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 THEFOLLOWING 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
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 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.
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, LLP or 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.
Kessler Topaz Meltzer & Check, LLP James Maro, Jr., Esq. 280 King of Prussia Road Radnor, PA 19087 (484) 270-1453 info@ktmc.com
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CAMBRIDGE, Mass. & NORTH CHICAGO, Ill.–(BUSINESS WIRE)–The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the granting of a marketing authorization for ZINBRYTA™ (daclizumab) intended for the treatment of relapsing forms of multiple sclerosis (RMS), Biogen (NASDAQ: BIIB) and AbbVie (NYSE: ABBV) announced today. ZINBRYTA is a once-monthly, self-administered, subcutaneous investigational treatment for RMS. ZINBRYTA is also currently under regulatory review in the United States, Switzerland, Canada and Australia. “For people with relapsing forms of MS (RMS) and active disease, ZINBRYTA has the potential to offer robust efficacy, a manageable safety profile through patient monitoring, and once-monthly subcutaneous dosing,” said Alfred Sandrock, M.D., Ph.D., executive vice president and chief medical officer at Biogen. “ZINBRYTA may offer another option for people with multiple sclerosis (MS) with its targeted mechanism of action (MOA) which did not cause broad and prolonged immune cell depletion.” The CHMP positive opinion is now referred to the European Commission (EC), which grants marketing authorizations for centrally authorized medicines in the European Union. A decision from the EC is expected within the coming months. “Together with Biogen, AbbVie is committed to meeting the needs of patients with MS, and the positive opinion issued by the CHMP is a critical step that moves us closer to bringing ZINBRYTA to patients in Europe,” said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. According to the CHMP opinion, the benefits of ZINBRYTA are its ability to reduce the annualized relapse rate (ARR), as well as the risk of 24-week confirmed disability progression. The opinion is based on results from two clinical trials, DECIDE and SELECT, in which ZINBRYTA 150 mg, administered subcutaneously every four weeks improved results on key measures of MS disease activity in patients with RMS compared to AVONEX 30 mcg intramuscular injection administered weekly and placebo, respectively. In the DECIDE study, the overall incidence of adverse events was similar in the ZINBRYTA and AVONEX groups. In patients treated with ZINBRYTA compared to AVONEX, there was an increased incidence of serious infections (4% versus 2%), serious cutaneous reactions (2% versus <1%), elevations of liver transaminases greater than five times the upper limit of normal (6% versus 3%), gastrointestinal disorders (31% versus 24%), and depression (8% versus 6%). About ZINBRYTA™ (daclizumab) ZINBRYTA (daclizumab) is an investigational compound being developed for the treatment of relapsing forms of MS. ZINBRYTA is a new form of a humanized monoclonal antibody that selectively binds to the high-affinity interleukin-2 (IL-2) receptor subunit (CD25) that is expressed at high levels on T-cells that become activated in people with MS. ZINBRYTA modulates IL-2 signaling without general immune cell depletion. Biogen and AbbVie are jointly developing ZINBRYTA. About Biogen Through cutting-edge science and medicine, Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological, autoimmune and rare diseases. Founded in 1978, Biogen is one of the world’s oldest independent biotechnology companies and patients worldwide benefit from its leading multiple sclerosis and innovative hemophilia therapies. For more information, please visit www.biogen.com. Follow us on Twitter. Biogen Safe Harbor This press release contains forward-looking statements, including statements about the anticipated timing of the EC’s decision on the marketing authorization for ZINBRYTA, and potential impact of ZINBRYTA, if approved. These statements may be identified by words such as “believe,” “expect,” “may,” “potential,” “will” and similar expressions, and are based on our current beliefs and expectations. You should not place undue reliance on these statements. Drug development and commercialization involve a high degree of risk. Factors which could cause actual results to differ materially from our current expectations include the risk that the EC may fail to approve or may delay approval of ZINBRYTA or may not follow the recommendation of the CHMP, uncertainty of success in commercialization of ZINBRYTA For more detailed information on the risks and uncertainties associated with our drug development and commercialization activities and risks relating to our collaborations with third parties, please review the Risk Factors section of our most recent annual or quarterly report filed with the Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this press release and we assume no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise. About AbbVie AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world’s most complex and serious diseases. Together with its wholly-owned subsidiary, Pharmacyclics, AbbVie employs more than 28,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page. Forward-Looking Statements Some statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words “believe,” “expect,” “anticipate,” “project” and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie’s operations is set forth in Item 1A, “Risk Factors,” in AbbVie’s 2014 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.
The biosimilar alliance between Merck (NYSE:MRK) and Samsung Bioepis appears to have paid off, as the companies have won South Korean approval for their copy of Amgen’s (NASDAQ:AMGN) blockbuster drug Enbrel. According to Fierce Biotech:
Korea’s Ministry of Food and Drug Safety signed off on the injection, to be marketed as Brenzys, to treat rheumatoid arthritis, psoriatic arthritis, spondyloarthritis and psoriasis in adults. The biosimilar, developed as SB4, proved itself equivalent to Amgen’s cash cow in a 596-patient study disclosed this year, reducing symptoms of rheumatoid arthritis on pace with its reference product, according to Merck and Samsung. Brenzys’ approval marks the first marketing victory for the two companies, a milestone Merck hopes will be a harbinger of future success in biosimilars. The approval could also have major implications for Samsung Bioepis, long rumored to be considering a U.S. IPO. Details of the company’s Wall Street plans have been tricking out for months, and The Wall Street Journal reported in August that Samsung is planning a $1 billion debut offering for its biologics division, valuing the company at about $7 billion. Samsung Bioepis, a joint venture with Biogen ($BIIB) that is 85% owned by the South Korean company, joined forces with Merck in 2013 in a wide-ranging deal designed to crack the growing market for off-patent biological treatments. Beyond Enbrel, the pair are working on copies of the similar Humira from AbbVie ($ABBV) and Remicade from Johnson & Johnson ($JNJ). The companies are also developing biosimilars of Sanofi’s ($SNY) blockbuster insulin Lantus and Roche’s ($RHHBY) cancer treatment Herceptin.
Click here to read the full article on Fierce Biotech.
Amgen (NASDAQ:AMGN) will present at the Goldman Sachs 43 rd Annual Healthcare Conference at 1:40 p.m. ET on Wednesday June 15, 2022. David M. Reese M.D., executive vice president of Research and Development and Peter H. Griffith executive vice president and chief financial officer at Amgen will present at the conference. The webcast will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.
The webcast, as with other selected presentations regarding developments in Amgen's business given by management at certain investor and medical conferences, can be found on Amgen's website, www.amgen.com , under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen's Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average and is also part of the Nasdaq-100 index. In 2021, Amgen was named one of the 25 World's Best Workplaces™ by Fortune and Great Place to Work™ and one of the 100 most sustainable companies in the world by Barron's.
For more information, visit www.amgen.com and follow us on www.twitter.com/amgen .
CONTACT: Amgen, Thousand Oaks Megan Fox , 805-447-1423 (media) Jessica Akopyan , 805-447-0974 (media) Arvind Sood , 805-447-1060 (investors)
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Boosh Plant-Based Brands Inc. (CSE: VEGI) (OTCQB: VGGIF) (FSE: 77I) ("Boosh" or the "Company") a premier plant-based brands company in the in-health food sector, is excited to announce the filing of a business acquisition report ("BAR") on the Company's SEDAR profile (www.sedar.com) in relation to its previously completed acquisition of the business of Beanfields, Inc. that occurred on February 16, 2022. Beautiful Beanfields Inc is now officially in our family of Brands.
The BAR includes audited carve out financial statements for the business of Beanfields for the year ended December 31, 2021 with unaudited comparative for the year ended December 30, 2020. The financial statements are prepared in accordance with International Financial Reporting Standards.
Beanfields produces and sells a healthy, gluten-free, non-GMO, vegan, top eight allergen-free flavored bean-based chip. The portfolio includes a broad offering of nine flavors, including Black Bean, Sour Cream and Onion, Fiery Hot and Nacho flavors. They have capitalized on the industry trends of 'Better For You' in the salty snack category. Beanfields received the 2019 "Rising Star Award" from NOSH (Natural, Organic, Sustainable and Healthy) organization. In June 2021, it introduced its Rings line, which became one of its fastest-selling products. This past December, NOSH recognized Rings as a Best New Product for 2021.
Since we acquired the Beanfields business in February, our team has been increasing production levels to meet high demands from retailers. Our first priority was to purchase large quantities of raw material to prevent supply disruption, increase production to match demand, and reach out to the current customer base - all of which has been successfully orchestrated. We've been able to maintain the vast majority of Beanfields' approximate 7,000 retailers, as we continue to stock shelves to meet customer demand. Beanfields chips are currently sold throughout all 50 states, Canada, and other countries. As can be seen in the audited carve out statements for the year ended December 31, 2021, the Beanfields brand generated Net Revenues of US$8.8M, which consisted of US$11.5M in gross sales, net of US$2.7M in sales discounts and manufacture chargebacks. We expect to continue to push sales momentum and drive further growth within the Company's full product portfolio.
On behalf of the Board of Directors
Connie Marples Founder/CEO connie@booshfood.com Telephone: 778 840 1700 www.Booshfood.com
About Boosh Plant-Based Brands Inc.:
Boosh Plant-Based Brands Inc., through its wholly owned subsidiary, Boosh Food (www.booshfood.com), offers high quality, non-GMO, gluten free, 100% plant-based nutritional comfort foods for the whole family. Through a separate subsidiary, Beautiful Beanfields, the Company owns Beanfields, a plant-based chips brand sold in over 7,000 stores throughout North America. Boosh, good for you and good for planet earth.
The information in this news release includes certain information and statements about management's view of future events, expectations, plans and prospects that constitute forward looking statements. These statements are based upon assumptions that are subject to significant risks and uncertainties. Because of these risks and uncertainties and as a result of a variety of factors, the actual results, expectations, achievements or performance may differ materially from those anticipated and indicated by these forward-looking statements. Forward-looking statements in this news release include, but are not limited to, the Company's expectations concerning the revenue growth potential of Beanfields and its ability to generate profits there from. Any number of factors could cause actual results to differ materially from these forward-looking statements as well as future results. Although the Company believes that the expectations reflected in forward looking statements are reasonable, it can give no assurances that the expectations of any forward-looking statements will prove to be correct. Except as required by law, the Company disclaims any intention and assumes no obligation to update or revise any forward-looking statements to reflect actual results, whether as a result of new information, future events, changes in assumptions, changes in factors affecting such forward-looking statements or otherwise.
Neither the Canadian Securities Exchange nor its Regulation Services Provider (as that term is defined in the policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this release.
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Naturally Splendid Enterprises Ltd. ("Naturally Splendid") (TSX-V:NSP) (OTC PINK:NSPDF) (Frankfurt:50N), as previously announced, presented the Plantein™ line of plant-based entrees at the Planted Expo Vancouver on June 4 and June 5, 2022, at the Vancouver Convention Center
Planted Expo is Canada's largest plant-based event of the year, focused on consumers looking to add more plant-based choices to their daily diets. Naturally Splendid presented eight (8) Plantein™ plant-based entrees, including our plant-based; Burger; Crispy Burger; Crumbed Tenders; Sweet Chili Tenders; Nuggets; Schnitzel (cutlet); Garlic Kiev; and a Phishy Fillet.
Although the show is primarily for consumers, several local independent and retail chain stores also had representatives at the Expo. Many of these retail operations have reached out to Naturally Splendid inquiring about listing our products. In addition to the existing leads from the previous Food Expo, the sales team will actively follow up on these inquiries.
Naturally Splendid VP Mr. Bryan Carson states, "As we are actively working our sales efforts on FoodService and Retail nationally, we didn't want to lose sight of creating some local excitement about our products. The Greater Vancouver Region has over 2.5 million consumers, and this Expo is a low-cost way to target the plant-based consumer; as part of the show, we teamed up with Directfoods.com to get our products home-delivered. With everything being local and with Directfoods.com delivery, we reduce our packaging costs significantly. The response from attendees at Planted Expo has been exceptional. The Company has been receiving orders online since the show started on Saturday, and we look for growth opportunities for the business everywhere. We invite you to check out Planted Expo attendee responses for yourselves at https://youtu.be/BJUsq_QDfG8.
About Naturally Splendid Enterprises Ltd.
Naturally Splendid is a plant-based food manufacturing and technology company that produces and distributes nutritious and delicious plant-based commodity products.
Founded in 2010, the Company operates a Safe Quality Food Level 2 certified food manufacturing facility located just outside Vancouver, BC in Canada, focusing on producing an extensive range of plant-based entrees.
Naturally Splendid has an exclusive 10-year manufacturing and distribution agreement for Canada with a division of Australia's largest plant-based food manufacturer, Flexitarian Foods Pty. Ltd.
In addition to producing the Company's own branded products, Naturally Splendid provides contract manufacturing services and private labeling for a variety of nutritional plant-based food products destined for multiple distribution channels.
The Company has established healthy, functional foods under brands such as Natera Sport™, Natera Hemp Foods™, CHII™, Elevate Me™ and Woods Wild Bar™. The Company launched Natera Plant Based Foods, a line of delicious plant-based meat alternatives for the rapidly growing plant-based market segment.
Naturally Splendid maintains a relationship Plasm Pharmaceutical, a company that has been approved for conducting a phase 2 clinical trial approved by Health Canada for the treatment of COVID-19.
NSE has also developed proprietary technologies for the extraction of healthy omega 3 and 6 oils, as well as a protein concentrate from hemp.
For more information e-mail info@naturallysplendid.com or call Investor Relations at 604-570-0902 ext 101
On Behalf of the Board of Directors Mr. J. Craig Goodwin CEO, Director
Contact Information: Naturally Splendid Enterprises Ltd. (NSP - TSX Venture; NSPDF - OTCQB; 50N Frankfurt) #108-19100 Airport Way Pitt Meadows, BC, V3Y 0E2 Office: (604) 570-0902 Fax: (604) 465-1128 E-mail: info@naturallysplendid.com Website: www.naturallysplendid.com
Information set forth in this news release contains forward-looking statements that are based on assumptions as of the date of this news release. These statements reflect management's current estimates, beliefs, intentions and expectations. They are not guarantees of future performance. Naturally Splendid cautions that all forward looking statements are inherently uncertain and that actual performance may be affected by a number of material factors, many of which are beyond Naturally Splendid's control including, Naturally Splendid's ability to compete with large food and beverage companies; sales of any potential products developed will be profitable; sales of shelled hemp seed will continue at existing rates or increase; the ability to complete the sales of all bulk hemp seed purchase orders; and the risk that any of the potential applications may not receive all required regulatory or legal approval. Accordingly, actual and future events, conditions and results may differ materially from the estimates, beliefs, intentions and expectations expressed or implied in the forward-looking information. Except as required under applicable securities legislation, Naturally Splendid undertakes no obligation to publicly update or revise forward-looking information.
NEITHER TSX VENTURE EXCHANGE NOR ITS REGULATION SERVICES PROVIDER (AS THAT TERM IS DEFINED IN THE POLICIES OF THE TSX VENTURE EXCHANGE) ACCEPTS RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.
SOURCE: Naturally Splendid Enterprises Ltd.
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ABBVie (NYSE: ABBV) today announced new data from Cohort 3 of its Phase 2 REFINE study of investigational navitoclax in combination with ruxolitinib in JAK inhibitor naïve patients with myelofibrosis (MF), a rare and difficult to treat blood cancer. These preliminary findings show spleen volume and symptomatic improvement in this cohort. These data are consistent with previously observed data from relapsedrefractory patients in Cohort 1a 1 and will be shared in an oral presentation at the 2022 European Hematology Association (EHA) Annual Congress (Abstract #S197). 2
REFINE is a Phase 2 non-randomized open-label multi-cohort study evaluating the safety and efficacy of navitoclax alone or in combination with ruxolitinib in MF.
"Current treatment options for myelofibrosis are limited and targeted toward controlling disease symptoms," said Mohamed Zaki , M.D., Ph.D., vice president and global head of oncology clinical development, AbbVie. "Together with pre-clinical findings, early results of this study demonstrating anti-fibrosis activity of navitoclax in combination with ruxolitinib are promising. Specifically, the data findings regarding reduction in spleen volume, symptoms and bone marrow fibrosis help support the further exploration of disease modification in myelofibrosis."
The results presented at EHA 2022 were from a preliminary analysis of 32 JAK inhibitor naïve MF patients from Cohort 3 of the Phase 2 REFINE trial (NCT03222609). 2 The primary endpoint was spleen volume reduction of ≥35 percent (SVR35) from baseline at week 24. 2 Key secondary endpoints include ≥50 percent reduction in total symptom score (TSS50) at week 24, anemia response and BMF reduction. 2
In the results, SVR35 was achieved by 63 percent of evaluable patients at week 24 (20/32) and by 78 percent at any time on treatment (25/32). 2 At week 24, 41 percent (11/27) of evaluable patients with measurable baseline symptoms reached TSS50; notably, 67 percent of patients (18/27) met this endpoint at any time during the study. 2 In this cohort, 35 percent of evaluable patients, with available fibrosis grade at baseline and during the study, (9/26) achieved reduction in BMF by ≥1 grade at any time during the study with three patients experiencing ≥2 grade reductions in BMF. 2 Additionally, 40 percent of patients evaluable for anemia response (6/15) experienced improvement in anemia, a common clinical feature of MF. 2
Preliminary safety analysis identified no new safety signals. Thirty-one (97 percent) patients reported one or more adverse event (AE). 1 The most common Grade ≥3 AEs were thrombocytopenia (47 percent), anemia (34 percent), and neutropenia (25 percent). 1 Seven patients (22 percent) reported experiencing serious AEs. 1 Three patients (9 percent) experienced an AE leading to navitoclax discontinuation and three patients (9 percent) reported an AE leading to ruxolitinib discontinuation. 2
"These data reinforce the importance of early intervention in myelofibrosis and the potential to achieve improved clinical outcomes," said Francesco Passamonti, Full Professor of Hematology, University of Insubria and Chief, Hematology, Varee Hospital. "These preliminary results show good responses to combination therapy with navitoclax that may continue to improve over time."
About Navitoclax Navitoclax is an investigational, oral BCL-X L /BCL-2 inhibitor. The BCL-2 family of proteins are known regulators of the apoptosis pathway. 3
Navitoclax is not approved by the U.S. Food and Drug Administration (FDA) or any Health Authority worldwide at this time. Its safety and efficacy are under evaluation as part of ongoing Phase 2 and registrational Phase 3 studies.
AbbVie has an extensive late-stage clinical trial program for investigational navitoclax that is currently enrolling. For more information about enrolling in a clinical trial, please visit us here .
About the REFINE Study REFINE is a multi-cohort, Phase 2, randomized, open-label, multicenter study evaluating the tolerability and efficacy of navitoclax alone or when added to ruxolitinib in patients with myelofibrosis (MF). 4 The primary outcome measure is the percentage of patients who achieve Spleen Volume Reduction of greater than or equal to 35 percent (SVR35) from baseline to Week 24. Secondary outcomes measures include percentage of participants achieving 50 percent reduction in Total Symptom Score from baseline to Week 24 and change in grade of bone marrow fibrosis assessed according to the European Consensus Grading System.
Data presented at EHA 2022 include preliminary safety and efficacy results from Cohort 3 of REFINE (n=32). Patients in Cohort 3 had primary or secondary MF with splenomegaly and had not received JAK-2 therapy or BET inhibitors prior to enrollment. Data presented at EHA 2022 are representative of data from Cohort 3 of the REFINE study as of February 7, 2022 .
Data included in the official EHA 2022 Abstract Book are representative of data from Cohort 3 of the REFINE study as of October 4 , 2021.
More information can be found on https://www.clinicaltrials.gov/ (NCT03222609).
About Myelofibrosis Myelofibrosis (MF) is a rare, difficult-to-treat blood cancer that results in excessive scar tissue formation (fibrosis) in the bone marrow. Patients living with MF experience symptoms such as an enlarged spleen, fatigue, weakness, and severe anemia, that are often debilitating and greatly impact quality of life. MF also carries a risk of transformation to more aggressive disease such as acute myeloid leukemia. 4
About AbbVie in Oncology At AbbVie, we are committed to transforming standards of care for multiple blood cancers while advancing a dynamic pipeline of investigational therapies across a range of cancer types. Our dedicated and experienced team joins forces with innovative partners to accelerate the delivery of potentially breakthrough medicines. We are evaluating more than 20 investigational medicines in over 300 clinical trials across some of the world's most widespread and debilitating cancers. As we work to have a remarkable impact on people's lives, we are committed to exploring solutions to help patients obtain access to our cancer medicines. For more information, please visit http://www.abbvie.com/oncology .
About AbbVie AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .
Forward-Looking Statements Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, failure to realize the expected benefits from AbbVie's acquisition of Allergan plc ("Allergan"), failure to promptly and effectively integrate Allergan's businesses, competition from other products, challenges to intellectual property, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry and the impact of public health outbreaks, epidemics or pandemics, such as COVID-19. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2021 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.
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The plant-based meat market is expected to grow at an impressive CAGR of 25.14 percent as consumers seek more plant-based options. The segment has the potential to grow by US$7.21 billion from 2015 to 2021. In 2019 alone, the plant-based meat market was valued at a significant US$3.77 billion. The high growth rate of this segment of the plant-based market presents an exciting opportunity for investors seeking to grow their capital.
A key geographic market in the plant-based category is North America, and Canada is a global leader in plant protein. The Government of Canada recently invested C$153 million into the Protein Industries SuperCluster, which seeks to increase the value of key Canadian crops such as canola, wheat and pulses. A significant opportunity for these crops revolves around the growing plant-based meat alternatives markets in North America, with further export opportunities in Asia and Europe. The Canadian government expects the investment to generate more than C$4.5 billion in GDP over the next 10 years.
Naturally Splendid Enterprises (TSXV:NSP,OTCQB:NSPDF,FSE:50N) is a Canadian-based company focused on manufacturing delicious plant-based products. Their feature plant-based line is marketed under the PlanteinTM trademark. This line is manufactured under a 10-year exclusive manufacturing and distribution agreement with Flexitarian Foods Pty. Ltd., a division of Australia’s largest plant-based manufacturer.
As a result of this agreement, Naturally Splendid offers the most extensive plant-based meat alternative choices than any other plant protein company in North America, including Beyond Meat (NASDAQ: BYND), Gardein (owned by Conagra NASDAQ: CAG) and Impossible Meat.
Over the years, Naturally Splendid has developed a number of retail brands covering various consumer channels that have been sold in thousands of retail locations across Canada and online. The Company’s feature plant-based line boasts a number of appetizers and entrees prepared for those looking to add more plant-based nutrition into their diets, whether they be vegans, vegetarians or the rapidly growing ‘flexitarian consumer.’
ProSnack Natural Foods, a 100% owned division of Naturally Splendid, manufactures plant-based appetizers and entrees in their 17,000 square foot Safe Quality Food (SQF) Certified food manufacturing facility located in Pitt Meadows, British Columbia in, Canada. The facility is capable of manufacturing a wide range of plant-based appetizers and entrees. While upgrading the Prosnack facility, the SQF Certification is temporarily on hold at the request of Company. SQF pre-certification inspection is expected in October 2022 with full certification expected Q2 2023. Previously the Company scored an 89/100 during their SQF certification process, indicating a high aptitude for manufacturing processes.
The facility is currently undergoing renovations to replicate the established, successful manufacturing processes that have made Plantein among Australia’s most popular plant-based entrees. Once completed in the latter part of 2022, the facility will have the capacity to produce 30 tons of plant-based products daily, or in dollar values, will have a manufacturing capacity of $45,000,000 CDN annually.
In addition to Naturally Splendid’s house brand, ‘Plantein,’ ProSnack will manufacture under Private Label agreements and manufacture for strategically selected companies, producing their proprietor formulations for plant-based products.
Flexitarian Foods has developed industry-disrupting IP in both product R&D as well as manufacturing. Rather than develop a ‘recipe’ for a single product, as most every other plant-based manufacturer does, Flexitarian Foods has perfected a system based on their IP for rapid product development. Flexitarian Food’s IP extends to manufacturing, and its success lies in using standardized equipment rather than custom manufactured equipment to process their plant-based foods.
The IP regarding product formulation creates the landscape to develop new plant-based SKUs in industry-leading time frames…typically 6-10 weeks for initial concept samples to be developed.
IP related to manufacturing provides a competitive pricing advantage due to the efficiency of the Company’s manufacturing processes. Flexitarian Food’s methodology based on their IP allows for rapid expansion to manufacturing capacity as capacity can be increased simply by adding additional equipment. This strategy lends itself to the opportunity to build multiple manufacturing facilities close to input sources and consumer bases, creating competitive advantages.
Initially, Naturally Splendid marketed its plant-based products under its Natera brand. The Company has since negotiated a 10-year licensing agreement to use the Plantein name in Canada. The licensing agreement has a 10-year extension, making this a 20-year agreement.
In August 2021, the company announced an exciting milestone in which NATERA’s plant-based chicken tenders and plant-based chicken nuggets will soon be available at 71 Denny’s Corporation (NASDAQ:DENN) restaurant locations across Canada. These items are currently being served in all Canadian Denny’s locations.
The Company has established relationships with Canada’s two largest food distributors, who in combination hold an estimated 85% market share.
Gordon Food Service (GFS) – Services Denny’s Canada account as well as others
Naturally Splendid’s initial foray into plant-based nutrition began over a decade ago and focused on hemp and the incredible nutritional profile the plant provided. The Company’s journey has included significant technological advances in hemp protein and the omegas contained in hemp, resulting in unique ingredients that may be incorporated into plant-based product formulations. Naturally Splendid is the owner of Chii Pure Hemp, an online store selling hemp seed and protein and manufactures nutritional bars and bites in their certified food manufacturing facility. This facility is now being retrofitted to manufacture a diverse range of plant-based appetizers and entrees. The Company’s previous technological advances in the area of micro-encapsulation of omegas and concentrating of plant proteins, has provided an opportunity to use these value-added ingredients in their own plant-based products. Additionally, these value-added ingredients have the potential to be marketed to other plant-based manufacturers creating new revenue stream. The opportunity within the plant-based market space has created new opportunities for these Company owned technologies and ingredients.
In addition to the Company’s plant-based appetizer and entree business, Naturally Splendid’s other plant-based brands include CHII, ElevateMe, NATERA Sport, and Pawsitive FX. CHII is one of Canada’s oldest hemp companies, established in 2019. The brand offers hemp seeds, oils, and proteins sold primarily online. Elevate Me, and Woods Wild Bars are the company’s bars offerings. These products are currently going through re-formulation to offer 100% plant-based nutrition. Pawsitive FX is the company’s foray into topical pet products, which feature 100% plant-based formulations.
ProSnack Natural Foods operates a 17,000 square foot Safe Quality Food (SQF) Certified Food Manufacturing facility in Pitt Meadows, British Columbia, Canada.
ProSnack Natural Foods facility is undergoing retrofitting and will manufacture the Plantein line of plant-based products upon commissioning. Upon retrofit completion, the facility will be capable of producing 30 tons of plant-based products per day, resulting in a manufacturing capacity in dollars of an estimated $40M CDN annually.
Additionally, and as importantly, Prosnack Natural Foods offers contract manufacturing for various clients, including private label programs.
Prior to retrofitting to manufacture plant-based entrees, Prosnack manufactured nutritional bars and bites for themselves under multiple ‘house brands’ and several well-known brands.
Naturally Splendid has secured the rights to use the Plantein name in Canada exclusively for an initial 10-year term with a 10-year renewal option.
Plantein originated in Australia and is manufactured by a division of the largest plant-based manufacturer in Australia.
The PlanteinTM line of plant-based foods includes alternatives for beef, chicken, pork, fish and seafood. The Company has over 40 commercially ready plant-based entrees and has launched eight (8) SKUs initially in foodservice and retail in Canada.
The eight (8) products available today are 100% vegan and include a plant-based Burger, Crispy Burger, Crumbed Tenders, Sweet Chili Tenders, Nuggets, Schnitzel, Garlic Kiev and Phishy Fillet.
Naturally Splendid has developed and owns several brands covering multiple categories, including CHII Pure Hemp, Elevate Me, Woods Wild Bar, NATERA Sport and Pawsitive FX focusing on plant-based ingredients.
CHII is one of Canada’s pioneering hemp companies, established in 1998. The brand offers hemp hearts, hemp oil and hemp seed protein through an online e-commerce platform. Chii hemp foods include hemp seed hearts, hemp protein powder and hemp seed oil.
The Company has developed, manufactured and distributed several nutritional bars and bites, including Elevate Me, Woods Wild Bar and KEY-TO-LIFE.
NATERA Sport also recently launched Procurc 30, an advanced curcumin-based supplement that Health Canada approved for phase two clinical trial as a potential treatment for Covid-19.
Pawsitive FX consists of three (3) all-natural balms for snout and paw health; Happy Paws, Strong Paws, Happy Snouts.Pawsitive FX as well as offers raw hemp oil for canine nutrition!
J. Craig Goodwin is a co-founder of Naturally Splendid. As CEO, Goodwin has been instrumental in the transition from a private company to a public company raising over CA$20,000,000 in the process. In addition to his role as CEO, Goodwin’s responsibilities included international business development where he oversaw the development of a South Korean project generating over C$7,000,000 in 2016.
Currently, Goodwin is developing business in South Korea, Japan, China, Germany and Australia to name a few. Previous to his appointment as CEO of Naturally Splendid, Goodwin accumulated over 30 years of sales and marketing experience including senior account executive for one of the largest outdoor advertising companies in the world, The Jim Pattison Sign Group. While with The Jim Pattison Sign Group, Craig was one of the most successful sales executives in Western Canada and received numerous awards for outstanding sales achievements.
In addition to sales and marketing, Goodwin has consulted for numerous public companies providing services including investor relations, raising venture capital and business development.
Bryan Carson’s vision of a company distributing healthy food choices is a driving force behind Naturally Splendid® and the foundations from which this company originated. For the past four years, Carson has overseen the operations of Naturally Splendid® including establishing supply channels, packaging and product development. Carson’s insight and vision have proved invaluable as part of the management team.
Carson created, operated and sold a successful retail store in Vancouver, B.C. His hands-on retail expertise from the conceptual planning stages through construction and launch is of great value in developing our relationship with major food distribution channels.
George Ragogna has over 30 years of experience in the Canadian financial services industry. Ragogna also has over 20 years of experience in a progressive leadership role specializing in strategic planning, corporate sales, workforce optimization and regulatory compliance. Ragogna successfully manages and supports a call center of over 550 employees, ensuring new and existing staff are trained and knowledgeable in the financial services industry and compliance processes.
Ragogna brings unique business acumen and strong technical skills that will strengthen the board at Naturally Splendid.
Larry Gilmour's professional career began in sales and marketing with internationally recognized brands such as Libby's (Libby, McNeil and Libby), Playtex Corp. and Black and Decker. Gilmour has also owned and operated chain grocery outlets including owner and operator of a Super Valu grocery store in Vancouver, B.C., for over five years. He has a successful track record of growing businesses with existing consumer bases.
Gilmour joined Independent Pharmacist Inc. where he leveraged his sales, marketing and management skills to drive membership up significantly –– increasing sales tenfold from $2 million to $22 million over four years. When the business was sold, Gilmour built another business called Vancouver Wholesale Drugs. Gilmour was a partner and general manager of Vancouver Wholesale Drugs and oversaw a sales increase from $5 million to $70 million in just six years. Gilmour then returned to the grocery world purchasing an IGA grocery store in Vancouver, B.C., that he operated for over eight years. More recently, Gilmour has been advising business owners of small- to medium-sized businesses in infrastructure, financing, sales and marketing.
Kris Tarr's professional career has spanned almost three decades as an information technology and internet marketing consultant. Tarr has held several senior marketing management and IT executive positions, applying his decades of experience in technology, management and leadership to deliver business results for organizations in the high-tech, pharmaceutical, tourism, entertainment, online gaming and real estate sectors.
Tarr has worked for globally recognized organizations such as Coca-Cola, Disney and Nickelodeon. As a consultant, he has guided over a hundred small and medium-sized businesses, developing and implementing online and e-commerce strategies.
In Vancouver, Canada, Tarr focused on internet marketing with an emphasis on search engine optimization and social media automation for the online gaming industry. Tarr held a position as senior SEO strategist for Bodog which is a major online gaming brand. Tarr has also held the positions of ITSM (IT service management) head, chief technology officer and IT solutions provider at Oriental Game which is Asia's leading online gaming solutions provider.
Tarr has started numerous lucrative business ventures and has built and operated many successful search engines including a property management franchise. He co-founded Waveless Websystems Inc., where he developed e-commerce solutions for the home building industry, which led him to Southeast Asia to expand the company's software development team.
Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) ("Cardiol" or the "Company"), a clinical-stage life sciences company focused on the research and clinical development of anti-inflammatory and anti-fibrotic therapies for the treatment of cardiovascular disease, is pleased to announce that it has entered into a sales agreement (the "ATM Agreement") with Canaccord Genuity LLC and Cantor Fitzgerald & Co. (the "Sales Agents") for an at-the-market offering program (the "ATM Program").
The ATM Agreement will allow the Company to offer and sell up to US$50 million of common shares of the Company (the "Offered Shares") under the ATM Program. The Offered Shares may be offered and sold by the Company to the public from time to time, through the sales agents. The Offered Shares sold under the ATM Program, if any, will be sold by means of ordinary brokers' transactions on the Nasdaq Capital Market (the "Nasdaq") or any other trading markets for the common shares in the United States at the prevailing market prices at the time of the sale. No Offered Shares will be offered or sold through the Toronto Stock Exchange or otherwise in Canada.
The timing and extent of the use of the ATM Program will be at the discretion of the Company and the Company has no obligation to sell any shares pursuant to the ATM Program. Accordingly, total gross proceeds from offerings under the ATM Program could be less than US$50 million. The ATM Program will be effective until the earlier of the issuance and sale of all of the Offered Shares issuable pursuant to the ATM Program and March 8, 2024, unless terminated prior to such date by Cardiol or the sales agents.
The sale of the Offered Shares through the ATM Program will be made pursuant to a prospectus supplement dated June 9, 2022 to the Company's Canadian final base shelf prospectus dated February 8, 2022, and the Company's United States final base shelf prospectus dated February 8, 2022 contained in the Company's registration statement Form F-10 (File No. 333-262342), as amended and effective on February 8, 2022, filed in each of the provinces and territories of Canada and in the United States with the United States Securities and Exchange Commission (the "SEC"). As outlined in the prospectus supplement, the Company intends to use the net proceeds of any such sales under the ATM Program for working capital purposes and other general corporate purposes, including the development of CardiolRx™ and other product candidates. Current and potential investors should read the base shelf prospectus in the registration statement, and the prospectus supplement relating to the at-the-market offering and other documents the Company has filed with the SEC for more complete information about Cardiol and the ATM Program.
A copy of the prospectus supplement and accompanying base shelf prospectus relating to these securities may be obtained by visiting the SEDAR at www.sedar.com and on EDGAR at www.sec.gov. Copies may also be obtained by contacting: Canaccord Genuity LLC, Attn: Syndicate Department, 99 High Street, Suite 1200, Boston, Massachusetts 02110, or by email at prospectus@cgf.com or from Cantor Fitzgerald & Co., Attn: Capital Markets, 499 Park Avenue, 4th floor, New York, New York 10022; Email: prospectus@cantor.com.
The Toronto Stock Exchange has conditionally approved the ATM Program and the Nasdaq has been notified of the ATM Program.
This news release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.
Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) is a clinical-stage life sciences company focused on the research and clinical development of cannabidiol as an anti-inflammatory and anti-fibrotic therapy for the treatment of cardiovascular disease.
Cautionary statement regarding forward-looking information:
This news release contains "forward-looking information" within the meaning of applicable securities laws. All statements, other than statements of historical fact, that address activities, events, or developments that Cardiol believes, expects, or anticipates will, may, could, or might occur in the future are "forward-looking information". Forward-looking information contained herein may include, but is not limited to, statements relating to the Company's focus on developing innovative anti-inflammatory therapies for the treatment of cardiovascular disease, the timing and extent of the use of the ATM Program, that Offered Shares under the ATM Program will be sold on the Nasdaq, when the ATM Program will be effective and the use of proceeds from sales made under the ATM Program. Forward-looking information contained herein reflects the current expectations or beliefs of Cardiol based on information currently available to it and is based on certain assumptions and is also subject to a variety of known and unknown risks and uncertainties and other factors that could cause the actual events or results to differ materially from any future results, performance or achievements expressed or implied by the forward-looking information, and are not (and should not be considered to be) guarantees of future performance. These risks and uncertainties and other factors include the risks and uncertainties referred to in the Company's Annual Information Form dated March 23, 2022, as well as the risks and uncertainties associated with product commercialization and clinical studies. These assumptions, risks, uncertainties, and other factors should be considered carefully, and investors should not place undue reliance on the forward-looking information. Any forward-looking information speaks only as of the date on which it is made and, except as may be required by applicable securities laws, Cardiol disclaims any intent or obligation to update or revise such forward-looking information, whether as a result of new information, future events, or results, or otherwise.
For further information, please contact:
Trevor Burns, Investor Relations +1-289-910-0855 trevor.burns@cardiolrx.com
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/127137
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