Life Science News

  • MEASURE-AD was a real-world study of moderate to severe atopic dermatitis patients across 28 countries designed to assess the multidimensional burdens that diagnosed patients face 1-3
  • Additional findings show that lower clinical burden and work impairment had a positive association with quality of life and lower disease severity scores 1
  • Atopic dermatitis, also known as eczema, impacts up to an estimated 10 percent of adults and 25 percent of children globally and causes significant physical, psychological and economic impact 4-7

An analysis from ABBVie's (NYSE: ABBV) three-year, 28-country MEASURE-AD study revealed that people living with moderate to severe atopic dermatitis (an immune-mediated skin disease) who are not receiving systemic therapy had greater clinical, psychosocial and economic burdens compared to those receiving systemic therapy. 1 A separate analysis from the MEASURE-AD study demonstrated that better quality of life – as measured by Dermatology Life Quality Index (DLQI) scores – and lower disease severity scores were associated with lower clinical burden and work impairment. 2 Results from the MEASURE-AD subanalyses were featured at the 31 st European Academy of Dermatology and Venereology (EADV) Hybrid Congress onsite in Milan and online from September 7-10 as a poster and an oral presentation.

"Results from MEASURE-AD broaden awareness of the continued burden that people living with atopic dermatitis experience every day and of the potential link between disease severity, treatment approach and overall impact on patient-reported quality of life," said Juan Francisco Silvestre , M.D., attending dermatologist, General University Hospital of Alicante in Alicante, Spain , and investigator for the MEASURE-AD study. "These real-world analyses underscore the multidimensional burden of atopic dermatitis and the need for more therapeutic options for patients."

Evaluation of Real-World Burden for Moderate to Severe Atopic Dermatitis in Patients with or without Systemic Therapy

This post-hoc analysis titled, "Real-World Burden in Patients with Atopic Dermatitis Who Are Candidates for Systemic Therapy and Currently Receiving No Systemic Therapy, No Treatment, Topical Therapy Only, or Systemic Therapy: Results from a Real-World Multicountry Study, " showed greater clinical, psychosocial and economic burden among adult patients with moderate to severe atopic dermatitis not receiving systemic therapy versus those receiving systemic therapy. 1 Additionally, data suggested that many patients living with atopic dermatitis may be undertreated, with only half of eligible patients receiving systemic therapy. 1

Mean disease severity scores across six measures* were higher for patients receiving no systemic therapy versus those receiving systemic therapy (all p 1 Additionally, patients who received systemic therapy reported significantly better DLQI scores, Short-Form Health Survey Mental Health Component Summary (SF-12 MCS) mean scores and Physical Component Summary (SF-12 PCS) mean scores versus patients not receiving systemic therapy (p 1 Overall work productivity impairment and hours missed from work were also greater among patients receiving no systemic therapy versus patients receiving systemic therapy (p 1

Examining the Link Between Patient-Reported Quality of Life and Disease Burden in Atopic Dermatitis

A separate analysis from MEASURE-AD titled, "Associations Between Patient-Reported Outcomes and Disease Severity Measures with Disease Burden in Atopic Dermatitis: Results from a Real-World Multicountry Study," evaluated how improvements in a patient's quality of life and low disease severity often lead to lower clinical burden of disease and work impairment. 2 In this analysis, patients were stratified by patient-reported effect on quality of life – assessed using DLQI and disease severity measures (Patient-Oriented Eczema Measure categories [POEM] and the Atopic Dermatitis Symptom Scale 7-Item Total Symptom Score categories [ADerm-SS TSS-7]). 2 Clinical burden was assessed using Eczema Area and Severity Index (EASI) and Worst Pruritus Numeric Rating Scale (WP-NRS). 2 Work Productivity and Activity Impairment-AD (WPAI-AD) measures absenteeism, presenteeism, overall work productivity impairment and activity impairment.

Results from this analysis showed that EASI and WP-NRS scores were lower among patients with lower DLQI, lower POEM and lower ADerm-SS TSS-7 score categories (p 2 Similarly, overall work productivity impairment was lower among patients with lower DLQI, lower POEM and lower ADerm-SS TSS-7 score categories (p 2 Trends for absenteeism, presenteeism and activity impairment were similar to those for overall work productivity impairment (all p 2

"Patients are our purpose – their needs fuel our passion to propel dermatology research forward. The results of these studies help shed light on the cumulative impact of atopic dermatitis on patients' quality of life," said Chiedzo Mpofu, MBChB, Ph.D., vice president, Global Medical Affairs, Immunology, AbbVie. "We're proud to help advance understanding of the real-world experience of those living with atopic dermatitis, to uncover disparities in outcomes and inspire efforts to develop and deliver therapies to patients."

About MEASURE-AD 1,2,3

MEASURE-AD was a cross-sectional, 28-country study that characterized the real-world burden of moderate to severe atopic dermatitis in adolescent and adult patients (≥12 years of age) with physician-confirmed atopic dermatitis who were either candidates for or who were receiving systemic therapy. Patients were enrolled between December 2019 and December 2020 in 28 countries, with a total of 1,558 patients enrolled, consisting of 1,434 adults (≥18 years of age) as well as 124 adolescents (12 to 17 years) with moderate to severe atopic dermatitis receiving or who were eligible for systemic therapy.

About AbbVie in Dermatology

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

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across 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.

References:

  1. Silvestre, J.F., et al. Real-World Burden in Patients With Atopic Dermatitis Who Are Candidates for Systemic Therapy and Currently Receiving No Systemic Therapy, No Treatment, Topical Therapy Only, or Systemic Therapy: Results From a Real-World Multicountry Study. FC02.02. 2022European Academy of Dermatology and Venereology (EADV) Hybrid Congress.
  2. Gooderham, M., et al. Associations Between Patient-Reported Outcomes and Disease Severity Measures With Disease Burden in Atopic Dermatitis: Results From a Real-World Multicountry Study. P0286. 2022 European Academy of Dermatology and Venereology (EADV) Hybrid Congress.
  3. Eyerich, K., et al. The Burden of Flare in Atopic Dermatitis: Results From a Multi-Country Study. P0229. 2021 EADV Meeting. 2021 European Academy of Dermatology and Venereology (EADV) Congress.
  4. Kapur, S., et al. Allergy Asthma Clin Immunol . 2018;14(Suppl 2):52.
  5. Drucker, A.M. Allergy Asthma Proc. 2017;38(1):3-8.
  6. Weidinger, S. and Novak, N. Atopic Dermatitis. Lancet . 2016 Mar 12;387(10023):1109-1122.doi: 10.1016/S0140-6736(15)00149-X. Epub 2015 Sep 13.
  7. Eicheneld L.F., Tom W.L., Chamlin S.L., et al. Guidelines of care for the management of atopic dermatitis: section 1. Diagnosis and assessment of atopic dermatitis. J Am Acad Dermatol. 2014;70(2):338-351. doi:10.1016/j.jaad.2013.10.010.

* Measures included Eczema Area and Severity Index (EASI), Worst Pruritus Numeric Rating Scale (WP-NRS), Validated Investigator Global Assessment for AD (vlGA-AD), body surface area affected (BSA), average hours slept per night and number of participants with inadequately controlled atopic dermatitis.

Cision View original content: https://www.prnewswire.com/news-releases/new-measure-ad-analyses-evaluate-clinical-psychosocial-and-economic-burdens-in-atopic-dermatitis-patients-301619636.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."

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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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Gilead Joins First-of-its-Kind Public-Private Initiative to Improve Management of Viral Hepatitis in Vietnam and the Philippines

- Public-Private Effort to Shift Traditional Model of Hepatitis Management to Primary Care and Help to Expand Care to More People in Need -

Gilead Sciences, Inc. today announced a new public-private initiative with the Partnership for Health Advancement in Vietnam (HAIVN), a collaboration between Brigham and Women's Hospital, Harvard Medical School and Beth Israel Deaconess Medical Center. This multi-year initiative will have a phased approach to help address barriers that limit viral hepatitis diagnosis and care at primary healthcare facilities in Vietnam and the Philippines, two countries with high burdens of hepatitis B and C.

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The Forces of Beauty® Report from The DREAM Initiative® Reveals Demand for New Standards of Beauty and Imagery

--Initiative Creates Groundbreaking New, Royalty Free Inclusive Image Gallery In Strategic Partnership with Shutterstock Studios--

Today, Allergan Aesthetics, an ABBVie company (NYSE: ABBV), and skinbetter science ® announce a new report from their DREAM (Driving Racial Equity in Aesthetic Medicine) Initiative ® along with a long-term partnership with Shutterstock Studios. The report, titled Forces of Beauty ® provides a new understanding of what inclusive and representative beauty looks like today by shedding light on how narrowly defined Eurocentric ideals continue to impact women of color. By surveying over 4,000 women aged 21-65, from multiple geographic locations and backgrounds, the report explores what defines beauty, how beauty impacts women's lives, and the interplay between beauty and race. Some key insights include:

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The Gummy Project Expands in US After Receiving Purchase Order from 5-Star Luxury Four Seasons Hotel San Francisco to Become Supplier of Gummy Products for Guest Room Mini-Bars

The Gummy Project Expands in US After Receiving Purchase Order from 5-Star Luxury Four Seasons Hotel San Francisco 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 277 guest rooms at the 5-star luxury Four Seasons Hotel San Francisco
  • Purchase order from world class hotel marks the achievement of another milestone in The Gummy Project's ongoing multi-channel sales strategy

The Gummy Project (CSE: GUMY) (FSE: 0OS) (OTCQB: GUMYF) ("GUMY" or the "Company") is pleased to announce that it has received a purchase order from the 5-star luxury Four Seasons Hotel San Francisco to become a supplier of gummies for each of the hotel's 277 guest room mini-bars.

"We are thrilled to continue our strategic expansion in the US and honoured to have been selected by the luxury 5-star Four Seasons Hotel San Francisco to be a supplier of Peachy Bees and Watermelon sharks for hotel guest rooms," said Charlie Lamb, President & CEO of GUMY. "We very much look forward to developing a long-term relationship with The Four Seasons Hotel San Francisco, who not only are a world class hotel but who also share our commitment to a more sustainable future for everyone."

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Komo Plant Based Foods Expands Distribution through Quality Foods Grocery Chain

Komo Plant Based Foods Expands Distribution through Quality Foods Grocery Chain

Komo Plant Based Foods Inc. (CSE:YUM) (OTCQB:KOMOF) (FRA:9HB) ("Komo") is pleased to announce Quality Foods will be carrying Komo's 2 serving Lasagna, Shepherd's Pie and Mac & Greens as well as both Meal Helpers (Bolognese and Taco Filling) at all Quality Foods locations

Quality Foods is a British Columbia owned, award-winning leader in the Canadian grocery industry with brick and mortar stores in 13 locations in B.C. including Qualicum Foods in Qualicam Beach, Quality Foods in Parksville, Nanoose Bay, Nanaimo (Harewood), Nanaimo (Northridge Village), Port Alberni, Comox, Courtenay, Campbell River, Powell River, Victoria (Langford) and Victoria (View Royal).

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Gilead Sciences Completes Acquisition of MiroBio

Gilead Sciences, Inc. (Nasdaq: GILD) today announced the completion of the previously announced transaction to acquire MiroBio, a privately held U.K.-based biotechnology company focused on restoring immune balance with agonists targeting immune inhibitory receptors, for approximately $405 million in cash. The acquisition provides Gilead with MiroBio's proprietary discovery platform and entire portfolio of immune inhibitory receptor agonists. MiroBio's lead investigational antibody, MB272, is a selective agonist of immune inhibitory receptor B- and T-Lymphocyte Attenuator (BTLA) and has entered Phase 1 clinical trials, with the first patient dosed in early August 2022. MB272 targets T, B and dendritic cells to inhibit or blunt activation and suppress an inflammatory immune response.

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Aurinia Pharmaceuticals Announces Presentations at American College of Rheumatology Convergence 2022

Five abstracts underscore the long-term safety and efficacy of voclosporin, including in Latino patients and patients with Class V lupus nephritis

Data presentation on pre-clinical asset AUR200 reinforces Aurinia's commitment to autoimmune disease

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