunosuppressive and immunomodulating agent and Mozobil, a hematopoietic stem cell mobilizer. Both products are among General Medicines core assets and are currently registered and marketed in more than 65 countries.

In July 2021, the FDA approved Rezurock for the treatment of adult and pediatric patients 12 years and older with cGVHD after the failure of at least two prior lines of systemic therapy. Rezurock was launched in August in the United States. It is the first and only approved small molecule therapy that inhibits the Rho-associated coiled-coil kinase 2 (ROCK2), a signaling pathway that modulates inflammatory response and fibrotic processes. Sanofi will work closely with regulatory authorities across different geographies to ensure that patients suffering from cGVHD can benefit from belumosudil treatment as early as possible. Kadmon is also developing Rezurock for the treatment of diffuse cutaneous systemic sclerosis, with an open-label phase 2 clinical trial currently ongoing. The company’s pipeline also includes drug candidates for immune and fibrotic diseases as well as immuno-oncology therapies.

“By leveraging Sanofi’s global resources and long-standing expertise in developing and commercializing innovative medicines, Rezurock is now well positioned for global accessibility, faster,” said Harlan Waksal, president and CEO of Kadmon.

The transaction is subject to customary closing conditions, including the approval of holders of a majority of the outstanding shares of Kadmon voting stock, and other customary conditions. Following the successful completion of the merger, a wholly owned subsidiary of Sanofi will merge with Kadmon and the outstanding Kadmon shareholders will receive $9.50 per share in cash. Sanofi plans to fund the transaction with available cash resources and expects to complete the acquisition in the fourth quarter of 2021.

Photo: Olivier Charmeil, executive vice president of General Medicines for Sanofi

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