SEOUL, KOREA, June 24, 2009 -- HanAll Pharmaceutical Co., Ltd. announced that the company has been awarded global and exclusive ownership to all patents, data and documentation related to Nautilus Biotech’s high-speed throughput protein engineering technology and products. With only a small number of companies working in this area, this positions HanAll as a leader in the development of proprietary and novel protein therapeutics.
Nautilus has developed a world-class high-speed throughput protein engineering platform. A French Court’s decision awarded all rights to HanAll in February 2009 with the final contract signed on June 10, 2009. HanAll now has in its portfolio a series of 50 patents covering composition of matter of the mutated proteins which through single point mutations develop resistance to human gastric and plasma proteolysis.
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). This is because native protein therapeutics are only 0.1% orally bioavailable due to degradation through acidic digestion in the stomach, enzymatic digestion (proteases) in the small intestine, limited permeability of large molecules across mucosal membranes and first pass liver metabolism. Although many attempts have been made to enhance oral bioavailability of proteins through absorption enhancers or attempting to protect the native protein from GI degradation, these formulations are still limited, resulting in less than 2% bioavailability.
To improve the PK profile of injectable proteins, formulation technology such as pegylation has been employed. In contrast, amino acid mutation 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). However, HanAll’s process and technique for engineering of the native protein can significantly increase oral bioavailability by as much as 10-15% and greatly improves the overall PK profile when administered subcutaneously. This is achieved by creating resistance to protease degradation. The re-engineered protein can also be coupled to formulation technology to further increase oral bioavailability. In addition, HanAll has been successful in developing a proprietary and highly efficient E. coli derived production process that is 1/10 - 1/15 the cost of production compared to current proteins on the market.
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 and the digestive tract especially in the case of oral delivery. 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 ‘single point mutations at the entry sites’ inhibits proteolysis and render proteins orally bioavailable and 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 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-α), and there is an active IND for the second lead molecule, human growth hormone. There are a series of preclinical candidates at various stages of development, all demonstrating 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 $150 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.
Contact: Andrew J. Gorman, Ph.D. Vice President & Chief, Corporate Development HPI, Inc. (301) 738-3980 (215) 757-9096 ajgorman@hanall.co.kr www.hanall.co.kr