March 04, 2015 – Sirona Biochem Corp.
Vancouver, British Columbia – March 4, 2015 – Sirona Biochem Corp. (TSX-V: SBM) (FSE: ZSB) today announced that Wanbang Biopharmaceuticals has successfully completed the toxicology study in the pre-clinical validation of its anti-diabetic SGLT2 Inhibitor, SBM-TFC-039, for the treatment of Type 2 diabetes.
In the study, SBM-TFC-039 was orally administered to Sprague Dawley (SD) rats for 14 days to evaluate safety and simultaneously observe toxicokinetics. Dosing of SBM-TFC-039 was either 0, 100, 300 or 800 milligrams per kilogram per day (mg/kg/day) as well as 300 mg/kg/day of the reference drug Canagliflozin.
The results of the study demonstrated that the maximum tolerated dose (MTD) of SBM-TFC-039 was greater than 800 mg/kg/day, which was significantly greater than the 300 mg/kg/day of the Canagliflozin reference. There was no mortality in the groups treated with SBM-TFC-039 and the histopathology showed no visual abnormalities.
The reference drug Canagliflozin is Johnson and Johnson’s SGLT2 inhibitor for type 2 diabetes. It was the first SGLT2 inhibitor launched and it has been on the market in many countries including the United States since 2013. Sales in 2013 were $150 million and in 2014 were $622 million. Sales forecasts for this year are $1 billion.
The completion of this test will trigger a milestone payment to Sirona from Wanbang Biopharmaceuticals as part of the $9.5M in upfront and milestone payments.
â€œThe results of the toxicology study are very encouraging. They provide the preclinical validation to proceed to second line testing which comprises of additional safety and tolerability testing with pharmacokinetics. This is the last step required before moving towards investigational new drug (IND) status in humansâ€, said Attila Hajdu, Chief Business Development Officer of Sirona Biochem.
About Wanbang Biopharmaceuticals
Wanbang Biopharmaceuticals is the leading pharmaceutical company in China that specializes in research, production and marketing of medicines for diabetes, cardiovascular disease and endocrinology. Among domestic pharmaceutical companies, Wanbang Biopharmaceuticals is one of the largest manufacturers and marketers of a comprehensive portfolio of drugs for diabetes.
Wanbang Biopharmaceuticals is a subsidiary of Shanghai Pharmaceutical Group which is listed on the Shanghai Stock Exchange. Fosun Pharma, one of the major shareholders of Sinopharm Group, the largest drug distributor in China, is part of Fosun International, the leading non-state owned enterprise group in China which is listed on the Hong Kong Stock Exchange.