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HanAll BioPharma Co., Ltd. (009420.KS) Release: U.S. IND Accepted by the FDA in Support of the Clinical Development HL 007, a Unique Fixed Dose Combination to Treat Cardiovascular Disease


7/9/2010 5:09:00 PM

Seoul, Korea; Rockville, MD, July 8, 2010: HanAll BioPharma, a top 15 Korean-based company, with corporate development offices in Rockville, MD and Philadelphia, announces that through its U.S. affiliate, HanAll Pharmaceutical International, Inc., a U.S. IND has been accepted by the FDA to support the future clinical development of HL 007. The drug is a unique fixed dose combination of simvastatin and amlodipine. This is a major milestone for HanAll and demonstrates its global strategy in the development of novel therapeutics for the benefit of patients worldwide.

HanAll is the innovator of a novel series of combination products for the treatment of cardiovascular disease (hypertension, hyperlipidemia). The formulations combine well characterized statins, anti-hypertensives (CCB, ARBs) and other potential combinations with a time delayed release profile that avoids the potential for drug-drug interactions and maximizes efficacy and outcome measures of the separate entities. Thus, this novel approach provides a PK profile that mimics monotherapy BUT provides the convenience of fixed dose combinations. The lead product, HL 007, is the combination of simvastatin (immediate release) and amlodipine (4-5 hour delayed release). A Phase II HL 007clinical trial has been completed in Korea for HL 007 with a U.S. trial planned for Q4 2010. HanAll has identified over 30 proprietary combinations and formulations in the XC Hybrid Combination portfolio.

ABOUT HANALL BIOPHARMA CO., LTD.

HanAll BioPharma is a publicly traded global pharma company listed on the Korean Stock Exchange. It is developing innovative and unique products to treat major diseases for the global market. The company has proprietary programs with broad therapeutic applications.

In the pipeline of modified protein therapeutic molecules, called Resistein™ technology, include Hanferon™ (interferon alpha), HanTropin™ (hGH), Interferon beta, TPO and anti-TNF alpha. The molecules are modified through amino acid substitutions and domain engineering to resulting in resistance to GI and serum proteolysis for the development of next generation injectables as well as molecules for ORAL administration. The lead protein therapeutic, Hanferon™, will undergo Phase 1b/2a clinical testing in hepatitis C patients in the U.S. Substance patents have been issued for the lead molecules with other patents pending in the U.S, Europe and Asia. HanAll was the recipient of a $4 million dollar SMART award from the Korean government to support the global development of Hanferon™.

Recent publications from some very prominent cancer institutions have touted and endorsed the use of metformin as neoadjuvant anticancer treatment to improve overall response rates, reduce recurrence and lower the incidence of metastases. HanAll has developed a series of metformin salts that may improve the overall PK and efficacy/side effect profile compared to metformin HCl. In addition, the company has developed a series of biguanide derivatives that have demonstrated potencies 100x that seen with metformin. These series of metformin salts and biguanide derivatives are proprietary to HanAll.

HanAll is seeking regional and/or global partners for the development and commercialization of its product pipelines. For more information please visit our website at www.hanallbiopharma.co.kr

Contact: Andrew J. Gorman, Ph.D.; (301) 738-3980, (215) 757-9096; ajgorman@hanall.co.kr



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