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Sirona Biochem Announces CFDA Approval of SGLT2 Inhibitor for Phase I Clinical Trial
VANCOUVER, British Columbia, July 12, 2018 (GLOBE NEWSWIRE) -- Sirona Biochem Corp. (TSX-V:SBM) (FSE:ZSB) (the “Company”) announced today that partner, Jiangsu Wanbang Biopharmaceuticals (“Wanbang”), has confirmed the Investigational New Drug (IND) submission to China’s Food and Drug Administration (CFDA) for its SGLT2 inhibitor was approved for clinical trial. Wanbang will be entering a Phase I clinical trial for the treatment of Type 2 diabetes. The CFDA approval triggers a $500,000 USD milestone payment to Sirona Biochem.
Sirona Biochem’s SGLT2 inhibitor, TFC-039, was licensed to Wanbang’s parent company, Shanghai Fosun Pharmaceuticals in 2014 with rights for China. Since the initial licensing agreement, Fosun Pharma has invested more than RMB 29 million toward the development of the SGLT2 inhibitor.
According to the International Diabetes Federation and the World Health Organization, China now has some of the highest rates of diabetes cases, affecting 110 million people, or 11% of the population. Over 90% of the cases are Type 2 diabetes.
“Wanbang has been very dedicated to this project and we are pleased to be advancing to the clinic with the compound,” said Dr. Howard Verrico, CEO. “With the surging rates of diabetes in China, there remains a need for new therapies. TFC-039 will be able to enter this market as a once-daily drug or add-on therapy for the many people struggling with this disease.”
About Jiangsu Wanbang Biopharmaceuticals
Jiangsu Wanbang Pharmaceuticals manufactures and sells a variety of products including those for chronic disease treatment, antibiotics, and other endocrine diseases. Parent company, Fosun Pharma, is a leader in the pharmaceutical industry and regarded as one of the top five domestic pharmaceutical companies in China.
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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For more information regarding this press release, please contact:
Christopher Hopton, CFO
Sirona Biochem Corp.
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.