Vancouver, British Columbia – September 9, 2020 – Sirona Biochem Corp. (TSX-V: SBM) (FSE: ZSB) (US-OTC: SRBCF) (“Sirona”) is pleased to announce it has signed an agreement with Contract Manufacturing Organization (CMO) WuXi AppTec (“WuXi”), Shanghai, to launch large-scale production of TFC-1067, a novel skin dark spot remover, for global commercialization.
WuXi has spent four months developing their manufacturing process for commercial grade TFC-1067. This process was recently completed, resulting in a highly pure production of TFC-1067 with the ability to scale to any quantity needed by Sirona.
Sirona anticipates the need for multi-kilogram production of TFC-1067 through the remainder of 2020 with sustained large-scale quantities for commercialization required in 2021. To prevent gaps in manufacturing, and minimize risk, the compound will be produced in multiple locations. Roowin, the current CMO in France, will remain a producer in addition WuXi.
Given the high potency of TFC-1067, each kilogram of Sirona’s active ingredient will produce up to ten thousand consumer size (fifty milliliters) containers of finished product.
“With our current agreement, as well as potential new global organizations developing interest in TFC-1067 as an active ingredient, we anticipate needing significant quantities of product. WuXi AppTec is one of the most highly regarded CMOs in China and have been excellent to work with thus far”, said Dr. Howard Verrico, CEO of Sirona Biochem. “We’ve taken our time choosing a manufacturer in China to ensure we have the most qualified company for the job. We look forward to our relationship with WuXi and are confident about meeting further milestones near-term.”
About WuXi AppTec
WuXi AppTec provides a broad portfolio of R&D and manufacturing services that enable companies in the pharmaceutical, biotech and medical device industries worldwide to advance discoveries and deliver groundbreaking treatments to patients. As an innovation-driven and customer-focused company, WuXi AppTec helps partners improve the productivity of advancing healthcare products through cost-effective and efficient solutions.
With industry-leading capabilities such as R&D and manufacturing for small molecule drugs, cell and gene therapies, and testing for medical devices, WuXi AppTec’s open-access platform is enabling more than 3,900 collaborators from over 30 countries to improve the health of those in need – and to realize the vision that “every drug can be made and every disease can be treated.”
For more information, please visit: www.wuxiapptec.com
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 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.