Life Science News

- UBRELVY ® is the first and only oral CGRP receptor antagonist (gepant) approved by Health Canada for the acute treatment of migraine

-- UBRELVY ® was demonstrated to reduce or eliminate migraine pain with a single oral tablet, with the flexibility to take an optional second dose for persistent pain

ABBVie (NYSE: ABBV) announced today that Health Canada has approved UBRELVY ® (ubrogepant tablet) for the acute treatment of migraine, with or without aura, in adults. 1 UBRELVY ® is the first orally-administered calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) for the treatment of migraine attacks once they start.

AbbVie logo (CNW Group/AbbVie Canada)

An estimated 2.7 million Canadians have been diagnosed with migraine, which is estimated to underrepresent today's migraine prevalence. 2 Migraine is a complex neurological disease with recurrent attacks that lasts 4-72 hours. It can be defined by symptoms such as moderate to severe pain intensity, nausea, vomiting, photophobia and phonophobia. 3 It is one of the leading causes of disability in the world. 4

"I see first-hand the incredible impact migraines can have on my patients. When you suffer an attack, some patients are forced to seek solitude and remove themselves from everything in their lives. It can be unbearable and impact one's interaction with family, friends, school and work," said Dr. Jonathan Gladstone , MD, FRCPC, neurologist and Director of the Gladstone Headache Clinic in Toronto . "Health Canada's approval of UBRELVY is an important step forward allowing physicians to provide a new migraine-specific option for migraine sufferers. The gepant class is one of the most evaluated targeted therapies for migraine treatment. I'm excited to have another treatment option available to help patients successfully manage their migraines."

Calcitonin gene-related peptide (CGRP) is a neuropeptide present in the peripheral and central nervous system. CGRP is released from sensory nerve endings during a migraine attack, particularly the nerve endings of sensory trigeminal ganglion neurons. Ubrogepant is a small molecule, high affinity (K i = 0.07nM) CGRP receptor antagonist (gepant) that blocks the binding of CGRP to its receptor and antagonizes CGRP receptor function. UBRELVY® was demonstrated to reduce or eliminate migraine pain with a single oral tablet, with the flexibility to take an optional second dose for persistent pain. 1

"Migraine can often be a debilitating disease that can impact a person's ability to function and perform their daily routines. Being able to successfully address migraine attacks as they occur is essential," says Wendy Gerhart , Executive Director, Migraine Canada. "Migraine Canada welcomes the approval of UBRELVY ® in Canada as a new and innovative treatment option. This will have a positive impact for the migraine community across the country."

The efficacy of UBRELVY ® for the acute treatment of migraine was demonstrated in two multicenter, randomized, double-blind, placebo-controlled, single migraine attack studies. These studies enrolled patients with a history of migraine with and without aura, according to the ICHD-3 beta diagnostic criteria, and who experienced 2 to 8 migraine attacks per month with moderate to severe headache pain.  In Study 1 (ACHIEVE I), patients were randomized to receive UBRELVY 50 mg or 100 mg or placebo; and in Study 2 (ACHIEVE II), patients were randomized to receive UBRELVY 50 mg or placebo. Patients were permitted to use standard migraine preventive medications during the study. At baseline, 23% percent of patients were taking preventive medications for migraine. The most commonly used preventive medications were topiramate, onabotulinumtoxinA, propranolol, and amitriptyline. 1

"UBRELVY ® as the first oral gepant approved in Canada for the acute treatment of migraine is an important milestone in our commitment to bring innovative new medicines to Canadians with the goal make a meaningful difference for patients," says Tracey Ramsay , Vice President and General Manager, AbbVie Canada.

About UBRELVY ® (ubrogepant tablet) 1
UBRELVY ® (ubrogepant tablet) is indicated for the acute treatment of migraine, with or without aura, in adults.

Calcitonin gene-related peptide (CGRP) is a neuropeptide present in the peripheral and central nervous system. CGRP is released from sensory nerve endings during a migraine attack, particularly the nerve endings of sensory trigeminal ganglion neurons. Ubrogepant is a small molecule, high affinity (K i = 0.07nM) CGRP receptor antagonist (gepant) that blocks the binding of CGRP to its receptor and antagonizes CGRP receptor function. UBRELVY ® was demonstrated to reduce or eliminate migraine pain with a single oral tablet, with the flexibility to take an optional second dose for persistent pain.

UBRELVY ® is contraindicated:

  • In patients with hypersensitivity to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container
  • With concomitant use of strong CYP3A4 Inhibitors (e.g., ketoconazole, itraconazole, clarithromycin)

Please consult the UBRELVY ® Product Monograph here .

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.ca . Follow AbbVie Canada on Twitter , on Instagram or find us on LinkedIn.

__________________________________
1
UBRELVY Product Monograph. AbbVie Canada. November 2022.

2 Ramage-Morin P., & Gilmour, H. (2014). Prevalence of migraine in the Canadian household population. Health Reports, 25(6): 10-16. https://www150.statcan.gc.ca/n1/en/pub/82-003-x/2014006/article/14033-eng.pdf?st=CSyp19VF . Accessed November 2022.

3 Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia . 2018;38(1):1-211.

4 Steiner, T.J., Stovner, L.J., Jensen, R. et al. Migraine remains second among the world's causes of disability, and first among young women: findings from GBD2019. J Headache Pain 21, 137 (2020). https://doi.org/10.1186/s10194-020-01208-0

SOURCE AbbVie Canada

Cision View original content to download multimedia: http://www.newswire.ca/en/releases/archive/November2022/16/c7697.html

News Provided by Canada Newswire via QuoteMedia

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

Keep reading...Show less

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.

Keep reading...Show less

European Commission Grants Expanded Marketing Authorization for Gilead's Biktarvy® for the Treatment of HIV in Pediatric Populations

EC Authorizes a Low-Dose Tablet for HIV Treatment in Virologically Suppressed Children at Least Two Years of Age and Weighing at Least 14 kg, Helping to Address a Critical Unmet Need –

– Biktarvy Provides an Effective Therapy Choice for a Diverse Range of People Living with HIV, including Children with Limited Treatment Options –

News Provided by Business Wire via QuoteMedia

Keep reading...Show less

Envisagenics Announces Research Collaboration with Bristol Myers Squibb

Collaboration will leverage Envisagenics' SpliceCore® AI platform for accelerated discovery and development of oncology therapeutic candidates

Envisagenics an Artificial Intelligence ("AI")-driven biotechnology company that delivers therapies for RNA splicing diseases, today announced a research collaboration agreement with Bristol Myers Squibb (NYSE: BMY). The multi-year collaboration will leverage Envisagenics' SpliceCore® AI platform to identify alternative splicing derived targets for therapeutic development to expand Bristol Myers Squibb's vast oncology pipeline. Envisagenics will receive an upfront payment and milestone payments based on development, regulatory, and commercial achievements.

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less
Komo Reports Fiscal Year 2022 Financial Results

Komo Reports Fiscal Year 2022 Financial Results

Komo Plant Based Foods Inc. (CSE: YUM) (OTCQB: KOMOF) (FSE: 9HB0) ("Komo"), a premium plant-based food company, today reports financial results for the year ended July 31, 2022.

"We began our fiscal year as a new brand with a mission to make plant-based meals a staple on every dinner table by sharing our love for feel-good food that connects the people to the planet. Thanks to the strength of our team and the love of Komo products, we were successful in achieving sales growth of 935 percent over last year," says Komo founder and CEO William White. "The consistently strong retail sales of our products have allowed us to demonstrate to large retail chains that our products sell well and have repeat customers. We recently completed a national listing with Loblaws and we are in discussions with several other large national chains. As a result, we are anticipating continued significant revenue increases in 2023."

News Provided by Newsfile via QuoteMedia

Keep reading...Show less
The Gummy Project Announces Grant of Stock Options

The Gummy Project Announces Grant of Stock Options

The Gummy Project Inc. (CSE: GUMY) (FSE: 0OS0) (OTCQB: GUMYD) ("GUMY" or the "Company") announces that it has issued a total of 2,300,000 stock options pursuant to its incentive stock option plan ("Plan") to consultants which vest on the grant date. Each option entitles the holder to subscribe for one common share of the Company for $0.06 for a period of 5 years, subject to the terms of the Plan. Over the past quarter, 1,664,800 options have lapsed or been cancelled.

About The Gummy Project

News Provided by Newsfile via QuoteMedia

Keep reading...Show less

AMGEN TO WEBCAST INVESTOR CALL AT WCIRDC 2022

Amgen (NASDAQ:AMGN) will host a webcast call for the investment community in conjunction with the World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease (WCIRDC) at 8:00 a.m. ET on Monday Dec. 5, 2022. David M. Reese M.D., executive vice president of Research and Development at Amgen, along with members of Amgen's R&D team, will discuss the Phase 1 data from AMG 133, a novel bispecific glucose-dependent insulinotropic polypeptide receptor (GIPR) antagonist and glucagon-like peptide-1 (GLP-1) receptor agonist molecule.

The webcast will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less

Gilead and Arcus Biosciences Announce Positive Update on Joint TIGIT Program From Interim Analysis of ARC-7 Study in Non-small Cell Lung Cancer

Fourth Interim Analysis Shows Continued Clinically Meaningful Differentiation Across All Efficacy Measures, Including PFS, in Both Domvanalimab-Containing Arms Compared to the Anti-PD-1 Zimberelimab Monotherapy Arm in First-Line NSCLC Patients –

Data will be Presented on December 20, 2022 at the American Society of Clinical Oncology (ASCO) Monthly Plenary Series

News Provided by Business Wire via QuoteMedia

Keep reading...Show less

Latest Press Releases

Related News

×