Han All Pharmaceutical Co., Ltd. (009420.KS) Awarded $3.2 MM USD from the South Korean Government to Support Global Development of its Novel Hanferon(TM) SC Protein Therapeutic
7/21/2009 2:05:01 PM
SEOUL, KOREA, July 20, 2009: HanAll Pharmaceutical Co., Ltd. is pleased to announce that the company has been awarded a $3.2 MM USD grant from the South Korean government under the New Growth Engine (SMART) Project. HanAll is one of only four companies from a total of 48 project proposals to be awarded SMART funding. The purpose of this government program is assist Korean-based companies to accelerate the commercialization of protein therapeutics for the United States and European markets. The funding is specifically awarded to support a U.S. Phase II clinical study of its lead product, Hanferon™ SC, in Hepatitis C patients. Hanferon™ SC is an injectable form of an amino acid mutated analogue of interferon-alpha 2b which has demonstrated a superior product profile compared to Intron-A and native interferon in preclinical and clinical studies. A Phase I pharmacokinetic and safety study has been completed. Repeated dosing of Hanferon™ SC in preclinical toxicology studies demonstrate that no new epitopes or neutralizing antibodies are produced.
Various reports estimate that the global protein therapeutic market will grow from $57 Billion in 2006 at a CAGR of 12.8% till 2013. Of the total number of protein therapeutics, 98% are administered by injection (IV or SC).
To improve the PK profile of injectable proteins, formulation technology such as pegylation has been employed. However, toxicity issues and limitations in patient populations are evident with pegylated therapeutics, especially in the case of long-term treatment of pegylated proteins, such as 48 weeks treatmet of pegylated interferon-alpha for hepatitis C patients. Amino acid substitution technology has recently been employed to improve the physiochemical properties of proprietary, injectable proteins currently on the market, such as Lantus® (Sanofi Aventis), Lispro® (Eli Lilly) and Aranesp® (Amgen). In contrast, HanAll utilizes high throughput, point mutation utilizing 2-D scanning technology to develop biologics demonstrating significant resistance to human proteases (GI tract and serum) while retaining their biological activity.
The pharmacokinetic profile of protein therapeutics is highly related to protein stability. The stability of a protein in vivo is highly affected by proteolysis in tissue/blood. Proteolysis is a highly defined and structured process in which proteolytic digestion occurs at a defined ‘entry site(s)’ on the protein and follow a specific pathway down to protein fragments. Point mutation at the ‘entry sites’ results in a protein’s resistance to proteolytic degradation, without altering its biological activity. Thus, HanAll’s proprietary process of ‘domain engineering’ and ‘point mutations at the entry sites’ inhibits proteolysis allowing the proteins to be orally bioavailable but also results in orders of magnitude greater potency and longer half life compared to native proteins when administered subcutaneously.
Included in HanAll’s protein therapeutic pipeline are oral and injectable formulations of interferon-alpha, human growth hormone, interferon-beta, EPO, TPO and anti-TNF alpha proteins. A Phase I clinical trial has been completed under a FDA sponsored IND for HanAll’s lead molecule, Hanferon™ SC (Interferon-alpha), and there is an active IND for the second lead molecule, Vitatropin™, an orally bioavailable human growth hormone. There are a series of preclinical candidates at various stages of development, all demonstrating significant resistance to proteolysis.
About HanAll Pharmaceuticals Co., Ltd.
HanAll is a top-10 Korean-based R&D company established in 1973 with U.S. offices in Rockville, MD and Philadelphia, PA (subsidiary HanAll Pharmaceutical International, Inc.). The company was listed on the Korean stock market in 1989 with 2008 revenue of $90 MM and a market capitalization of $160 MM. In addition to its novel protein therapeutic pipeline, HanAll conducts R&D in the areas of cardiovascular (XC Hybrid Combinations), diabetes and dermatology. The company is currently in active discussions with multinational companies in support of its out licensing strategy for its pipeline of products and welcomes further inquiries from interested parties about licensing opportunities.