CASI Pharmaceuticals Provides Update On Evomela®
CASI Receives Advisory Meeting Notice from China Center for Drug Evaluation
ROCKVILLE, Md. (April 5, 2018) – CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company dedicated to bringing high quality, cost-effective pharmaceutical products and innovative oncology therapeutics to patients, announces receipt of a letter from the Center for Drug Evaluation (CDE) (group within the China FDA in charge of technical review) indicating that EVOMELA® (melphalan) for injection has been scheduled for review by the Expert Advisory Anti-Tumor (Oncology) Drugs Committee (the “Advisory Committee”), which is scheduled to take place between April 25-26, 2018 (the “Advisory Committee Meeting”).
The Advisory Committee Meeting is a closed meeting. No additional information on the EVOMELA® application has been requested by the CDE in advance of the Advisory Committee Meeting, however, CASI will submit a Clinical Data Briefing Package which will summarize the various components contained in the previously submitted application.
EVOMELA® was accepted under CFDA’s new guidelines for priority review and the review by the Advisory Committee was expected as part of the recently implemented CFDA reforms. CASI anticipates that after the Advisory Committee Meeting, the Advisory Committee will make a recommendation to CDE, followed by CDE recommendation to CFDA, and CFDA notification of review status to CASI.
As reported previously, the September 2017 CFDA letter provided the following reasons for granting priority review of EVOMELA®:
- EVOMELA® is indicated for the treatment of multiple myeloma, which is classified as a rare disease in China;
- There is no melphalan in any formulation available in China to address this unmet medical need;
- EVOMELA® has clear therapeutic advantage to currently available therapeutics.
Wei-Wu He, Ph.D., CASI Pharmaceuticals Executive Chairman, commented, “Receiving notice from CDE regarding the Advisory Committee Meeting is very exciting news. This indicates the completion of the CDE’s initial review of the EVOMELA® NDA package and referral to the panel of independent experts is the next step in the review process. Multiple myeloma is the second most common hematological malignancy which often occurs in elderly patients. The Advisory Committee review of the EVOMELA® application marks a significant milestone toward addressing an unmet medical need for patients with multiple myeloma in China, as there are no versions of melphalan commercially available. EVOMELA®’s innovative and proprietary new formulation of melphalan offers significant advantages in that it does not contain propylene glycol which causes significant side effects, has long stability and is the only intravenous melphalan product approved for use in the high-dose conditioning indication in pre- transplant therapy”.
About CASI Pharmaceuticals, Inc.
CASI is a U.S. based biopharmaceutical company dedicated to bringing high quality, cost-effective pharmaceutical products and innovative oncology therapeutics to patients.CASI’s product pipeline features (1) EVOMELA®, MARQIBO®, and ZEVALIN®, all U.S. Food and Drug Administration (FDA) approved drugs in-licensed from Spectrum Pharmaceuticals, Inc. for China regional rights, and currently in various stages in the regulatory process for market approval in China, (2) an acquired portfolio of 25 FDA-approved abbreviated new drug applications (ANDAs), one ANDA that was tentatively approved and three ANDAs that are pending FDA approval, from which CASI will prioritize a select subset for product registration and commercialization in China, (3) our proprietary drug candidate, ENMD-2076, currently in Phase 2 clinical development, and (4) proprietary early-stage candidates in immuno-oncology preclinical development. CASI is headquartered in Rockville, Maryland and has a wholly owned subsidiary and R&D operations in Beijing, China. More information on CASI is available at www.casipharmaceuticals.com and in the Company’s filings with the U.S. Securities and Exchange Commission.
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 risk that we may be unable to continue as a going concern as a result of our inability to raise sufficient capital for our operational needs; the possibility that we may be delisted from trading on the Nasdaq Capital Market; the volatility in the market price of our common stock; risks relating to interests of our largest stockholders that differ from our other stockholders; the risk of substantial dilution of existing stockholders in future stock issuances, the difficulty of executing our business strategy in China; the risk that we will not be able to effectively select, register and commercialize products from our recently acquired portfolio of ANDAs; our inability to predict when or if our product candidates will be approved for marketing by CFDA authorities; our inability to enter into strategic partnerships for the development, commercialization, manufacturing and distribution of our proposed product candidates or future candidates; risks relating to the need for additional capital and the uncertainty of securing additional funding on favorable terms; risks associated with our product candidates; risks associated with any early- stage products under development; the risk 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; dependence on third parties; and risks relating to the commercialization, if any, of our proposed products (such as marketing, safety, regulatory, patent, product liability, supply, competition and other risks). 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.