Life Science News

Did you lose money on investments in AbbVie? If so, please visit AbbVie Inc. Shareholder Class Action Lawsuit or contact Peter Allocco at (212) 951-2030 or pallocco@bernlieb.com to discuss your rights.

- Bernstein Liebhard LLP announces that a securities class action lawsuit has been filed on behalf of investors who purchased or acquired the securities of ABBVie Inc. ("ABBVie" or the "Company") (NYSE: ABBV) between April 30, 2021 and August 31, 2021 inclusive (the "Class Period"). The lawsuit was filed in the United States District Court for the Northern District of Illinois and alleges violations of the Securities Exchange Act of 1934.

Bernstein Liebhard LLP. (PRNewsFoto/Bernstein Liebhard LLP) (PRNewsfoto/Bernstein Liebhard LLP)

AbbVie is one of the world's largest pharmaceutical companies. The Company's biggest drug, Humira (an anti-inflammatory drug used to treat illnesses such as Crohn's disease, ulcerative colitis, rheumatoid arthritis ("RA")) was, in 2021 (aside from COVID-19 vaccines), the world's best-selling prescription drug, with net revenue of more than $20 billion in 2021. Humira accounts for more than a third of AbbVie's net revenue.

While patents have protected Humira's blockbuster profits for years, biosimilar drugs will be permitted to enter the market and compete directly with Humira beginning in 2023. Accordingly, AbbVie's future revenue and earnings depend in large part on the Company's ability to develop new sources of revenue to offset reduced Humira sales. Rinvoq, an anti-inflammatory drug manufactured by AbbVie and used to treat RA and other diseases by inhibiting Janus kinase ("JAK") enzymes, was touted as one such drug.

Rinvoq was initially approved in the United States to treat only moderate to severe RA. However, AbbVie was actively pursuing additional treatment indications and, in 2020, asked the U.S. Food and Drug Administration (the "FDA") to approve Rinvoq for the treatment of several other diseases, including psoriatic arthritis, ankylosing spondylitis, and atopic dermatitis.

Rinvoq uses the same mechanism of action as other JAK inhibitor drugs, including Xeljanz and Xeljanz XR (collectively, "Xeljanz"), which are manufactured by Pfizer Inc. ("Pfizer"), and Olumiant, manufactured by Eli Lilly and Company ("Eli Lilly"). Beginning in February 2019 , the FDA repeatedly warned the public that the Xeljanz safety trial indicated that certain dosages of Xeljanz were associated with elevated risks of serious heart-related issues, cancer, and other adverse events.

Notwithstanding the pharmacological similarities between Rinvoq and Xeljanz, during the Class Period, Defendants conditioned investors to view Rinvoq as far safer than Xeljanz while downplaying the likelihood that the FDA would take regulatory action against Rinvoq as a result of Xeljanz's problematic safety profile.

On June 25, 2021 , AbbVie revealed that contrary to a previous announcement, the FDA would not complete its review of several of the expanded treatment indications for Rinvoq by the end of June due to its ongoing evaluation of safety concerns associated with Xeljanz. On this news, the price of AbbVie common stock declined $1.76 per share, or approximately 1.5%, from a close of $114.74 per share on June 24, 2021 , to close at $112.98 per share on June 25, 2021 .

Then, on September 1, 2021 , the FDA announced that final results from the Xeljanz safety trial established an increased risk of serious adverse events, even with low doses of Xeljanz. As a result, the FDA determined that it would require new and updated warnings for Xeljanz and Rinvoq because Rinvoq "share[s] similar mechanisms of action with Xeljanz" and "may have similar risks as seen in the Xeljanz safety trial." The FDA also indicated that it would further limit approved indications for Rinvoq as a result of these safety concerns.

On this news, the price of AbbVie common stock declined more than 7% to close at $112.27 per share on September 1, 2021 .

If you wish to serve as lead plaintiff, you must move the Court no later than June 6, 2022 . A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation. Your ability to share in any recovery doesn't require that you serve as lead plaintiff. If you choose to take no action, you may remain an absent class member.

If you purchased ABBV securities, and/or would like to discuss your legal rights and options please visit AbbVie Inc. Shareholder Class Action Lawsuit or contact Peter Allocco at (212) 951-2030 or pallocco@bernlieb.com .

Since 1993, Bernstein Liebhard LLP has recovered over $3.5 billion for its clients. In addition to representing individual investors, the Firm has been retained by some of the largest public and private pension funds in the country to monitor their assets and pursue litigation on their behalf. As a result of its success litigating hundreds of lawsuits and class actions, the Firm has been named to The National Law Journal's "Plaintiffs' Hot List" thirteen times and listed in The Legal 500 for ten consecutive years.

ATTORNEY ADVERTISING. © 2022 Bernstein Liebhard LLP. The law firm responsible for this advertisement is Bernstein Liebhard LLP, 10 East 40th Street, New York, New York 10016, (212) 779-1414. Prior results do not guarantee or predict a similar outcome with respect to any future matter.

Contact Information:
Peter Allocco
Bernstein Liebhard LLP
https://www.bernlieb.com
(212) 951-2030
pallocco@bernlieb.com

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SOURCE Bernstein Liebhard LLP

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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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Bristol Myers Squibb and Turning Point Therapeutics Announce Expiration of HSR Act Waiting Period and Clearance from Federal Cartel Office of Germany Related to Pending Acquisition of Turning Point Therapeutics

Bristol Myers Squibb (NYSE:BMY) and Turning Point Therapeutics, Inc. (NASDAQ:TPTX) ("Turning Point") today announced the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended ("HSR Act"), and the receipt of merger control clearance from the Federal Cartel Office of Germany ("FCO"), in connection with the previously announced offer (the "Offer") to acquire all outstanding shares of common stock of Turning Point at a price of $76.00 per share in an all-cash transaction for total consideration of approximately $4.1 billion. The expiration of the HSR Act waiting period occurred at 11:59 p.m. Eastern Time on August 15, 2022, and the FCO clearance was received on August 15, 2022. The Offer expired at 5:00 p.m. Eastern Time on August 15, 2022 (the "Expiration Time"), and the Offer was not extended.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220816005404/en/

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Gilead to Acquire Remaining Worldwide Rights of Trodelvy®

Gilead will Assume Responsibility for Clinical Development and Commercialization in Greater China and South Korea, among Other Asian Markets –

Gilead Sciences, Inc. (Nasdaq: GILD) today announced an agreement with Everest Medicines to transfer all development and commercialization rights to Gilead for Trodelvy ® (sacituzumab govitecan) in Greater China, South Korea, Singapore, Indonesia, Philippines, Vietnam, Thailand, Malaysia and Mongolia.

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Trodelvy® Significantly Improves Overall Survival in Pre-Treated HR+/HER2- Metastatic Breast Cancer Patients in the TROPiCS-02 Study

Trodelvy is the First TROP-2 Directed ADC to Show a Significant Improvement in Overall Survival in HR+HER2- Breast Cancer –

Planned Second Interim Analysis Demonstrated a Statistically Significant and Clinically Meaningful Benefit for Overall Survival

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The Gummy Project Announces Launch of New Investor Relations Website

The Gummy Project Announces Launch of New Investor Relations Website

The Gummy Project (CSE: GUMY) (FSE: 0OS) (OTCQB: GUMYF) ("GUMY" or the "Company")  is pleased to announce the launch of its new investor relations website at https:shopgummies.compagesinvestors.

The investor relations website features excellent functionality and streamlined access to essential investor information, including recent company press releases, sector information and more.

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bowl with healthy food on it alongside an avocado and cutlery

Hungry for Change: Investing in the Plant-based Food Industry

Animal agriculture is one of the top five sources of greenhouse gas emissions, much of which is directly attributable to livestock. It's been estimated by the United Nations, for instance, that the livestock sector represents approximately 14.5 percent of all global greenhouse gas emissions. Given the current international push for sustainability, this is a problem — and people are demanding a solution.

Driven by concerns about health, climate change and animal welfare, consumers are demandingethical and sustainable alternatives to meat, dairy, fish, and poultry. Nearly two-thirds (63 percent) of respondents to a survey on flexitarian diets would swap to plant-based alternatives because they're more ethical.

Unsurprisingly, this demand represents a considerable opportunity for anyone interested in sustainable investing. According to Bloomberg Intelligence, the global plant-based food market is expected to reach a total value of US$162 billion by 2030. A survey from the Food Institute shows that 79 percent of Americans from Generation Z choose meatless options at least once or twice a week.

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BELLUS Health Reports Second Quarter 2022 Financial Results and Business Highlights

- Completed positive End-of-Phase 2 meeting with the Food and Drug Administration ("FDA") and received scientific advice from the European Medicines Agency ("EMA") to support design of its CALM Phase 3 program, which is expected to initiate in Q4 2022 -

- Ended second quarter 2022 with approximately US$384.6 million in pro-forma cash, cash equivalents and short-term investments, including net proceeds from the July 2022 financing; Cash runway extended to 2H 2025 and through the topline results of both CALM-1 and CALM-2 trials -

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