AbbVie Presents Data at the 64th American Society of Hematology Annual Meeting Adds to Robust IMBRUVICA® Science

Updated data presented at ASH include CAPTIVATE and GLOW studies and real-world evidence abstracts

ABBVie (NYSE: ABBV) today announced new and updated data across clinical and real-world studies in chronic lymphocytic leukemia (CLL). Presentations featured during the 64 th American Society of Hematology (ASH) Annual Meeting and Exposition will include two clinical trials investigating once daily, fixed-duration treatment with IMBRUVICA ® (ibrutinib) plus VENCLEXTA ® VENCLYXTO ® (venetoclax) (I+V) in adults with CLL and several analyses from real-word data evaluating front-line treatment in CLL.

"As the only Bruton's Tyrosine Kinase inhibitor (BTKi) studied across many clinical trials, including up to eight years of follow-up data in CLL and small lymphocytic lymphoma (SLL), these latest data add to overall evidence for IMBRUVICA," said James Dean , M.D., Ph.D., global development lead and executive medical director, Pharmacyclics LLC, an AbbVie company. "These findings further inspire our commitment to the continued investigation of IMBRUVICA in the treatment of patients with CLL."

Presentations will include the five-year median follow-up efficacy and safety data from the minimal residual disease (MRD) Cohort of the Phase 2 CAPTIVATE study ( Abstract #92 ) ¹ and data on MRD kinetics from the randomized, open-label Phase 3 GLOW study ( Abstract #93 ). ² Additionally, new data from three studies evaluating the impact of IMBRUVICA ^® treatment in the real-world setting will be presented (Abstracts #797 , #1809 , #3132 ). ^3,4,5

Five-Year Update from the CAPTIVATE Study Adds to Clinical Data Investigating the Potential of a Fixed-Duration Regimen

The MRD Cohort of the Phase 2 CAPTIVATE ( NCT02910583 ) study evaluated 164 patients age 70 years or younger with previously untreated CLL; those who achieved confirmed undetectable minimal residual disease (uMRD) after completion of I+V fixed-duration treatment were randomly assigned to placebo (PBO) (n=43), or continued IMBRUVICA ^® treatment (n=43). ¹ For patients with confirmed uMRD, median time on study was 56 months (PBO arm range, 40‒65 months; IMBRUVICA ^® arm range, 25‒68 months); median post-randomization follow-up was 41 months in both arms. ¹ At four years of follow-up, estimated progression-free survival (PFS) was 88 percent (95 percent Confidence Interval [CI], 74-95, seven progressive disease events) with PBO compared to 95 percent (95 percent CI, 82-99, two progressive disease events) with continued IMBRUVICA ^® treatment. ¹ Additionally, at year four, patients in the PBO arm of the study achieved an estimated overall survival (OS) rate of 100 percent (95 percent CI, NA) compared to 98 percent (95 percent CI, 84-99.7) in the IMBRUVICA ^® treatment arm. ¹

No new atrial fibrillation (AF) or Grade three or higher hemorrhage events occurred in the PBO arm during the three year post-randomization period, and one patient in the IMBRUVICA ^® arm had AF in the second year post-randomization. ¹ During the three-year post-randomization period, adverse events (AEs) of any grade for patients treated with IMBRUVICA ^® were arthralgia (4/41), hypertension (2/41), neutropenia (1/41) and diarrhea (1/41). No new grade three or higher hemorrhage events occurred in either arm. ¹

The Data of IMBRUVICA ^® in the Treatment of CLL Through Real-World Studies

An oral presentation ( Abstract #797 ) will report findings comparing time to next treatment (TTNT) in patients with CLL who received first-line treatment with IMBRUVICA ^® or acalabrutinib based on a real-world study utilizing electronic medical records. ³

A poster presentation ( Abstract #1809 ) will highlight results from a pooled analysis of the RESONATE-2 ( NCT01722487 ), ECOG1912 ( NCT02048813 ), and iLLUMINATE ( NCT02264574 ) clinical studies investigating the comparison of OS in previously untreated CLL patients treated with IMBRUVICA ^® to that of the available age-matched general population, as well as comparative results of OS in patients treated with IMBRUVICA ^® versus chemotherapy and chemoimmunotherapy. ⁴

Thirdly, the final analysis from the informCLL™ real-world (RW) registry, which assessed RW outcomes with first-line IMBRUVICA ^® versus chemoimmunotherapy (CIT) in patients with CLL and SLL, will be presented as a poster ( Abstract #3132 ). ⁵ The informCLL™ registry enrolled 1,459 patients, of whom 59 percent were previously untreated. ⁵ First-line treatment with IMBRUVICA ^® was associated with longer TTNT than with CIT and sustained benefit, with up to four years of follow-up. ⁵ In the IMBRUVICA ^® cohort (n=383), serious adverse events (AEs) occurred in 144 patients (38 percent), most commonly (greater or equal to three percent of patients) pneumonia (six percent) and atrial fibrillation (five percent); AEs led to discontinuation of IMBRUVICA ^® in 135 patients (35 percent), most commonly atrial fibrillation (five percent) and fatigue (three percent). In the CIT cohort (n=363), serious AEs occurred in 85 patients (23 percent), most commonly febrile neutropenia (four percent) and pneumonia (three percent). AEs led to discontinuation of CIT in 61 patients (17 percent), and no single AE term led to discontinuation in three percent or more of patients (most common was anemia, two percent). ⁵ The spectrum and frequency of AEs observed with first-line treatment appeared consistent with data from clinical studies and other RWE studies. ⁵

About IMBRUVICA ^® IMBRUVICA ^® (ibrutinib) is a once-daily oral medication that is jointly developed and commercialized by Janssen Biotech, Inc. and Pharmacyclics LLC, an AbbVie company. IMBRUVICA ^® blocks the Bruton's tyrosine kinase (BTK) protein, which is needed by normal and abnormal B cells, including specific cancer cells, to multiply and spread. By blocking BTK, IMBRUVICA ^® may help move abnormal B cells out of their nourishing environments and inhibits their proliferation. ^6,7,8

IMBRUVICA ^® is approved in more than 100 countries and has been used to treat more than 270,000 patients worldwide. There are more than 50 company-sponsored clinical trials, including 18 Phase 3 studies, over 11 years evaluating the efficacy and safety of IMBRUVICA ^® .

IMBRUVICA ^® was first approved by the U.S. Food and Drug Administration (FDA) in November 2013, and today is indicated for adult patients in six disease areas, including five hematologic cancers. These include indications to treat adults with CLL/SLL with or without 17p deletion (del17p), adults with Waldenström's macroglobulinemia (WM), adults with previously treated mantle cell lymphoma (MCL)*, adult patients with previously treated marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy*, as well as adult and pediatric patients one year of age and older with previously treated chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy. ⁹

*Accelerated approval was granted for MCL and MZL based on overall response rate. Continued approval for MCL and MZL may be contingent upon verification and description of clinical benefit in confirmatory trials.

For more information, visit www.IMBRUVICA.com .

IMPORTANT SIDE EFFECT INFORMATION

Before taking IMBRUVICA ^® , tell your healthcare provider about all of your medical conditions, including if you:

have had recent surgery or plan to have surgery. Your healthcare provider may stop IMBRUVICA ^® for any planned medical, surgical, or dental procedure.
have bleeding problems
have or had heart rhythm problems, smoke, or have a medical condition that increases your risk of heart disease, such as high blood pressure, high cholesterol, or diabetes
have an infection
have liver problems
are pregnant or plan to become pregnant. IMBRUVICA ^® can harm your unborn baby. If you are able to become pregnant, your healthcare provider will do a pregnancy test before starting treatment with IMBRUVICA ^® . Tell your healthcare provider if you are pregnant or think you may be pregnant during treatment with IMBRUVICA ^® .

Females who are able to become pregnant should use effective birth control (contraception) during treatment with IMBRUVICA ^® and for 1 month after the last dose.
Males with female partners who are able to become pregnant should use effective birth control, such as condoms, during treatment with IMBRUVICA ^® and for 1 month after the last dose.

are breastfeeding or plan to breastfeed. Do not breastfeed during treatment with IMBRUVICA ^® and for 1 week after the last dose.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking IMBRUVICA ^® with certain other medicines may affect how IMBRUVICA ^® works and can cause side effects.

How should I take IMBRUVICA ^® ?

Take IMBRUVICA ^® exactly as your healthcare provider tells you to take it.
Take IMBRUVICA ^® 1 time a day at about the same time each day.

IMBRUVICA ^® comes as capsules, tablets, and oral suspension.

If your healthcare provider prescribes IMBRUVICA ^® capsules or tablets:

Swallow IMBRUVICA ^® capsules or tablets whole with a glass of water.
Do not open, break, or chew IMBRUVICA ^® capsules.
Do not cut, crush, or chew IMBRUVICA ^® tablets.

If your healthcare provider prescribes IMBRUVICA ^® oral suspension:

See the detailed Instructions for Use that comes with IMBRUVICA ^® oral suspension for information about the correct way to give a dose to your child. If you have questions about how to give IMBRUVICA ^® oral suspension, talk to your healthcare provider.
Do not use if the carton seal is broken or missing.

If you miss a dose of IMBRUVICA ^® take it as soon as you remember on the same day. Take your next dose of IMBRUVICA ^® at your regular time on the next day. Do not take extra doses of IMBRUVICA ^® to make up for a missed dose.
If you take too much IMBRUVICA ^® call your healthcare provider or go to the nearest hospital emergency room right away.

What should I avoid while taking IMBRUVICA ^® ?

You should not drink grapefruit juice, eat grapefruit, or eat Seville oranges (often used in marmalades) during treatment with IMBRUVICA ^® . These products may increase the amount of IMBRUVICA ^® in your blood.

What are the possible side effects of IMBRUVICA ^® ?
IMBRUVICA ^® may cause serious side effects, including:

Bleeding problems (hemorrhage) are common during treatment with IMBRUVICA ^® , and can also be serious and may lead to death. Your risk of bleeding may increase if you are also taking a blood thinner medicine. Tell your healthcare provider if you have any signs of bleeding, including: blood in your stools or black stools (looks like tar), pink or brown urine, unexpected bleeding, or bleeding that is severe or that you cannot control, vomit blood or vomit looks like coffee grounds, cough up blood or blood clots, increased bruising, dizziness, weakness, confusion, change in your speech, or a headache that lasts a long time or severe headache.
Infections can happen during treatment with IMBRUVICA ^® . These infections can be serious and may lead to death. Tell your healthcare provider right away if you have fever, chills, weakness, confusion, or other signs or symptoms of an infection during treatment with IMBRUVICA ^® .
Heart problems. Serious heart rhythm problems (ventricular arrhythmias, atrial fibrillation and atrial flutter), heart failure and death have happened in people treated with IMBRUVICA ^® , especially in people who have an infection, an increased risk for heart disease, or have had heart rhythm problems in the past. Your heart function will be checked before and during treatment with IMBRUVICA ^® . Tell your healthcare provider if you get any symptoms of heart problems, such as feeling as if your heart is beating fast and irregular, lightheadedness, dizziness, shortness of breath, swelling of the feet, ankles or legs, chest discomfort, or you faint. If you develop any of these symptoms, your healthcare provider may do tests to check your heart and may change your IMBRUVICA ^® dose.
High blood pressure (hypertension). New or worsening high blood pressure has happened in people treated with IMBRUVICA ^® . Your healthcare provider may start you on blood pressure medicine or change current medicines to treat your blood pressure.
Decrease in blood cell counts. Decreased blood counts (white blood cells, platelets, and red blood cells) are common with IMBRUVICA ^® , but can also be severe. Your healthcare provider should do monthly blood tests to check your blood counts.
Second primary cancers. New cancers have happened during treatment with IMBRUVICA ^® , including cancers of the skin or other organs.
Tumor lysis syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure and the need for dialysis treatment, abnormal heart rhythm, seizure, and sometimes death. Your healthcare provider may do blood tests to check you for TLS.

The most common side effects of IMBRUVICA ^® in adults with B-cell malignancies (MCL, CLL/SLL, WM and MZL) include:

· diarrhea

· tiredness

· muscle and bone pain

· rash

· bruising

The most common side effects of IMBRUVICA ^® in adults or children 1 year of age and older with cGVHD include:

· tiredness

· low red blood cell count (anemia)

· bruising

· diarrhea

· low platelet count

· muscle and joint pain

· fever

· muscle spasms

· mouth sores (stomatitis)

· bleeding

· nausea

· stomach pain

· pneumonia

· headache

Diarrhea is a common side effect in people who take IMBRUVICA ^® . Drink plenty of fluids during treatment with IMBRUVICA ^® to help reduce your risk of losing too much fluid (dehydration) due to diarrhea. Tell your healthcare provider if you have diarrhea that does not go away.

These are not all the possible side effects of IMBRUVICA ^® . Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of IMBRUVICA ^® Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use IMBRUVICA ^® for a condition for which it was not prescribed. Do not give IMBRUVICA ^® to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about IMBRUVICA ^® that is written for health professionals.

Please click here for full Prescribing Information.

About VENCLYXTA ^® (venetoclax)
VENCLYXTA ^® (venetoclax) is a first-in-class medicine that selectively binds and inhibits the B-cell lymphoma-2 (BCL-2) protein. In some blood cancers, BCL-2 prevents cancer cells from undergoing their natural death or self-destruction process, called apoptosis. VENCLYXTA targets the BCL-2 protein and works to help restore the process of apoptosis.

VENCLYXTA is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S. Together, the companies are committed to BCL-2 research and to studying venetoclax in clinical trials across several blood and other cancers. Venetoclax is approved in more than 80 countries, including the U.S.

Approved Uses of VENCLEXTA

VENCLEXTA is a prescription medicine used:

to treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
in combination with azacitidine, or decitabine, or low-dose cytarabine to treat adults with
newly diagnosed acute myeloid leukemia (AML) who:

are 75 years of age or older, or
have other medical conditions that prevent the use of standard chemotherapy.

It is not known if VENCLEXTA is safe and effective in children.

Important Safety Information

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

VENCLEXTA can cause serious side effects, including:

Tumor lysis syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure, the need for dialysis treatment, and may lead to death. Your healthcare provider will do tests to check your risk of getting TLS before you start taking VENCLEXTA. You will receive other medicines before starting and during treatment with VENCLEXTA to help reduce your risk of TLS.

You may also need to receive intravenous (IV) fluids into your vein. Your healthcare provider will do blood tests to check for TLS when you first start treatment and during treatment with VENCLEXTA.

It is important to keep your appointments for blood tests. Tell your healthcare provider right away if you have any symptoms of TLS during treatment with VENCLEXTA, including fever, chills, nausea, vomiting, confusion, shortness of breath, seizures, irregular heartbeat, dark or cloudy urine, unusual tiredness, or muscle or joint pain.

Drink plenty of water during treatment with VENCLEXTA to help reduce your risk of getting TLS.

Drink 6 to 8 glasses (about 56 ounces total) of water each day, starting 2 days before your first dose, on the day of your first dose of VENCLEXTA, and each time your dose is increased.

Your healthcare provider may delay, decrease your dose, or stop treatment with VENCLEXTA if you have side effects. When restarting VENCLEXTA after stopping for 1 week or longer, your healthcare provider may again check for your risk of TLS and change your dose.

Who should not take VENCLEXTA?

Certain medicines must not be taken when you first start taking VENCLEXTA and while your dose is being slowly increased because of the risk of increased TLS.

Tell your healthcare provider about all the medicines you take, including prescription and over-the- counter medicines, vitamins, and herbal supplements. VENCLEXTA and other medicines may affect each other causing serious side effects.
Do not start new medicines during treatment with VENCLEXTA without first talking with your healthcare provider.

Before taking VENCLEXTA, tell your healthcare provider about all of your medical conditions, including if you:

have kidney or liver problems.
have problems with your body salts or electrolytes, such as potassium, phosphorus, or calcium.
have a history of high uric acid levels in your blood or gout.
are scheduled to receive a vaccine. You should not receive a "live vaccine" before, during, or after treatment with VENCLEXTA, until your healthcare provider tells you it is okay. If you are not sure about the type of immunization or vaccine, ask your healthcare provider. These vaccines may not be safe or may not work as well during treatment with VENCLEXTA.
are pregnant or plan to become pregnant. VENCLEXTA may harm your unborn baby. If you are able to become pregnant, your healthcare provider should do a pregnancy test before you start treatment with VENCLEXTA, and you should use effective birth control during treatment and for 30 days after the last dose of VENCLEXTA. If you become pregnant or think you are pregnant, tell your healthcare provider right away.
are breastfeeding or plan to breastfeed. It is not known if VENCLEXTA passes into your breast milk.
Do not breastfeed during treatment with VENCLEXTA and for 1 week after the last dose.

What should I avoid while taking VENCLEXTA?

You should not drink grapefruit juice or eat grapefruit, Seville oranges (often used in marmalades), or starfruit while you are taking VENCLEXTA. These products may increase the amount of VENCLEXTA in your blood.

What are the possible side effects of VENCLEXTA?

VENCLEXTA can cause serious side effects, including:

Low white blood cell counts (neutropenia). Low white blood cell counts are common with VENCLEXTA, but can also be severe. Your healthcare provider will do blood tests to check your blood counts during treatment with VENCLEXTA and may pause dosing.
Infections. Death and serious infections such as pneumonia and blood infection (sepsis) have happened during treatment with VENCLEXTA. Your healthcare provider will closely monitor and treat you right away if you have a fever or any signs of infection during treatment with VENCLEXTA.

Tell your healthcare provider right away if you have a fever or any signs of an infection during treatment with VENCLEXTA.

The most common side effects of VENCLEXTA when used in combination with obinutuzumab or rituximab or alone in people with CLL or SLL include low white blood cell counts; low platelet counts; low red blood cell counts; diarrhea; nausea; upper respiratory tract infection; cough; muscle and joint pain; tiredness; and swelling of your arms, legs, hands, and feet.

The most common side effects of VENCLEXTA in combination with azacitidine or decitabine or low-dose cytarabine in people with AML include nausea; diarrhea; low platelet count; constipation; low white blood cell count; fever with low white blood cell count; tiredness; vomiting; swelling of arms, legs, hands, or feet; fever; infection in lungs; shortness of breath; bleeding; low red blood cell count; rash; stomach (abdominal) pain; infection in your blood; muscle and joint pain; dizziness; cough; sore throat; and low blood pressure.

VENCLEXTA may cause fertility problems in males. This may affect your ability to father a child. Talk to your healthcare provider if you have concerns about fertility.

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

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

If you cannot afford your medication, contact genentech-access.com/patient/brands/venclexta for assistance.

About AbbVie in Oncology
At AbbVie, we are committed to transforming standards of care for multiple blood cancers while advancing a dynamic pipeline of investigational therapies across a range of cancer types. Our dedicated and experienced team joins forces with innovative partners to accelerate the delivery of potentially breakthrough medicines. We are evaluating more than 20 investigational medicines in over 300 clinical trials across some of the world's most widespread and debilitating cancers. As we work to have a remarkable impact on people's lives, we are committed to exploring solutions to help patients obtain access to our cancer medicines. For more information, please visit https://www.abbvie.com/oncology and our Blood Cancer Press kit page .

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, 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.

IMBRUVICA ^® is a registered trademark of Pharmacyclics LLC.

¹ Allen J., et al. Treatment Outcomes After Undetectable MRD With First-Line Ibrutinib (Ibr) Plus Venetoclax (Ven): Fixed Duration Treatment (Placebo) Versus Continued Ibr With Up to 5 Years Median Follow-up in the CAPTIVATE Study. 2022 American Society of Hematology (ASH) Annual Meeting. December 11, 2022.

² Neimann C., et al. Residual Disease Kinetics Among Patients with High-Risk Factors Treated with First-Line Fixed-Duration Ibrutinib plus Venetoclax (Ibr+Ven) versus Chlorambucil plus Obinutuzumab (Clb+O): the GLOW Study. 2022 American Society of Hematology Annual Meeting. December 11, 2022.

³ Jacobs R., et. al. Real-World Comparison of Time to Next Treatment for Patients with CLL Initiated on First-line Treatment with Ibrutinib versus Acalabrutinib. American Society of Hematology Congress 2022.

⁴ Ghia P., et. al. Initiating First-Line (1L) Ibrutinib (Ibr) in Patients (pts) with Chronic Lymphocytic Leukemia (CLL) Improves Overall Survival (OS) Outcomes to Rates Approximating an Age-Matched Population of ≥65 Years. American Society of Hematology Congress 2022.

⁵ Ghosh N., et. al. Real-World Outcomes With First-Line Ibrutinib (Ibr) Versus Chemoimmunotherapy (CIT) in Patients With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL): Final Analysis Results From the informCLL Registry. American Society of Hematology Congress 2022.

⁶ Genetics Home Reference. Isolated growth hormone deficiency. https://ghr.nlm.nih.gov/condition/isolated-growth-hormone-deficiency. Accessed November 2022.

⁷ Turetsky A, et al. Single cell imaging of Bruton's tyrosine kinase using an irreversible inhibitor. Scientific Reports. 2014;6:4782.

⁸ de Rooij MF, Kuil A, Geest CR, et al. The clinically active BTK inhibitor PCI-32765 targets B-cell receptor- and chemokine-controlled adhesion and migration in chronic lymphocytic leukemia. Blood. 2012;119(11):2590-2594.

⁹ IMBRUVICA® U.S. Prescribing Information, August 2022.

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“Together with Biogen, AbbVie is committed to meeting the needs of
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ZINBRYTA (daclizumab) is an investigational compound being developed for
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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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AMGEN ANNOUNCES 2025 FIRST QUARTER DIVIDEND

Amgen (NASDAQ:AMGN) today announced that its Board of Directors declared a $2.38 per share dividend for the first quarter of 2025. The dividend will be paid on March 7, 2025 to all stockholders of record as of the close of business on February 14, 2025 .

About Amgen
Amgen discovers, develops, manufactures and delivers innovative medicines to help millions of patients in their fight against some of the world's toughest diseases. More than 40 years ago, Amgen helped to establish the biotechnology industry and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today. Amgen is advancing a broad and deep pipeline that builds on its existing portfolio of medicines to treat cancer, heart disease, osteoporosis, inflammatory diseases and rare diseases.

News Provided by PR Newswire via QuoteMedia

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AMGEN ANNOUNCES $1 BILLION MANUFACTURING EXPANSION IN NORTH CAROLINA

Investment Establishes Second Facility in Holly Springs ; Builds on Previous $550M Commitment

Amgen (NASDAQ: AMGN) today announced a $1 billion expansion to establish a second drug substance manufacturing facility in North Carolina . This brings the company's total planned investment in Holly Springs to more than $1.5 billion building on its previously announced $550 million commitment.

News Provided by PR Newswire via QuoteMedia

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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

AbbVie Presents Data at the 64th American Society of Hematology Annual Meeting Adds to Robust IMBRUVICA® Science

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