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The findings also show majority of HCPs view treating CLL patients as different from treating other cancers - The emotional complexities of this slow-growing cancer point to patient and caregiver need for greater support from HCPs at time of diagnosis

NORTH CHICAGO, Ill. , June 24, 2022 /PRNewswire/ -- AbbVie today shared findings from the newly launched Emotional Impact Report , a survey of more than 300 chronic lymphocytic leukemia (CLL) patients, caregivers and healthcare providers (HCPs), which uncovered insights about the emotional journey associated with a CLL diagnosis.

CLL is a slow-growing form of blood cancer in which the bone marrow makes too many lymphocytes, a type of white blood cell. 1 CLL progresses much slower than other forms of leukemia and many do not experience symptoms for several years. This leads to disease management with an approach called "watch and wait" in which the disease progression is monitored until treatment is deemed necessary. 2

A CLL diagnosis can take a mental and emotional toll on patients, caregivers and HCPs and the Emotional Impact Report seeks to better understand that impact, raise awareness of the need for additional support and the importance of considering overall Quality of Life when making treatment decisions. 3

Among a sample of 111 CLL patients, emotions ranged from angry and bitter to optimistic and grateful. For those CLL patients who were newly diagnosed and/or told by their HCP to watch and wait, many may feel hopeful (41%) and optimistic (36%), expressing they are looking forward to the future success of their treatment and their long-term prognosis. And once patients first receive treatment, many (42%) feel positive, including mentions of feeling confident, satisfied, or relieved as they see the medication working. Others mention feeling anxious, never knowing when they will need treatment again and not knowing what is next, further reinforcing the variation and complexity of emotions experienced by CLL patients.

"These findings highlight the ups and downs CLL patients can go through from potentially waiting to start treatment to the prospect of being on continuous therapy," said Ahmed Kotb , vice president, US medical affairs, oncology, AbbVie. "But patients don't have to navigate a disease like CLL on their own. Based on insights from the Emotional Impact Report , there is an opportunity for increased dialogue between patients and their physicians to set treatment goals and understand available treatment options."

Furthermore, HCPs understand the importance of talking to their patients about the emotional impact of CLL. In fact, 71% said they are likely to discuss the emotional impact of CLL with their patients. Specifically, 90% recognize that a patient's emotional well-being has an impact on their treatment plan. Physicians cited specific impacts, including adherence to treatment, ability to cope with treatment and how they respond to treatment. HCPs recognize that treating a CLL patient differs from treating other cancer patients, in that CLL is treated similarly to the way a chronic disease is treated, which increases the need to consider Quality of Life when making treatment decisions.

Among a sample of 100 caregivers, most (81%) feel positively about caring for someone with CLL and feel it is their duty to help their loved one. Yet, nearly three in four state that being a caregiver is more difficult than expected. As one caregiver noted, the biggest reason why they are nervous in their role is because they don't know what's going to happen from one minute to the next.

This U.S.-based survey was conducted between March 11 April 7, 2022 , and responses were obtained from 313 participants, which included 111 CLL patients, 100 caregivers and 102 HCPs. The online survey was sponsored by AbbVie and developed in consultation with C Space.

To learn more about CLL, navigating a diagnosis and understanding treatment goals, visit CLLCancer.com .

About Chronic Lymphocytic Leukemia
CLL is one of the two most common forms of leukemia in adults and is a type of cancer that can develop from cells in the bone marrow that later mature into certain white blood cells (called lymphocytes). 1 While these cancer cells start in the bone marrow, they later spread into the blood. In 2019, there were approximately 200,766 people with CLL living in the United States with more than 20,000 new cases expected in 2022. 4 CLL is predominately a disease of the elderly, with a median age at diagnosis of 65 to 70 years and is more common among men than women. 5

About the Survey
Participants in the 31-35-question self-administered online survey included three groups, each with its own set and number of survey questions: patients, caregivers, and physicians who specialize in treating cancer. The patient group (n = 111) and the caregiver group (n = 100) included adults ages 18 and older from the U.S., and the physician group (n = 102) included board-certified hematologic oncologists, hematologists or medical oncologists who had treated at least five patients with CLL in the previous 12 months in the U.S. All surveys were completed between March 11, 2022 , and April 7, 2022 . Using the field services of C Space, the surveys asked both qualitative and quantitative questions. This online survey is not based on a probability sample and therefore no estimate of theoretical sampling error can be calculated.

About C Space
C Space is a global customer agency, that builds customers into the ways companies work.

Working with some of the world's best-known brands – including Walmart, McDonald's, IKEA and more – C Space builds the world's most relevant brands by unlocking the power of human relationships. By building ongoing relationships with customers, brands can stay relevant, deliver superior experiences, and build loyalty. C Space's customized customer programs are tailored based on specific business needs and include private online communities, in-person live events, visual storytelling, co-creation workshops, and business consulting.

Headquartered in Boston , C Space also has offices in London , New York , Tokyo , San Francisco , and Mexico City . C Space is a part of the Interbrand Group.

To learn more, visit www.cspace.com

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 .

References:

  1. American Cancer Society. Leukemia – Chronic Lymphocytic Leukemia. https://www.cancer.org/cancer/chronic-lymphocytic-leukemia/about/what-is-cll.html . Accessed June 2022 .
  2. Leukemia & Lymphoma Society – CLL: Watch and Wait. https://www.lls.org/leukemia/chronic-lymphocytic-leukemia/treatment/watch-and-wait . Accessed June 2022 .
  3. C Space Database [Data on File].
  4. National Cancer Institute. Cancer Stat Facts: Leukemia - Chronic Lymphocytic Leukemia (CLL). https://seer.cancer.gov/statfacts/html/clyl.html . Accessed June 2022 .
  5. Shanafelt, et al. Age at Diagnosis and the Utility of Prognostic Testing in Patients with Chronic Lymphocytic Leukemia (CLL). Cancer. 2010; 116(20): 4777–4787.

US-ONCC-220026

Cision View original content: https://www.prnewswire.com/news-releases/new-survey-offers-perspective-on-mental-and-emotional-journey-for-patients-diagnosed-with-slow-growing-blood-cancer-301574649.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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AMGEN DATA AT WCLC 2022 HIGHLIGHTS POTENTIAL TO DELIVER TRANSFORMATIVE MEDICINES FOR HISTORICALLY DIFFICULT-TO-TREAT LUNG CANCERS

First Data From LUMAKRAS Plus Immunotherapy and LUMAKRAS Plus SHP2 Inhibitor Combinations Show Clinical Activity and Support Ongoing Investigation

Updated Phase 1 Tarlatamab Data Reinforce Potential of BiTE ® Therapy in Small Cell Lung Cancer

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Boosh Settles $190,000 In Debt

Boosh Settles $190,000 In Debt

Boosh Plant-Based Brands Inc. (CSE: VEGI) (OTCQB: VGGIF) (FSE: 77i) ("Boosh" or the "Company") announces that it has entered into a settlement agreement with an arm's length third party for the settlement of $191,428.52 in debt for services previously provided through the issuance of 1,519,274 common shares at a deemed price of $$0.126 per share.

All securities issued in the debt settlement are subject to a four month and one day hold period expiring on December 04, 2022.

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AMGEN REPORTS SECOND QUARTER 2022 FINANCIAL RESULTS

Amgen (NASDAQ:AMGN) today announced financial results for the second quarter of 2022. Key results include:

  • Total revenues increased 1% to $6.6 billion in comparison to the second quarter of 2021, resulting from 3% growth in global product sales partially offset by lower Other Revenue from our COVID-19 manufacturing collaboration.
    • Volumes grew double-digits for a number of products including Repatha ® (evolocumab), Prolia ® (denosumab), LUMAKRAS ® /LUMYKRAS™ (sotorasib) and EVENITY ® (romosozumab-aqqg).
  • GAAP earnings per share (EPS) increased from $0.81 to $2.45 driven by a decrease in operating expenses due to the write-off of $1.5 billion in Acquired In-Process Research & Development (Acquired IPR&D) associated with our acquisition of Five Prime Therapeutics in Q2 2021 and lower weighted-average shares outstanding in Q2 2022, partially offset by an impairment charge related to the divestiture of GENSENTA, a generics subsidiary in Turkey .
    • GAAP operating income increased from $0.8 billion to $2.2 billion , and GAAP operating margin increased 21.1 percentage points to 34.6%.
  • Non-GAAP EPS increased from $1.77 to $4.65 driven by a decrease in operating expenses due to the write-off of $1.5 billion in Acquired IPR&D associated with our acquisition of Five Prime Therapeutics in Q2 2021 and lower weighted-average shares outstanding in Q2 2022.
    • Non-GAAP operating income increased from $1.6 billion to $3.3 billion , and non-GAAP operating margin increased 26.8 percentage points to 53.1%.
  • The Company generated $1.7 billion of free cash flow for the second quarter versus $1.7 billion in the second quarter of 2021.
  • 2022 total revenues guidance revised to $25.5 - $26.4 billion ; EPS guidance revised to $11.01 - $12.15 on a GAAP basis, and reaffirmed at $17.00 - $18.00 on a non-GAAP basis.

"We are focused on delivering our long-term objectives by serving an ever-increasing number of patients around the world with our medicines," said Robert A. Bradway , chairman and chief executive officer. "We are advancing our pipeline and look forward to important readouts over the next few months."

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The Gummy Project Secures Additional Repeat Order from Existing Customer Flair Airlines

The Gummy Project Secures Additional Repeat Order from Existing Customer Flair Airlines

  • The Company had previously announced its first repeat order with existing customer Bard on the Beach.
  • Partnership with Flair rapidly accelerates The Gummy Project's growth across Canada with GUMY products being featured for sale on all Flair flights.
  • As the "Better for You" gummy company, The Gummy Project, through its Flair Airlines partnership, will extend the reach and effectiveness of its purpose driven mission to support endangered keystone species.

The Gummy Project (CSE: GUMY) (FSE: 0OS) (OTCQB: GUMYF) ("GUMY" or the "Company") is excited to announce that the Company has received a repeat order from its existing customer Flair Airlines ("Flair").

"We are very pleased to receive our second repeat order from an existing customer. We view this as another vote of confidence that our customers are very much enjoying our gummies and strongly embracing our mandate to support endangered keystone species," said Charlie Lamb, President & CEO of The Company. "We look forward to building upon the momentum that the Company has created as we continue to accelerate revenue generation and brand awareness."

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Gilead Sciences to Acquire MiroBio

Acquisition Provides Gilead with MiroBio's Pipeline of Immune Checkpoint Agonists and Proprietary Discovery Platform –

– MiroBio's Scientific Approach to Restoring Immune Balance for the Treatment of Autoimmune Diseases Complements Gilead's Inflammation Research and Development Strategy –

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AMGEN TO ACQUIRE CHEMOCENTRYX FOR $4 BILLION IN CASH

Acquisition Includes TAVNEOS ® (avacopan), a First-in-Class Medicine for Patients With Serious Autoimmune Disease

Tavneos Adds to Amgen's Decades-Long Leadership in Inflammation and Nephrology

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