Sanofi is intent on investing more into its transplant operations through a $1.9 billion merger deal with Kadmon Holdings, another biopharma company that develops therapies for diseases with large unmet medical needs.

The acquisition expands Sanofi’s General Medicines core assets and highlights the addition of Rezurock (belumosudil) to its transplant portfolio. In July, the U.S. Food and Drug Administration approved Rezurock as a treatment for chronic graft-versus-host disease (cGVHD) for adults and pediatric patients aged 12 years and older who have had at least two lines of systemic therapy but failed on both occasions.

Chronic graft-versus-host disease is an illness that develops in about 50 percent of patients who have been transplanted with stem cells from a mismatched related donor or a matched unrelated donor. It is different from acute GVHD and is not a complication for patients transplanted with their own stem cells. Patients diagnosed with this cGVHD are commonly placed on long-term immunosuppressive medicines and treatment could take months to years.

In a statement, Sanofi said it will work closely with regulatory authorities to ensure that those who are suffering from cGVHD will have access to Rezurock as early as possible to increase their chances for success. Kadmon is also developing the drug for the treatment of diffused cutaneous systemic sclerosis and is currently overseeing an ongoing Phase II clinical trial on the product.

“We are thrilled to add Kadmon’s Rezurock to our well-established transplant portfolio. 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,” said Olivier Charmeil, executive vice president of General Medicines at Sanofi.

Most cGVHD treatments act as immunosuppressants, but Rezurock is not limited to being just that. It is designed to rebalance the immune system by blocking the ROCK2 pathway in a way that could reduce symptoms of fibrosis and inflammation. However, its drug literature says that it has the potential to be hepatotoxic. Patients taking Rezurock are, thus, advised to have their livers checked monthly throughout the course of the treatment. The drug also might affect fertility in both men and women.

The acquisition of Kadmon values the company at around $1.9 billion, with shareholders expecting to receive $9.50 per share in cash upon completion of the deal, which is still pending due process, shareholder approvals, and regulatory approvals.

“We are excited that Sanofi has acknowledged the value of Rezurock and the deep potential of our pipeline. 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,” commented Harlan Waksal, M.D., president and chief executive officer of Kadmon.

The addition of Rezurock to Sanofi’s assets strengthens its transplant portfolio, specifically its General Medicines core asset arm, which is currently known for two products: Thymoglobulin (anti-thymocyte globulin), a broad immunosuppressive and immunomodulating agent, and Mozobil (plerixafor), a hematopoietic stem cell mobilizer.

Thymoglobulin is a T-cell-depleting agent taken as prophylaxis for acute organ rejection, while Mozobil is typically used as part of treatment for multiple myeloma and Non-Hodgkin’s lymphoma. Both are registered for the mentioned indications in over 65 countries.

Transplant News Sharing // “Pediatric Transplant” – Google News from Source www.biospace.com

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