Vancouver, British Columbia – December 19, 2017 – Sirona Biochem Corp. (TSX-V: SBM) (FSE: ZSB) (Xetra: ZSB) (the “Company”) announces that all resolutions tabled at its Annual General Meeting held on December 18, 2017, were passed. The resolutions included:
- Fixing the number of directors of the Company at seven;
- Electing Geraldine Deliencourt-Godefroy, Christopher Hopton, Alex Marazzi, Casper Bych and Howard Verrico as directors;
- Appointing MNP LLP, Chartered Accountants, as the Company’s auditor for the ensuing year and authorizing the directors to set the auditor’s remuneration;
- Confirming and approving the Company’s existing stock option plan
As we enter this holiday season, I’d like to take this time to thank you for the continued support of Sirona. We understand that this has been a difficult year due to unexpected delays and we are grateful that you have remained on board with us and share our confidence in the potential of the science.
Following are some highlights from 2017 and what we look forward to in 2018.
Skin Lightener Portfolio
In 2017 we greatly increased the value of the Skin Lightening Portfolio through the development of additional compounds, bringing the total to 7. The expanded portfolio allows the company to penetrate a variety of indications in the skin lightening market in multiple geographic regions. As well, completion of the patent family was necessary to protect our IP, create new opportunities and reduce competitive threats.
2018 will bring a renewed focus on the pursuit of a licensing agreement for TFC-1067. While we had been making considerable progress, we were unable to conclude a definitive agreement in the timeline expected. In light of the challenges faced, we have accelerated the clinical development strategy. A successful clinical trial will yield compelling scientific data which will further increase the value and marketability of the compound.
In addition to developing a clinical trial strategy, we have brought on Kevin Green as a consultant, to drive our 2018 Business Development Strategy. Kevin was previously a Senior Director of Business Development at Allergan PLC. He is well versed in pharmaceutical licensing, from full partner search-and-evaluation through post-close integration. Kevin received his BA from California State University and an MBA in Marketing and Finance from the University of California, Irvine.
Kevin will be part of the Sirona Biochem team attending the JPMorgan parallel conference in San Francisco, California in early January.
SGLT2 Inhibitor, SBM-TFC-039 (Wanbang)
Wanbang Biopharmaceuticals provided a progress report on TFC-039 several days ago. They confirmed that they expect to complete the Investigational New Drug (IND) filing with the China Food and Drug Administration (CFDA) in January 2018. The IND filing will trigger a milestone payment of $500,000 USD.
In May 2017, the CFDA published a series of amendments to its clinical trial evaluation system to speed up approvals. Under the current system, the CFDA has a 60-day limit to respond to a filing. Our consulting legal team for China anticipates it could be less than three months to approve the filing. Approval for the Phase I clinical trial, will result in an additional $500,000 USD payment.
In 2017 Sirona had received interest from a Mumbai, India based pharma company. Although a licensing agreement is not anticipated in the near future, we are optimistic, with added clinical data generated from the Wanbang trials, we will have more interest in the compound.
Cell Preservation and Anti-Aging (Glycoprotein) Library
In September 2017, we announced that interested partners requested a better understanding of the mechanism of action of the compound and that we decided to go back to testing and do a full genomic study. This is a complex study and even more complex analysis and as such, the final report is still being written by the Contract Research Organization (CRO) in Europe. We have received raw data and have evidence of a promising anti-aging technology. We now know far more about the mechanism of action of the compounds. Another very exciting potential indication in the cosmeceutical field has been discovered. However, we are still completing the patent on this and cannot share details at this time.
Several of the compounds have completed chemistry but remain ongoing optimization at the lab. The project has been slowed due to resource allocation, but some preliminary studies are planned in Q1 2018.
This project is on hold due to resource allocation however a development plan is being refined.
Skin Lightener, TFC-849 (Obagi)
The transaction between Valeant and Haitong International Zhonghua Finance Acquisition Fund I LP has been completed. Obagi Medical Products is very busy undergoing restructuring and we have scheduled a dialogue about next steps with our collaboration. Technical issues with commercializing the scale up of this compound persist which are not an issue for TFC-1067 or several other new generation skin lighteners.
Again, we thank you for the support and wish you and yours a Merry Christmas and Happy New Year!
Dr. Howard Verrico, CEO
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.