South Korean pharmaceutical firms are seeking ways to develop combination drugs to challenge Pfizer Pharmaceuticals Korea’s osteoporosis treatment Viviant (ingredient: bazedoxifene), after failing to break Pfizer’s drug patent, industry sources said Monday.
Their strategies are mostly combining bazedoxifene with a Vitamin D, cholecalciferol.
The latest move came from Hyundai Pharmaceutical, which received approval from the Ministry of Food and Drug Safety on its clinical trial plan with a combination drug of bazedoxifene and cholecalciferol. Earlier, Korea Kolmar and Youyoung Pharmaceutical also received similar grants from the ministry. Inisti Bio Pharmaceutical is seeking a joint developer in a similar move.
Youyoung Pharmaceutical got the ministry’ approval on “YYC401,” a Viviant combination product, 18 for a first-stage clinical trial, on July 18. The trial was to be on 52 people, consisting of healthy men and postmenopausal women, comparing efficacy and pharmacodynamics of YYC401 with separate intakes of bazedoxifene and cholecalciferol together. The firm is reportedly developing the drug in partnership with four other pharmaceutical companies.
Korea Kolmar also got an approval on a similar clinical trial on Sept. 8, testing Viviant combo “KKM-171” on 52 healthy men and postmenopausal women.
Hyundai Pharmaceutical received the go-ahead on Sept. 14 to conduct “HDDO-1614” first-stage clinical trial on 36 men and women, comparing pharmacodynamics of HDDO-1614 with separate intakes of bazedoxifene and cholecalciferol together.
Viviant is prescribed for the treatment of postmenopausal osteoporosis, using major ingredient bazedoxifene, or a selective estrogen receptor modulator (SERM). The drug’s annual sales reached 7.3 billion won ($6.4 million) last year, according to UBIST data.
Viviant’s patent in Korea expires on Dec. 14, 2018. Local pharmaceutical companies’ attempts to break the patent have failed to date. As the firms realized that prescriptions for osteoporosis usually come with a prescription of a Vitamin D, they have searched ways to develop combination drugs.
Pfizer Pharmaceuticals Korea does not have a Vitamin D combination product involving Viviant. The company has Duavive, a combo between bazedoxifene and conjugated estrogens.