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AbbVie Showcases Strength of Dermatology Portfolio with New Data Presented at the 2023 AAD Annual Meeting

- More than 20 abstracts, including one late-breaking presentation, underscore AbbVie's dedication to advancing care for dermatologic conditions

ABBVie (NYSE: ABBV) today announced it will present more than 20 abstracts, including one late-breaking presentation during the 2023 American Academy of Dermatology (AAD) Annual Meeting, March 17-21 in New Orleans, Louisiana .

"The data at this year's AAD conference demonstrate AbbVie's commitment to investing in its dermatology portfolio to further improve outcomes for patients with immune-mediated skin conditions," said Celine Goldberger , M.D., vice president, head of U.S. medical affairs, AbbVie. "We look forward to sharing new evidence that further builds upon AbbVie's strong scientific foundation and helps to elevate the standards of care for patients."

The oral and poster presentations from AbbVie highlight research across the company's collective portfolio, further demonstrating leadership in dermatology innovation. Data feature outcomes in psoriatic disease, atopic dermatitis and hidradenitis suppurativa to support patients living with immune-mediated skin conditions. Notable data presentations will include:

  • A late-breaking oral presentation and several poster abstracts assessing the efficacy, durability, and safety of risankizumab in patients with moderate to severe plaque psoriasis, including follow-up of over 256 weeks in patients with prior biologic treatment, as well as abstracts assessing long-term outcomes of risankizumab in patients with active psoriatic arthritis.
  • Subgroup analyses of outcomes, including skin clearance (EASI 75, vIGA 0/1) and patient-reported outcomes (pruritis, skin symptoms, sleep and quality of life), in adults and adolescents with atopic dermatitis from three Phase 3 trials assessing the efficacy and safety of upadacitinib across 52 weeks.
  • A Phase 2 study evaluating the efficacy and safety of upadacitinib in moderate-to-severe hidradenitis suppurativa.

Select AbbVie abstracts at AAD 2023 are outlined below. The 2023 AAD Annual Meeting e-Posters are available here and late-breaking sessions are available here .

Abstract Title

Presentation Details
(All Times CT)

Psoriasis

Efficacy and Safety in Psoriasis Patients Switching to Risankizumab After
Suboptimal Response to Secukinumab or Ixekizumab After 52 Weeks

Late-Breaking Oral Presentation;

Theater B;
March 18, 2023

11:40-11:50 a.m.

Long-Term Safety and Efficacy of Risankizumab for the Treatment of Moderate-to-
Severe Plaque Psoriasis: Interim Analysis of Results from the LIMMitless Open-
Label Extension Trial Up to Five Years of Follow-Up

Poster #43928;
Poster Center 2:

Poster with Oral;

March 19, 2023
1:25-1:30 p.m.

Long-Term Real-World Treat-to-Target Skin Clearance and Maintenance of
Response with Risankizumab in Patients with Moderate to Severe Psoriasis from
the CorEvitas Psoriasis Registry

Poster #44047

Poster Center 2

Poster with Oral;

March 19, 2023

1:30-1:35 p.m.

Risankizumab Efficacy for Moderate-to-Severe Plaque Psoriasis Over 256 Weeks
in Patients with Prior Biologic Treatments

Poster #44102;

Poster Center 2;
Poster with Oral;
March 19, 2023
1:40-1:45 p.m.

Real-World Switch Rates of Biologics and Associated Costs in Patients with
Psoriasis

Poster #41279;

Poster Center 2;

Poster with Oral;
March 19, 2023
1:45-1:50 p.m.

Long-Term Efficacy of Continuous Risankizumab in Psoriasis by Body Region: An
Updated Integrated Analysis from the LIMMitless Open-Label Extension Study

Poster #44022;

E-poster

Long-Term Improvement in Difficult-To-Treat Areas and Quality of Life in Patients
with Psoriasis Up to 204 Weeks Post Switch from Ustekinumab To Risankizumab

Poster #44134;

E-poster

Psoriatic Arthritis

Impact of Risankizumab on Nail Psoriasis and Enthesitis Among Psoriatic Arthritis
Patients with High Nail Symptom Burden

Poster #44094

Poster Center 2

Poster with Oral;

March 19, 2023

1:35-1:40 p.m.

Improvements in Patient-Reported Outcomes Among Patients with Resolution of
Enthesitis and/or Dactylitis: Post Hoc Analyses from the KEEPsAKE 1 and 2 Trials
of Risankizumab in Patients with Active Psoriatic Arthritis

Poster #42267;

Poster Center 2;

Poster with Oral;

March 19, 2023
2:05-2:10 p.m.

Improvements in Manifestations of Active Psoriatic Arthritis with Risankizumab
Treatment After Intolerance or Inadequate Response to Prior Biologic Therapy:
Subgroup Analyses from the KEEPsAKE 2 Trial

Poster #43944;

E-poster

Atopic Dermatitis

Sustained Improvement Over 52 Weeks in Patient-Reported Itch, Symptoms, and
Quality of Life with Upadacitinib in Patients with Atopic Dermatitis: Results from
Phase 3 Studies (Measure Up 1, Measure Up 2, and AD Up)

Poster #42262;

Poster Center 2;

Poster with Oral;
March 17, 2023
1:40-1:45 p.m.

Improvement in Itch, Symptoms and Quality of Life with Upadacitinib Through
Week 16 in Adults and Adolescents with Atopic Dermatitis: results from Phase 3
Studies (Measure Up 1, Measure Up 2 and AD Up)

Poster #42065

E-poster

Efficacy and Safety of Upadacitinib in Adults and Adolescents with Moderate-to-
Severe Atopic Dermatitis: Subgroup Analysis of the Measure Up 1, Measure Up 2
and AD Up Phase 3 Clinical Trials at 52 Weeks

Poster #43049;

E-poster

Hidradenitis Suppurativa

Efficacy and Safety of Upadacitinib in Moderate-to-Severe Hidradenitis
Suppurativa: A Phase 2, Randomized, Placebo-Controlled Study

Poster #43799;

Poster Center 2;

Poster with Oral;
March 19, 2023
1:25-1:30 p.m.

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

About SKYRIZI ® (risankizumab-rzaa)
SKYRIZI is an interleukin-23 (IL-23) inhibitor that selectively blocks IL-23 by binding to its p19 subunit. 1 IL-23, a cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases, including psoriasis. 1 Phase 3 trials of SKYRIZI in psoriasis, Crohn's disease, ulcerative colitis and psoriatic arthritis are ongoing. 2-7

SKYRIZI U.S. Uses and Important Safety Information 8

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 medicine 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
-  cough
-  shortness of breath
-  blood in your mucus (phlegm)
-  muscle aches
-  warm, red, or painful skin or sores on your body different from your psoriasis
-  weight loss
-  diarrhea or stomach pain
-  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. See the Medication Guide or Consumer Brief Summary for a complete list of ingredients.

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.
  • become pregnant while taking SKYRIZI. You are encouraged to enroll in the Pregnancy Registry, which is used to collect information about the health of you and your baby. Talk to your healthcare provider or call 1-877-302-2161 to enroll in this registry.

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 Crohn's disease: A person with Crohn's disease who received SKYRIZI through a vein in the arm developed changes in liver blood tests with a rash that led to hospitalization. Your healthcare provider 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 healthcare provider 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, headache, joint pain, stomach (abdominal) pain, injection site reactions, low red blood cells (anemia), fever, back pain, and urinary tract infection.

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

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 vial for intravenous infusion, and a 180 mg/1.2 mL or 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. 9 Based on enzymatic and cellular assays, RINVOQ demonstrated greater inhibitory potency for JAK-1 vs JAK-2, JAK-3, and TYK-2. 10 The relevance of inhibition of specific JAK enzymes to therapeutic effectiveness and safety is not currently known.

The use of upadacitinib in hidradenitis suppurativa is not approved and its safety and efficacy have not been established by global regulatory authorities. Phase 3 trials of RINVOQ in rheumatoid arthritis, atopic dermatitis, psoriatic arthritis, axial spondyloarthritis, Crohn's disease, ulcerative colitis, giant cell arteritis and Takayasu arteritis are ongoing. 11-18

RINVOQ ® (upadacitinib) U.S. Use and Important Safety Information 10

USES

RINVOQ is a prescription medicine used to treat:

  • Adults with moderate to severe rheumatoid arthritis (RA) 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 (PsA) 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 (UC) 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 (AS) when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated.
  • Adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation when a TNF blocker medicine has 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, ankylosing spondylitis, or non-radiographic axial spondyloarthritis.

  • Adults and children 12 years of age and older with moderate to severe eczema (atopic dermatitis [AD]) 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. See the Medication Guide or Consumer Brief Summary for a complete list of ingredients.

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 avoid while taking RINVOQ?

Avoid food or drink containing grapefruit during treatment with RINVOQ as it may increase the risk of side effects.

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 for RINVOQ .

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

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 , LinkedIn or Instagram .

AbbVie 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.

References:

  1. Duvallet E., Sererano L., Assier E., et al. Interleukin-23: a key cytokine in inflammatory diseases. Ann Med . 2011. Nov 43(7):503-11.
  2. A Study on the long-term efficacy and safety of risankizumab for the treatment of moderate-to-severe plaque psoriasis. ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03047395 . Accessed on February 17, 2023 .
  3. A Study of the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease. ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03105128 . Accessed on March 8, 2022 .
  4. A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Ulcerative Colitis. ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03398135 . Accessed on March 8, 2022 .
  5. A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Ulcerative Colitis. Available at: https://clinicaltrials.gov/ct2/show/NCT03398148 . Accessed on March 8, 2022 .
  6. BI 655066/ABBV-066/Risankizumab Compared to Placebo in Patients With Active Psoriatic Arthritis. Available at: https://clinicaltrials.gov/ct2/show/NCT03675308 . Accessed on March 8, 2022 .
  7. BI 655066/ABBV-066/Risankizumab Compared to Placebo in Patients With Active Psoriatic Arthritis. Available at: https://clinicaltrials.gov/ct2/show/NCT03671148 . Accessed on March 8, 2022 .
  8. SKYRIZI (risankizumab) [Package Insert]. North Chicago, Ill. : AbbVie Inc.
  9. Pipeline – Our Science | AbbVie. AbbVie. 2019. Available at: https://www.abbvie.com/our-science/pipeline.html . Accessed on March 8, 2022 .
  10. RINVOQ (upadacitinib) [Package Insert]. North Chicago, Ill. : AbbVie Inc.
  11. A Study Comparing Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response to csDMARDs Alone (SELECT-NEXT). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT02675426 . Accessed on March 8, 2022 .
  12. Evaluation of Upadacitinib in Adolescent and Adult Patients With Moderate to Severe Atopic Dermatitis (Eczema) (Measure Up 1). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03569293 . Accessed on March 8, 2022 .
  13. A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Participants With Psoriatic Arthritis Who Have an Inadequate Response to at Least One Non-Biologic Disease Modifying Anti-Rheumatic Drug (SELECT - PsA 1). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03104400 . Accessed on March 8, 2022 .
  14. A Study to Evaluate Efficacy and Safety of Upadacitinib in Adult Participants With Axial Spondyloarthritis (SELECT AXIS 2). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT04169373 . Accessed on March 8, 2022 .
  15. A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Biologic Therapy. ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03345836 . Accessed on Accessed on March 8, 2022 .
  16. A Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis (UC). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT02819635 . Accessed on March 8, 2022 .
  17. A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants With Giant Cell Arteritis (SELECT-GCA). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03725202 . Accessed on March 8, 2022 .
  18. A Study to Evaluate the Efficacy and Safety of Upadacitinib in Subjects With Takayasu Arteritis (TAK) (SELECT-TAK). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT04161898 . Accessed on March 8, 2022 .

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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."

News Provided by GlobeNewswire via QuoteMedia

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CAMBRIDGE, Mass. & NORTH CHICAGO, Ill.–(BUSINESS WIRE)–The Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) has adopted a positive opinion
recommending the granting of a marketing authorization for ZINBRYTA™
(daclizumab) intended for the treatment of relapsing forms of multiple
sclerosis (RMS), Biogen
(NASDAQ: BIIB) and AbbVie (NYSE:
ABBV) announced today. ZINBRYTA is a once-monthly, self-administered,
subcutaneous investigational treatment for RMS. ZINBRYTA is also
currently under regulatory review in the United States, Switzerland,
Canada and Australia.
For people with relapsing forms of MS (RMS) and active disease,
ZINBRYTA has the potential to offer robust efficacy, a manageable safety
profile through patient monitoring, and once-monthly subcutaneous
dosing,” said Alfred Sandrock, M.D., Ph.D., executive vice president and
chief medical officer at Biogen. “ZINBRYTA may offer another option for
people with multiple sclerosis (MS) with its targeted mechanism of
action (MOA) which did not cause broad and prolonged immune cell
depletion.”
The CHMP positive opinion is now referred to the European Commission
(EC), which grants marketing authorizations for centrally authorized
medicines in the European Union. A decision from the EC is expected
within the coming months.
Together with Biogen, AbbVie is committed to meeting the needs of
patients with MS, and the positive opinion issued by the CHMP is a
critical step that moves us closer to bringing ZINBRYTA to patients in
Europe,” said Michael Severino, M.D., executive vice president, research
and development and chief scientific officer, AbbVie.
According to the CHMP opinion, the benefits of ZINBRYTA are its ability
to reduce the annualized relapse rate (ARR), as well as the risk of
24-week confirmed disability progression. The opinion is based on
results from two clinical trials, DECIDE and SELECT, in which ZINBRYTA
150 mg, administered subcutaneously every four weeks improved results on
key measures of MS disease activity in patients with RMS compared to
AVONEX 30 mcg intramuscular injection administered weekly and placebo,
respectively.
In the DECIDE study, the overall incidence of adverse events was similar
in the ZINBRYTA and AVONEX groups. In patients treated with ZINBRYTA
compared to AVONEX, there was an increased incidence of serious
infections (4% versus 2%), serious cutaneous reactions (2% versus <1%),
elevations of liver transaminases greater than five times the upper
limit of normal (6% versus 3%), gastrointestinal disorders (31% versus
24%), and depression (8% versus 6%).
About ZINBRYTA™ (daclizumab)
ZINBRYTA (daclizumab) is an investigational compound being developed for
the treatment of relapsing forms of MS. ZINBRYTA is a new form of a
humanized monoclonal antibody that selectively binds to the
high-affinity interleukin-2 (IL-2) receptor subunit (CD25) that is
expressed at high levels on T-cells that become activated in people with
MS. ZINBRYTA modulates IL-2 signaling without general immune cell
depletion.
Biogen and AbbVie are jointly developing ZINBRYTA.
About Biogen
Through cutting-edge science and medicine, Biogen discovers, develops
and delivers worldwide innovative therapies for people living with
serious neurological, autoimmune and rare diseases. Founded in 1978,
Biogen is one of the world’s oldest independent biotechnology companies
and patients worldwide benefit from its leading multiple sclerosis and
innovative hemophilia therapies. For more information, please visit www.biogen.com.
Follow us on Twitter.
Biogen Safe Harbor
This press release contains forward-looking statements, including
statements about the anticipated timing of the EC’s decision on the
marketing authorization for ZINBRYTA, and potential impact of ZINBRYTA,
if approved. These statements may be identified by words such as
“believe,” “expect,” “may,” “potential,” “will” and similar expressions,
and are based on our current beliefs and expectations. You should not
place undue reliance on these statements. Drug development and
commercialization involve a high degree of risk. Factors which could
cause actual results to differ materially from our current expectations
include the risk that the EC may fail to approve or may delay approval
of ZINBRYTA or may not follow the recommendation of the CHMP,
uncertainty of success in commercialization of ZINBRYTA For more
detailed information on the risks and uncertainties associated with our
drug development and commercialization activities and risks relating to
our collaborations with third parties, please review the Risk Factors
section of our most recent annual or quarterly report filed with the
Securities and Exchange Commission. Any forward-looking statements speak
only as of the date of this press release and we assume no obligation to
update any forward-looking statements, whether as a result of new
information, future events or otherwise.
About AbbVie
AbbVie is a global, research-based biopharmaceutical company formed in
2013 following separation from Abbott Laboratories. The company’s
mission is to use its expertise, dedicated people and unique approach to
innovation to develop and market advanced therapies that address some of
the world’s most complex and serious diseases. Together with its
wholly-owned subsidiary, Pharmacyclics, AbbVie employs more than 28,000
people worldwide and markets medicines in more than 170 countries. For
further information on the company and its people, portfolio and
commitments, please visit www.abbvie.com.
Follow @abbvie on
Twitter or view careers on our Facebook or LinkedIn
page.
Forward-Looking Statements
Some statements in this news release may be forward-looking statements
for purposes of the Private Securities Litigation Reform Act of 1995.
The words “believe,” “expect,” “anticipate,” “project” and similar
expressions, among others, generally identify forward-looking
statements. AbbVie cautions that these forward-looking statements are
subject to risks and uncertainties that may cause actual results to
differ materially from those indicated in the forward-looking
statements. Such risks and uncertainties include, but are not limited
to, challenges to intellectual property, competition from other
products, difficulties inherent in the research and development process,
adverse litigation or government action, and changes to laws and
regulations applicable to our industry.
Additional information about the economic, competitive, governmental,
technological and other factors that may affect AbbVie’s operations is
set forth in Item 1A, “Risk Factors,” in AbbVie’s 2014 Annual Report on
Form 10-K, which has been filed with the Securities and Exchange
Commission. AbbVie undertakes no obligation to release publicly any
revisions to forward-looking statements as a result of subsequent events
or developments, except as required by law.

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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Aptose Reports Results for the Fourth Quarter and Full Year 2022

─ APTIVATE Expansion Trial of Tuspetinib as Single Agent in Relapsed/Refractory AML Patients is Up and Running; Initiated Enrollment of Combination Treatment Arm with Venetoclax ─

─ RAS Mutated AML Clinically Sensitive to Tuspetinib ─

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Sirona Biochem Announces Debenture Financing

Sirona Biochem Announces Debenture Financing

Sirona Biochem Corp . (TSX-V: SBM) (FSE: ZSB) (OTC: SRBCF) (" Sirona " or the " Company ") is pleased to announce a non-brokered private placement offering of unsecured, convertible debentures (the " Convertible Debentures "). The Company is offering Convertible Debentures units (the " Debenture Units ") at a price of $1,000 per Debenture Unit for aggregate gross proceeds of up to $1,500,000 (the " Offering ").

Each Debenture Unit will have a face value of (the " Face Value ") of $1,120, consisting of $1,000 in principal (the " Principal ") and $120 in prepaid interest (the " Prepaid Interest "). The Principal of the Debenture Units will accrue interest at a rate of 12% per annum, which accrued interest (" Accrued Interest ") will be paid semi-annually, in arrears. The Company will pay the Prepaid Interest and Accrued Interest in cash or, subject to TSX Venture Exchange (" TSXV ") acceptance, may elect to satisfy payment in kind by issuing Shares (" Interest Shares "). In the event of payment in kind, the number of Interest Shares due will be calculated using a conversion price (the " Interest Conversion Price ") equal to, subject to acceptance by the TSXV, the maximum Discounted Market Price (as defined in TSXV policies) on the applicable payment due date.

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AbbVie Advances Upadacitinib to Phase 3 Clinical Trials in Systemic Lupus Erythematosus

  • Results of the M19-130 (SLEek) Phase 2 trial of upadacitinib given alone or as a combination therapy (ABBV-599) met the primary endpoint of systemic lupus erythematosus (SLE) Responder Index (SRI-4) and steroid dose less than or equal to 10 mg prednisone equivalent once per day at week 24 in patients with moderately to severely active SLE 1 , 2
  • No new safety signals were identified with upadacitinib, and a similar safety profile was observed for the combination therapy (ABBV-599) as for treatment with upadacitinib alone 2, 3 , 4 , 5 , 6 , 7
  • SLE is a complex autoimmune disorder in which the body's immune system attacks healthy tissue of the musculoskeletal system, skin, kidneys, lungs and other critical organs, leading to symptoms such as fatigue, joint pain and impaired function. 8 , 9

ABBVie (NYSE: ABBV) today announced topline results from a Phase 2 study of upadacitinib (RINVOQ ® 30 mg) given alone or as combination therapy (ABBV-599) with a Bruton's Tyrosine Kinase inhibitor (elsubrutinib, 60 mg), once daily in patients with moderately to severely active systemic lupus erythematosus (SLE). 1 The SLEek study met the primary endpoint of SLE Responder Index (SRI-4) and steroid dose less than or equal to 10 mg prednisone equivalent once per day at week 24 in the upadacitinib 30 mg group. 1,2 Based on the results, ABBVie is advancing its clinical program of upadacitinib in SLE to Phase 3.

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Risankizumab Achieves Primary and All Secondary Endpoints in Phase 3 Induction Study in Patients With Ulcerative Colitis

  • A significantly higher proportion of patients with moderately to severely active ulcerative colitis treated with risankizumab achieved the primary endpoint of clinical remission a (per Adapted Mayo Score) compared to placebo at week 12 in the Phase 3 INSPIRE induction study
  • All secondary endpoints, including clinical, endoscopic and histologic outcomes, were met
  • Safety results in this study were consistent with the known safety profile of risankizumab, with no new safety risks observed 1
  • Building on AbbVie's growing gastroenterology portfolio, risankizumab is an IL-23 inhibitor being evaluated as a treatment for adults with moderate to severe ulcerative colitis and approved for Crohn's disease, psoriatic arthritis, and psoriasis 1

ABBVie (NYSE: ABBV) today announced positive top-line results from INSPIRE, a Phase 3 induction study, showing risankizumab (SKYRIZI ® ,1200 mg intravenous [IV], at weeks 0, 4 and 8) met the primary endpoint of clinical remission (per Adapted Mayo Score) at week 12, as well as all secondary endpoints in adult patients with moderately to severely active ulcerative colitis. 1 In the study, 20.3% of patients receiving risankizumab achieved clinical remission compared to 6.2% of patients receiving placebo (p

"Our commitment to people living with gastroenterological conditions continues to grow," said Roopal Thakkar , M.D., senior vice president, development, regulatory affairs and chief medical officer, AbbVie. "These encouraging results help support the potential risankizumab has to improve clinical, endoscopic and histologic outcomes in patients with ulcerative colitis."

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Gilead Sciences Announces $3 Million in Grant Funding to Eight Organizations Addressing HIV Disparities in Rural U.S. Communities

Funding Will Reach Under-Resourced Communities Impacted by the HIV Epidemic as Part of Gilead's Zeroing In™: Ending the HIV Epidemic Grant Program –

Gilead Sciences, Inc. (Nasdaq: GILD) today announced it is providing a total of $3 million in grant funding to eight organizations to provide services to communities disproportionately impacted by HIV in rural areas in the United States. My Brother's Keeper, based in Ridgeland, Mississippi, will provide technical assistance and capacity building to the organizations funded through this initiative. These grants are part of Gilead's ongoing Zeroing In™ program to help end the HIV epidemic by supporting organizations working to improve the overall health and wellness of communities most impacted by the HIV epidemic.

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AbbVie Provides Regulatory Update on ABBV-951 New Drug Application

ABBVie (NYSE: ABBV) today announced it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the New Drug Application (NDA) for ABBV-951 (foscarbidopafoslevodopa) for the treatment of motor fluctuations in adults with advanced Parkinson's disease.

In its letter, the FDA requested additional information about the device (pump) as part of the NDA review. The CRL does not request that AbbVie conduct additional efficacy and safety trials related to the drug. AbbVie plans to resubmit the NDA as soon as possible.

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