Life Science News

  • The U.S. Food and Drug Administration approved the use of IMBRUVICA for the treatment of pediatric patients one year and older with cGVHD after failure of one or more lines of systemic therapy
  • This is the first approved treatment option for children with cGVHD under 12 years of age and the only Bruton's tyrosine kinase inhibitor (BTKi) treatment for a pediatric patient population
  • cGVHD is a rare condition that can occur in patients after receiving peripheral blood or bone marrow stem cell transplantation often related to blood cancer treatment
  • IMBRUVICA was the first treatment approved in the U.S. in 2017 for adult patients with cGVHD after failure of one or more lines of systemic therapy

ABBVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) approved the use of IMBRUVICA ® (ibrutinib) for the treatment of pediatric patients one year and older with chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy.

The approval is AbbVie's first pediatric indication for IMBRUVICA, marking the 12 th FDA approval for IMBRUVICA and the first Bruton's tyrosine kinase inhibitor (BTKi) treatment approved for a pediatric patient population. This approval also marks the first approved treatment option for children under 12 years of age suffering from cGVHD. The approval is primarily based on positive results from the iMAGINE Phase 1/2 clinical trial.

cGVHD occurs when donated peripheral blood or bone marrow stem cells view the recipient's body as foreign and the donated cells launch an immune attack on the body. 1 cGVHD impacts major organs, including the skin, eyes, mouth and liver as the most commonly affected. 2 About 35% of the estimated 8,000 patients who undergo life-saving allogeneic hematopoietic stem cell transplant (HSCT) per year develop cGVHD that requires systemic treatment. 1 Additionally, cGVHD is the most common cause of morbidity after an allogeneic transplant. 3 Steroids are the current standard treatment for pediatric cGVHD. 4

"For a substantial fraction of children who develop moderate or severe chronic graft versus host disease after blood or marrow transplantation, treatment options supported by methodical, formal study in children are limited," said Dr. Paul A. Carpenter , attending physician at Seattle Children's Hospital and a study principal investigator. "Now, healthcare professionals have another effective treatment option for both pediatric and adult patients living with this disease after failure of one or more lines of systemic therapy. Additionally, having an oral suspension formulation designed for children is a helpful alternative."

"This approval is incredibly meaningful as AbbVie's first pediatric approval for IMBRUVICA as well as within our company's oncology portfolio. As a Pediatric Oncologist, when my patients describe the physical pain they experience from simply hugging their parents due to their cGVHD, the importance of researching alternative treatment options in this patient population is further validated," said Gauri Sunkersett, D.O., associate medical director at AbbVie. "At AbbVie, we are committed to driving oncology research and developing therapies that have the potential to help patients of all ages, including underserved populations like children diagnosed with cGVHD."

The iMAGINE study demonstrated an Overall Response Rate (ORR) through week 25 of 60% (Confidence Interval [CI] 95%; 44-74) in patients median age 13 years (range, 1-19 years) (n=47) with relapsed/refractory (R/R) moderate to severe cGVHD. 5 The median duration of response was 5.3 months (95% CI: 2.8, 8.8). 5 Safety was consistent with the established profile for IMBRUVICA, with observed adverse reactions (ARs) consistent with those observed in adult patients with moderate to severe cGVHD. 5 The most common ARs (occurring in 20% or more of patients), including laboratory abnormalities, were anemia, musculoskeletal pain, pyrexia, diarrhea, pneumonia, abdominal pain, stomatitis, thrombocytopenia, and headache. 5

Since 2017 , IMBRUVICA has been approved as a single-agent therapy for adult patients with cGVHD who have experienced failure of prior systemic therapy, becoming the first FDA-approved treatment for cGVHD.

"In some ways, children struggling with cGVHD have been an 'orphan population' in relation to having treatment options available. Although there has been progress in approved treatment options for adults with cGVHD, the safety and efficacy of these have not been well studied in children," said Susan Stewart , executive director of BMT InfoNet, a non-profit advocacy organization for bone marrow, stem cell and cord blood transplant patients. "This FDA approval of IMBRUVICA gives children and their families struggling with this very difficult disease newfound hope."

The recommended dose of IMBRUVICA for cGVHD patients 12 years and older is 420 mg taken orally once daily until disease progression or unacceptable toxicity. 6 In cGVHD patients one year old to less than 12 years of age, the recommended dose of IMBRUVICA is 240 mg/m 2 taken orally once daily (up to a dose of 420 mg) until disease progression or unacceptable toxicity. 6 This FDA approval also includes an oral suspension formulation of IMBRUVICA to provide an alternative and child-friendly administration option.

About the iMAGINE Study 5
iMAGINE ( PCYC-1146-IM ) is an open-label, multi-center, single-arm trial of IMBRUVICA for the treatment of pediatric and young adult patients aged one year to less than 22 years with moderate or severe cGVHD as defined by NIH Consensus Criteria. The study included 47 patients who required additional therapy after failure of one or more prior lines of systemic therapy. Patients aged 12 years and older were treated with IMBRUVICA 420 mg orally once daily, and patients aged one year to less than 12 years were treated with IMBRUVICA 240 mg/m 2 orally once daily. Primary endpoints included pharmacokinetics (PK) and safety, and secondary endpoints included overall response rate (ORR; CR/PR) per 2014 NIH criteria, overall survival, and duration of response (DOR).

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. 7,8,9

IMBRUVICA ® is approved in more than 100 countries and has been used to treat more than 250,000 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 with previously treated chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy. 6

*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.

Since 2019, the National Comprehensive Cancer Network ® (NCCN ® ), recommends ibrutinib (IMBRUVICA ® ) as a preferred regimen for the initial treatment of CLL/SLL and has Category 1 treatment status for treatment-naïve patients without deletion 17p/ TP53 mutation and as a preferred treatment for treatment-naïve patients with deletion 17p/ TP53 mutation. The NCCN Guidelines ® also recommend IMBRUVICA ® , with or without rituximab, as a preferred regimen for the treatment of relapsed/refractory MCL, as a Category 1 preferred regimen for both untreated and previously treated WM patients, and as a preferred regimen for relapsed/refractory MZL. 10

For more information, visit www.IMBRUVICA.com .

IMPORTANT SAFETY 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 see the full Important Product Information .

Uses
What is IMBRUVICA ® (ibrutinib)?
IMBRUVICA ® (ibrutinib) is a prescription medicine used to treat:

  • Adults with mantle cell lymphoma (MCL) who have received at least one prior treatment.
  • Adults with chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL).
  • Adults with chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) with 17p deletion.
  • Adults with Waldenström's macroglobulinemia (WM).
  • Adults with marginal zone lymphoma (MZL) who require a medicine by mouth or injection (systemic therapy) and have received a certain type of prior treatment.
  • Adults and children 1 year of age and older with chronic graft versus host disease (cGVHD) after failure of 1 or more lines of systemic therapy.

It is not known if IMBRUVICA ® is safe and effective in children under 1 year of age.

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 http://www.abbvie.com/oncology .

About AbbVie
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .

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 Martin PJ, Lee SJ, Przepiorka D, et al. National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: VI. The 2014 Clinical Trial Design Working Group Report. Biol Blood Marrow Transplant. 2015;21(8):1343-1359. doi:10.1016/j.bbmt.2015.05.004.

2 Lee SJ. Classification systems for chronic graft-versus-host disease. Blood . 2017;129(1):30-37. Doi:10.1182/blood-2016-07-686642.

3 Cooke KR, Luznik L, Sarantopoulos S, et al. The Biology of Chronic Graft-versus-Host Disease: A Task Force Report from the National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease. Biol Blood Marrow Transplant . 2017;23(2):211-234. doi:10.1016/j.bbmt.2016.09.023.

4 Baird K, Cooke K, Schultz KR. Chronic graft-versus-host disease (GVHD) in children. Pediatr Clin North Am. 2010;57(1):297-322. doi:10.1016/j.pcl.2009.11.003.

5 "Phase 1/2 Dose Finding and Safety Study of Ibrutinib in Pediatric Subjects with Chronic Graft versus Host Disease (CGVHD) - Full Text View." ClinicalTrials.gov, https://clinicaltrials.gov/ct2/show/NCT03790332 . Accessed August 2022.

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

7 Genetics Home Reference. Isolated growth hormone deficiency. http://ghr.nlm.nih.gov/condition/isolated-growth-hormone-deficiency. Accessed July 2022.

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

9 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.

10 NCCN ® Clinical Practice Guidelines in Oncology (NCCN Guidelines ® ) for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma V2.2022. National Comprehensive Cancer Network. Accessed July 2022.

Cision View original content: https://www.prnewswire.com/news-releases/children-with-chronic-graft-versus-host-disease-cgvhd-may-now-be-prescribed-imbruvica-ibrutinib-301612041.html

SOURCE AbbVie

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ABBV
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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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

News Provided by PR Newswire via QuoteMedia

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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 -

News Provided by GlobeNewswire via QuoteMedia

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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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