Life Science News

  • CHMP positive opinion is based on results from three Phase 3 studies: two for induction and one for maintenance 1-3
  • Ulcerative colitis is a chronic, immune-mediated inflammatory bowel disease that can lead to substantial burden and often disability among patients 4-6
  • If approved by the European Commission (EC), this would be upadacitinib's fifth therapeutic indication in the EU
  • The EC decision is anticipated in the third quarter of 2022

ABBVie (NYSE: ABBV) today announced the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the approval of upadacitinib (RINVOQ ® 45 mg [induction dose] and 15 mg and 30 mg [maintenance dose]) for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.*

UC is the chronic inflammation of the large intestine, usually beginning in the rectum and lower colon, but may also spread continuously to involve the entire colon, which could lead to a significant burden and disability for patients. 5 Living with UC impacts all aspects of a patient's life, largely due to unpredictable symptoms such as bowel urgency, abdominal pain, rectal bleeding and bowel incontinence. 5

"As leaders in the advancement of care for people with inflammatory bowel disease, we are committed to continued research and development of treatment options that go beyond managing symptoms and include endoscopic and histologic outcomes," said Neil Gallagher , M.D., Ph.D., vice president, development, chief medical officer, AbbVie. "With today's CHMP recommendation of upadacitinib in ulcerative colitis, we've taken a giant step forward toward helping more patients achieve their treatment goals."

AbbVie's application for the approval of upadacitinib in UC is supported by data from two induction studies, U-ACHIEVE induction and U-ACCOMPLISH, and one maintenance study, U-ACHIEVE maintenance. 1-3 Across all three Phase 3 studies, significantly more patients treated with upadacitinib achieved the primary endpoint of clinical remission and all secondary endpoints. This includes statistically significant improvements in these endpoints compared to placebo with 45 mg once daily for the induction studies, and with both 15 mg and 30 mg once-daily doses for the maintenance study. 1-3 Additionally, safety results of upadacitinib in UC were consistent with the known safety profile of upadacitinib in rheumatoid arthritis, with no new important safety risks observed. 1-3, 7-10

"Patients with ulcerative colitis often face numerous complications and risk relapse. Achieving critical endpoints like clinical remission and mucosal healing can make a significant difference in symptom management and health related quality of life," said Silvio Danese , M.D., Ph.D., director of Gastroenterology and Endoscopy at San Raffaele Hospital and professor of gastroenterology at University Vita-Salute San Raffaele, Milan, Italy . "Upadacitinib could be a promising option for adult patients who continue to have moderately to severely active disease despite treatment with conventional or biologic therapies and I look forward to the European Commission's final decision on its use in ulcerative colitis."

About the U-ACHIEVE Induction, U-ACCOMPLISH and U-ACHIEVE Maintenance Studies 1-3,11-13

The three Phase 3 studies are multicenter, randomized, double-blind, placebo-controlled studies to evaluate the efficacy and safety of upadacitinib 45 mg once daily as induction therapy, and upadacitinib 15 mg and 30 mg once daily as maintenance therapy in subjects with moderate to severe ulcerative colitis. Topline results of the U-ACHIEVE induction study were announced in December 2020 , topline results of the second induction study, U-ACCOMPLISH, were announced in February 2021 , and topline results of the U-ACHIEVE maintenance study were announced in June 2021 . More information can be found on http://www.clinicaltrials.gov (NCT03006068, NCT03653026, NCT02819635).

About upadacitinib (RINVOQ ® )

Discovered and developed by AbbVie scientists, RINVOQ is a selective and reversible JAK inhibitor that is being studied in several immune-mediated inflammatory diseases. 15-20 In human cellular assays, upadacitinib preferentially inhibits signalling by JAK1 or JAK1/3 with functional selectivity over cytokine receptors that signal via pairs of JAK2. 14

Phase 3 trials of RINVOQ in rheumatoid arthritis, atopic dermatitis, psoriatic arthritis, axial spondyloarthritis, Crohn's disease, ulcerative colitis, giant cell arteritis and Takayasu arteritis are ongoing. 13,15-20 The use of upadacitinib in ulcerative colitis is not approved and its safety and efficacy have not been evaluated by regulatory authorities outside of the U.S. and Puerto Rico.

EU Indications and Important Safety Information about RINVOQ ® (upadacitinib) 14

Rheumatoid arthritis
RINVOQ is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). RINVOQ may be used as monotherapy or in combination with methotrexate.

Psoriatic arthritis
RINVOQ is indicated for the treatment of active psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs. RINVOQ may be used as monotherapy or in combination with methotrexate.

Ankylosing spondylitis
RINVOQ is indicated for the treatment of active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy.

Atopic dermatitis
RINVOQ is indicated for the treatment of moderate to severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy.

Contraindications
RINVOQ is contraindicated in patients hypersensitive to the active substance or to any of the excipients, in patients with active tuberculosis (TB) or active serious infections, in patients with severe hepatic impairment, and during pregnancy.

Special warnings and precautions for use
Immunosuppressive medicinal products
Use in combination with other potent immunosuppressants is not recommended.

Serious infections
Serious and sometimes fatal infections have been reported in patients receiving upadacitinib. The most frequent serious infections reported included pneumonia and cellulitis. Cases of bacterial meningitis have been reported. Among opportunistic infections, TB, multidermatomal herpes zoster, oral/esophageal candidiasis, and cryptococcosis have been reported with upadacitinib. As there is a higher incidence of infections in patients ≥65 years of age, caution should be used when treating this population.

Viral reactivation
Viral reactivation, including cases of herpes zoster, was reported in clinical studies. The risk of herpes zoster appears to be higher in Japanese patients treated with upadacitinib.

Vaccinations
The use of live, attenuated vaccines during or immediately prior to therapy is not recommended. It is recommended that patients be brought up to date with all immunizations, including prophylactic zoster vaccinations, prior to initiating upadacitinib, in agreement with current immunization guidelines.

Malignancy
The risk of malignancies, including lymphoma is increased in patients with rheumatoid arthritis (RA). Malignancies, including nonmelanoma skin cancer (NMSC), have been reported in patients treated with upadacitinib. Consider the risks and benefits of upadacitinib treatment prior to initiating therapy in patients with a known malignancy other than a successfully treated NMSC or when considering continuing upadacitinib therapy in patients who develop a malignancy.

Hematological abnormalities
Treatment should not be initiated, or should be temporarily interrupted, in patients with hematological abnormalities observed during routine patient management.

Diverticulitis
Upadacitinib should be used with caution in patients with diverticular disease and especially in patients chronically treated with concomitant medications associated with an increased risk of diverticulitis.

Cardiovascular risk
RA patients have an increased risk for cardiovascular disorders. Patients treated with upadacitinib should have risk factors (e.g., hypertension, hyperlipidemia) managed as part of usual standard of care.

Lipids
Upadacitinib treatment was associated with dose-dependent increases in lipid parameters, including total cholesterol, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol.

Hepatic transaminase elevations
Treatment with upadacitinib was associated with an increased incidence of liver enzyme elevation compared to placebo.

Venous thromboembolisms
Events of deep vein thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients receiving JAK inhibitors, including upadacitinib. Upadacitinib should be used with caution in patients at high risk for DVT/PE.

Adverse reactions
The most commonly reported adverse reactions in rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis clinical trials (≥2% of patients in at least one of the indications) with upadacitinib 15 mg were upper respiratory tract infections, blood creatine phosphokinase (CPK) increased, alanine transaminase (ALT) increased, bronchitis, nausea, cough, aspartate transaminase (AST) increased, and hypercholesterolemia.

The most commonly reported adverse reactions in atopic dermatitis trials (≥2% of patients) with upadacitinib 15 mg or 30 mg were upper respiratory tract infection, acne, herpes simplex, headache, CPK increased, cough, folliculitis, abdominal pain, nausea, neutropenia, pyrexia, and influenza.

The most common serious adverse reactions were serious infections.

The safety profile of upadacitinib with long term treatment was generally similar to the safety profile during the placebo-controlled period across indications.

Overall, the safety profile observed in patients with psoriatic arthritis or active ankylosing spondylitis treated with upadacitinib 15 mg was consistent with the safety profile observed in patients with RA.

In atopic dermatitis, dose-dependent increased risks of infection and herpes zoster were observed with upadacitinib. Based on limited data, there was a higher rate of overall adverse reactions with the upadacitinib 30 mg dose compared to the 15 mg dose in patients aged 65 years and older. The safety profile for upadacitinib 15 mg in adolescents was similar to that in adults. The safety and efficacy of the 30 mg dose in adolescents are still being investigated. Dose-dependent changes in ALT increased and/or AST increased (≥ 3 x ULN), lipid parameters, CPK values (> 5 x ULN), and neutropenia (ANC 9 cells/L) associated with upadacitinib treatment were similar to what was observed in the rheumatologic disease clinical studies.

This is not a complete summary of all safety information.

See RINVOQ full summary of product characteristics (SmPC) at www.ema.europa.eu .

Globally, prescribing information varies; refer to the individual country product label for complete information.

About AbbVie in Gastroenterology

With a robust clinical trial program, AbbVie is committed to cutting-edge research to drive exciting developments in inflammatory bowel diseases (IBD), like ulcerative colitis and Crohn's disease. By innovating, learning and adapting, AbbVie aspires to eliminate the burden of IBD and make a positive long-term impact on the lives of people with IBD. For more information on AbbVie in gastroenterology, visit https://www.abbvie.com/our-science/therapeutic-focus-areas/immunology/immunology-focus-areas/gastroenterology.html .

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 our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , LinkedIn or Instagram .

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 2020 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.

References:

  1. Vermeire, S., et al. OP23 Efficacy and safety of upadacitinib as induction therapy in patients with Moderately to Severely Active Ulcerative Colitis: Results from phase 3 U-ACCOMPLISH study, Journal of Crohn's and Colitis, Volume 15, Issue Supplement 1 . May 2021 .
  2. Danese, S., et al. OP24 Efficacy and safety of upadacitinib induction therapy in patients with Moderately to Severely Active Ulcerative Colitis: Results from the phase 3 U-ACHIEVE study, Journal of Crohn's and Colitis, Volume 15, Issue Supplement 1. May 2021 .
  3. Danese, S., et al. OP08 The effects of maintenance therapy with upadacitinib on abdominal pain, bowel urgency, and fatigue in patients with moderately to severely active Ulcerative Colitis: Phase 3 U-ACHIEVE maintenance results, Journal of Crohn's and Colitis , Volume 16, Issue Supplement 1. January 2022 .
  4. Gajendran M., et al. A comprehensive review and update on ulcerative colitis. Dis Mon. 2019 Dec;65(12):100851. doi: 10.1016/j.disamonth.2019.02.004. Epub 2019 Mar 2 .
  5. The Facts about Inflammatory Bowel Diseases. Crohn's & Colitis Foundation of America. 2014. Available at: https://www.crohnscolitisfoundation.org/sites/default/files/2019-02/Updated%20IBD%20Factbook.pdf . Accessed on March 29, 2022 .
  6. Mehta F. Report: economic implications of inflammatory bowel disease and its management. Am J Manag Care. 2016 Mar;22(3 Suppl):s51-60.
  7. Cohen S., et al. Safety profile of upadacitinib in rheumatoid arthritis: integrated analysis from the SELECT phase III clinical programme. Ann Rheum Dis. 2020 Oct 28;80(3):304-11.
  8. Mease, P.J., et al. Upadacitinib in Patients with Psoriatic Arthritis and Inadequate Response to Biologics: 56-Week Data from the Randomized Controlled Phase 3 SELECT-PsA 2 Study. Rheumatol Ther. 2021 Apr 28. doi: 10.1007/s40744-021-00305-z. Online ahead of print.
  9. Guttman-Yassky E ., et al. Once-daily upadacitinib versus placebo in adolescents and adults with moderate-to-severe atopic dermatitis (Measure Up 1 and Measure Up 2): results from two replicate, double-blind, randomized controlled phase 3 studies. Lancet. doi:10.1016/s0140-6736(21)00588-2.
  10. Van der Heijde D ., et al. Efficacy and Safety of Upadacitinib in a Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 2/3 Clinical Study of Patients With Active Ankylosing Spondylitis. 2019 ACR/ARP Annual Meeting; 2728.
  11. A Study to Evaluate the Long-Term Safety and Efficacy of Upadacitinib (ABT-494) in Participants With Ulcerative Colitis (UC). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03006068 . Accessed on March 29, 2022 .
  12. A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Ulcerative Colitis (U-Accomplish). ClinicalTrials.gov 2021. Available at: https://www.clinicaltrials.gov/ct2/show/NCT03653026 . Accessed on March 29, 2022 .
  13. A Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis (UC). ClinicalTrials.gov 2021. Available at: https://www.clinicaltrials.gov/ct2/show/NCT02819635 . Accessed on March 29, 2022 .
  14. RINVOQ [Summary of Product Characteristics]. AbbVie Deutschland GmbH & Co. KG; September 2021 . Available at: https://www.ema.europa.eu/en/documents/product-information/rinvoq-epar-product-information_en.pdf.
  15. Pipeline – Our Science | AbbVie. AbbVie. 2021. Available at: https://www.abbvie.com/our-science/pipeline.html . Accessed on March 29, 2022 .
  16. A Study to Compare Safety and Efficacy of Upadacitinib to Dupilumab in Adult Participants With Moderate to Severe Atopic Dermatitis (Heads Up). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03738397 . Accessed on March 29, 2022 .
  17. A Study to Evaluate Efficacy and Safety of Upadacitinib in Adult Participants With Axial Spondyloarthritis (SELECT AXIS 2). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT04169373 . Accessed on March 29, 2022 .
  18. A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Immunomodulators or Anti-TNF Therapy. ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT02365649 . Accessed on Accessed on March 29, 2022 .
  19. A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants With Giant Cell Arteritis (SELECT-GCA). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03725202 . Accessed on March 29, 2022 .
  20. A Study to Evaluate the Efficacy and Safety of Upadacitinib in Subjects With Takayasu Arteritis (TAK) (SELECT-TAK). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT04161898 . Accessed on March 29, 2022 .

__________________________

* This recommendation is without prejudice to the final conclusions of the ongoing referral procedure under Article 20 of Regulation (EC) No 726/2004 resulting from pharmacovigilance data.


per Adapted Mayo Score

Cision View original content: https://www.prnewswire.com/news-releases/chmp-recommends-european-commission-approval-of-upadacitinib-rinvoq-for-the-treatment-of-adults-with-moderate-to-severe-ulcerative-colitis-301552630.html

SOURCE AbbVie

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ABBV
Sirona Biochem Announces Exclusive Global Licensing Agreement with Allergan Aesthetics

Sirona Biochem Announces Exclusive Global Licensing Agreement with Allergan Aesthetics

Sirona Biochem Corp . (TSX-V: SBM) (FSE: ZSB) (OTC: SRBCF) (" Sirona ") is pleased to announce it has entered into a global exclusive licensing agreement with Allergan Aesthetics, an AbbVie company (NYSE: ABBV), pursuant to which Allergan Aesthetics will develop and commercialize topical skin care treatments based on active ingredients derived from certain of Sirona's patents for TFC-1067 and related family of compounds.

"We are very pleased to have finalized terms with a global leader in medical aesthetics and the innovator behind SkinMedica™, a leader in the science of skin rejuvenation," said Dr. Howard Verrico, CEO of Sirona Biochem. "Our most recent clinical trial of TFC-1067 was a collaborative effort with Allergan Aesthetics to demonstrate the clinical potential in topical skin care treatments. This further validates our platform technology as viable for additional commercial products which we are actively pursuing. We would like to thank Dr. Linda Pullan of Pullan Consulting who assisted with our current success."

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Biogen and AbbVie Receive Positive Opinion from the CHMP on ZINBRYTA™ (Daclizumab) for Treatment of Multiple Sclerosis

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.

Enbrel Biosimilar Marks Victory for Merck and Samsung

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.

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The Gummy Project Announces Official Launch of E-Commerce Sales Channel

The Gummy Project Announces Official Launch of E-Commerce Sales Channel

  • The Gummy Project'S Watermelon Sharks and Peachy Bees are now available for pre-sale purchase at www.shopgummies.com
  • Shipping and fulfilment of online orders will commence on July 11, 2022

The Gummy Project (CSE: GUMY) (FSE: 0OS2) (OTCQB: POTVF) ("GUMY" or the "Company") is pleased to announce the official launch of its new e-commerce site at www.shopgummies.com.

"The launch of our e-commerce site is a major milestone, making our product available across Canada for the first time," said Anthony Gindin, Chief Marketing Officer at GUMY. "This really marks our official launch into the Canadian market with e-commerce being a major component in our overall sales channel strategy. The site provides a vehicle for continued growth as well as a platform to share our story and fulfil our mandate to support endangered keystone species."

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Cardiol Therapeutics Reports Results of 2022 Annual General Meeting

Cardiol Therapeutics Reports Results of 2022 Annual General Meeting

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 cannabidiol as an anti-inflammatory and anti-fibrotic therapy for the treatment of cardiovascular diseases ("CVD"), announces the results from its Annual General Meeting of Shareholders (the "AGM") held virtually via live audio webcast, on June 28, 2022. Shareholders voted in favour of all management resolutions proposed in the Company's Information Circular.

Resolutions proposed and approved at the AGM were:

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The Gummy Project Announces Another Milestone with Entry into Canadian Retail Market

The Gummy Project Announces Another Milestone with Entry into Canadian Retail Market

  • The Gummy Project'S Watermelon Sharks and Peachy Bees to be sold at Vancouver based Stong's Markets
  • Stong's are Vancouver owned full-service grocery stores that have operated in Vancouver since 1931

The Gummy Project (CSE: GUMY) (FSE: 0OS2) (OTCQB: POTVF) ("GUMY" or the "Company") is pleased to announce that as of June 29, 2022 it has partnered with Stong's to launch its Watermelon Sharks and Peachy Bees into the Canadian retail market.

"This partnership represents another great step in our ongoing sales strategy and we're extremely proud to partner with Stong's, an iconic grocery store in Vancouver," said Charlie Lamb, President and CEO of GUMY. "Following our recent partnership announcements with Flair Airlines and Bard on the Beach, the upcoming launch of our ecommerce site on June 30 2022, and our distribution partnership with Dean's Dairy and Specialty Foods, consumers will soon be able to purchase our products at locations across Canada."

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Health Canada Approves OPDIVO® as Monotherapy for the Adjuvant treatment of Adults with Urothelial Carcinoma at High Risk of Recurrence after Undergoing Radical Resection of UC

First adjuvant Immunotherapy for patients at high risk of disease recurrence

Today, Bristol Myers Squibb Canada (BMS) announced Health Canada has issued a Notice of Compliance with Conditions (NOCc) for OPDIVO ® , as a monotherapy for the adjuvant treatment of adult patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection of UC. i OPDIVO ® is the first immuno-oncology treatment to bring benefit in the adjuvant setting of UC and represents a potential new standard of care for patients at high risk of disease recurrence. ii Unlike traditional cancer therapies that target the tumour directly, immuno-oncology activates the body's own immune system to help recognize and attack cancer cells. iii

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Kite's CAR T-cell Therapy Yescarta® Granted European Marketing Authorization for the Treatment of Relapsed or Refractory Follicular Lymphoma

Pivotal ZUMA-5 Study Demonstrates Overall Response Rate of 91% and a Complete Response rate of 77% in Patients Who Received Yescarta After Three or More Lines of Therapy –

Kite's Third Approved Cell Therapy Indication in Europe

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Gilead Resubmits New Drug Application to U.S. Food and Drug Administration for Lenacapavir, an Investigational, Long-Acting HIV-1 Capsid Inhibitor

NDA Resubmission Addresses Issues Related to Vial Compatibility –

If Approved, Lenacapavir Would be the First and the Only HIV-1 Treatment Option Administered Twice-Yearly

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