Research & Development
Ligand Partner CASI Pharmaceuticals Launches EVOMELA in China
12 August 2019 - - US-based Ligand Pharmaceuticals Inc. (NASDAQ: LGND) partner CASI Pharmaceuticals, Inc. (NASDAQ: CASI), a US biopharmaceutical company focused on developing and accelerating the launch of innovative therapeutics and pharmaceutical products in China, the US, and throughout the world, has launched of melphalan hydrochloride for injection (EVOMELA) in China which is the first commercial product launch for CASI, the companies said.

EVOMELA uses Ligand's Captisol technology in its formulation.

Melphalan hydrochloride for injection (EVOMELA) received market approval by the China National Medical Products Administration for use as high-dose conditioning treatment prior to hematopoietic progenitor cell transplant in patients with multiple myeloma, and as a palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate. It is the only approved melphalan product available in China.

Multiple myeloma is a malignant hematological disorder that is characterised by abnormal proliferation of clonal plasma cells in the bone marrow and the secretion of monoclonal immunoglobulins that are detectable in the serum or urine. CASI Pharmaceuticals estimates that multiple myeloma accounts for 10-13% of hematological malignancies and in Western countries, the estimated incidence is 5.6 cases per 100,000 persons.

The estimated incidence of multiple myeloma in China is ~2.0 cases per 100,000 persons, for an estimated annual incidence of approximately 27,8003.

The estimated number of patients in China with multiple myeloma who are candidates for hematopoietic progenitor cell transplantation is estimated to be approximately 16,900/year.

The current number of patients with multiple myeloma who undergo hematopoietic progenitor cell transplantation in China is estimated to be approximately 800/year.

Autologous stem cell transplantation has been demonstrated to improve complete response rates and prolong median overall survival in patients with multiple myeloma and is considered standard of care for transplant-eligible patients. The preferred conditioning regimen for ASCT is melphalan.

Captisol is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs.

Captisol was invented and initially developed by scientists in the laboratories of Dr. Valentino Stella, University Distinguished Professor at the University of Kansas' Higuchi Biosciences Center for specific use in drug development and formulation.

This unique technology has enabled several FDA-approved products, including Amgen's KYPROLIS, Baxter International's NEXTERONE, Acrotech Biopharma L.L.C.'s EVOMELA (US marketer), Melinta Therapeutics' BAXDELA and Sage Therapeutics' ZULRESSO. There are many Captisol-enabled products currently in various stages of development.

CASI Pharmaceuticals is a US biopharmaceutical company focused on developing and accelerating the launch of pharmaceutical products and innovative therapeutics in China, the US, and throughout the world.

Ligand is a biopharmaceutical company focused on developing or acquiring technologies that help pharmaceutical companies discover and develop medicines.