CASI Pharmaceuticals Highlights 2014 Accomplishments And 2015 Milestones

Jan 16, 2015, 07:00 ET from CASI Pharmaceuticals, Inc.

ROCKVILLE, Md., Jan. 16, 2015 /PRNewswire/ -- CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company dedicated to the acquisition, development and commercialization of innovative therapeutics addressing cancer and other unmet medical needs for the global market with a primary commercial focus on China, today highlighted the Company's accomplishments in 2014 and anticipated milestones for 2015.

Ken K. Ren, Ph.D., CASI's Chief Executive Officer, stated, "Our long term value proposition and near term value drivers are built on the execution of our mission to become an integrated pharmaceutical company with a deep product pipeline. 2014 was a foundation year for us as we added three additional late-stage oncology products, moved forward with ENMD-2076 and developed a novel drug delivery technology that will allow us to move forward with a reformulated 2-ME2 and other potential compounds. We will continue our diversified and risk managed approaches of: (i) acquiring drug candidates from the U.S. for commercialization in the greater China market; (ii) internally developing novel drug candidates to address significant unmet needs, and (iii) internally developing proprietary candidates using our novel drug delivery technology for the worldwide market. Moving forward, we have a strong balance sheet and believe that 2015 will be a breakout year for us. We are excited about our prospects and are confident in our ability to achieve new milestones."

2014 Accomplishments

  • Acquired the exclusive commercial rights to two U.S. FDA-approved drugs, ZEVALIN®, MARQIBO®, and one NDA-stage asset, Captisol-EnabledTM Melphalan for the greater China region from Spectrum Pharmaceuticals, Inc.
  • Further advanced three Phase II trials of ENMD-2076 that are currently ongoing in North America in patients with triple-negative breast cancer (TNBC), soft tissue sarcoma (STS), and ovarian clear cell carcinoma.
  • Received CFDA's approval to expand Phase II trials of ENMD-2076 TNBC and STS into China.
  • Established an R&D center in Beijing and developed a novel drug delivery technology to significantly increase the bioavailability and stability of certain known oncology drug compounds, including its drug candidate 2-methoxyestradiol (2-ME2).
  • Identified two additional oncology drug candidates as a result of the above-mentioned drug delivery technology.

2015 Anticipated Milestones

  • Meet with FDA, finalize clinical trial protocol and development plan leading to NDA filing of ENMD-2076 in the first-line treatment of fibrolamellar carcinoma (FLC).
  • File Orphan Drug Designation for FLC in EU.
  • Initiate an advanced-stage ENMD-2076 trial for first-line treatment of FLC.
  • Continue progress of ENMD-2076 Phase II trials and correlative biomarker analysis, report study data of TNBC and STS trials in North America.
  • Expand ENMD-2076 Phase II TNBC and STS trials into China.
  • Launch ZEVALIN in Hong Kong.
  • File Import drug registration for ZEVALIN in China and Taiwan.
  • File Import drug registration for MARQIBO in China, Hong Kong, and Taiwan.
  • Advance 2-ME2 and one additional oncology drug candidate from our novel drug delivery technology into human proof-of-concept clinical trials.
  • Expand management team by adding additional key talent for clinical and commercial advancement.
  • Acquire additional drug candidates for the greater China region or worldwide.

About CASI Pharmaceuticals, Inc.

CASI is a biopharmaceutical company dedicated to the acquisition, development and commercialization of innovative therapeutics addressing cancer and other unmet medical needs for the global market with a primary commercial focus on China. CASI's product pipeline includes exclusive rights to ZEVALIN® (ibritumomab tiuxetan), MARQIBO® (vinCRIStine sulfate LIPOSOME injection) and Captisol-EnabledTM (propylene glycol-free) melphalan (CE melphalan) for greater China (including Taiwan, Hong Kong and Macau).  CASI's development pipeline also includes its proprietary drug candidate ENMD-2076, a selective angiogenic kinase inhibitor currently in multiple Phase 2 oncology studies, and 2ME2 (2-methoxyestradial) currently under reformulation development, with additional two oncology drug candidates recently identified and under development with its drug delivery technology. 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. In addition, CASI will be updating its Corporate Presentation to be available on its website at www.casipharmaceuticals.com/investor-relations

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; the difficulty of executing our business strategy in China; our inability to enter into strategic partnerships for the development, commercialization, manufacturing and distribution of our proposed product candidate 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 models are not necessarily indicative of 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; risks relating to the commercialization, if any, of our proposed products (such as marketing, safety, regulatory, patent, product liability, supply, competition and other risks); risks relating to interests of our largest stockholders that differ from our other stockholders; and the risk of substantial dilution of existing stockholders in future stock issuances.  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.

ZEVALIN® and MARQIBO® are registered trademarks of Spectrum Pharmaceuticals, Inc. and its affiliates. Captisol-Enabled™ is the trademark property of its owner.

COMPANY CONTACT:
CASI Pharmaceuticals, Inc.
240.864.2643
ir@casipharmaceuticals.com

INVESTOR CONTACT:
LHA
Kim Sutton Golodetz
212.838.3777
kgolodetz@lhai.com     

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SOURCE CASI Pharmaceuticals, Inc.



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