Cellulite

- CBL-514 is the first and only drug to receive both Orphan Drug Designation and Fast Track designation for Dercum's disease treatment. NEW TAIPEI CITY, March 3, 2024 /PRNewswire/ -- Caliway Biopharmaceuticals (Caliway) announced that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to CBL-514 for Dercum's disease treatment. CBL-514 is a lipolysis injection that can reduce local subcutaneous fat by inducing adipocyte apoptosis, and is the first drug to receive both ODD and Fast Track designation for Dercum's disease treatment. "Receiving Orphan Drug Designation and Fast Track designation from the U.S. FDA is a huge milestone in CBL-514 development. Moreover, of all Dercum's disease treatment studies, CBL-514 is by far the most advanced program with the clinical efficacy being proven to reduce the size of the painful lipoma by more than 50% significantly," said Vivian Ling, CEO of Caliway. "With these two designations, we look forward to accelerating CBL-514 clinical development, and becoming the first approved drug for Dercum's disease treatment with a 7-year marketing exclusivity." Caliway has completed a Phase 2 study (CBL-0201DD, NCT05387733) to evaluate CBL-514's efficacy and safety in treating Dercum's disease last year. The study results demonstrated that after treating with CBL-514, 64.5% of painful lipomas showed dimension reduction of more than 50%, 38.7% of painful lipomas showed complete clearance, with pain being reduced by 4.7 point. In January 2024, a placebo-controlled Phase 2b study (CBL-0202DD) to evaluate efficacy of CBL-514 for treating Dercum's disease has been approved by the U.S. FDA. The subject recruitment will be initiated in Q2 2024. About Orphan Drug Designation To support the development and evaluation of new treatments for rare diseases, the U.S. FDA grants orphan drug designation to a drug or biological product to prevent, diagnose, or treat a rare disease or condition that affects fewer than 200,000 people in the United States. Orphan drug designation qualifies sponsors for incentives including 7-year marketing exclusivity to sponsors of approved orphan products, federal tax credit for expenses, waiver of Prescription Drug User Fee Act (PDUFA) fees, and eligibility for regulatory assistance and guidance from the FDA in the design of a drug development plan. For more information regarding Orphan Drug Designation, please visit the U.S. FDA official website: About Dercum's Disease Dercum's disease is a rare disorder that is characterized by the development of painful lipomas primarily located on the trunk region, and the extremities close to the trunk. The pain is chronic (>3 months), symmetrical, often disabling, and resistant to traditional analgesics. The etiology of Dercum's disease remains unknown. There is no approved drug nor recommended standard treatment for Dercum's disease yet. The current treatment options, including surgical removal, liposuction, electrotherapy, and inflammation inhibitors, are symptomatic, and the efficacies are limited with numerous adverse events. The clinical need for Dercum's disease remains unmet. According to the Global Dercum's Disease Market Research Report, the global Dercum's disease treatment market size in 2021 was $11.3 billion. With a compound annual growth rate (CAGR) of 6.76%, the global market of Dercum's disease treatment in 2030 is estimated to expand to $19.95 billion. About CBL-514 CBL-514, a potentially first-in-class small-molecule drug, is an injection lipolysis drug that can induce adipocytes apoptosis and lipolysis to reduce subcutaneous adiposity in treatment areas in animal studies without causing any systematic side effects on the central nervous system, cardiovascular system, and respiratory system. Caliway's nonclinical studies showed that CBL-514 upregulates the apoptosis mediators caspase 3 and Bax/Bcl-2 ratio, and then induces dose-dependent adipocyte apoptosis in vivo and in vitro. Caliway is investigating multiple indications for CBL-514, including non-invasive subcutaneous fat reduction, Dercum's disease, cellulite, and lipoma treatment. About Caliway Biopharmaceuticals Caliway Biopharmaceuticals (Caliway) is a Taiwan-headquartered, clinical-stage biopharmaceutical company driven to breakthrough drug discovery of novel small-molecule therapeutics. Listed on the emerging stock market in Taiwan (TPEX6919), Caliway aims to become an innovative pharmaceutical leader in aesthetic medicine and other diseases. For more information, please visit: Disclaimer This article and related information on this site contain forward-looking statements. The forward-looking information requires the Company to make numerous assumptions and is subject to inherent risks, uncertainties, and other factors that are beyond the control of the Company which may cause actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by such forward-looking statements. The Company undertakes no obligation to timely inform, update, or revise the information on this site if circumstances should change. SOURCE Caliway Biopharmaceuticals

- Fast Track designation indicates CBL-514's potential in filling the unmet medical need of Dercum's disease. - CBL-514 is the first drug to receive Fast Track designation for Dercum's disease treatment. - CBL-514 Phase 2 study in Dercum's disease demonstrated its efficacy in significant painful lipomas' size reduction of more than 50%, complete clearance and pain improvement by 4.7 points. NEW TAIPEI CITY, Feb. 14, 2024 /PRNewswire/ -- Caliway Biopharmaceuticals (Caliway) announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the investigation of CBL-514 in Dercum's disease treatment. CBL-514 is a lipolysis injection that can reduce local subcutaneous fat by selectively inducing adipocyte apoptosis, and is the first drug to receive Fast Track designation for Dercum's disease treatment. "We are very pleased to see the FDA's decision on granting Fast Track designation to CBL-514," said Vivian Ling, CEO of Caliway. "Dercum's disease is a rare disease characterized by the growth of painful lipomas, the pain can often be chronic and disturbing. With the Fast Track designation, Caliway can benefit from more frequent engagement with the FDA, which will support the collection of appropriate clinical data to accelerate CBL-514 development, and provide the treatment to patients who have been suffering with this disease." Fast Track Designation Fast track designation is a process that the FDA designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need, providing a therapy where none exists, or providing a therapy which may be potentially better than available therapy. For more information on the Fast Track process, please visit the U.S. FDA official website: . The FDA's decision was based on Caliway's preclinical and CBL-0201DD Phase 2 (NCT05387733) clinical study results, showing that CBL-514 is the first and only product to demonstrate clinically meaningful and statistically significant in painful lipomas complete clearance or dimensions reduction of more than 50%, as well as significant pain improvement by 4.7 points. Therefore, the CBL-0201DD Phase 2 study demonstrated the substantial improvement over available therapies to address the unmet medical need for Dercum's disease. Expanded Access Program The Expanded Access Program is a program recognized by the FDA as a follow-on to their Fast Track Designation. An EAP provides a potential pathway for patients with a serious or life-threatening condition to gain access to an investigational drug for treatment outside of a clinical trial, particularly when no comparable or satisfactory alternative therapy options are available. For physicians that have identified a patient, or have spoken to a patient who contacted you, please contact Caliway at [email protected]. Caliway's goal is to acknowledge receipt to the requesting physician within (10-12) business days. About Dercum's Disease Dercum's disease is a rare disorder that is characterized by the development of painful lipomas primarily located on the trunk region, and the extremities close to the trunk. The pain is chronic (>3 months), symmetrical, often disabling, and resistant to traditional analgesics. The main symptoms of Dercum's disease, according to the early reports, are obesity, pain from the lipomas, and numerous psychiatric manifestations, including sleep disturbances, depression, and anxiety. The etiology of Dercum's disease remains unknown. There is no approved drug nor recommended standard treatment for Dercum's disease yet. The current treatment options, including surgical removal, liposuction, electrotherapy, and inflammation inhibitors, are symptomatic, and the efficacies are limited with numerous adverse events. The clinical need for Dercum's disease remains unmet. According to the Global Dercum's Disease Market Research Report, the global Dercum's disease treatment market size in 2021 was $11.3 billion. With a compound annual growth rate (CAGR) of 6.76%, the global market of Dercum's disease treatment in 2030 is estimated to expand to $19.95 billion. About CBL-514 CBL-514, a potentially first-in-class small-molecule drug, is an injection lipolysis drug that can induce adipocytes apoptosis and lipolysis to reduce subcutaneous adiposity in treatment areas in animal studies without causing any systematic side effects on the central nervous system, cardiovascular system, and respiratory system. Caliway's nonclinical studies showed that CBL-514 upregulates the apoptosis mediators caspase 3 and Bax/Bcl-2 ratio, and then induces dose-dependent adipocyte apoptosis in vivo and in vitro. Caliway is investigating multiple indications for CBL-514, including non-invasive subcutaneous fat reduction, Dercum's disease, cellulite, and lipoma treatment. About Caliway Biopharmaceuticals Caliway Biopharmaceuticals (Caliway) is a Taiwan-headquartered, clinical-stage biopharmaceutical company driven to breakthrough drug discovery of novel small-molecule therapeutics. Listed on the emerging stock market in Taiwan (TPEX6919), Caliway aims to become an innovative pharmaceutical leader in aesthetic medicine and other diseases. For more information, please visit: Disclaimer This article and related information on this site contain forward-looking statements. The forward-looking information requires the Company to make numerous assumptions and is subject to inherent risks, uncertainties, and other factors that are beyond the control of the Company which may cause actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by such forward-looking statements. The Company undertakes no obligation to timely inform, update, or revise the information on this site if circumstances should change. SOURCE Caliway Biopharmaceuticals

VANCOUVER, British Columbia, Jan. 24, 2024 (GLOBE NEWSWIRE) -- Sirona Biochem Corp. (TSX-V: SBM) (FSE: ZSB) (OTC: SRBCF) (“Sirona”) provides the following update: Dear shareholders, We are pleased to provide an update on our recent milestones and strategic decisions shaping Sirona Biochem's path forward. Trademark of TFC-1326 as GlycoProteMim We recently trademarked TFC-1326 as GlycoProteMimTM. This branding decision aims to distinguish our anti-aging active ingredient in a competitive market by giving it an easily recognizable identity, while also enhancing its marketability and positioning it as a sought-after solution in the beauty industry. With a diverse array of options for consumers to address visible signs of aging, our brand aims to be one that people can be educated about, understanding its benefits and easily identifying it in the marketplace. Establishment of Sirona Laboratories We are excited to introduce Sirona LaboratoriesTM, a newly established entity dedicated to commercializing GlycoProteMim. This decision is rooted in our commitment to expedite the commercialization process and provide a streamlined avenue for market penetration. Sirona Biochem will maintain majority ownership in the subsidiary. This will ensure a more streamlined and efficient commercialization process by eliminating the common delays associated with external partnerships. We are poised to bring this innovative skincare solution to market in the shortest time possible. Ultimately, the creation of Sirona Laboratories stands as a strategic move that directly benefits our stakeholders. It not only safeguards shareholder interests but also positions GlycoProteMim as a valuable asset within a separate entity, presenting potential avenues for capitalization on its technology while preserving the integrity of Sirona Biochem. In the aesthetic space brand acquisitions at high valuations are common and novel technology optimally capitalized when part of an established brand. Beauty brand M&A is predicted to be a growing market trend. Preparation for commercialization of GlycoProteMim Final process development for the manufacturing of GlycoProteMim by Wuxi AppTec has been completed and they are ready to produce multi-kilogram orders upon request. Work is well underway on multiple other fronts necessary to produce a high quality consumer product. Further updates will be made near term regarding the team of experts we are assembling for this task. It is our intention to launch our first consumer product containing GlycoProteMim in both Europe and North America through our subsidiary Sirona Laboratories, then expanding to other markets globally. With the necessary funding, we have set out a plan to launch our first product early in the 1st quarter of 2024. The fundamental science is clinically proven, and safety established so the work needed is mainly to satisfy technical requirements of a new product and re-establish its effectiveness necessary to allow appropriate product claims. TFC-1067 – Global Licensing Agreement with Allergan Aesthetics Allergan continues to work toward integration of TFC-1067 into its pipeline. Once permissible, we will update our shareholders accordingly. Sirona’s management remains in regular communication with Allergan Anesthetic’s team. Antiviral Library, Diabetes and other new R&D projects TFChem's scientists at Sirona are actively involved in progressing the antiviral and SGLT 2 diabetic project. Despite this ongoing effort, these projects are not currently the top priority. The primary focus of the team is directed towards pioneering new developments within the aesthetic space. It's worth noting that certain aspects of their work are kept confidential until they reach a stage where intellectual property (IP) can be securely established. Making Sirona Laboratories a Market Success To materialize the success of GlycoProteMim, we will be securing strategic funding from private equity funds and investors. This infusion of substantial upfront capital is earmarked for crucial aspects such as inventory, retail infrastructure, and impactful marketing efforts, which will all contribute to a robust and successful product launch. Envisioning beyond a single product, Sirona Biochem sees a future of diversified offerings with multiple products utilizing GlycoProteMim. Preserving shareholder value is a core principle in our strategy. By avoiding significant dilution and control issues, we ensure that our shareholders enjoy a substantial portion of the revenue stream generated by GlycoProteMim. Other Profitable Markets Beyond GlycoProteMim, we can continue to advance projects in areas such as Cellulite, Wound care, and Keloid treatments, underscoring our commitment to comprehensive skincare solutions. Sirona Laboratories is poised to bring to market not only GlycoProteMim but also new cosmeceuticals developed by TFChem. This collaboration enhances our ability to introduce a diverse and wide range of innovative skincare solutions. By pursuing a quicker route to profitability, we reduce reliance on recurrent financing, ensuring stability and a sustainable growth trajectory for Sirona Biochem and its subsidiaries. Sirona Biochem's stable financial source paves the way for bringing numerous backlogged ideas from our scientific team into commercial reality. This proactive approach to innovation ensures that our pipeline remains dynamic and responsive to emerging skincare needs. About Sirona Biochem Corp. Sirona Biochem is a cosmetic ingredient and drug discovery company with 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 an hour north of Paris, France, and is the recipient of multiple French national scientific awards and European Union and French government grants. For more information, please visit . For more information regarding this press release, please contact: Investor Enquiries: Email: Info@sironabiochem.com Christopher Hopton, CFO, 778-908-4734 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.