Allergan Aesthetics to Present Data from Its Leading Aesthetic Portfolio at the 2022 American Society for Dermatologic Surgery Meeting

Data results shared across facial injectables, body contouring and skincare portfolio highlights Allergan Aesthetics' continued commitment to advancing aesthetic medicine Analyses of 15 years of post-marketing surveillance data demonstrate the global reported rate of delayed-onset nodules associated with dermal fillers on the Vycross technology platform is low (

IRVINE, Calif. , Oct. 7, 2022 /PRNewswire/ -- Allergan Aesthetics, an ABBVie company, (NYSE: ABBV) announced today that eight scientific abstracts from its leading portfolio of aesthetic products and treatments will be presented at the American Society for Dermatologic Surgery (ASDS) meeting taking place October 6-10 in Denver .

Allergan Aesthetics has one of the largest, most-researched portfolio and pipeline in the medical aesthetics industry. Data presented across a broad spectrum of aesthetic indications aims to further scientific research and improve patient outcomes.

"Our scientific excellence continues to help drive advancements in aesthetic medicine, as well bring impactful treatments to our customers and patients globally," said Darin Messina , Senior Vice President, Allergan Aesthetics R&D. "The data presented at ASDS reinforces our leadership in aesthetics and also the commitment of our research and development team to drive innovation for the industry and share learnings with the broader medical community."

At the meeting, researchers will spotlight global post-marketing surveillance data on the reported rates of delayed-onset nodules presenting four or more weeks after injection of hyaluronic acid fillers based on the Vycross technology platform. The analyses of 15 years of data demonstrate the global reported rate of delayed-onset nodules associated with dermal fillers on the Vycross technology platform is low (

Additionally, Dr. DiAnne Davis , a board-certified cosmetic dermatologist out of Dallas, Texas , will discuss the new Forces of Beauty ^® Report from Allergan Aesthetics' DREAM (Driving Racial Equity in Aesthetic Medicine) Initiative ^® at the Diversity, Equity and Inclusion (DEI) reception on Friday, October 7 . The report provides a new understanding of what inclusive and representative beauty looks like today by shedding light on how narrowly defined Eurocentric ideals continue to impact women of color. By surveying over 4,000 women aged 21-65, from multiple geographic locations and backgrounds, the report explores what defines beauty, how beauty impacts women's lives, and the interplay between beauty and race.

Key abstracts are outlined below. Complete abstracts and details on presentation dates and times can be found on the ASDS website .

Abstract Title	Presentation Details
Facial
Hyaluronic Acid Filler VYC-25L for Jawline Restoration Yields High Satisfaction, Improved Jawline Measurements, and Sustained Effect Across Age, Gender, and Skin Types for up to 12 Months	Virtual Presentation
Delayed-onset Nodules Following Vycross Hyaluronic Acid Filler Injections: Reported Rates From Global Post-marketing Surveillance	Virtual Presentation
Body Contouring
A Prospective, Open-Label Study to Evaluate Functional Changes Following Electromagnetic Muscle Stimulation of Abdominal Muscle	Virtual Presentation
Multi-Country Study to Evaluate Patient Satisfaction with a Dual Applicator Cryolipolysis System for Non-Invasive Fat Reduction in Abdomen, Flanks, Upper Arms, Inner Thighs, Outer Thighs, and Submental Area (Study Design)	Virtual Presentation
Mechanism for Improvement in the Appearance of Skin Laxity Resulting from a Single Treatment With Acoustic Subcision: Induction of New Collagen (Type III) and Elastin	Virtual Presentation
Skincare
Efficacy and Tolerability of Novel Topical Pigment-Correcting Serums With Biweekly Diamond Tip Microdermabrasion Treatments on Facial Hyperpigmentation (HP), Including Melasma and Post-inflammatory HP	Virtual Presentation
Efficacy of Novel Multimodality Pigment-Correcting Serum for Moderate to Severe Facial Hyperpigmentation, Including Melasma, in a 12-Week, Split-Face, Double-blind, Randomized Controlled Trial	Virtual Presentation
Efficacy of a Targeted Pigment-Correcting Spot Treatment Cream for Solar Lentigines and Post-inflammatory Hyperpigmentation in a 12-Week, Single-Center Clinical Study	Virtual Presentation

IMPORTANT SAFETY INFORMATION & APPROVED USES

JUVÉDERM ^® Collection of Fillers Important Information

INDICATIONS

JUVÉDERM ^® VOLUMA ^® XC injectable gel is indicated for deep (subcutaneous and/or supraperiosteal) injection for cheek augmentation to correct age-related volume deficit in the mid-face and for augmentation of the chin region to improve the chin profile in adults over the age of 21.

JUVÉDERM ^® VOLUX™ XC injectable gel is indicated for subcutaneous and/or supraperiosteal injection for improvement of jawline definition in adults over the age of 21 with moderate to severe loss of jawline definition.

JUVÉDERM® VOLLURE® XC injectable gel is indicated for injection into the mid-to-deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds) in adults over the age of 21.

JUVÉDERM ^® VOLBELLA ^® XC injectable gel is indicated for injection into the lips for lip augmentation and correction of perioral rhytids, and for the improvement of infraorbital hollowing in adults over the age of 21.

JUVÉDERM ^® Ultra Plus XC and JUVÉDERM® Ultra XC injectable gels are indicated for injection into the mid-to-deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds).

JUVÉDERM ^® Ultra XC injectable gel is also indicated for injection into the lips and perioral area for lip augmentation in adults over the age of 21.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

These products should not be used in patients who have severe allergies, marked by a history of anaphylaxis or history or presence of multiple severe allergies, and should not be used in patients with a history of allergies to Gram-positive bacterial proteins or lidocaine contained in these products.

WARNINGS

Do not inject into blood vessels. Introduction of these products into the vasculature may lead to embolization, occlusion of the vessels, ischemia, or infarction. Take extra care when injecting soft tissue fillers; for example, after insertion of the needle and just before injection, the plunger rod can be withdrawn slightly to aspirate and verify the needle is not intravascular, inject the product slowly, and apply the least amount of pressure necessary. Rare, but serious, adverse events associated with the intravascular injection of soft tissue fillers in the face have been reported and include temporary or permanent vision impairment, blindness, cerebral ischemia or cerebral hemorrhage leading to stroke, skin necrosis, and damage to underlying facial structures. Immediately stop the injection if a patient exhibits any of the following symptoms: changes in vision, signs of a stroke, blanching of the skin, unusual pain during or shortly after the procedure. Patients should receive prompt medical attention and, possibly, evaluation by an appropriate healthcare professional specialist should an intravascular injection occur
Product use at specific sites in which an active inflammatory process (skin eruptions such as cysts, pimples, rashes, or hives) or infection is present should be deferred until the underlying process has been controlled

PRECAUTIONS

To minimize the risk of potential complications, these products should only be used by healthcare professionals who are knowledgeable about the anatomy and the product(s) for use in indicated area(s), and who have appropriate training in facial anatomy, vasculature, safe injection techniques, and identification and management of potential adverse events, including intravascular complications
The potential risks of soft issue injections should be discussed with patients prior to treatment to ensure they are aware of signs and symptoms of complications
The safety and effectiveness for the treatment of anatomic regions other than indicated areas for each product have not been established in controlled clinical studies
The safety for use of these products in patients with known susceptibility to keloid formation, hypertrophic scarring, and pigmentation disorders has not been studied
The safety for use during pregnancy and in breastfeeding females has not been established
The safety for use of JUVÉDERM ^® VOLUMA ^® XC has been established in patients between 35 and 65 years of age for cheek augmentation and in patients between 22 and 80 years of age for chin augmentation
The safety for use of JUVÉDERM ^® Ultra Plus XC and JUVÉDERM ^® Ultra XC in patients under 18 years, and the safety for use of JUVÉDERM ^® VOLUX™ XC, JUVÉDERM® VOLLURE ^® XC, and JUVÉDERM ^® VOLBELLA ^® XC in patients under 22 years, has not been established
Dermal filler implantation carries a risk of infection. Follow standard precautions
Dermal fillers should be used with caution in patients on immunosuppressive therapy
Patients taking medications that can prolong bleeding (such as aspirin, nonsteroidal anti-inflammatory drugs, and warfarin) may experience increased bruising or bleeding at treatment sites
Patients who experience skin injury near the site of implantation may be at a higher risk for adverse events
If laser treatment, chemical peel, or any other procedure based on active dermal response is considered after treatment, or before skin has healed from a procedure prior to treatment, there is a possible risk of eliciting an inflammatory reaction at the injection site
The safety for use of JUVÉDERM ^® VOLUMA ^® XC injectable gel in patients with very thin skin in the mid-face has not been established
The safety for use of JUVÉDERM ^® VOLUMA ^® XC with cannula for cheek augmentation has not been established in patients with Fitzpatrick Skin Types V and VI
JUVÉDERM ^® VOLUMA ^® XC was not evaluated in subjects with significant skin laxity of the chin, neck, or jaw in the chin augmentation study
The effect of JUVÉDERM ^® VOLUMA ^® XC injection into the chin on facial hair growth has not been studied
Patients may experience late-onset adverse events with injectable gel implants, and late-onset nodules with use of JUVÉDERM ^® VOLUMA ^® XC
Based on preclinical studies, patients should be limited to 20 mL of any JUVÉDERM ^® injectable gel per 60 kg (132 lb) body mass per year. The safety of injecting greater amounts has not been established
Injection of more than 9 mL of JUVÉDERM ^® VOLUX™ XC for improvement of jawline definition has not been studied

ADVERSE EVENTS

The most common reported side effects for JUVÉDERM ^® injectable gels were redness, swelling, pain, tenderness, firmness, lumps/bumps, bruising, discoloration, and itching. For JUVÉDERM ^® VOLBELLA ^® XC, dryness was also reported. The majority were mild or moderate in severity.

To report an adverse reaction with any product in the JUVÉDERM ^® Collection, please call Allergan ^® Product Support at 1-877-345-5372. Please visit JuvedermDFU.com for more information.

Products in the JUVÉDERM ^® Collection are available only by a licensed physician or properly licensed practitioner.

Please see Directions for Use or visit https://www.rxabbvie.com/pdf/juvederm-voluma-xc_dfu.pdf for JUVÉDERM® VOLUMA ^® XC

Please see Directions for Use or visit https://www.rxabbvie.com/pdf/juvederm-volux-xc_dfu.pdf for JUVÉDERM ^® VOLUX™ XC

Please see Directions for Use or visit https://www.rxabbvie.com/pdf/juvederm-vollure-xc_dfu.pdf for JUVÉDERM ^® VOLLURE ^® XC

Please see Directions for Use or visit https://www.rxabbvie.com/pdf/juvederm-volbella_dfu.pdf for JUVÉDERM ^® VOLBELLA ^® XC

Please see Directions for Use or visit https://www.rxabbvie.com/pdf/juvederm-ultra-plus-xc_dfu.pdf for JUVÉDERM ^® Ultra Plus XC

Please see Directions for Use or visit https://www.rxabbvie.com/pdf/juvederm-ultra-xc_dfu.pdf for JUVÉDERM ^® Ultra XC

Indications
CoolSculpting ^® Elite is FDA-cleared for the treatment of visible fat bulges in the thigh, abdomen, and flank, along with bra fat, back fat, underneath the buttocks (also known as banana roll), and upper arm in patients with a Body Mass Index (BMI) of ≤ 30, and in submental and submandibular areas in patients with a BMI of ≤ 46.2. It is also FDA-cleared to affect the appearance of lax tissue with submental area treatments.

Important Safety Information
CoolSculpting ^® Elite is contraindicated in patients with cryoglobulinemia, cold agglutinin disease, or paroxysmal cold hemoglobinuria.

Ask your patient about any medical conditions including recent surgery, pre-existing hernia, and any known sensitivities or allergies.

During the procedure patients may experience sensations of pulling, tugging, mild pinching, intense cold, tingling, stinging, aching, and cramping at the treatment site. These sensations subside as the area becomes numb. Following the procedure, typical side effects include temporary redness, swelling, blanching, bruising, firmness, tingling, stinging, tenderness, cramping, aching, itching, or skin sensitivity, and sensation of fullness in the back of the throat after submental or submandibular area treatment.

Rare side effects may also occur. Paradoxical hyperplasia (visibly enlarged tissue volume in the treated area) may develop 2 to 5 months after treatment, will not resolve on its own, and may require surgical intervention for correction.

As with any medical procedure, a consultation should be done by a licensed healthcare professional to determine if the patient is a candidate for treatment. For a complete list of Contraindications, Warnings, Precautions, and Potential Side Effects, consult the CoolSculpting ^® Elite System User Manual. Treatment applications that deviate from the guidelines are not recommended.

CoolTone ^® Uses
The CoolTone ^® device is FDA-cleared for improvement of abdominal tone, strengthening of the abdominal muscles, and development for firmer abdomen. CoolTone ^® is also FDA-cleared for strengthening, toning, and firming of buttocks and thighs.

CoolTone® Important Safety Information
The CoolTone ^® procedure is not for everyone. You should not have the CoolTone ^® treatment in areas with metal, electrical, or electronic implants/devices like cardiac pacemakers, implanted hearing devices, implanted defibrillators, implanted neurostimulators, drug pumps, or hearing aids.

Tell your doctor if you have any medical conditions as CoolTone ^® should not be used over a menstruating uterus, over areas of the skin that lack normal sensation, in patients with fever, malignant tumor, hemorrhagic conditions, epilepsy, recent surgical procedure, pulmonary insufficiency, or pregnancy.

CoolTone ^® should be used with caution in patients with Graves' disease (an autoimmune disorder that causes overactive thyroid), active bleeding disorders, or seizure disorders.

Women who are close to menstruation may find that it comes sooner, or cramping is increased or intensified with CoolTone ^® treatments, therefore, it is recommended to not undergo treatment during this time of the month.

CoolTone ^® should not be used in the heart or head areas, areas of new bone growth, over the carotid sinus nerves, or over the neck or mouth. CoolTone ^® should not be applied over swollen, infected, inflamed areas or skin eruptions. Caution should be used for patients with suspected or diagnosed heart problems.

Common side effects may include, but may not be limited to, muscular pain, temporary muscle spasm, temporary joint or tendon pain, and redness at or near the treatment site.

Ask your Healthcare Provider if CoolTone ^® is right for you.

Please see full Important Safety Information for additional information at coolsculpting.com/cooltone .

Patient results may vary.

RESONIC™ Important Safety Information
RESONIC™ (Rapid Acoustic Pulse™ device) is indicated for use as an accessory to the 1064 nm Q-Switched laser for black ink tattoo removal in Fitzpatrick Skin Type I-III patients. The RESONIC device is also indicated for long-term improvement in the appearance of cellulite as supported by clinical data demonstrating treatment benefits up to 1 year of observation. The most common side effects may include mild to moderate temporary redness of the treatment site, mild pain, heat, and pinpoint redness. Your results and experience may vary, so it is important to talk to your healthcare provider about whether RESONIC is right for you. For full safety information, please visit www.RESONIC.com/ISI .

DiamondGlow ^® Uses
The DiamondGlow ^® device is a general dermabrasion device that gently removes the top layer of skin and delivers topical cosmetic serums onto the skin.

DiamondGlow ^® Important Safety Information
The DiamondGlow ^® treatment is not for everyone. You should not have a DiamondGlow ^® treatment if you have compromised skin quality. Tell your provider if you are pregnant or lactating, or if you have medical condition, including allergies, and if you are using topical medications on the area to be treated.

Typical side effects include a scratchy, stinging sensation during the treatment and temporary tightness, redness or slight swelling after the treatment. Rare serious side effects may also occur and include severe skin irritation and allergic reactions.

SkinMedica ^® Pro-Infusion Serums Disclaimer
SkinMedica ^® Pro-Infusion Serums are intended to meet the FDA's definition of a cosmetic product, an article applies to the human body to cleanse, beautify, promote attractiveness, and alter appearances. These products are not intended to be drugs that diagnose, treat, cure, or prevent any disease or condition. These products have not been approved by the FDA and the statements have not been evaluated by the FDA.

About Allergan Aesthetics
Allergan Aesthetics, an AbbVie company, develops, manufactures, and markets a portfolio of leading aesthetics brands and products. Their aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more. Their goal is to consistently provide customers worldwide with innovation, education, exceptional service, and a commitment to excellence, all with a personal touch. www.AllerganAesthetics.com

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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SOURCE AbbVie

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Health Canada Approves AbbVie's RINVOQ® for the Treatment of Adults with Active Non-Radiographic Axial Spondyloarthritis

- Approval is based on results from the Phase 3 SELECT-AXIS 2 pivotal clinical trial in which RINVOQ delivered rapid and meaningful disease control, meeting the primary endpoint of ASAS40 response at week 14 versus placebo ¹ - RINVOQ is the first and only Janus Kinase (JAK) inhibitor approved to treat patients across the spectrum of axial spondyloarthritis (nr-axSpA and ankylosing spondylitis) in Canada ^{1, 2, 3}

AbbVie (NYSE: ABBV), today announced that Health Canada has approved RINVOQ ® (upadacitinib, 15 mg), the first oral, once-daily selective and reversible JAK inhibitor for the treatment of adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation who have had an inadequate response to a biologic disease modifying anti-rheumatic drug (DMARD) or when use of those therapies is inadvisable.

News Provided by Canada Newswire via QuoteMedia

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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."

News Provided by GlobeNewswire via QuoteMedia

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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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Cardiex Announces Publication of Breakthrough Study Validating Noninvasive Fingertip Photoplethysmography for Central Aortic Pressure Waveform Analysis

- Cardiex Limited (ASX: CDX), a global health technology company focused on cardiovascular diagnostics and arterial health solutions, today announced the publication of a peer-reviewed study validating its innovative method for measuring central aortic pressure—an important indicator of heart health—using a noninvasive fingertip sensor. The study, co-authored by Cardiex's team, was published in the respected journal Pulse.

The study, titled "Validation of Noninvasive Derivation of the Central Aortic Pressure Waveform from Fingertip Photoplethysmography Using a Novel Selective Transfer Function Method," demonstrates that Cardiex's technology can accurately capture key cardiovascular data from a simple fingertip sensor. The method leverages photoplethysmography (PPG)—an optical technique widely used in wearables such as fitness trackers and smartwatches—offering a powerful and accessible tool for advanced heart health monitoring.

Key findings include:

Strong correlation between fingertip sensor measurements and traditional methods, with heart health indicators showing excellent alignment.
The fingertip sensor offers a user-friendly, noninvasive way to measure central aortic pressure parameters without calibration, making heart health monitoring more accessible and comfortable.
Twenty clinically relevant parameters were captured from the converted PPG waveforms, including central systolic blood pressure, central diastolic blood pressure, central pulse pressure, central augmentation pressure, central augmentation index, subendocardial viability, and pulse pressure amplification, amongst others.

Relevance in the Wearable Health Market:

The use of PPG technology in this study is especially significant as the wearable market continues to expand, with consumers seeking more advanced health insights without the need for frequent calibration. Cardiex's innovation aligns with this trend offering consumers the ability to track clinical grade biomarkers in real-time. These biomarkers have applications in various healthcare fields, including cognitive, renal, maternal, metabolic health, and heart failure management. The technology's ease of use and capacity for continuous monitoring place Cardiex at the forefront of the growing wearable health sector, which increasingly prioritizes deeper and more accurate health data.

"This study is a significant validation of Cardiex's technology and its ability to deliver critical heart health insights in a simpler, more convenient way," said Craig Cooper , CEO of Cardiex. "Our PPG-based fingertip technology has the potential to transform heart health monitoring, offering a more accessible option for both patients and healthcare providers. This breakthrough also opens up exciting opportunities for integration into the wearable health tech market, where continuous and noninvasive monitoring is becoming the gold standard."

The study confirms that Cardiex's PPG-based solution can provide valuable cardiovascular data in a comfortable, portable format, paving the way for broader adoption in both medical and consumer-grade wearables.

The full study is now available online in the journal Pulse DOI: 10.1159/000540666.

View original content to download multimedia: https://www.prnewswire.com/news-releases/cardiex-announces-publication-of-breakthrough-study-validating-noninvasive-fingertip-photoplethysmography-ppg-for-central-aortic-pressure-waveform-analysis-302259185.html

SOURCE Cardiex Limited

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TEPEZZA® RECEIVES APPROVAL IN JAPAN FOR THE TREATMENT OF ACTIVE THYROID EYE DISEASE

Amgen (NASDAQ:AMGN) today announced TEPEZZA ® (JAN: Teprotumumab (Genetical Recombination)) has been approved for the treatment of active or high clinical activity score (CAS) Thyroid Eye Disease (TED) by Japan's Ministry of Health, Labour and Welfare (MHLW).

TED is a serious, progressive and potentially vision-threatening rare autoimmune disease that can cause proptosis (eye bulging), diplopia (double vision), eye pain, redness and swelling. ¹ There are approximately 25,000 - 35,000 people living with TED in Japan , inclusive of both active and chronic (low CAS) TED. ² TEPEZZA is now the first and only medicine approved in Japan to treat active TED. A separate trial to study the efficacy of TEPEZZA in chronic TED patients in Japan is currently ongoing.

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AMGEN TO HOST CONFERENCE CALL TO DISCUSS NEW TOPLINE DATA IN INFLAMMATION AND RARE DISEASE

Amgen (NASDAQ:AMGN) will host a webcasted call for the investment community at 1:30 p.m. PT on Tuesday, Sept. 24, 2024 to discuss new topline clinical data from the rocatinlimab (AMG 451KHK4083) and UPLIZNA ® (inebilizumab-cdon) Phase 3 programs. Jay Bradner executive vice president of Research and Development and chief scientific officer at Amgen, and other members of the Amgen team will participate. 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.

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Cardiol Therapeutics Announces Completion of the MAvERIC Phase II Study in Recurrent Pericarditis with Results to be Presented at the American Heart Association Scientific Sessions 2024

Full clinical data will be reported in an oral presentation at the premier global event for advancements in cardiovascular science and medicine on November 18, 2024

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 heart disease, today announced the data from its Phase II open-label MAvERIC-Pilot study investigating the impact of CardiolRx™ administered to patients with symptomatic recurrent pericarditis will be reported in an oral presentation as part of the Laennec Clinician-Educator Award & Lecture that runs from 9:45 a.m. to 11:00 a.m. Central Time, on Monday, November 18th, 2024, at the American Heart Association Scientific Sessions 2024. Dr. S. Allen Luis, Co-Director, Pericardial Diseases Clinic and Associate Professor of Medicine, Department of Cardiovascular Medicine at the Mayo Clinic, will present on behalf of the MAvERIC-Pilot investigators.

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Abstract Title	Presentation Details All times CDT
Crohn's Disease
Efficacy and Safety of Upadacitinib for the Treatment of Fistulas and Fissures in Patients with Crohn's Disease	Oral Presentation #947 AGA IBD: Real World Data and Clinical Trials to Guide Care (Research Forum) May 9, 2023 8:30 – 8:45 AM
Upadacitinib Improves Endoscopic Outcomes in Patients with Moderate to Severely Active Crohn's Disease Irrespective of Previous Failure to Respond to Biologics or Conventional Therapies	Oral Presentation #1031 AGA Controlled Clinical Trials in IBD (Research Forum) May 9, 2023 11:00 – 11:15 AM
Delayed Clinical Responders in Patients with Crohn's Disease Receiving Upadacitinib Therapy	Poster #Tu1705 IBD: Controlled Clinical Trials in Humans (Poster Session) May 9, 2023 12:30 – 1:30 PM
Upadacitinib Pharmacokinetic and Exposure-Response Relationships in Subjects with Crohn's Disease - Analyses of Phase 3 Studies	Poster #Tu1733 IBD: Controlled Clinical Trials in Humans (Poster Session) May 9, 2023 12:30 – 1:30 PM
Additional Risankizumab Treatment Is Effective in Patients with Moderately to Severely Active Crohn's Disease Who Did Not Achieve CDAI Clinical Response with the Initial 12 Week Induction Treatment: Results From the ADVANCE, MOTIVATE, and FORTIFY Studies	Poster #Tu1710 IBD: Controlled Clinical Trials in Humans (Poster Session) May 9, 2023 12:30 – 1:30 PM
Long-Term Efficacy and Safety of Risankizumab Treatment in Patients with Moderately to Severely Active Crohn's Disease: 104-Week Results from the FORTIFY Study	Poster #Tu1730 IBD: Controlled Clinical Trials in Humans (Poster Session) May 9, 2023 12:30 – 1:30 PM
Safety Profile of Risankizumab in Crohn's Disease Patients by Age: Post-hoc Analysis of the Phase 3 ADVANCE, MOTIVATE, and FORTIFY Studies	Poster #Tu1717 IBD: Controlled Clinical Trials in Humans (Poster Session) May 9, 2023 12:30 – 1:30 PM
Functional Constipation
Efficacy and Safety of Linaclotide in Treating Functional Constipation in Pediatric Patients aged 6-17 years: a Phase 3 Pivotal Randomized Placebo-Controlled Trial	Oral Presentation: #145 AGA Pediatric Functional and Motility Disorders (Research Forum) May 6, 2023 10:15 – 10:30 AM
Time to Response of Linaclotide in Treating Functional Constipation in Pediatric Patients aged 6-17 years: Data from a Phase 3 Randomized Placebo-Controlled Trial	Poster #Mo2008 AGA Pediatric Functional and Motility Disorders (Poster Session) May 8, 2023 12:30 – 1:30 PM
Efficacy of Linaclotide in Treating Symptoms of Incomplete Evacuation and Straining in Pediatric Patients with Functional Constipation	Poster #Mo2007 AGA Pediatric Functional and Motility Disorders (Poster Session) May 8, 2023 12:30 – 1:30 PM
Long-term Safety of Linaclotide in Treating Functional Constipation in Pediatric Patients aged 6-17 years: Interim Analysis of an Open Label, Phase 3, Extension Trial	Poster #Mo2016 AGA Pediatric Functional and Motility Disorders (Poster Session) May 8, 2023 12:30 – 1:30 PM
Safety of Linaclotide in Pediatric Patients with Functional Constipation: A Pooled Analysis of Placebo-Controlled, Randomized Controlled Trials	Poster #Mo2015 AGA Pediatric Functional and Motility Disorders (Poster Session) May 8, 2023 12:30 – 1:30 PM
Exocrine Pancreatic Insufficiency
Development, Generalizability of a Clinical Screening Tool for Exocrine Pancreatic Insufficiency (EPI) in Patients with Definite Chronic Pancreatitis	Poster #Mo1419 AGA Exocrine Pancreatic Diseases and Diabetes (Poster Session) May 8, 2023 12:30 – 1:30 PM
Disease State
Patients with Crohn's Disease and Ulcerative Colitis Cycle Through Multiple Medications Prior To Starting Advanced Therapy: A Retrospective Study	Poster #Sa1814 May 6, 2023 12:30 – 1:30 PM
Food Security in Hispanics with IBD: A Barrier to Dietary Management	Poster #EP141 AGA Diet and IBD (ePoster section) May 6, 2023 9:30 AM – 4:00 PM
Incidence Rates of Gastrointestinal Perforation Among Patients with Inflammatory Bowel Disease: Real-world Evidence from a Large US Nationwide Claims Database	Poster #Su1769 IBD: Diagnostics in IBD (Poster Section) May 7, 2023 12:30 – 1:30 PM

PRODUCT NAME	TEPEZZA ^® for Intravenous Infusion 500 mg
Generic Name (JAN)	Teprotumumab (Genetical Recombination)
Indication	Active thyroid eye disease
Precautions related to indications	Hearing disorders (e.g., deafness, hypoacusis, Eustachian tube dysfunction, patulous Eustachian tube, hyperacusis, tinnitus, and tympanic membrane disorder) may occur during treatment with TEPEZZA, and serious and irreversible events have also been reported. Patients eligible for TEPEZZA therapy should be selected based on a thorough understanding of the information provided in "17. Clinical Results," the backgrounds of the patients in the clinical studies, and the results of the studies of the efficacy and safety of TEPEZZA. Clinical studies of the efficacy and safety in patients with mild active thyroid eye disease have not been conducted.
Dose and Administration	The usual adult dosage is 10 mg/kg as teprotumumab (genetical recombination) for the first dose and 20 mg/kg for the second and subsequent doses, administered intravenously every 3 weeks, for a total of 8 infusions.

Allergan Aesthetics to Present Data from Its Leading Aesthetic Portfolio at the 2022 American Society for Dermatologic Surgery Meeting

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