Life Science News

  • Analyses highlight long-term efficacy and safety results, including real-world data, from studies of SKYRIZI ® (risankizumab) in moderate to severe psoriasis and active psoriatic arthritis
  • Presentations include data from the largest-of-its-kind study that demonstrates the real-world burden of atopic dermatitis
  • Breadth of data underscores AbbVie's commitment to advancing research in dermatology for people living with immune-mediated skin diseases such as psoriasis, psoriatic arthritis, atopic dermatitis and vitiligo

ABBVie (NYSE: ABBV) today announced it will present 23 abstracts at the 31 st European Academy of Dermatology and Venereology (EADV) Congress, including a late-breaking oral presentation on long-term efficacy and safety data of SKYRIZI ® (risankizumab) in psoriatic arthritis and real-world data from MEASURE-AD to assess the multidimensional burden of atopic dermatitis. This research demonstrates ABBVie's commitment to deepening the understanding of immune-mediated skin diseases by investing in studies of difficult-to-treat patient populations, certain disease areas with few existing treatment options as well as real-world patient experience. The hybrid congress will take place from September 7-10 in Milan as well as virtually.

"Our leadership in dermatology runs deep – from developing innovative technologies to studying lesser-understood diseases where few to no treatment options currently exist," said Chiedzo Mpofu, MBChB, Ph.D., vice president, Global Medical Affairs, Immunology, AbbVie. "At this year's EADV Congress, we're presenting a range of data, including real-world, patient-centered research that will help elevate the community's understanding of the long-term impact of our treatments and the potential to support patients with difficult-to-treat diseases."

Key data to be presented include:

  • Late-breaking oral presentation of new data from the ongoing Phase 3 active psoriatic arthritis clinical trials, KEEPsAKE 1 and KEEPsAKE 2, evaluating long-term efficacy and safety, up to 100 weeks, in patients treated with SKYRIZI (risankizumab)
  • Analyses from MEASURE-AD, a cross-sectional, 28-country, burden of disease study aimed to characterize global treatment patterns, healthcare resource utilization and costs, and the clinical and economic burden of moderate to severe atopic dermatitis
  • Results from VALUE, a 13-month interim analysis from a long-term, prospective observational study that has enrolled 2,700 patients from 21 countries, evaluating real-world efficacy, durability of response and time to first treatment change for moderate to severe psoriasis patients treated with SKYRIZI (risankizumab) compared to other commonly used treatments
  • Results from aIMM, a Phase 3b , multicenter, interventional, open-label, single-arm study analyzing clinical efficacy, safety and quality-of-life outcomes after 16 weeks of treatment with SKYRIZI (risankizumab) in psoriasis patients who previously achieved suboptimal responses to one of two IL-17 inhibitors, either secukinumab or ixekizumab
  • Interim analysis of the nearly 5-year (256 weeks) LIMMitless open-label extension study evaluating long-term efficacy and safety data with continuous SKYRIZI (risankizumab) treatment in patients with moderate to severe plaque psoriasis
  • Two real-world insurance claims database analyses examining economic and comorbidity impacts on patients with vitiligo

AbbVie abstracts at the EADV Congress include:

Abstract Title

Session Details (All Times CEST)

Risankizumab / Psoriasis


Efficacy of Risankizumab in Psoriasis Patients Participating in the VALUE
Multi-Country Post-Marking Observational Study

Poster Session

P1538

Wednesday, Sept 7

7:00 a.m.

Efficacy and Safety of Risankizumab in Psoriasis Patients Who Had a
Suboptimal Response to Secukinumab or Ixekizumab

Poster Session

P1537

Wednesday, Sept 7

7:00 a.m.

Long-Term Safety and Efficacy of Risankizumab for the Treatment of
Moderate to Severe Plaque Psoriasis: A 4.5-year Interim Analysis of the
LIMMitless Open-Label Extension Trial

Poster Session

P1603

Wednesday, Sept 7

7:00 a.m.

Efficacy and Safety of Long-Term Risankizumab Treatment for Nail, Scalp,
and Palmoplantar Psoriasis: A 4.5-Year Interim Analysis from the LIMMitless
Open-Label Extension Trial

Poster Session

P1551

Wednesday, Sept 7

7:00 a.m.

Efficacy of Risankizumab for Moderate to Severe Plaque Psoriasis Through
256 Weeks: Subgroup Analysis by Baseline Demographics and Disease
Characteristics from the LIMMitless Trial

Poster Session

P1553

Wednesday, Sept 7

7:00 a.m.

Real-World Switching and Discontinuation Patterns for Interleukin-Inhibitor
Treatments in Patients with Moderate to Severe Psoriasis in Japan

Poster Session

P1558

Wednesday, Sept 7

7:00 a.m.

Dose Escalation of Biologic Treatment in Patients with Moderate to Severe
Psoriasis in Japan

Poster Session

P1606

Wednesday, Sept 7

7:00 a.m.

Real-World Achievement of Absolute Psoriasis Area and Severity Index
Thresholds with Risankizumab in Patients with Moderate to Severe Psoriasis
From the CorEvitas Psoriasis Registry

Poster Session

P1557

Wednesday, Sept 7

7:00 a.m.

Risankizumab / Psoriatic Arthritis


Efficacy and Safety of Risankizumab for Active Psoriatic Arthritis: 100-Week
Results from the KEEPsAKE 1 and KEEPsAKE 2 Trials

Late-breaking News Session

D3T01.1

Saturday, Sept 10
9:15 - 9:30 a.m.

Durability of Clinically Meaningful Improvements in Patient-Reported
Outcomes and Work Productivity Among Patients with Psoriatic Arthritis
Receiving Risankizumab: Results from KEEPsAKE 1 and 2

Poster Session

P1429

Wednesday, Sept 7

7:00 a.m.

Impact of Risankizumab on Enthesitis and Dactylitis: Integrated Analysis of the
Phase 3, Randomized, Double-Blind KEEPsAKE 1 and 2 Trials

Poster Session

P1605

Wednesday, Sept 7

7:00 a.m.

Risankizumab (RZB) Demonstrates Long-term Efficacy Across Subgroups in
Patients with Active Psoriatic Arthritis (PsA): A Post Hoc, Integrated Analysis
from the Phase 3 (KEEPsAKE 1 and KEEPsAKE 2) Studies

Poster Session

P1545

Wednesday, Sept 7

7:00 a.m.

Risankizumab Long-Term Safety in Patients with Psoriatic Disease: Integrated
Analyses of Data from Psoriasis and Psoriatic Arthritis Clinical Trials

Poster Session

P1607

Wednesday, Sept 7

7:00 a.m.

Efficacy Analysis in Patients with Active Psoriatic Arthritis and Significant
Involvement of Skin Manifestations

Poster Session

P1568

Wednesday, Sept 7

7:00 a.m.

Upadacitinib / Atopic Dermatitis


Efficacy of Upadacitinib vs Dupilumab for Moderate to Severe Atopic
Dermatitis: Analysis of Time Spent in Response State from the Heads Up Study

Poster Session

P0256

Wednesday, Sept 7

7:00 a.m.

Effect of Upadacitinib on Cutaneous Transcriptomic and Systemic Proteomic
Dysregulation in Patients with Moderate to Severe Atopic Dermatitis

Free Communications in Atopic Dermatitis Session

FC03.02

Thursday, Sept 8

14:25 - 14:35 p.m.

Efficacy and Safety of Upadacitinib with Topical Corticosteroids for the
Treatment of Atopic Dermatitis in Japan: 2-Year Interim Results from the
Phase 3 Rising Up Study

Free Communications in Atopic Dermatitis Session

FC03.05

Thursday, Sept 8

14:55 - 15:05 p.m.

Disease State Abstracts: Psoriasis


Epidemiologic Survey on Prevalence of Genital Psoriasis and Its Impact on
Patients' Sexual Life in Routine Care

Poster Session

P1564

Wednesday, Sept 7

7:00 a.m.

Disease State Abstracts: Atopic Dermatitis


Real-World Burden in Patients with Atopic Dermatitis Who Are Candidates for
Systemic Therapy and Currently Receiving No Systemic Therapy, No
Treatment, Topical Therapy Only, or Systemic Therapy: Results from a Real-
World Multicountry Study

Free Communications in Atopic Dermatitis Session

FC02.02

Thursday, Sept 8

10:25 - 10:35 a.m.

Associations Between Patient-Reported Outcomes and Disease Severity
Measures with Disease Burden in Atopic Dermatitis: Results from a Real-
World Multicountry Study

Poster Session

P0286

Wednesday, Sept 7

7:00 a.m.

Comparative Risk of Venous Thromboembolism (VTE) Among Patients with
Atopic Dermatitis (AD) or Other Immune-Mediated Diseases: A Cohort Study
Using United States Claims Data

Poster Session

P0201

Wednesday, Sept 7

7:00 a.m.

Disease State Abstracts: Vitiligo


Economic Burden Among Patients with Vitiligo in the US: A Retrospective
Database Claims Study

Poster Session

P1389

Wednesday, Sept 7

7:00 a.m.

Comorbidity Burden Among Patients with Vitiligo in the US: A Large-Scale
Retrospective Claims Database Analysis

Poster Session

P1378

Wednesday, Sept 7

7:00 a.m.

The full EADV scientific program is available here .

SKYRIZI is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading the development and commercialization of SKYRIZI globally.

About SKYRIZI ® (risankizumab)
SKYRIZI is an interleukin-23 (IL-23) inhibitor that selectively blocks IL-23 by binding to its p19 subunit. IL-23, a cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases. 1,2 Phase 3 trials of SKYRIZI in psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis are ongoing. 3-5

US Indications and Important Safety Information about SKYRIZI ® (risankizumab-rzaa) 2

SKYRIZI is a prescription medicine used to treat adults with:

  • moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or treatment using ultraviolet or UV light (phototherapy).
  • active psoriatic arthritis (PsA).
  • moderate to severe Crohn's disease.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about SKYRIZI ® (risankizumab-rzaa)?

SKYRIZI is a prescription medication that may cause serious side effects, including:

Serious Allergic Reactions:
Stop using SKYRIZI and get emergency medical help right away if you get any of the following symptoms of a serious allergic reaction:

  • Fainting, dizziness, feeling lightheaded (low blood pressure)
  • Swelling of your face, eyelids, lips, mouth, tongue, or throat
  • Trouble breathing or throat tightness
  • Chest tightness
  • Skin rash, hives
  • Itching

Infections:

SKYRIZI may lower the ability of your immune system to fight infections and may increase your risk of infections. Your healthcare provider should check you for infections and tuberculosis (TB) before starting treatment with SKYRIZI and may treat you for TB before you begin treatment with SKYRIZI if you have a history of TB or have active TB. Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment with SKYRIZI.

  • Tell your healthcare provider right away if you have an infection or have symptoms of an infection, including:
    • fever, sweats, or chills
    • muscle aches
    • weight loss
    • cough
    • warm, red, or painful skin or sores on your body different from your psoriasis
    • diarrhea or stomach pain
    • shortness of breath
    • blood in your mucus (phlegm)
    • burning when you urinate or urinating more often than normal

Do not use SKYRIZI if you are allergic to risankizumab-rzaa or any of the ingredients in SKYRIZI.

Before using SKYRIZI, tell your healthcare provider about all of your medical conditions, including if you:

  • have any of the conditions or symptoms listed in the section "What is the most important information I should know about SKYRIZI?"
  • have an infection that does not go away or that keeps coming back.
  • have TB or have been in close contact with someone with TB.
  • have recently received or are scheduled to receive an immunization (vaccine). Medicines that interact with the immune system may increase your risk of getting an infection after receiving live vaccines. You should avoid receiving live vaccines right before, during, or right after treatment with SKYRIZI. Tell your healthcare provider that you are taking SKYRIZI before receiving a vaccine.
  • are pregnant or plan to become pregnant. It is not known if SKYRIZI can harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if SKYRIZI passes into your breast milk.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are the possible side effects of SKYRIZI?

SKYRIZI may cause serious side effects. See "What is the most important information I should know about SKYRIZI?"

Liver problems in people with Crohn's disease: A person with Crohn's disease who received SKYRIZI by intravenous infusion developed changes in liver blood tests with a rash that led to hospitalization. Your doctor will do blood tests to check your liver before, during, and up to 12 weeks of treatment and may stop treatment with SKYRIZI if you develop liver problems. Tell your doctor right away if you notice any of the following symptoms: unexplained rash, nausea, vomiting, stomach (abdominal) pain, tiredness (fatigue), loss of appetite, yellowing of the skin and eyes (jaundice) and dark urine.

The most common side effects of SKYRIZI in people treated for Crohn's Disease include upper respiratory infections, injection site reactions, fever, headache, stomach (abdominal) pain, back pain, joint pain, and low red blood cells (anemia).

The most common side effects of SKYRIZI in people treated for plaque psoriasis and psoriatic arthritis include upper respiratory infections, feeling tired, fungal skin infections, headache, and injection site reactions.

These are not all the possible side effects of SKYRIZI. Call your doctor for medical advice about side effects.

Use SKYRIZI exactly as your healthcare provider tells you to use it.

SKYRIZI is available in a 150 mg/mL prefilled syringe and pen, a 600 mg/10 mL intravenous infusion, and a 360 mg/2.4 mL single-dose prefilled cartridge with on-body injector.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/myAbbVieAssist to learn more.

Please click here for Full Prescribing Information and Medication Guide for SKYRIZI.

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

About RINVOQ® (upadacitinib)
Discovered and developed by AbbVie scientists, RINVOQ is a selective JAK inhibitor that is being studied in several immune-mediated inflammatory diseases. 6 Based on enzymatic and cellular assays, RINVOQ demonstrated greater inhibitory potency for JAK-1 vs JAK-2, JAK-3 and TYK-2. 6 The relevance of inhibition of specific JAK enzymes to therapeutic effectiveness and safety is not currently known. Phase 3 trials of RINVOQ in atopic dermatitis, axial spondylarthritis, Crohn's disease, giant cell arteritis, psoriatic arthritis, rheumatoid arthritis, Takayasu arteritis and ulcerative colitis are ongoing. 5,7-15

US Indications and Important Safety Information about RINVOQ ® (upadacitinib) 6

USES
RINVOQ is a prescription medicine used to treat:

  • Adults with moderate to severe rheumatoid arthritis when 1 or more medicines called tumor necrosis factor (TNF) blockers have been used, and did not work well or could not be tolerated.
  • Adults with active psoriatic arthritis when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated.
  • Adults with moderate to severe ulcerative colitis when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated.
  • Adults with active ankylosing spondylitis when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated.

It is not known if RINVOQ is safe and effective in children with juvenile idiopathic arthritis, psoriatic arthritis, ulcerative colitis, or ankylosing spondylitis.

  • Adults and children 12 years of age and older with moderate to severe eczema (atopic dermatitis) that did not respond to previous treatment and their eczema is not well controlled with other pills or injections, including biologic medicines, or the use of other pills or injections is not recommended.

RINVOQ is safe and effective in children 12 years of age and older weighing at least 88 pounds (40 kg) with atopic dermatitis.

It is not known if RINVOQ is safe and effective in children under 12 years of age with atopic dermatitis.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about RINVOQ?

RINVOQ may cause serious side effects, including:

  • Serious infections. RINVOQ can lower your ability to fight infections. Serious infections have happened while taking RINVOQ, including tuberculosis (TB) and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections. Your healthcare provider (HCP) should test you for TB before starting RINVOQ and check you closely for signs and symptoms of TB during treatment with RINVOQ. You should not start taking RINVOQ if you have any kind of infection unless your HCP tells you it is okay. If you get a serious infection, your HCP may stop your treatment until your infection is controlled. You may be at higher risk of developing shingles (herpes zoster).
  • Increased risk of death in people 50 years and older who have at least 1 heart disease (cardiovascular) risk factor.
  • Cancer and immune system problems. RINVOQ may increase your risk of certain cancers. Lymphoma and other cancers, including skin cancers, can happen. Current or past smokers are at higher risk of certain cancers, including lymphoma and lung cancer. Follow your HCP's advice about having your skin checked for skin cancer during treatment with RINVOQ. Limit the amount of time you spend in sunlight. Wear protective clothing when you are in the sun and use sunscreen.
  • Increased risk of major cardiovascular (CV) events, such as heart attack, stroke, or death, in people 50 years and older who have at least 1 heart disease (CV) risk factor, especially if you are a current or past smoker.
  • Blood clots. Blood clots in the veins of the legs or lungs and arteries can happen with RINVOQ. This may be life-threatening and cause death. Blood clots in the veins of the legs and lungs have happened more often in people who are 50 years and older and with at least 1 heart disease (CV) risk factor.
  • Allergic reactions. Symptoms such as rash (hives), trouble breathing, feeling faint or dizzy, or swelling of your lips, tongue, or throat, that may mean you are having an allergic reaction have been seen in people taking RINVOQ. Some of these reactions were serious. If any of these symptoms occur during treatment with RINVOQ, stop taking RINVOQ and get emergency medical help right away.
  • Tears in the stomach or intestines and changes in certain laboratory tests. Your HCP should do blood tests before you start taking RINVOQ and while you take it. Your HCP may stop your RINVOQ treatment for a period of time if needed because of changes in these blood test results.

Do not take RINVOQ if:

  • You are allergic to upadacitinib or any of the ingredients in RINVOQ.

What should I tell my HCP BEFORE starting RINVOQ?

Tell your HCP if you:

  • Are being treated for an infection, have an infection that won't go away or keeps coming back, or have symptoms of an infection, such as:
  • Fever, sweating, or chills
  • Shortness of breath
  • Warm, red, or painful skin or sores on your body
  • Muscle aches
  • Feeling tired
  • Blood in phlegm
  • Diarrhea or stomach pain

  • Cough
  • Weight loss
  • Burning when urinating or urinating more often than normal
  • Have TB or have been in close contact with someone with TB.
  • Are a current or past smoker.
  • Have had a heart attack, other heart problems, or stroke.
  • Have or have had any type of cancer, hepatitis B or C, shingles (herpes zoster), blood clots in the veins of your legs or lungs, diverticulitis (inflammation in parts of the large intestine), or ulcers in your stomach or intestines.
  • Have other medical conditions, including liver problems, low blood cell counts, diabetes, chronic lung disease, HIV, or a weak immune system.
  • Live, have lived, or have traveled to parts of the country, such as the Ohio and Mississippi River valleys and the Southwest, that increase your risk of getting certain kinds of fungal infections. If you are unsure if you've been to these types of areas, ask your HCP.
  • Have recently received or are scheduled to receive a vaccine. People who take RINVOQ should not receive live vaccines.
  • Are pregnant or plan to become pregnant. Based on animal studies, RINVOQ may harm your unborn baby. Your HCP will check whether or not you are pregnant before you start RINVOQ. You should use effective birth control (contraception) to avoid becoming pregnant during treatment with RINVOQ and for 4 weeks after your last dose.
  • Are breastfeeding or plan to breastfeed. RINVOQ may pass into your breast milk. Do not breastfeed during treatment with RINVOQ and for 6 days after your last dose.

Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. RINVOQ and other medicines may affect each other, causing side effects.

Especially tell your HCP if you take:

  • Medicines for fungal or bacterial infections
  • Rifampicin or phenytoin
  • Medicines that affect your immune system

If you are not sure if you are taking any of these medicines, ask your HCP or pharmacist.

What should I do or tell my HCP AFTER starting RINVOQ?

  • Tell your HCP right away if you have any symptoms of an infection. RINVOQ can make you more likely to get infections or make any infections you have worse.
  • Get emergency help right away if you have any symptoms of a heart attack or stroke while taking RINVOQ, including:
    • Discomfort in the center of your chest that lasts for more than a few minutes or that goes away and comes back
    • Severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
    • Pain or discomfort in your arms, back, neck, jaw, or stomach
    • Shortness of breath with or without chest discomfort
    • Breaking out in a cold sweat
    • Nausea or vomiting
    • Feeling lightheaded
    • Weakness in one part or on one side of your body
    • Slurred speech
  • Tell your HCP right away if you have any signs or symptoms of blood clots during treatment with RINVOQ, including:
  • Swelling
  • Pain or tenderness in one or both legs
  • Sudden unexplained chest or upper back pain
  • Shortness of breath or difficulty breathing
  • Tell your HCP right away if you have a fever or stomach-area pain that does not go away, and a change in your bowel habits.

What are other possible side effects of RINVOQ?

Common side effects include upper respiratory tract infections (common cold, sinus infections), shingles (herpes zoster), herpes simplex virus infections (including cold sores), bronchitis, nausea, cough, fever, acne, headache, increased blood levels of creatine phosphokinase, allergic reactions, inflammation of hair follicles, stomach-area (abdominal) pain, increased weight, flu, tiredness, lower number of certain types of white blood cells (neutropenia, lymphopenia), muscle pain, flu-like illness, rash, increased blood cholesterol levels, and increased liver enzyme levels.

A separation or tear to the lining of the back part of the eye (retinal detachment) has happened in people with atopic dermatitis treated with RINVOQ. Call your HCP right away if you have any sudden changes in your vision during treatment with RINVOQ.

These are not all the possible side effects of RINVOQ.

How should I take RINVOQ?

RINVOQ is taken once a day with or without food. Do not split, crush, or chew the tablet. Take RINVOQ exactly as your HCP tells you to use it. RINVOQ is available in 15 mg, 30 mg, and 45 mg extended-release tablets.

This is the most important information to know about RINVOQ. For more information, talk to your HCP.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/myAbbVieAssist to learn more.

Please click here for the Full Prescribing Information and Medication Guide .

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

About AbbVie in Dermatology
For more than a decade, AbbVie has worked to uncover new solutions and improve care for people with serious skin diseases, including psoriasis, psoriatic arthritis, hidradenitis suppurativa and atopic dermatitis. With a broad clinical trial program, we continue to actively research and adapt to the evolving needs of the dermatology community and advance our pipeline to help people achieve their treatment goals and live beyond their skin disease. For more information on AbbVie in dermatology, visit https://www.abbvie.com/our-science/therapeutic-focus-areas/immunology/immunology-focus-areas/dermatology.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, Instagram, YouTube and LinkedIn.

Forward-Looking Statements
Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, failure to realize the expected benefits from AbbVie's acquisition of Allergan plc ("Allergan"), failure to promptly and effectively integrate Allergan's businesses, competition from other products, challenges to intellectual property, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry and the impact of public health outbreaks, epidemics or pandemics, such as COVID-19. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2021 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

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  14. A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants with Giant Cell Arteritis. clinicaltrials.gov; 2022. August 5, 2022 . https://clinicaltrials.gov/ct2/show/NCT03725202 .
  15. A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants with Crohn's Disease Who Completed the Studies M14-431 or M14-433. clinicaltrials.gov; 2022. August 5, 2022 . https://clinicaltrials.gov/ct2/show/NCT03345823 .

Cision View original content: https://www.prnewswire.com/news-releases/abbvie-showcases-new-analyses-and-real-world-data-across-multiple-immune-mediated-skin-diseases-at-the-european-academy-of-dermatology-and-venereology-eadv-2022-congress-301613527.html

SOURCE AbbVie

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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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How to Invest in Biotechnology

How to Invest in Biotechnology

Investors interested in the life sciences are well aware of the importance that biotechnology and biotech companies have in this exciting market.

From finding cures for diseases to feeding future generations, there are many areas of day-to-day life that are influenced by players in the biotechnology space.

But how can investors gain exposure to biotechnology? And what investing options exist in the sector? Here’s a brief overview of how to invest in biotechnology, from stocks to watch to exchange-traded funds (ETFs).

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AbbVie to Host Third-Quarter 2022 Earnings Conference Call

ABBVie (NYSE: ABBV) will announce its third-quarter 2022 financial results on Friday, October 28, 2022 before the market opens. ABBVie will host a live webcast of the earnings conference call at 8 a.m. CT . It will be accessible through ABBVie's Investor Relations website investors.ABBVie.com . An archived edition of the session will be available later that day.

About AbbVie

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Autolus Therapeutics Announces Collaboration with Bristol Myers Squibb for Use of Autolus' Proprietary Safety Switch System

- Bristol Myers Squibb to receive access to Autolus' RQR8 safety switch for use in cell therapy programs -

- Autolus to receive an upfront payment, with potential for near term option exercise fees and development milestone payments plus royalties -

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Kite Receives U.S. FDA Approval of Viral Vector Manufacturing Facility in Southern California to Produce Commercial Product

-- Viral Vector Facility Further Strengthens Vertical Integration of Kite's Global CAR T-cell Therapy Manufacturing Network, Supports Growing Demand of Company's Blood Cancer Treatments --

-- Kite is the Only Cell Therapy Company with In-House Viral Vector Manufacturing Capabilities for Both Commercial Products and Clinical Trials --

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Cardiol Therapeutics Announces Pre-Clinical Study Results Demonstrating CardiolRx Inhibits and also Promotes Reversal of Mechanisms Leading to Cardiac Fibrosis

Cardiol Therapeutics Announces Pre-Clinical Study Results Demonstrating CardiolRx Inhibits and also Promotes Reversal of Mechanisms Leading to Cardiac Fibrosis

Data Presented at The Annual Scientific Meeting of the Heart Failure Society of America September 30th, 2022

Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) ("Cardiol" or the "Company"), a clinical-stage life sciences company focused on the research and clinical development of anti-inflammatory and anti-fibrotic therapies for the treatment of cardiovascular diseases ("CVD"), announced today that study results demonstrate the active pharmaceutical ingredient ("API") in CardiolRx™ inhibits and also promotes the reversal of mechanisms known to play a role in the occurrence and development of fibrotic CVD. The data were presented by its research collaborators from Houston Methodist DeBakey Heart & Vascular Center at The Annual Scientific Meeting of the Heart Failure Society of America ("HFSA2022").

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The Gummy Project Continues Strategic Expansion in US Hotel Sector After Receiving Purchase Order from Virgin Hotels Chicago to Become Supplier of Gummy Products for Guest Room Mini-Bars

The Gummy Project Continues Strategic Expansion in US Hotel Sector After Receiving Purchase Order from Virgin Hotels Chicago to Become Supplier of Gummy Products for Guest Room Mini-Bars

  • The Gummy Project's Peachy Bees and Watermelon Sharks expected to be featured for sale in all 250 guest rooms at the Virgin Hotel Chicago.
  • Purchase order continues The Gummy Projects strategic expansion in the Canadian and US Hotel sector.

The Gummy Project (CSE: GUMY) (FSE: 0OS0) (OTCQB: GUMYF) ("GUMY" or the "Company") is pleased to announce that it has received a purchase order from the Virgin Hotels Chicago to become a supplier of gummies for each of the hotel's 250 guest room mini-bars.

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