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ABBVie is confirming prior revenue guidance of greater than $15 billion in combined Rinvoq and Skyrizi risk-adjusted sales in 2025. ABBVie now expects 2025 risk-adjusted sales of greater than $7.5 billion for Rinvoq and greater than $7.5 billion for Skyrizi. The new Rinvoq sales guidance is the result of lower expected Rinvoq sales in the U.S. following the recent label updates in approved indications, partially ...

ABBVie (NYSE: ABBV) is confirming prior revenue guidance of greater than $15 billion in combined Rinvoq (upadacitinib) and Skyrizi (risankizumab) risk-adjusted sales in 2025. ABBVie now expects 2025 risk-adjusted sales of greater than $7.5 billion for Rinvoq and greater than $7.5 billion for Skyrizi. The new Rinvoq sales guidance is the result of lower expected Rinvoq sales in the U.S. following the recent label updates in approved indications, partially offset by higher anticipated sales in international markets, as well as higher anticipated global sales in Crohn's disease and ulcerative colitis following positive Phase 3 study readouts. The updated Skyrizi sales guidance is based on continued strong performance in psoriasis.

Forward-Looking Statements and Other Notices

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, the failure to realize the expected benefits of AbbVie's acquisition of Allergan or to effectively integrate Allergan's business, 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," of AbbVie's 2020 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. 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.

Rinvoq has not been approved by the U.S. Food and Drug Administration (FDA) for use in atopic dermatitis or ankylosing spondylitis and AbbVie's regulatory applications for these indications are currently under review. Rinvoq has not been approved by the FDA or European Medicines Agency (EMA) for use in ulcerative colitis, Crohn's disease, or non-radiographic axial spondyloarthritis. AbbVie's regulatory applications for Rinvoq in ulcerative colitis and non-radiographic axial spondyloarthritis are currently under review by the FDA and EMA. Skyrizi has not been approved by the FDA for use in psoriatic arthritis and AbbVie's regulatory application for this indication is currently under review. Skyrizi has not been approved by the FDA or EMA for use in Crohn's disease or ulcerative colitis. AbbVie's regulatory applications for Skyrizi in Crohn's disease are currently under review by the FDA and EMA.

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 .

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SOURCE AbbVie

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ABBV

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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FDA Approves Veklury® for the Treatment of Non-Hospitalized Patients at High Risk for COVID-19 Disease Progression

-- Approval Based on Phase 3 Data Showing Veklury Significantly Reduced Risk of Hospitalization By 87% Compared with Placebo --

-- NIH Guidelines Recommend Veklury for the Treatment of Non-Hospitalized Patients at High Risk --

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U.S. FDA Approves Second Indication for SKYRIZI® to Treat Adults with Active Psoriatic Arthritis

ABBVie (NYSE: ABBV) today announced the U.S. Food and Drug Administration (FDA) has approved SKYRIZI ® (risankizumab-rzaa) for the treatment of adults with active psoriatic arthritis (PsA), a systemic inflammatory disease that affects the skin and joints and impacts approximately 30 percent of patients with psoriasis. 1,4-7

The FDA approval is supported by data from two pivotal studies, KEEPsAKE-1 and KEEPsAKE-2, which evaluated the efficacy and safety of SKYRIZI in adults with active PsA, including those who had responded inadequately or were intolerant to biologic therapy and/or non-biologic disease-modifying antirheumatic drugs (DMARDs). 2,3 Across the two Phase 3 studies, SKYRIZI met the primary endpoint of ACR20 response at week 24 compared to placebo and demonstrated significant improvements across several other manifestations of PsA, including swollen, tender and painful joints. 2,3

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Boosh Launches AMUSE BOOSH Appetizer Line

Boosh Launches AMUSE BOOSH Appetizer Line

Boosh Plant-Based Brands Inc. (CSE: VEGI) (OTCQB: VGGIF) (FSE: 77I) ("Boosh" or the "Company") is proud to announce the launch of their appetizer line "Amuse Boosh".

Inspired by the French term Amuse-bouche, which refers to a small appetizer and literally translated means "mouth amuser" it is a perfect way to spotlight our recently acquired brands Saltspring Harvest Végé-pâté and Dips, and Pulse Kitchen Plant Based Cheese under one fun, vibrant Boosh Brand.

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BioHarvest Sciences Inc. Plans to Build a Production Facility in Ontario to Serve the Canadian Market with Unique Cannabis Products

BioHarvest Sciences Inc. Plans to Build a Production Facility in Ontario to Serve the Canadian Market with Unique Cannabis Products

The Company is now producing Cannabis in industrial scale bioreactors and has entered the final stage of its Cannabis commercialization program

BioHarvest Sciences Inc. (CSE: BHSC) ("BioHarvest" or the "Company") has announced its plan to build a production facility in Canada, as part of the next phase in the global expansion of its Cannabis vertical. To that end, the Company is exploring opportunities to acquire an existing licensed facility or a Licensed Producer (LP), which would enable the Company to use its BioFarming technology to produce and then sell unique cannabis products into the Canadian market.

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LUMAKRAS® RECEIVES APPROVAL IN JAPAN FOR PATIENTS WITH KRAS G12C-MUTATED ADVANCED NON-SMALL CELL LUNG CANCER

Amgen (NASDAQ: AMGN) today announced that LUMAKRAS ® (sotorasib) has been approved in Japan for the treatment of KRAS G12C-mutated positive, unresectable, advanced andor recurrent non-small cell lung cancer (NSCLC) that has progressed after systemic anticancer therapy.

"Today's approval of LUMAKRAS as the first and only KRAS G12C inhibitor marks a paradigm shift in the treatment of patients with non-small cell lung cancer in Japan ," said David M. Reese , M.D., executive vice president of Research and Development at Amgen. "In just over three years since the first patient was dosed in the pivotal CodeBreaK 100 trial, LUMAKRAS is now approved in nearly 40 countries, illustrating our commitment to accelerating transformative medicines for patients living with cancers that have yet to be fully addressed."

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BriaCell Therapeutics Corp. Announces Results of 2022 Annual and Special Meeting of Shareholders

BriaCell Therapeutics Corp. Announces Results of 2022 Annual and Special Meeting of Shareholders

BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) ("BriaCell" or the "Company") is pleased to announce that all resolutions proposed to shareholders at the Annual and Special Meeting of Shareholders (the "Meeting" ) held virtually via teleconference on January 18, 2022 were passed. Voting for each of the director nominees was as follows:

Nominee
For Withheld
Actual Percentage Actual Percentage
Dr. William V. Williams 2,286,353 97.68% 54,346 2.32%
Mr. Jamieson Bondarenko 2,286,214 97.67% 54,485 2.33%
Mr. Marc Lustig 2,285,435 97.64% 55,263 2.36%
Dr. Rebecca Taub 2,327,126 99.42% 13,573 0.58%
Mr. Vaughn C. Embro-Pantalony 2,285,426 97.64% 55,273 2.36%
Mr. Martin Schmieg 2,326,345 99.39% 14,353 0.61%
Dr. Jane Gross 2,327,674 99.44% 13,024 0.56%

Shareholders also voted in favour of: (i) setting the number of directors for the ensuing year at seven; (ii) re-appointing MNP LLP as auditors of the Company; (iii) approving the Company's stock option plan; and (iv) approving an amendment to the authorized share structure and articles of the Company by creating a new class of subordinate voting shares, and to vary the special rights and restrictions attached to the Common Shares to reflect the creation of the new class of shares, as more particularly described in the Company's Management Information Circular dated December 20, 2021 and posted to SEDAR on January 4, 2022. Please see the report of voting results filed under BriaCell's profile at www.sedar.com for the detailed results of these other matters voted on by shareholders at the Meeting.

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