On May 28, 2009, Yuhan Pharma agreed to in-license HanAll Pharmaceutical’s HL 040, a unique and proprietary time-delayed release formulation combining atorvastatin Ca (immediate release) and losartan potassium (delayed release). Yuhan obtains exclusive rights to co-develop and commercialize HL 040 for the Korean territory. This is the first out-licensing of HanAll’s unique XC Hybrid Combination Cardiovascular pipeline of products. Terms were not disclosed.
About HanAll Pharmaceuticals and XC Hybrid Combination Cardiovascular products: The Company has developed over 30 different combinations of cardiovascular products through its innovative and proprietary XC Hybrid Combination formulation technology. XC Hybrid Combination formulation provides the efficacy, safety and lack of drug-drug interaction of monotherapy BUT also provides the benefits of cardiovascular combination drugs desired by patients and prescribers. The unique formulation avoids the drug-drug interaction at the cytochrome P-450 isoenzyme, CYP3A4, and also P-glycoprotein transporter interactions. This is achieved by the unique time separation and delayed release PK profile of the combination products. These drug-drug interactions with co-administration or conventional combination products (simultaneous release profile) could prove to be serious in older patients and patients with mild to severe renal dysfunction.
HanAll will begin Phase Ib/II clinical studies in the U.S. and Korea in Q3 2009 with its lead product, HL 007, a double matrix combination formulation of simvastatin (immediate release) and amlodipine (delayed release). Bioequivalency and drug interaction studies will be carried out. A second U.S. clinical trial is scheduled for later this year to confirm the time-delayed release product profile of HanAll’s second lead product, HL 008, a combination of losartan and amlodipine.
In addition, HanAll also conducts R&D in the promising areas of oral biologics, anti-atopic dermatitis and second generation metformin products. The company seeks global or regional partners to commercialize these innovative programs.
About Yuhan Corporation
Yuhan is one of the largest pharmaceutical companies in Korea with sales of $500 million USD in 2008. With over 82 years of history, Yuhan founded joint ventures with worldwide pharmaceutical companies (Yuhan-SmithKline, Yuhan-SP, and Yuhan-Cyanamid Co., Ltd.) in Korea. The company is developing and commercializing many leading drugs in the areas of cardiovascular/metabolic, respiratory, anti-infectives, rheumatology and gastrointestinal disorders. The company currently markets the generic versions of atorvastatin and losartan. In addition, Yuhan exported YH1885 (anti-ulcer substance) technologies to SmithKline Beecham Corp. in 2000 and commercialized Revanex (Revaprazan: anti-ulcer substance) in 2008.