Biotech

Sirona Biochem Inc.

Sirona Biochem Inc.

Overview

Sirona Biochem Inc. (TSXV:SBM) is a biotechnology company with an innovative platform for developing safer, more effective cosmetic and pharmaceutical active ingredients. The technology is based on proprietary fluorination chemistry developed by the company’s wholly-owned French subsidiary, research and development (R&D) laboratory TFChem. Sirona Biochem’s business model centers on leveraging its technology platform and chemistry expertise to build strategic R&D partnerships with leading global companies through contract services, licensing and royalty agreements as well as joint ventures.

TFChem has developed a fluorination chemistry that can improve the safety and efficacy of carbohydrate-based molecules. Carbohydrate-based molecules are valuable in that they have broad application potential for the development of pharmaceuticals and cosmeceuticals. Examples of commercially available carbohydrate-based drugs include viral neuraminidase inhibitor Tamiflu, and Johnson & Johnson’s (NYSE:JNJ) SGLT2 inhibitor Invokana™. However, carbohydrate-based molecules are extremely challenging to develop due to their inherent instability. Sirona Biochem’s proprietary chemistry technique overcomes that challenge by stabilizing carbohydrates, allowing the company to explore commercial opportunities for these valuable molecules.

Sirona Biochem’s product pipeline includes an SGLT2 inhibitor for the treatment of type 2 diabetes as well as cosmeceuticals such as compound libraries for safe and effective skin lighteners and anti-aging compounds. The company has completed two successful licensing agreements. The first, for its SGLT2 inhibitor to Wanbang/Fosun Pharmaceutical in China, which is now in advanced Phase I clinical trials. The second was a non-exclusive license to Rodan + Fields, the leading skin care brand in the United States, for Sirona’s skin lightening compound TFC-1067. The compound has proven safe and effective in clinical trials.

Sirona Biochem is led by a highly experienced team of finance and biotechnology professionals. The company’s Chief Scientific Officer Dr. Géraldine Deliencourt-Godefroy is an award-winning synthetic chemist and the founder of the French biotechnology company TFChem. Her scientific research in carbohydrate chemistry has led to the discovery of new drug families and the development of drug candidates for diabetes and obesity, cosmetic ingredients and biological adjuvants. She is the recipient of the acclaimed Francinov Research and Innovation Medal, the French Ministry of Research Award and the French Senate Award.

Sirona Biochem’s Company Highlights

  • Proven technology platform based on a proprietary fluorination chemistry leading to a pipeline of products across a broad range of applications, including therapeutics, cosmeceuticals and biological ingredients.
  • Diabetes drug TFC-039 has been licensed to Wanbang/Fosun Pharmaceutical and is currently in advanced Phase 1 clinical studies. Fosun Pharma is one of the largest healthcare companies in China.
  • China represents the world’s largest population of diabetic patients.
  • Skin lightener product TFC-1067 has had positive results from efficacy and safety trials in the United States and was shown to be better than 2 percent hydroquinone for treating skin discoloration.
  • Sirona Biochem has licensed its skin lightener product TFC-1067 to Rodan + Fields under a non-exclusive agreement and is seeking further partnering opportunities for the product.
  • Several potential multinational licensing deals are expected in 2020.
  • Has an experienced management team of capital market and biotechnology professionals.

Sirona Biochem’s Technology Platform

Sirona Biochem’s technology platform is based on a fluorination chemistry that stabilizes carbohydrate-based molecules to improve their cosmeceutical and pharmaceutical qualities. Carbohydrate molecules play a central role in cell to cell communication and have the ability to interact with proteins, hormones, viruses, toxins and bacteria. In this way, carbohydrates perform a variety of essential biological functions in the human body, making them valuable components for the development of therapeutics and cosmeceuticals.

While they have broad application potential, carbohydrates are extremely challenging to develop due to their inherent instability. Using chemistry techniques originally developed by TFChem, Sirona has overcome the challenge of stabilizing carbohydrates to develop safer, more effective cosmetic and pharmaceutical active ingredients. This proprietary chemistry method involves strengthening the bond of a carbohydrate molecule by strategically placing fluorine atoms with the molecule. The result is enhanced stability and bioavailability of carbohydrate-based molecules.

Sirona Biochem’s fluorination platform has multiple applications, including improving the properties of drugs in development or discontinued drugs that may have been shelved for stability reasons as well as for the development of new products for cosmetics and biological manufacturing.

Sirona Biochem’s Product Pipeline and Partnerships

Sirona Biochem is exploring multiple commercial opportunities and partnerships for its fluorination technology platform and currently has three high-value programs in development. Each program was chosen for its high market potential and attractive development timeline.

  • Therapeutics – Diabetes, anti-inflammatories and anti-infectives
  • Cosmeceuticals – Anti-aging and depigmenting agents (skin lighteners)
  • Biological Ingredients – Inducers and adjuvants for biological development and preservation

The three most advanced products on this platform include diabetes therapeutics, cosmetic skin lighteners and anti-aging cream.

sirona product pipeline may 2020

Therapeutics: Diabetes Drug TFC-039

Sirona Biochem’s diabetes drug TFC-039 is a sodium-glucose co-transporter SGLT2 Inhibitor compound developed using the company’s proprietary fluorination technology. SGLT2 Inhibitors act in the kidneys to reduce the reabsorption of glucose into the bloodstream. TFC-039 has achieved positive results in head-to-head preclinical studies, performing better than Johnson & Johnson’s canagliflozin (Invokana™), which was given US FDA market approval in March 2013 and in European market approval in November 2013.

Globally, diabetes caused 4.2 million deaths in 2019 and at least US$760 billion in health expenditures. The number of adults living with diabetes in 2019 totaled approximately 463 million, and that figure is projected to rise to 700 million by 2045.

In 2014, Sirona licensed SGLT2 Inhibitor TFC-039 to Wanbang Biopharmaceuticals for development and commercialization exclusively in the People’s Republic of China, the largest population of diabetes patients in the world. In exchange for this license, Wanbang Biopharma has provided an upfront payment and will give milestone payments of up to US$9.5 million in addition to royalty payments for product sales. Wanbang is currently in Phase I clinical studies with SGLT2 Inhibitor TFC-039.

Cosmeceuticals: Skin Lighteners and Anti-Aging Cream

Sirona Biochem has a library of skin lightening compounds and is in partnership discussions for compound TFC-1067. The French government awarded a C$1.9 million innovation grant to the company’s subsidiary TFChem in 2011 to develop its cosmetic skin lightener program to the commercial-ready stage. The product has indications for treating various skin conditions including hyperpigmentation, melasma, vitiligo and rosacea. The most common skin lightening agent today is hydroquinone, however, this compound has been linked to cancer and has been banned in Europe since 2001.

Sirona Biochem is working to meet the demand for a safer and more effective skin lightening cream. In 2019, the company conducted safety and efficacy trials for the depigmenting agents in its TFC-1067 product. In April of 2019, the company announced that during a US-based clinical trial the product was shown to perform better than the gold standard 2 percent hydroquinone in improving irregular or patchy discoloration to create an even skin tone. In January of 2020, Sirona Biochem announced the product demonstrated 100 percent safety in a final toxicology test for the increased dose (0.4 percent) of TFC-1067. Clinical trials of the product are expected to begin later in 2020.

The global market for skin lightening products is witnessing increasing demand with the largest growth in Asia, while North America and Europe are also epicenters of demand growth.

Sirona Biochem Global Skin Lightening Market

In September 2019, Sirona signed a definitive non-exclusive agreement with Rodan + Fields for the licensing and commercial sales of novel ingredient TFC-1067 to brighten and even skin tone. Under the terms of the agreement, Sirona will receive upfront and milestone payments as well as ongoing revenue in return for the manufacturing and supply of TFC-1067.

Anti-aging cream

Sirona Biochem is also developing an anti-aging compound library based on the naturally occurring antifreeze glycoproteins found in Antarctic fish and the company’s proprietary chemistry technology. Sirona’s studies have shown that these glycoproteins can protect against environmental stressors such as UV light, oxidation and nutrient deprivation. The company is working to prove its anti-aging products can potentially protect people’s skin cells against many of the stresses associated with natural aging and environmental effects. The global market for anti-aging products reached US$20.25 billion in 2018 and is projected to experience a CAGR of 5.7 percent from 2019 to 2025.

Sirona Biochem’s Management Team

Dr. Howard J. Verrico, MD — CEO and Chairman of the Board

Dr. Howard Verrico obtained his medical degree from the University of Toronto in 1985 and has been a member of the College of Physicians and Surgeons of British Columbia since July 1986. Dr. Verrico is currently a practicing emergency room physician. In addition, Dr. Verrico has extensive experience as a venture capitalist in the junior capital markets.

Géraldine Deliencourt-Godefroy, PhD — Chief Scientific Officer

Dr. Géraldine Deliencourt-Godefroy is an award-winning synthetic chemist and the founder of French-based biotechnology company TFChem. Since the acquisition of TFChem by Sirona Biochem in March 2011, Dr. Deliencourt-Godefroy has assumed the role of Chief Scientific Officer. Her scientific research in carbohydrate chemistry has led to the discovery of new drug families and the development of drug candidates for diabetes and obesity, cosmetic ingredients and biological adjuvants. Previous to founding TFChem, Dr. Deliencourt-Godefroy was a scientific leader at INSA (National Institute of Applied Sciences) in Rouen, France, where she developed a new technology on stabilized carbohydrates. Previous roles also include a post-doctoral position at the University College London and doctoral research at the Research Institute of Fine Organic Chemistry in Rouen, France. Dr. Deliencourt-Godefroy received a PhD and Masters in Organic Chemistry as well as her business degree from the University of France. She is the author of several publications and patents and is also the recipient of the acclaimed Francinov Research and Innovation Medal, French Ministry of Research Award and the French Senate Award.

Christopher Hopton, CGA — Chief Financial Officer

Christopher Hopton brings 25 years of expertise in financial management and operations. His extensive experience covers areas of financial planning, accounting policy and business process improvement. As a business investment and finance consultant, Hopton has worked with several public and privately-held companies. Most recently, Hopton was the Chief Financial Officer of Central Resources Corp., a junior mineral exploration company. Formerly, he held the position of Division Controller at Canadian Airlines where he was responsible for an annual operating budget of $200M. Hopton was also involved in the restructuring of 360 Networks, a network communications company, which led to a buyout by Bell Canada. Hopton earned his Bachelor of Business Administration from Simon Fraser University in British Columbia, Canada and received his professional designation as a Certified General Accountant.

Michelle Seltenrich, MBA — Vice President, Operations

Michelle Seltenrich brings 19 years of expertise in public biotech companies. Her experience ranges from both academic and industry R&D lab management to corporate mergers and acquisitions. Seltenrich was previously the Manager of Business Development at Forbes MediTech and was responsible for international business development, in-licensing and M&A. She played a key role in the successful acquisition of a U.S. based biotech company. Seltenrich holds a BSc from the University of British Columbia and an MBA in Technology Management from Simon Fraser University.

Dr. Alex Sandro Marazzi, MD — Director

Dr. Alex Marazzi is a family physician with certification in both Family and Emergency Medicine. He has been in family practice in Mission, British Columbia since 1997. He is also a part owner of a well established walk-in-clinic. Most recently he served as the Chief of the Emergency Department at Mission Memorial Hospital. Prior to practicing medicine in British Columbia, Dr. Marazzi was an Emergency Room physician for 7 years in Midland, Ontario. Dr. Marazzi earned his Bachelor of Pharmaceutical Sciences at UBC in 1985. While studying medicine he worked as a Hospital Pharmacist at Langley Memorial Hospital. He earned his Doctor of Medicine at UBC in 1989 and pursued an internship at Toronto East General Hospital.

Jason Tian — Director

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.

Dr. Denis Richard, PH.D. — Scientific Advisory Board Member

Dr. Denis Richard earned his Ph.D. in Physiology at Laval University and received further postdoctoral training in nutrition and physiology at the Dunn Nutrition Unit at the University of Cambridge, Cambridge, England. Dr. Richard is a full professor at the Department of Medicine at Université Laval. Together with serving as director of the Research Centre of the Institut de Cardiologie et de Pneumologie de Québec, and director of the Groupe Interdisciplinaire de Recherche sur l’Obésité de l’Université Laval, he is the recipient of the Merck Frosst / CIHR Research Chair in Obesity, the first Chair devoted to obesity research in Canada. He is active with several societies and associations and is a member of: The Canadian Obesity Network, The American Physiological Society, The Society for Neuroscience, The Endocrine Society, and The Society for the Study of Ingestive Behavior. Dr. Richard is a well-established scientist with regard to the study of (i) neurosystems involved in the control and regulation of food intake, thermogenesis, and energy balance, (ii) the mechanisms whereby the gastrointestinal hormones influence energy balance regulation, (iii) the relationship between stress and obesity, (iv) the role of the sympathetic nervous system in controlling uncoupling protein 1 in brown adipose tissue, and (v) the role of uncoupling protein 2 in energy metabolism, oxidative stress and neuroprotection. He lists over 200 publications in his career.

Dr. Bruce Verchere, PH.D. — Scientific Advisory Board Member

Dr. Bruce Verchere is a Professor in the Departments of Surgery and Pathology & Laboratory Medicine at the University of British Columbia (UBC). He is also head of the Diabetes Research Program at the Child & Family Research Institute, and holds the Irving K Barber Chair in Diabetes Research. Dr. Verchere’s research aims to understand the function of pancreatic islet beta cells and their relevance in both type 1 and type 2 diabetes, with a goal of developing therapeutic approaches for enhancing beta cell survival and function. He has published more than 90 manuscripts in the field of islet biology and diabetes and has been invited to present his research worldwide. Dr. Verchere was a Senior Scholar of the Michael Smith Foundation for Health Research (MSFHR) and was awarded the UBC Outstanding Young Alumnus award in 2000 and the Canadian Diabetes Association Young Scientist award in 2006. He is currently chair of the CIHR Diabetes Obesity Lipid and Lipoprotein Disorders panel, Chair of the National Research Council of the Canadian Diabetes Association, and Chair of the MSFHR Research Advisory Council. He currently sits on the editorial board of the publications Diabetes and Canadian Journal of Diabetes.

Dr. Michael Walker, PH.D. — Scientific Advisory Board Member

Dr. Michael Walker has been a director and CEO of Verona Pharma since September 2006. He is an Emeritus Professor at the Department of Anesthesiology, Pharmacology & Therapeutics, University of British Columbia, Canada and has founded and managed various biotech companies in Canada and the UK. His research interests are wide including many aspects of general pharmacology (from basic to clinical studies), marine toxins and respiratory and cardiac pharmacology. Dr. Walker was the founder of Rhythm Search Developments (RSD) Ltd., which company evolved into Nortran Pharmaceuticals Inc. and subsequently Cardiome Pharma Corp. (TSX:COM, NASDAQ: CRME) whose drug, RSD1235, for the acute termination of atrial fibrillation (a disorder of heart beating), is currently the subject of a New Drug Application filed with the US Food and Drug Administration.

Dr. Caigan Du — Scientific Advisory Board Member

Dr. Caigan Du is a scientist at the Vancouver Coastal Health Research Institute and an Associate Professor in the Department of Urologic Sciences at the University of British Columbia. He received a Ph.D. degree in Biochemistry in the UK and postdoctoral training in Immunology in the USA. He is interested in the pathogenesis of kidney ischemia-reperfusion injury and transplant rejection, and molecular control of urinary malignancies. He has been studying the impact of kidney donor-derived factors on renal allograft rejection, and the molecular pathways of kidney injury and regeneration in experimental models. He is also interested in developing medical solutions including drugs made from natural compounds for all kinds of health problems, including immune disorders, organ preservation, kidney failure and urinary cancer. He is the PI of many grant supports from the Kidney Foundation of Canada and the Canadian Institutes of Health Research.

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Class Action Reminder: Kessler Topaz Meltzer & Check, LLP Reminds Investors of Securities Fraud Class Action Lawsuit Filed Against AbbVie, Inc.

The law firm of Kessler Topaz Meltzer & Check, LLP(www.ktmc.com) informs investors that the firm has filed a securities class action lawsuit against ABBVie, Inc. (ABBVie) (NYSE:ABBV) on behalf of all persons and entities who purchased or otherwise acquired ABBVie securities between April 30, 2021, and August 31, 2021, inclusive (the "Class Period

CLICK HERE TO SUBMIT YOUR ABBVIE LOSSES. YOU CAN ALSO CLICK ON THE FOLLOWING LINK OR COPY AND PASTE IN YOUR BROWSER: https://www.ktmc.com/new-cases/abbvie-inc?utm_source=PR&utm_medium=link&utm_campaign=abbvie&mktm=r

CANNOT VIEW THIS VIDEO? PLEASE CLICK HERE

TO VIEW OUR COMPLAINT, PLEASE CLICK HERE

LEAD PLAINTIFF DEADLINE: JUNE 6, 2022

CLASS PERIOD: APRIL 30, 2021 through AUGUST 31, 2021

CONTACT AN ATTORNEY TO DISCUSS YOUR RIGHTS:

James Maro, Esq. (484) 270-1453 or Email at info@ktmc.com

Kessler Topaz is one of the world's foremost advocates in protecting the public against corporate fraud and other wrongdoing. Our securities fraud litigators are regularly recognized as leaders in the field individually and our firm is both feared and respected among the defense bar and the insurance bar. We are proud to have recovered billions of dollars for our clients and the classes of shareholders we represent.

ABBVIE'S ALLEGED MISCONDUCT

AbbVie is one of the world's largest pharmaceutical companies. The company's revenues will come under significant pressure in the coming years when its best-selling drug, Humira, will lose patent protection in 2023. Accordingly, AbbVie's future revenue and earnings depend in large part on its ability to develop new sources of revenue to offset Humira's lost sales. Rinvoq-an anti-inflammatory drug manufactured by AbbVie and used to treat rheumatoid arthritis (RA) and other diseases by inhibiting Janus kinase (JAK) enzymes-was touted as one such drug. Rinvoq was initially approved in the United States to treat only moderate to severe RA. However, AbbVie was actively pursuing additional treatment indications and, in 2020, asked the U.S. Food and Drug Administration (FDA) to approve Rinvoq for the treatment of several other diseases.

As is relevant here, Rinvoq is similar to other JAK inhibitor drugs, including Xeljanz, manufactured by Pfizer Inc. When the FDA approved Xeljanz in 2012 for the treatment of RA, it required an additional safety trial to evaluate Xeljanz's risk of triggering certain serious side effects. Beginning in February 2019, the FDA repeatedly warned the public that the safety trial indicated that Xeljanz's use could lead to serious heart-related issue, cancer, and other adverse events. Notwithstanding the similarities between Rinvoq and Xeljanz, during the Class Period, Defendants assured investors that Rinvoq was far safer than Xeljanz and not subject to the same regulatory risks.

However, investors began to learn the truth about Rinvoq's significant risks on June 25, 2021, when AbbVie revealed that the FDA was delaying its review of expanded treatment applications for Rinvoq due to the safety concerns associated with Xeljanz. On this news, the price of AbbVie common stock declined $1.76 per share, or approximately 1.5%, from a close of $114.74 per share on June 24, 2021, to close at $112.98 per share on June 25, 2021.

Then, on September 1, 2021, the FDA announced that final results from the Xeljanz safety trial established an increased risk of serious adverse events, even with low doses of Xeljanz. As a result, the FDA determined that it would require new and updated warnings for Xeljanz and Rinvoq because Rinvoq "share[s] similar mechanisms of action with Xeljanz" and "may have similar risks as seen in the Xeljanz safety trial." The FDA also indicated that it would further limit approved indications for Rinvoq as a result of these safety concerns. On this news, the price of AbbVie common stock declined $8.51 per share, or more than 7%, from a close of $120.78 per share on August 31, 2021, to close at $112.27 per share on September 1, 2021.

After the Class Period, on December 3, 2021, AbbVie announced that the FDA had updated Rinvoq's label to require additional safety warnings and limit marketing of Rinvoq to only its use after treatment with other drugs has failed. On January 11, 2022, Defendants admitted that these changes to Rinvoq's label would negatively impact sales, forcing the Company to reduce its long-term guidance for Rinvoq's sales in 2025.

The complaint alleges that, throughout the Class Period, the Defendants made materially false and/or misleading statements, about the company's business and operations. Specifically, Defendants misrepresented and/or failed to disclose that: (1) safety concerns about Xeljanz extended to Rinvoq and other JAK inhibitors; (2) as a result, it was likely that the FDA would require additional safety warnings for Rinvoq and would delay the approval of additional treatment indications for Rinvoq; and (3) therefore, Defendants' statements about the company's business, operations, and prospects lacked a reasonable basis, As a result of the Defendants' wrongful acts and omissions, and the significant decline in the market value of AbbVie's securities, AbbVie investors have suffered significant damages.

WHAT CAN I DO?

AbbVieinvestors may, no later than June 6, 2022, seek to be appointed as a lead plaintiff representative of the class through Kessler Topaz Meltzer & Check, LLPor other counsel, or may choose to do nothing and remain an absent class member. Kessler Topaz Meltzer & Check, LLP encourages AbbVie investors who have suffered significant losses to contact the firm directly to acquire more information.

CLICK HERE TO SIGN UP FOR THE CASE

WHO CAN BE A LEAD PLAINTIFF?

A lead plaintiff is a representative party who acts on behalf of all class members in directing the litigation. The lead plaintiff is usually the investor or small group of investors who have the largest financial interest and who are also adequate and typical of the proposed class of investors. The lead plaintiff selects counsel to represent the lead plaintiff and the class and these attorneys, if approved by the court, are lead or class counsel. Your ability to share in any recovery is not affected by the decision of whether or not to serve as a lead plaintiff.

ABOUT KESSLER TOPAZ MELTZER & CHECK, LLP

Kessler Topaz Meltzer & Check, LLP prosecutes class actions in state and federal courts throughout the country and around the world. The firm has developed a global reputation for excellence and has recovered billions of dollars for victims of fraud and other corporate misconduct. All of our work is driven by a common goal: to protect investors, consumers, employees and others from fraud, abuse, misconduct and negligence by businesses and fiduciaries. For more information about Kessler Topaz Meltzer & Check, LLP please visit www.ktmc.com.

CONTACT:

Kessler Topaz Meltzer & Check, LLP
James Maro, Jr., Esq.
280 King of Prussia Road
Radnor, PA 19087
(484) 270-1453
info@ktmc.com

SOURCE: Kessler Topaz Meltzer & Check, LLP



View source version on accesswire.com:
https://www.accesswire.com/702145/Class-Action-Reminder-Kessler-Topaz-Meltzer-Check-LLP-Reminds-Investors-of-Securities-Fraud-Class-Action-Lawsuit-Filed-Against-AbbVie-Inc

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Kessler Topaz Meltzer & Check, LLP Reminds Investors of June 6, 2022 Deadline in Securities Fraud Class Action against AbbVie, Inc. and Urges Investors with Substantial Losses to Contact the Firm

The law firm of Kessler Topaz Meltzer & Check, LLP ( www.ktmc.com ) informs investors that the firm has filed a securities class action lawsuit in the United States District Court for the Northern District of Illinois against ABBVie, Inc. (ABBVie) ( NYSE: ABBV ) on behalf of all persons and entities who purchased or otherwise acquired ABBVie securities between April 30, 2021, and August 31, 2021, inclusive (the "Class Period").

CLICK HERE TO SUBMIT YOUR ABBVIE LOSSES . YOU CAN ALSO CLICK ON THE FOLLOWING LINK OR COPY AND PASTE IN YOUR BROWSER: https://www.ktmc.com/new-cases/abbvie-inc?utm_source=PR&utm_medium=link&utm_campaign=abbvie&mktm=r

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ROSEN, Top Ranked Investor Counsel, Encourages AbbVie Inc. Investors to Secure Counsel Before Important June 6 Deadline in Securities Class Action - ABBV

 WHY: Rosen Law Firm, a global investor rights law firm, reminds purchasers of the securities of ABBVie Inc. (NYSE: ABBV) between April 30, 2021 and August 31, 2021, inclusive (the "Class Period"), of the important June 6, 2022 lead plaintiff deadline.

SO WHAT: If you purchased AbbVie securities during the Class Period you may be entitled to compensation without payment of any out of pocket fees or costs through a contingency fee arrangement.

News Provided by Newsfile via QuoteMedia

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CLASS ACTION ALERT: Kessler Topaz Meltzer & Check, LLP Reminds AbbVie, Inc. Investors of Upcoming Lead Plaintiff Deadline

The law firm of Kessler Topaz Meltzer & Check, LLP(www.ktmc.com) informs investors that the firm has filed a securities class action lawsuit against ABBVie, Inc. (ABBVie) (NYSE:ABBV) on behalf of all persons and entities who purchased or otherwise acquired ABBVie securities between April 30, 2021, and August 31, 2021, inclusive (the "Class Period

CLICK HERE TO SUBMIT YOUR ABBVIE LOSSES. YOU CAN ALSO CLICK ON THE FOLLOWING LINK OR COPY AND PASTE IN YOUR BROWSER: https://www.ktmc.com/new-cases/abbvie-inc?utm_source=PR&utm_medium=link&utm_campaign=abbvie&mktm=r

CANNOT VIEW THIS VIDEO? PLEASE CLICK HERE

TO VIEW OUR COMPLAINT, PLEASE CLICK HERE

LEAD PLAINTIFF DEADLINE: JUNE 6, 2022

CLASS PERIOD: APRIL 30, 2021 through AUGUST 31, 2021

CONTACT AN ATTORNEY TO DISCUSS YOUR RIGHTS:

James Maro, Esq. (484) 270-1453 or Email at info@ktmc.com

Kessler Topaz is one of the world's foremost advocates in protecting the public against corporate fraud and other wrongdoing. Our securities fraud litigators are regularly recognized as leaders in the field individually and our firm is both feared and respected among the defense bar and the insurance bar. We are proud to have recovered billions of dollars for our clients and the classes of shareholders we represent.

ABBVIE'S ALLEGED MISCONDUCT

AbbVie is one of the world's largest pharmaceutical companies. The company's revenues will come under significant pressure in the coming years when its best-selling drug, Humira, will lose patent protection in 2023. Accordingly, AbbVie's future revenue and earnings depend in large part on its ability to develop new sources of revenue to offset Humira's lost sales. Rinvoq-an anti-inflammatory drug manufactured by AbbVie and used to treat rheumatoid arthritis (RA) and other diseases by inhibiting Janus kinase (JAK) enzymes-was touted as one such drug. Rinvoq was initially approved in the United States to treat only moderate to severe RA. However, AbbVie was actively pursuing additional treatment indications and, in 2020, asked the U.S. Food and Drug Administration (FDA) to approve Rinvoq for the treatment of several other diseases.

As is relevant here, Rinvoq is similar to other JAK inhibitor drugs, including Xeljanz, manufactured by Pfizer Inc. When the FDA approved Xeljanz in 2012 for the treatment of RA, it required an additional safety trial to evaluate Xeljanz's risk of triggering certain serious side effects. Beginning in February 2019, the FDA repeatedly warned the public that the safety trial indicated that Xeljanz's use could lead to serious heart-related issue, cancer, and other adverse events. Notwithstanding the similarities between Rinvoq and Xeljanz, during the Class Period, Defendants assured investors that Rinvoq was far safer than Xeljanz and not subject to the same regulatory risks.

However, investors began to learn the truth about Rinvoq's significant risks on June 25, 2021, when AbbVie revealed that the FDA was delaying its review of expanded treatment applications for Rinvoq due to the safety concerns associated with Xeljanz. On this news, the price of AbbVie common stock declined $1.76 per share, or approximately 1.5%, from a close of $114.74 per share on June 24, 2021, to close at $112.98 per share on June 25, 2021.

Then, on September 1, 2021, the FDA announced that final results from the Xeljanz safety trial established an increased risk of serious adverse events, even with low doses of Xeljanz. As a result, the FDA determined that it would require new and updated warnings for Xeljanz and Rinvoq because Rinvoq "share[s] similar mechanisms of action with Xeljanz" and "may have similar risks as seen in the Xeljanz safety trial." The FDA also indicated that it would further limit approved indications for Rinvoq as a result of these safety concerns. On this news, the price of AbbVie common stock declined $8.51 per share, or more than 7%, from a close of $120.78 per share on August 31, 2021, to close at $112.27 per share on September 1, 2021.

After the Class Period, on December 3, 2021, AbbVie announced that the FDA had updated Rinvoq's label to require additional safety warnings and limit marketing of Rinvoq to only its use after treatment with other drugs has failed. On January 11, 2022, Defendants admitted that these changes to Rinvoq's label would negatively impact sales, forcing the Company to reduce its long-term guidance for Rinvoq's sales in 2025.

The complaint alleges that, throughout the Class Period, the Defendants made materially false and/or misleading statements, about the company's business and operations. Specifically, Defendants misrepresented and/or failed to disclose that: (1) safety concerns about Xeljanz extended to Rinvoq and other JAK inhibitors; (2) as a result, it was likely that the FDA would require additional safety warnings for Rinvoq and would delay the approval of additional treatment indications for Rinvoq; and (3) therefore, Defendants' statements about the company's business, operations, and prospects lacked a reasonable basis, As a result of the Defendants' wrongful acts and omissions, and the significant decline in the market value of AbbVie's securities, AbbVie investors have suffered significant damages.

WHAT CAN I DO?

AbbVieinvestors may, no later than June 6, 2022, seek to be appointed as a lead plaintiff representative of the class through Kessler Topaz Meltzer & Check, LLPor other counsel, or may choose to do nothing and remain an absent class member. Kessler Topaz Meltzer & Check, LLP encourages AbbVie investors who have suffered significant losses to contact the firm directly to acquire more information.

CLICK HERE TO SIGN UP FOR THE CASE

WHO CAN BE A LEAD PLAINTIFF?

A lead plaintiff is a representative party who acts on behalf of all class members in directing the litigation. The lead plaintiff is usually the investor or small group of investors who have the largest financial interest and who are also adequate and typical of the proposed class of investors. The lead plaintiff selects counsel to represent the lead plaintiff and the class and these attorneys, if approved by the court, are lead or class counsel. Your ability to share in any recovery is not affected by the decision of whether or not to serve as a lead plaintiff.

ABOUT KESSLER TOPAZ MELTZER & CHECK, LLP

Kessler Topaz Meltzer & Check, LLP prosecutes class actions in state and federal courts throughout the country and around the world. The firm has developed a global reputation for excellence and has recovered billions of dollars for victims of fraud and other corporate misconduct. All of our work is driven by a common goal: to protect investors, consumers, employees and others from fraud, abuse, misconduct and negligence by businesses and fiduciaries. For more information about Kessler Topaz Meltzer & Check, LLP please visit www.ktmc.com.

CONTACT:

Kessler Topaz Meltzer & Check, LLP
James Maro, Jr., Esq.
280 King of Prussia Road
Radnor, PA 19087
(484) 270-1453
info@ktmc.com

SOURCE: Kessler Topaz Meltzer & Check, LLP



View source version on accesswire.com:
https://www.accesswire.com/702143/CLASS-ACTION-ALERT-Kessler-Topaz-Meltzer-Check-LLP-Reminds-AbbVie-Inc-Investors-of-Upcoming-Lead-Plaintiff-Deadline

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SHAREHOLDER ALERT: ABBV NTRA MULN: The Law Offices of Vincent Wong Reminds Investors of Important Class Action Deadlines

The Law Offices of Vincent Wong announce that class actions have commenced on behalf of certain shareholders in the following companies. If you suffered a loss you have until the lead plaintiff deadline to request that the court appoint you as lead plaintiff. There will be no obligation or cost to you

AbbVie Inc. (NYSE:ABBV)

If you suffered a loss, contact us at:https://www.wongesq.com/pslra-1/abbvie-inc-loss-submission-form-2?prid=27532&wire=1
Lead Plaintiff Deadline: June 6, 2022
Class Period: April 30, 2021 - August 31, 2021

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SHAREHOLDER ALERT: AUPH LILM AXSM: The Law Offices of Vincent Wong Reminds Investors of Important Class Action Deadlines

The Law Offices of Vincent Wong announce that class actions have commenced on behalf of certain shareholders in the following companies. If you suffered a loss you have until the lead plaintiff deadline to request that the court appoint you as lead plaintiff. There will be no obligation or cost to you

Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH)

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