San Diego, CA (Press Release) – Ligand Pharma­ceu­ticals Incorporated (NASDAQ: LGND) partner CASI Pharma­ceu­ticals, Inc. (Nasdaq: CASI), a U.S. bio­pharma­ceu­tical com­pany focused on devel­op­ing and accelerating the launch of inno­va­tive thera­peutics and pharma­ceu­tical prod­ucts in China, the U.S., and through­out the world, announces the official prod­uct launch of mel­phalan hydro­chlo­ride for injection (EVOMELA) in China which is the first commercial prod­uct launch for CASI. EVOMELA uses Ligand’s Captisol tech­nology in its for­mu­la­tion.

Melphalan hydro­chlo­ride for injection (EVOMELA) received mar­ket approval by the China National Medical Products Admin­istra­tion (NMPA) for use as high-dose con­di­tioning treat­ment prior to hema­to­poietic progenitor (stem) 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.

About Multiple Myeloma

Multiple myeloma is a malignant hema­to­logical disorder that is char­ac­ter­ized 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^1,2 and in Western countries, the esti­mated in­ci­dence is 5.6 cases per 100,000 persons². The esti­mated in­ci­dence of multiple myeloma in China is ~2.0 cases per 100,000 persons³, 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 (stem) cell trans­plan­ta­tion is esti­mated to be approx­i­mately 16,900 / year. The current number of patients with multiple myeloma who undergo hema­to­poietic progenitor (stem) cell trans­plan­ta­tion in China is esti­mated to be approx­i­mately 800 / year. Autologous stem cell trans­plan­ta­tion (ASCT) has been dem­onstrated to im­prove com­plete response rates and prolong median over­all survival in patients with multiple myeloma^1,3 and is con­sidered standard of care for trans­plant-eligible patients. The preferred con­di­tioning regi­men for ASCT is mel­phalan¹.

About Captisol®

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.

About CASI Pharma­ceu­ticals

CASI Pharma­ceu­ticals is a U.S. bio­pharma­ceu­tical com­pany focused on devel­op­ing and accelerating the launch of pharma­ceu­tical prod­ucts and inno­va­tive thera­peutics in China, the U.S., and through­out the world. More in­for­ma­tion on CASI is avail­able at www.casipharmaceuticals.com.

About Ligand Pharma­ceu­ticals

Ligand is a bio­pharma­ceu­tical com­pany focused on devel­op­ing or acquiring tech­nolo­gies that help pharma­ceu­tical com­pa­nies discover and develop med­i­cines. Ligand’s business model creates value for stockholders by providing a di­vers­i­fied portfolio of bio­tech and pharma­ceu­tical prod­uct revenue streams that are sup­ported by an efficient and low corporate cost structure. Ligand’s goal is to offer in­vestors an oppor­tu­ni­ty to par­tic­i­pate in the promise of the bio­tech industry in a profitable, di­vers­i­fied and lower-risk business than a typical bio­tech com­pany. Ligand’s business model is based on doing what we do best: drug discovery, early-stage drug devel­op­ment, prod­uct reformulation and partnering. Ligand partners with other pharma­ceu­tical com­pa­nies to leverage what they do best (late-stage devel­op­ment, regu­la­tory man­agement and com­mer­cial­iza­tion) to ultimately generate our revenue. Ligand’s Captisol® plat­form tech­nology is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. OmniAb® is a patent-protected transgenic animal plat­form used in the discovery of fully human mono-and bispecific thera­peutic anti­bodies. Ligand has estab­lish­ed multiple alliances, licenses and other business rela­tion­ships with the world's leading pharma­ceu­tical com­pa­nies in­clud­ing Amgen, Merck, Pfizer, Gilead, Janssen, Baxter Inter­na­tional and Eli Lilly.

Forward-Looking Statements

This news release con­tains for­ward-looking state­ments by Ligand that involve risks and un­cer­tain­ties and reflect Ligand’s judgment as of the date of this release. These in­clude state­ments re­gard­ing the ex­pec­ted royalties Ligand ex­pec­ts to receive from the sale of Evomela in China and the esti­mated patient pop­u­la­tion size of multiple myelopma in the China and elsewhere. Actual events or results may differ from our ex­pec­ta­tions. For example, CASI Pharma­ceu­ticals could fail to execute on its business strategy in China; CASI Pharma­ceu­ticals’ lack of ex­peri­ence in manu­fac­tur­ing prod­ucts and un­cer­tainty about its resources and capabilities to do so on a clin­i­cal or commercial scale; CASI Pharma­ceu­ticals may encounter issues, delays or other chal­lenges in launching or com­mer­cial­iz­ing Evomela in China, in­clud­ing issues related to mar­ket acceptance and reim­burse­ment; CASI Pharma­ceu­ticals may encounter unexpected safety or tolerability issues with Evomela; and the number of patients in China or elsewhere with multiple myeloma may be sig­nif­i­cantly smaller than CASI Pharma­ceu­ticals has reported. The failure to meet ex­pec­ta­tions with respect to any of the foregoing matters may reduce Ligand’s stock price. Additional in­for­ma­tion con­cern­ing these and other im­por­tant risk factors affecting Ligand can be found in Ligand’s prior press releases avail­able at www.ligand.com as well as in Ligand’s public periodic filings with the Se­cu­ri­ties and Exchange Com­mis­sion, avail­able at www.sec.gov. Ligand disclaims any intent or obli­ga­tion to update these for­ward-looking state­ments beyond the date of this press release, except as required by law. This caution is made under the safe harbor provisions of the Private Se­cu­ri­ties Lit­i­ga­tion Reform Act of 1995.

References

1. S. Rajkumar, Mayo Clin Proc. 2016 Jan­u­ary­; 91(1): 101–119
2. A. Palumbo, N Engl J Med, 2011; 364: 1046-60
3. J. Lu, Blood Cancer Journal (2014) 4, e239; doi:10.1038/bcj.2014.55

Source: Ligand.