Sirona Biochem Reports 2019 AGM Voting and CEO Update
Momentum Public Relations
Press Release: June 20, 2019
Sirona Biochem Corp. (TSX-V: SBM) (FSE: ZSB) (OTC: SRBCF) (“Sirona“) is pleased to announce the voting results from its Annual General Meeting of Shareholders (the “Meeting”), held in Vancouver, British Columbia on June 20, 2019. The total number of shares represented by shareholders present in person and by proxy at the meeting was 32,141,666 million representing 15.47% of Sirona’s issued and outstanding Common Shares.
All of the matters put forward before shareholders for consideration and approval as set out in the Company’s Management Information Circular dated 22nd of May, 2019, were approved by the requisite majority of votes cast at the Meeting. The details of the voting results for the election of directors are set out below:
Nominee |
# Votes for |
% Votes for |
Géraldine Deliencourt-Godefroy |
31,845,566 |
99.1 |
Howard Verrico |
31,595,566 |
98.3 |
Christopher Hopton |
31,595,566 |
98.3 |
Alex Marazzi |
31,595,566 |
98.3 |
Jason Tian |
Appointed director |
The shareholders also approved: (i) fixing of the number of directors of the Company at five; (ii) appointing MNP LLP, Chartered Accountants, as the Company’s auditor for the ensuing year and authorizing the directors to set the auditor’s remuneration; and (iii) confirming and approving the Company’s existing stock option plan.
The Company will file a report of voting results on all resolutions voted on at the Meeting on www.sedar.com shortly.
CEO AGM Update
Dear Shareholders,
I’d like to take this opportunity to thank you for the continued support of Sirona. It is of great satisfaction to have over 98% of votes cast to support the current management team. This has been an exciting breakthrough year and we are grateful that you have remained on board with us, sharing our successes of Sirona’s novel platform technology.
Rodan + Fields have completed extensive due diligence on TFC-1067. This included both the data package provided by Sirona as well as their independent research and analysis on the compound. Rodan + Fields, the No. 1 skincare brand in North America in terms of total sales, are now moving our novel skin lightener towards full commercialization. The anticipated definitive agreement with Rodan + Fields has enormous value to Sirona, far beyond North America.
It is particularly important for our European shareholders to understand that Rodan + Fields utilizes approximately 300,000 consultants to sell products. Their skincare starter kits are aimed at reducing the appearance of lines, dark spots, and acne in adult women. Rodan + Fields are a perfect fit for Sirona and vice versa. We are confident Rodan + Fields will deliver industry leading products incorporating Sirona’s skin lightener TFC-1067.
After the heavy lifting is done and while we work together with Rodan + Fields through the stages of commercialization, further partners for other sales channels and regions will beat a path to our door. The discussions with our potential TFC-1067 partner for China are also nearing completion.
We anticipate more exciting news from China as Wanbang’s management meets to approve the release of information. We are also in advanced discussions on a large new project with a global corporation that we hope to share with you in Q4/2019.
The current market capitalization for Sirona Biochem has increased substantially thanks to positive company developments as well as growing shareholder support. Sirona’s management has now decided to establish a shareholder rights plan (“Poison Pill”) and has asked our legal counsel to take the necessary steps to put this in place.
The adoption of the Poison Pill is intended to protect Sirona Biochem and its shareholders from the actions of third parties that the Board of Directors determines are not in the best interests of Sirona Biochem and its shareholders, and to enable all shareholders to realize the long-term value of their investment in Sirona Biochem.
The Board of Directors believes that the Poison Pill will ensure that the Board of Directors remains in the best position to discharge its fiduciary duties to Sirona Biochem and its shareholders. The Poison Pill is not intended to interfere with any sale, merger, tender or exchange offer, or other business combination approved by the Board of Directors. Nor does the Poison Pill prevent the Sirona Biochem Board of Directors from considering any offer that it deems to be in the best interest of Sirona Biochem’s shareholders.
We have exciting times ahead of us.
Sincerely,
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.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
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.
SOURCE Sirona Biochem Corp.
View original content to download multimedia: http://www.newswire.ca/en/releases/archive/June2019/20/c1114.html
Contact:
For more information regarding this press release, please contact: Investor Enquiries: Jonathan Williams, Managing Director, Momentum PR, Phone: 1.450.332.6939, Email: jwilliams@momentumpr.com
- Published in Life Sciences, News Home, Sirona Biochem
Sirona Biochem Billion Dollar Skin Lightening Opportunity With TFC-1067 Compound
Sirona Biochem is the center of attention on signing a landmark licensing deal for its proprietary skin-lightening compound with a company topping billions of dollars in sales. The signing of the deal comes at a time of growing demand for skin lightening products with the market poised to reach $20 billion by 2022.
Sirona | Rodan + Field Deal
The cosmetic ingredient and drug discovery company remain well positioned to generate significant value on the burgeoning skin lightening market. Backed by a proprietary platform technology that has already given rise to TFC-1067, the company is already eliciting strong interest from some of the biggest skin care brands.
The signing of a term sheet with Rodan + Fields LLC for proprietary TFC-1067 compound might as well have opened the door for the company to generate significant value going forward. Under the terms of the agreement, Sirona Biochem is to manufacture and supply TFC-1067 for use by Rodan + Fields in its products.
The company stands to generate significant revenues on the sale of the skin-lightening compound. In addition, it is entitled to a fee by Rodan + Fields on the signing of the definitive agreement. The company will also earn milestone fees on each product that Rodan + Fields sales, utilizing the skin-lightening agent TFC-1067. The two have also agreed to establish regular formal meetings to explore future opportunities.
A partnership with Rodan + Fields marks an important milestone as Sirona Biochem seeks to generate significant value from its proprietary skin lighting compound. Skincare brand Rodan + Fields has generated more than $1 billion in sales since 2016, seen as an ideal partner for Sirona after years of TFC-1067 R&D investments.
The compound stands out in part because it is superior to current actives in the market in addition to being safe and free of hydroquinone. TFC-1067 has also proved to be superior in the treatment of dyschromia with no adverse effects.
The use of TFC-1067 in Rodan + Fields products opens the door for Sirona Biochem to recoup a substantial amount of money spent on the development of the skin lighting agent.
“After many years of developing TFC-1067 with the support of the French government and European Union in the Cosmetic Valley, France, we are excited to partner with skincare industry leader Rodan + Fields. This marks an important milestone for Sirona Biochem,” explained Dr. Howard Verrico CEO of Sirona Biochem.
Skin Lightening Opportunity
Sirona Biochem is on the cusp of something great in the skin care market. The company has already secured a U.S patent for the flagship skin-lightening agent TFC-1067 further strengthening its IP portfolio. The new patent adds to similar patents granted in Germany, France, and the United Kingdom.
With the patent, the company can now pursue licensing deals similar to the one signed with Rodan + Fields. Such deals should go a long way in helping the company strengthen its revenue streams through licensing fees as well as milestone fees and royalty payments.
Sirona Biochem is currently in advanced negotiations in North America and Asia as it eyes licensing deals for the skin-lightening compound. Given the potential impact of TFC-1067 in the multi-billion dollar skin lightening market, the company could be a potential acquisition target for big companies wishing to own TFC-1067 outright.
- Published in Bio technology, Dermatology, Sirona Biochem, Skin Care
Sirona Biochem Signs Term Sheet for TFC-1067 with Skincare Industry Leader Rodan + Fields
Momentum Public Relations
Press Release: June 19, 2019
Sirona Biochem Corp. (TSX-V: SBM) (FSE: ZSB) (OTC: SRBCF) (“Sirona“) is pleased to announce that a non-binding term sheet has been signed with Rodan + Fields, LLC (Rodan + Fields) for the commercial sales of novel ingredient TFC-1067. This term sheet covers all material terms and conditions of a definitive agreement with San Francisco-based, industry leading, Rodan + Fields. The definitive agreement is expected to be signed in Q3/2019.
The term sheet stipulates Sirona will become a manufacturer and supplier of TFC-1067 for use by Rodan + Fields on a non-exclusive basis in its current markets (USA, Canada and Australia) as well as future regions. Sirona has initiated preparations for manufacturing TFC-1067 to be in place near term for anticipated product launches. In addition to revenue from the sale of TFC-1067, a fee will be paid by Rodan + Fields on signing of the definitive agreement followed by milestone fees paid for each product launched by Rodan + Fields that incorporates Sirona’s innovative skin lightening agent TFC-1067.
The term sheet incorporates establishing regular formal meetings between Sirona’s scientists at TFChem and the scientists at the research department of Rodan + Fields. Future commercial opportunities based on the platform technology of Sirona Biochem will be explored. This term sheet is the result of extensive due diligence by Rodan + Fields spanning more than one year. This agreement is fitting for both Rodan + Fields and Sirona because of a mutual desire to deliver premium consumer products that are safe and effective.
Founded by Stanford-trained dermatologists, Dr. Katie Rodan and Dr. Kathy Fields, Rodan + Fields was launched with the mission of giving consumers the best skin of their lives and bring dermatology-inspired skincare to everyone. With clinic-quality skincare Regimens and a powerful community of Independent Consultants, Rodan + Fields is the leading skincare brand in the United States and one of the fastest growing industry disruptors in beauty.
Rodan + Fields has been ranked the number one skincare brand in the U.S.1 and North America2 in 2018 by Euromonitor International Ltd. (“Euromonitor”), which publishes the world’s most comprehensive market research on the skincare industry. Rodan + Fields has received several other accolades from Euromonitor, including the number one premium acne brand in the US and Canada3and number one premium body care brand in North America in 20184.
“After many years of developing TFC-1067 with the support of the French government and European Union in the Cosmetic Valley, France, we are excited to partner with skincare industry leader Rodan + Fields”, reports Dr. Howard Verrico CEO of Sirona Biochem. “This marks an important milestone for Sirona Biochem. We highly value the successful due diligence of Rodan + Fields as further validation of our technology platform, in particular TFC-1067.”
“We are committed to providing our Consultant community and their consumers with products that feature cutting-edge technology that provide visible results. After an extensive search, we are pleased to partner with Sirona to leverage their new brightening agent in our products. With clinically proven effectiveness and an excellent safety profile, TFC-1067 will enable our products to improve the appearance of skin dullness, discoloration and uneven skin tone for a younger looking complexion. We look forward to leveraging this excellent new ingredient in future product lines and working together to bring more of our lifechanging skincare products to the market,” said Simon Craw, Senior Director R&D Business Development at Rodan + Fields.
1Source Euromonitor International Limited; Beauty and Personal Care 2019 Edition, retail value RSP terms; all channels, Skincare includes Sets & Kits. |
2Source Euromonitor International Limited; Beauty and Personal Care 2019 Edition, retail value RSP terms; all channels, Skin Care includes Sets and Kits; North America defined as Canada and the United States. |
3Source Euromonitor International Limited; Beauty and Personal Care 2019 Edition, retail value RSP terms; all channels; Premium Acne Treatments including Acne Treatments sold as part of Sets and Kits. |
4Source Euromonitor International Limited; Beauty and Personal Care 2019 Edition, retail value RSP terms; all channels, Premium Body Care includes Sets and Kits. |
About Rodan + Fields
Founded by Stanford-trained dermatologists Dr. Katie Rodan and Dr. Kathy Fields, Rodan + Fields was launched in 2002 with the mission of giving consumers the best skin of their lives. The brand is a result of the Doctors’ belief that healthy skin empowers people to feel confident. Born in the digital era and designed to directly reach consumers where they live and shop via mobile and social networks, Rodan + Fields is disrupting the industry with its regimen-based skincare and powerful Independent Consultant community.
For more information, please visit www.rodanandfields.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 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.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
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.
SOURCE Sirona Biochem Corp.
View original content to download multimedia: http://www.newswire.ca/en/releases/archive/June2019/19/c8969.html
Contact:
regarding this press release, please contact: Investor Enquiries: Jonathan Williams, Managing Director, Momentum PR, Phone: 1.450.332.6939, Email: jwilliams@momentumpr.com; Corporate Enquiries: Dr. Howard Verrico, CEO, Chairman of the Board, Sirona Biochem Corp., Phone: 1.604.641.4466, Email: info@sironabiochem.com; Rodan+ Fields: Corporate Communications + PR, Email: corporatepr@rodanandfields.com
- Published in Business, Life Sciences, News Home, Sirona Biochem
Sirona Biochem Announces TFC-1067 Skin Lightening Patent Granted in USA
Momentum Public Relations
Press Release: June 17, 2019
Sirona Biochem Corp. (TSX-V: SBM) (FSE: ZSB) is pleased to announce that the patent for TFC-1067 entitled “Gem Difluorocompounds as Depigmenting or Lightening Agents” was granted in the USA, as expected, and will be published in the official database in the coming month. To date, the TFC1067 skin lightening patent has been granted in Germany, France, United Kingdom and now the US. Further TFC-1067 patent applications are in the patent pending status in multiple other countries while they go through the normal approval process.
TFC-1067, Sirona’s proprietary skin lightening compound, is superior to current actives on the market, safe and free of hydroquinone. The compound has undergone extensive testing, both preclinical and clinical, including a double blinded study for dyschromia in the US. Clinical results were received in late February 2019 and showed the compound to be superior to hydroquinone in the treatment of dyschromia with no adverse side effects. Sirona is currently in advanced negotiations in North America and Asia in regards to licensing rights for TFC-1067.
“This patent grant in one of the largest skin care markets is another important milestone for TFC-1067. The patent application was without concern to our potential partners as determined by their IP lawyers however it is an important and exciting milestone to reach,” said Dr. Howard Verrico, CEO of Sirona Biochem. “This will allow our potential US partners’ absolute IP certainty to move forward with their product marketing plans.”
The global skin lightening market is expected to reach $23 Billion USD by 2022[1].
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.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
For more information regarding this press release, please contact:
Jonathan Williams
Managing Director
Momentum PR
Phone: 1.450.332.6939
Email: jwilliams@momentumpr.com
[1] https://www.factmr.com/report/309/skin-lightening-products-market
- Published in Life Sciences, News Home, Sirona Biochem
Sirona Biochem Appoints Chinese Lawyer Jason Tian to its Board of Directors
Momentum Public Relations
Press Release: June 12, 2019
Sirona Biochem Corp. (TSX-V: SBM) (FSE: ZSB) (the “Company“) announces that Mr. Jason Tian will be joining its Board of Directors. Jason Tian is a Senior Partner at Landing Law offices based in Shanghai, China. Jason has been working with Sirona since 2018 representing the Company at strategic partnering meetings in China and France.
Jason Tian has been providing legal services to international clients since 2007 and has worked in top firms in China such as Beijing Zhonglun, Beijing Zhongyin, Beijing Dacheng and is now a Senior Partner of Shanghai Landing Law Offices. He also worked as senior legal translator in UK-based firm, Clifford Chance LLP, before starting his legal career.
Shanghai Landing Law Offices is a full-service law firm with headquarters in Shanghai, China. Lawyers at Landing provide full-service to clients in industries such as healthcare and pharmaceuticals as well as consumer retail in China. Landing has several domestic branches and overseas branches in the United States, India, Singapore, Indonesia, Bangladesh, Philippines and Cambodia.
“Sirona’s management team has developed an excellent working relationship with Jason. His legal knowledge and extensive network in the Chinese business community are proving to be tremendous assets to Sirona”, reports Sirona Biochem’s CEO Dr Howard Verrico.
The company also announces Casper Bych has resigned from Sirona’s Board of Directors.
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.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
———————————————
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. The appointment of Jason Tian to the BOD is subject to exchange approval.
SOURCE Sirona Biochem Corp.
View original content to download multimedia: http://www.newswire.ca/en/releases/archive/June2019/12/c2009.html
Contact:
regarding this press release, please contact: Jonathan Williams, Managing Director, Momentum PR, Phone: 1.450.332.6939, Email: jwilliams@momentumpr.com
- Published in Business, Life Sciences, News Home, Sirona Biochem, Technology
Sirona Biochem Reports Approval to Test Higher Concentrations of Skin Lightening Compound TFC-1067
Momentum Public Relations
Press Release: June 11, 2019
Sirona Biochem Corp. (TSX-V: SBM) (FSE: ZSB) (“Sirona“) is pleased to announce that it will assess its novel skin lightener, TFC-1067, at a concentration 3 times higher than what was used in the previous clinical trial. Higher dosing is expected to have increased efficacy, but also the potential to work more quickly than the clinically effective dose established for TFC-1067. This positive development is of substantial commercial interest to potential cosmetic partners in North America and China who share Sirona’s goal to maximize efficacy without compromising safety.
Previous maximum dosing levels were limited due to technical issues with the standard regulatory in vitrotest used to assess TFC-1067 for skin irritation. A solution to these technical issues has been developed. Sirona’s consultant safety assessor at CEHTRA (https://www.cehtra.com) has now recommended further testing with up to a 3 times higher dose. Several higher doses will be assessed by Idea Lab (https://www.ideatestsgroup.com), experts in safety testing of cosmetics. If the in vitro results of the higher concentrations continue to show no evidence for skin irritation, Sirona will proceed to preparation for clinical testing on humans.
“The clinical effect of TFC-1067 to lessen dark spots or have an overall brightening effect is largely dose dependent”, reports Dr. Howard Verrico, CEO of Sirona Biochem. “We anticipate TFC-1067 will be used at higher doses without adverse effects. While we are pleased with the excellent clinical results achieved so far, being able to test at significantly higher concentrations will likely lead to better clinical effectiveness, potentially faster results and a better range of consumer dosing options.”
“We knew the standard regulatory tests prevented us from utilizing the full potential of TFC-1067 as a skin lightener. We anticipate we will proceed in the future to test our improved formulation combined with higher concentrations of TFC-1067 in further clinical trials. Such testing can be conducted either independently by Sirona or through our anticipated partnerships”, Dr. Verrico added.
The global skin lightening market is expected to reach US$31.2 Billion by 2024.1
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.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this press release.
- Published in Life Sciences, News Home, Sirona Biochem
Sirona Biochem Reports Excellent Preliminary Safety Assessment of Lead Anti-Wrinkle Compound LIP-01
Momentum Public Relations
Press Releases: May 28th, 2019
Sirona Biochem Corp. (TSX-V: SBM) (FSE: ZSB) (“Sirona“) is pleased to announce safety testing on its lead glycoprotein compound in the anti-wrinkle program yielded excellent results and the company will immediately move to the next steps of development. This project was generously supported by BPI France and the region Haute Normandie.
The comprehensive safety analysis was performed by CEHTRA (www.cehtra.com), cosmetic toxicology specialists in Paris, France. Key in vitro measures and in silico analyses of safety were evaluated, including skin irritation, skin sensitization, ocular tolerability, phototoxicity, genotoxicity and carcinogenicity. It was concluded that there is no evidence of these issues in the testing. Also, based on in silico analysis, no systemic toxicity is expected.
“These are very encouraging results for our anti-wrinkle program. Sirona’s scientists at our French subsidiary, TFChem, will be focusing their efforts on the next set of tests and a detailed project plan to make this a priority. There is still work to be done in the lab, but we have nicely de-risked the project by conducting these safety assays”, reports Dr. Howard Verrico, CEO of Sirona Biochem.
Next steps in the program will include additional in vitro assays for a second review by CEHTRA to determine dosing. This will be followed by synthetic process refinements, synthesis of a batch for formulation, skin permeation study and clinical safety evaluation.
Loss of elasticity and degradation of fat tissue are two markers seen in aging skin, leading to the appearance of lines and wrinkles. Compounds that increase the number and volume of adipocytes (fat cells) can act as plumping, volumizing, and densifying skin agents, thereby reducing the visibility of wrinkle and potentially providing a more youthful look. Novel solutions are actively being sought out by the dermatology industry to address this.
The global anti-aging market is forecast to reach up to US$271.0 Billion by 2024.1 The anti-wrinkle product category held the largest share in the anti-aging market, with 59.3% contribution in 2017.2
The anti-wrinkle potential of LIP-01 is as a non-invasive treatment for fine wrinkles by a mechanism very different from dermal fillers and Botox®. Botox®3 is generally limited to use on the upper third of the face, specifically the frown lines between the eyebrows. Botox® also requires administration by a properly trained professional.
“Less of our team’s resources are needed on the skin lightening project as its development is now mainly focused on manufacturing. We are excited to have the opportunity to continue expanding the powerful technology platform developed by our Chief Scientific Officer Dr. Geraldine Deliencourt and her team. This anti-wrinkle compound has fascinating properties in cells and we anticipate moving it along quickly. If clinically successful, LIP-01 could exceed Botox in market potential,” Dr. Verrico concluded.
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BOTOX COSMETIC® is a registered trademark of Allergan Inc. |
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.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this press release.
———————————————
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.
SOURCE Sirona Biochem Corp.
View original content to download multimedia: http://www.newswire.ca/en/releases/archive/May2019/28/c1000.html
Contact:
regarding this press release, please contact: Jonathan Williams, Managing Director, Momentum PR, Phone: 1.450.332.6939, Email: jwilliams@momentumpr.com
- Published in Life Sciences, News Home, Sirona Biochem
Sirona Biochem Hires Contract Research Organization for Manufacturing Process Optimization for TFC-1067
Momentum Public Relations
Press Release: May 22, 2019
Sirona Biochem Corp. (TSX-V: SBM) (FSE: ZSB) (“Sirona“) is pleased to announce it has commissioned Contract Research Organization (CRO) Roowin (www.roowin.com) to develop the final chemical process required for large scale manufacturing of TFC-1067. This is another important step in the commercialization of Sirona’s novel skin lightening agent.
Sirona anticipates the need for multiple kilogram production of TFC-1067 in the short term and is therefore taking this necessary intermediate step. Sirona will then proceed to manufacture an inventory of TFC-1067 of up to 20 kilograms to be ready for anticipated orders. Due to the high potency of the compound, each kilogram will supply Sirona’s active skin lightening ingredient to produce ten thousand consumer size (fifty milliliters) containers of finished product.
“The chemistry of TFChem (Sirona’s subsidiary) is unique and our science team has an excellent understanding of this chemistry. We have already successfully worked on production of TFC-1067 at the kilogram scale,” reports Patrice Rool, CEO of Roowin. “Our scientists will collaborate with TFChem to develop the most efficient final process to manufacture TFC-1067. We are very excited to be a part of the ongoing development of this innovative skin lightener.”
“Roowin’s expertise in manufacturing process development will move TFC-1067 closer to final commercialization. In addition, our scientists at TFChem have developed new chemistry that will further improve manufacturing efficiencies and lower cost of goods,” Dr. Verrico concluded. “The new manufacturing process for TFC-1067 we anticipate will be used at manufacturing sites globally down the road. Roowin has extensive experience with our chemistry and we are excited to be working together again.”
About Roowin
Roowin is a privately-owned Contract Research Organization (CRO) headquartered in Riom (Auvergne), France. Its core business being in high value-added fine chemistry, Roowin offers a large range of chemical services. Roowin supports customers and partners to advance their drug candidates from early research phase up to licensing out API in phase II or to the Market for small batches, about 20 kilograms.
Roowin is accredited ISO 9001. Roowin’s facilities include cGMP facilities: Kilo-laboratory / Pilot plant. Roowin can accompany its customers from early lead optimization through scale-up and small-scale GMP synthesis up to medium scale GMP manufacturing.
For more information, please visit www.roowin.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.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this press release.
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.
SOURCE Sirona Biochem Corp.
View original content to download multimedia: http://www.newswire.ca/en/releases/archive/May2019/22/c5079.htmlv
- Published in Bio technology, Life Sciences, News Home, Sirona Biochem
Sirona Biochem Receives Positive Clinical Results of its Skin Lightening Compound TFC-1067 from China
Momentum Public Relations
Press Release: May 15, 2019
Sirona Biochem Corp. (TSXV: SBM) (FSE: ZSB) (“Sirona“) is pleased to announce results of a clinical trial performed in the Peoples Republic of China (China) using Sirona’s novel skin lightening agent TFC-1067. Sirona’s TFC-1067 once again demonstrated significant clinical lightening effect without any reported adverse effects.
A major distributor of cosmetics materials in China arranged clinical testing of TFC-1067 to be done by a select group of its key cosmetic customers. The formulation used in the studies was the same as that used in Sirona’s first clinical trial in the USA by Dr. Zoe Draelos. The clinical trial design protocols and the testing was conducted independently of Sirona by the cosmetic companies. The studies were conducted in Guangzhou, China.
A total of 60 participants were involved in the studies conducted over several sites. All participants applied the formulation with TFC-1067 twice daily to the face. Each study duration was 4 weeks. During the 4 weeks 90% of participant reported a brightening effect with TFC-1067. Sirona is informed by the distributor that a second set of trials with Sirona’s improved, next generation, formulation is underway.
Dr. Géraldine Deliencourt-Godefroy, Chief Scientific Officer of Sirona Biochem stated, “These are excellent clinical results. Based on the outcome from our first clinical trial, we are pleased to see such results for the short 4-week duration of the testing. This positive testing result on Asian skin with the observed lightening effect supports the clinical effect of TFC-1067 over different skin types. A longer trial is required to assess dyschromia which was assessed in Sirona’s US based clinical trial. Sirona will await feedback on the further testing currently ongoing in China with our new formulation.”
“No clinical safety issues were reported with TFC-1067 during the trial. TFC-1067 has shown a lightening effect over a short clinical trial on Asian skin types.” reports Dr. Howard Verrico, CEO of Sirona Biochem. “Although we prefer to conduct trials with a double blinded protocol using a comparative compound and a longer trial duration as we arranged in the USA, it was important to have these cosmetic companies perform their own clinical testing independently and be confident of the results. TFC-1067 continues to deliver excellent clinical results as anticipated by our preclinical assays. A strong commercial interest in TFC-1067 is already reported by the distributor based on current results.”
“Sirona’s team remains dedicated to work towards entering this market with a safe and effective alternative to current options. We are moving forward on building our relationship with the Chinese distributor with more positive news anticipated near term”, Dr. Verrico concluded.
The global skin lightening market is estimated to grow to US$31.2 billion by 20241. Asia makes up the largest and fastest growing segment of the market. A World Health Organization survey reported that nearly 40 per cent of women polled in China said they regularly used whitening products many of which are toxic2.
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1 https://www.factmr.com/report/309/skin-lightening-products-market
2 http://theglobalfool.com/tag/mercury/
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.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this press release.
- Published in Business, Life Sciences, News Home, Sirona Biochem
Sirona Biochem’s TFC-1067 Demonstrates Superiority to Hydroquinone for the Treatment of Dyschromia
Momentum Public Relations
Press Release: April 10, 2019
Sirona Biochem Corp. (TSX-V: SBM) (FSE: ZSB) (the “Company“) is pleased to announce the results of its clinical trial performed by Dr. Zoe Draelos of Dermatology Consulting Services, conducted in North Carolina, USA. Sirona’s TFC-1067 demonstrates superiority to the gold standard, hydroquinone, for the treatment of dyschromia (hyperpigmentation or “dark spots” of the skin).
In the 12-week double blinded study involving 48 participants, TFC-1067 successfully achieved the endpoint of lightening dyschromic areas on the skin. With application of TFC-1067, areas of hyperpigmentation were significantly lightened and blended into surrounding skin, evening skin tone while preserving overall tone. TFC-1067, achieved this goal, while the hydroquinone comparator did not.
No clinical safety issues were observed with TFC-1067 during the trial. Combined with extensive preclinical safety testing, there is now strong evidence that TFC-1067 is a safe and superior replacement to hydroquinone for the treatment of facial hyperpigmentation.
Hydroquinone has remained the gold standard for skin lightening despite known toxicity which is an ongoing concern for the FDA and the dermatology community. Hydroquinone is banned or has restricted dosing in an increasing number of countries. Although many non-hydroquinone alternative lightening compounds are either toxic or ineffective, unfortunately, millions of people still resort to toxic treatments for hyperpigmentation despite poor aesthetic results. There is a clear unmet need for a safe and effective treatments in this 20-Billion-USD skin lightening market.1
The Company is currently pursuing publication of these results in a peer reviewed scientific journal. A detailed report of the clinical trial will then be made available to the scientific community including the dermatological and cosmetic community.
“Having demonstrated clinically in our human trial what we predicted in preclinical testing is further validation of the commercial value of our proprietary technology,” reports Dr. Howard Verrico, CEO Sirona Biochem. “These results were achieved with a very basic formulation. The full potential of TFC-1067 is yet to be demonstrated. Having validated the commercial value of TFC-1067 with the clinical trial’s success we have greatly improved our licensing opportunities and value globally. Currently we are in discussions for licensing TFC-1067 in specific markets. An update will be released when these discussions conclude.”
“TFC-1067 performed remarkably well in comparison to 2% hydroquinone, which traditionally has been challenging to approximate. Hydroquinone alternatives are needed,” said Dr. Zoe Draelos. “Most consumers desire lightening of dark spots to blend into surrounding skin. The study product achieved this goal.”
About Dr. Zoe Draelos
Zoe Diana Draelos, MD, is a practicing board-certified dermatologist and a Fellow of the American Academy of Dermatology with a research interest in cosmetics, toiletries, and biologically active skin medications. She is a researcher in High Point, North Carolina, and a Consulting Professor of Dermatology at Duke University. In 1988, she founded Dermatology Consulting Services to provide education, develop formulations, and conduct clinical studies in association with industry. Prior to pursuing a medical career, Dr. Draelos completed an undergraduate degree in Mechanical Engineering and was elected a Rhodes Scholar. A member of Sigma Xi research honorary and Alpha Omega Alpha medical honorary, she is author of 12 textbooks, including Cosmetics in Dermatology, now in its second edition after having been translated into 4 languages, Hair Cosmetics, as well as the editor of Cosmeceuticals, now in its third edition and translated into 5 languages. She has experience conducting FDA phase I, II, III, and IV studies and also specializes in OTC drug and cosmetic studies. Dermatology Consulting Services can develop protocols, write consents, organize case report forms, obtain IRB approval, recruit and administer the study, perform data entry, prepare the statistical analysis, and write the final report. She has successfully completed over 545 clinical studies as the primary investigator. This diversity of services offered by Dr. Draelos provides a unique start to finish approach to clinical research for drugs, OTC drugs, and cosmetic formulations. For further information, please visit http://www.zoedraelos.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.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this press release.
- Published in Life Sciences, News Home, Sirona Biochem