SOURCE: Sirona Biochem Corp.

Sirona Biochem Corp.

March 04, 2015 09:00 ET

Sirona Biochem: Positive Preclinical Toxicology Results for its SGLT2 Inhibitor Trigger Milestone Payment from Wanbang Biopharmaceuticals

VANCOUVER, BC--(Marketwired - March 04, 2015) - Sirona Biochem Corp. (TSX VENTURE: SBM) (FRANKFURT: 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.

"The 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 humans", 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.

About Sirona Biochem Corp.

Sirona Biochem is a cosmetic ingredient and drug discovery company with a proprietary platform technology. Sirona specializes in stabilizing carbohydrate molecules with the goal of improving efficacy and safety. New compounds are patented for maximum revenue potential.

Sirona's compounds are licensed to leading companies around the world in return for licensing fees, milestone fees and ongoing royalty payments. Sirona's laboratory, TFChem, is located in France and is the recipient of multiple French national scientific awards and European Union and French government grants. For more information please visit www.sironabiochem.com.

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Sirona Biochem cautions you that statements included in this press release that are not a description of historical facts may be forward-looking statements. Forward-looking statements are only predictions based upon current expectations and involve known and unknown risks and uncertainties. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of release of the relevant information, unless explicitly stated otherwise. Actual results, performance or achievement could differ materially from those expressed in, or implied by, Sirona Biochem's forward-looking statements due to the risks and uncertainties inherent in Sirona Biochem's business including, without limitation, statements about: the progress and timing of its clinical trials; difficulties or delays in development, testing, obtaining regulatory approval, producing and marketing its products; unexpected adverse side effects or inadequate therapeutic efficacy of its products that could delay or prevent product development or commercialization; the scope and validity of patent protection for its products; competition from other pharmaceutical or biotechnology companies; and its ability to obtain additional financing to support its operations. Sirona Biochem does not assume any obligation to update any forward-looking statements except as required by law.

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