Rockville, MD (Press Release) – CASI Pharma­ceu­ticals, Inc. (Nasdaq: CASI), a U.S. bio­pharma­ceu­tical com­pany focused on devel­op­ing and com­mer­cial­iz­ing thera­peutics and pharma­ceu­tical prod­ucts in China, U.S., and through­out the world, announces the prod­uct launch of EVOMELA® (melphalan for injection) in China which is the first commercial prod­uct for the Company.

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 and commercially avail­able mel­phalan prod­uct in China.

Wei-Wu He, Ph.D., CASI's Chairman and Chief Executive Officer commented, "This is a proud mile­stone for CASI. We have an estab­lish­ed commercial and supply chain infrastructure with hos­pi­tals and physicians ready to accommodate the antic­i­pated demand for this vital treat­ment. The launch of EVOMELA® officially marks the transition of CASI to a full-scale commercial operation. We look for­ward to ad­vanc­ing our prod­uct line and com­mer­cial­iz­ing addi­tional prod­ucts from our hematology on­col­ogy portfolio, as well as other prod­ucts where high unmet medical needs exist."

EVOMELA®, now owned by Acrotech Bio­pharma­ LLC., is one of three drugs that were part of a licensing agree­ment with Spectrum Pharma­ceu­ticals, Inc. which also in­cludes ZEVALIN® and MARQIBO®.

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. 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 auto-hematopoietic stem cell trans­plan­ta­tion is esti­mated to be approx­i­mately 16,900 cases per year. The current number of patients with multiple myeloma who undergo auto-hematopoietic stem cell trans­plan­ta­tion in China is esti­mated to be approx­i­mately 800 cases per 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 high dose mel­phalan 200 mg/m², it is the golden standard con­di­tioning treat­ment.

About CASI Pharma­ceu­ticals

CASI Pharma­ceu­ticals is a U.S. bio­pharma­ceu­tical com­pany focused on devel­op­ing and com­mer­cial­iz­ing inno­va­tive thera­peutics and pharma­ceu­tical prod­ucts in China, the U.S., and through­out the world. CASI's prod­uct pipe­line features (i) an au­tol­o­gous anti-CD19 T-cell ther­apy investigative prod­uct (CNCT19) being devel­oped for the treat­ment of B-ALL and NHL; (ii) CID-103, an anti-CD38 mono­clonal anti­body being devel­oped for the treat­ment of hema­to­logical malig­nan­cies; (iii) three U.S. Food and Drug Admin­istra­tion (FDA)-approved hematology on­col­ogy drugs in-licensed from Acrotech Bio­pharma­ L.L.C. and its affiliates for which CASI has exclusive rights to the greater China mar­ket, con­sist­ing of EVOMELA® (Melphalan for Injection), ZEVALIN® (Ibritumomab Tiuxetan) and MARQIBO® (Vincristine Sulfate Liposome Injection); and (iv) a portfolio of FDA-approved and pend­ing abbre­vi­ated new drug appli­ca­tions (ANDAs), in­clud­ing entecavir and tenofovir disoproxil fumarate (TDF) indicated for the treat­ment of hepatitis B virus. CASI has offices in Rockville, Maryland and a wholly owned sub­sid­i­ary in Beijing, China through which our China operations are conducted. More in­for­ma­tion on CASI is avail­able at www.casipharmaceuticals.com.

Forward-Looking Statements

This news release con­tains for­ward-looking state­ments within the meaning of the Private Se­cu­ri­ties Lit­i­ga­tion Reform Act with respect to the outlook for ex­pec­ta­tions for future financial or business per­for­mance, strategies, ex­pec­ta­tions and goals. Forward-looking state­ments are subject to numerous assump­tions, risks and un­cer­tainties, which change over time. Forward-looking state­ments speak only as of the date they are made, and no duty to update for­ward-looking state­ments is assumed. Actual results could differ ma­teri­ally from those cur­rently antic­i­pated due to a number of factors, in­clud­ing: the dif­fi­culty of executing our business strategy in China; our lack of ex­peri­ence in manu­fac­tur­ing prod­ucts and un­cer­tainty about our resources and capabilities to do so on a clin­i­cal or commercial scale; risks relating to the com­mer­cial­iza­tion, if any, of our prod­ucts and proposed prod­ucts (such as mar­ket­ing, safety, regu­la­tory, patent, prod­uct liability, supply, com­pe­ti­tion and other risks); our in­abil­ity to predict when or if our prod­uct can­di­dates will be approved for mar­ket­ing by the FDA, NMPA, or other regu­la­tory author­i­ties; our in­abil­ity to enter into strategic part­ner­ships for the devel­op­ment, com­mer­cial­iza­tion, manu­fac­tur­ing and distribution of our proposed prod­uct can­di­dates or future can­di­dates; the volatility in the mar­ket price of our common stock; risks relating to the need for addi­tional capital and the un­cer­tainty of securing addi­tional funding on favorable terms; risks asso­ci­ated with CID-103, CNCT19, and our prod­uct can­di­dates; risks asso­ci­ated with CID-103, CNCT19, and our other early-stage prod­ucts under devel­op­ment; risks that results in pre­clin­i­cal and early clin­i­cal models are not nec­es­sar­i­ly indicative of later clin­i­cal results; un­cer­tainties relating to pre­clin­i­cal and clin­i­cal trials, in­clud­ing delays to the commencement of such trials; the lack of success in the clin­i­cal devel­op­ment of any of our prod­ucts; and our dependence on third parties. Such factors, among others, could have a ma­teri­al adverse effect upon our business, results of operations and financial con­di­tion. We caution readers not to place undue reliance on any for­ward-looking state­ments, which only speak as of the date made. Additional in­for­ma­tion about the factors and risks that could affect our business, financial con­di­tion and results of operations, are con­tained in our filings with the U.S. Se­cu­ri­ties and Exchange Com­mis­sion, which are avail­able at www.sec.gov.

EVOMELA®, Zevalin® and Marqibo® are pro­pri­e­tary to Acrotech Bio­pharma­ LLC and its affiliates.

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: CASI Pharma­ceu­ticals.