- Companies will discover and develop novel targets for
the potential treatment of neuropsychiatric conditions
- New discovery program builds upon nearly two decades
of partnership between AbbVie and Gedeon
Richter
NORTH
CHICAGO, Ill. and BUDAPEST,
Hungary, Oct. 24, 2024 /PRNewswire/ -- AbbVie
(NYSE: ABBV) and Gedeon Richter Plc. ('Richter') today announced a
new discovery, co-development and license agreement to advance
novel targets for the potential treatment of neuropsychiatric
conditions. This collaboration expands upon the success of nearly
two decades of partnership on central nervous system (CNS)
projects, including globally launched products such as cariprazine
(VRAYLAR® / REAGILA®) and the discovery of investigational drug
candidate ABBV-932 for the treatment of bipolar depression and
generalized anxiety disorder.
"There remains a large unmet need for people living with
neuropsychiatric disorders, making it imperative that we continue
to innovate and pursue novel targets and approaches to discover and
develop new therapies," said Jonathon Sedgwick, Ph.D., senior
vice president and global head of discovery research, AbbVie. "We
are excited to expand our longstanding and successful partnership
with Richter to help address the complex needs of these
patients."
"This new agreement builds on years of successful partnership
allowing Richter to further support AbbVie's global ambition in
neuropsychiatry and validates the quality of science behind our
unique discovery platform," said Gábor Orbán, chief executive
officer of Gedeon Richter.
Under the terms of the agreement, the collaboration includes
both preclinical and clinical R&D activities with shared
financing by the parties. Richter will receive an upfront cash
payment of $25 million, along with
potential future development, regulatory and commercialization
milestones. In addition, Richter may also receive sales-based
royalties. AbbVie will have worldwide commercialization rights
except for traditional markets of Richter, such as geographic
Europe, Russia, other CIS countries and Vietnam.
VRAYLAR® (cariprazine) US Uses and Important Safety
Information
VRAYLAR is a prescription medicine used in adults:
- along with antidepressant medicines to treat major depressive
disorder (MDD)
- for short-term (acute) treatment of manic or mixed episodes
that happen with bipolar I disorder
- to treat depressive episodes that happen with bipolar I
(bipolar depression)
- to treat schizophrenia
What is the most important information I should know about
VRAYLAR?
Elderly people with dementia-related psychosis (having lost
touch with reality due to confusion and memory loss) taking
medicines like VRAYLAR are at an increased risk of death. VRAYLAR
is not approved for treating patients with dementia-related
psychosis. VRAYLAR and antidepressants may increase suicidal
thoughts or actions in some children and young adults especially
within the first few months of treatment or when the dose is
changed. Depression and other mental illnesses are the most
important causes of suicidal thoughts and actions. Patients on
antidepressants and their families or caregivers should watch for
new or worsening depression symptoms, especially sudden changes in
mood, behaviors, thoughts, or feelings. This is very important when
VRAYLAR or the antidepressant is started or when the dose is
changed. Report any change in these symptoms immediately to the
doctor.
VRAYLAR may cause serious side effects, including:
• Stroke (cerebrovascular problems) in elderly people with
dementia-related psychosis that can lead to death
•
Neuroleptic malignant syndrome (NMS): Call your healthcare
provider or go to the nearest hospital emergency room right away if
you have high fever, stiff muscles, confusion, increased sweating,
or changes in breathing, heart rate, and blood pressure. These can
be symptoms of a rare but potentially fatal side effect called NMS.
VRAYLAR should be stopped if you have NMS.
• Uncontrolled body movements (tardive dyskinesia or TD):
VRAYLAR may cause movements that you cannot control in your face,
tongue, or other body parts. Tardive dyskinesia may not go away,
even if you stop taking VRAYLAR. Tardive dyskinesia may also start
after you stop taking VRAYLAR.
• Late-occurring side effects: VRAYLAR stays in your body
for a long time. Some side effects may not happen right away and
can start a few weeks after starting VRAYLAR, or if your dose
increases. Your healthcare provider should monitor you for side
effects for several weeks after starting or increasing dose of
VRAYLAR.
• Problems with your metabolism, such as:
− High blood
sugar and diabetes: Increases in blood sugar can happen in some
people who take VRAYLAR. Extremely high blood sugar can lead to
coma or death. Your healthcare provider should check your blood
sugar before or soon after starting VRAYLAR and regularly during
treatment. Tell your healthcare provider if you have symptoms such
as feeling very thirsty, very hungry, or sick to your stomach,
urinating more than usual, feeling weak, tired, confused, or your
breath smells fruity.
− Increased fat levels (cholesterol and triglycerides) in your
blood: Your healthcare provider should check fat levels in your
blood before or soon after starting VRAYLAR and during
treatment.
− Weight gain: Weight gain has been reported with VRAYLAR.
You and your healthcare provider should check your weight before
and regularly during treatment.
• Low white blood cell count: Low white blood cell counts
have been reported with antipsychotic drugs, including VRAYLAR.
This may increase your risk of infection. Very low white blood cell
counts, which can be fatal, have been reported with other
antipsychotics. Your healthcare provider may do blood tests during
the first few months of treatment with VRAYLAR.
• Decreased blood pressure (orthostatic hypotension): You
may feel lightheaded or faint when you rise too quickly from a
sitting or lying position.
• Falls: VRAYLAR may make you sleepy or dizzy, may cause a
decrease in blood pressure when changing position (orthostatic
hypotension), and can slow thinking and motor skills, which may
lead to falls that can cause fractures or other injuries.
• Seizures (convulsions)
• Sleepiness, drowsiness,
feeling tired, difficulty thinking and doing normal activities:
Do NOT drive, operate machinery, or do other dangerous activities
until you know how VRAYLAR affects you. VRAYLAR may make you
drowsy.
• Increased body temperature: Do not become too hot or
dehydrated during VRAYLAR treatment. Do not exercise too much. In
hot weather, stay inside in a cool place if possible. Stay out of
the sun. Do not wear too much clothing or heavy clothing. Drink
plenty of water.
• Difficulty swallowing that can cause food or liquid to get
into your lungs
Who should not take VRAYLAR?
Do not take VRAYLAR if you are allergic to any of its
ingredients. Get emergency medical help if you are having an
allergic reaction (eg, rash, itching, hives, swelling of the
tongue, lip, face or throat).
What should I tell my healthcare provider before taking
VRAYLAR?
Tell your healthcare provider about any medical conditions and
if you:
• have or have had heart problems or a stroke
• have or have had low or high blood pressure
• have or have had diabetes or high blood sugar in you or your
family
• have or have had high levels of total cholesterol,
LDL-cholesterol, or triglycerides; or low levels of
HDLcholesterol
• have or have had seizures (convulsions)
• have or have had kidney or liver problems
• have or have had low white blood cell count
• are pregnant or plan to become pregnant. VRAYLAR may harm your
unborn baby. Taking VRAYLAR during your third trimester of
pregnancy may cause your baby to have abnormal muscle movements or
withdrawal symptoms after birth. Talk to your healthcare provider
about the risk to your unborn baby if you take VRAYLAR during
pregnancy. If you become pregnant or think you are pregnant during
treatment, talk to your healthcare provider about registering with
the National Pregnancy Registry for Atypical Antipsychotics at
1-866-961-2388 or
http://www.womensmentalhealth.org/clinicaland-research-programs/pregnancyregistry/.
• are breastfeeding or plan to breastfeed. It is not known if
VRAYLAR passes into breast milk.
Talk to your healthcare provider about the best way to feed your
baby during treatment with VRAYLAR. Tell your healthcare provider
about all medicines that you take, including prescriptions,
over-the counter medicines, vitamins, and supplements. VRAYLAR may
affect the way other medicines work, and other medicines may affect
how VRAYLAR works. Do not start or stop any medicines while taking
VRAYLAR without talking to your healthcare provider.
What are the most common side effects of VRAYLAR?
• The most common side effects include difficulty moving
or slow movements, tremors, uncontrolled body movements,
restlessness and feeling like you need to move around, sleepiness,
nausea, vomiting, indigestion, constipation, feeling tired, trouble
sleeping, increased appetite, and dizziness.
These are not all the possible side effects of VRAYLAR.
Please see the full Prescribing Information,
including Boxed Warnings, and Medication
Guide.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit
www.fda.gov/medwatch or call 1-800-FDA-1088.
If you are having difficulty paying for your medicine, AbbVie
may be able to help. Visit
AbbVie.com/myAbbVieAssist to learn more.
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines
and solutions 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, and eye care – and products and
services in our Allergan Aesthetics portfolio. For more information
about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on
LinkedIn, Facebook, Instagram, X (formerly Twitter), and
YouTube.
About Gedeon Richter
Gedeon Richter Plc. (www.gedeonrichter.com), headquartered in
Budapest/Hungary, is a major
pharmaceutical company in Central Eastern Europe, with an expanding
direct presence in Western Europe,
China, Latin America, and Australia. Having reached a market
capitalization of EUR 4.3bn
(USD 4.7bn) by the end of 2023,
Richter's consolidated sales were approximately EUR 2.1bn (USD
2.3bn) during the same year. The product portfolio of
Richter covers many important therapeutic areas, including Women's
Healthcare, Central Nervous System, and Cardiovascular areas.
Having the largest R&D unit in Central Eastern Europe,
Richter's original research activity focuses on CNS disorders. With
its widely acknowledged steroid chemistry expertise, Richter is a
significant player in the Women's Healthcare field worldwide.
Richter is also active in biosimilar product development,
manufacture and commercialization.
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 and uses
of future or conditional verbs, 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 expressed or implied 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," of
AbbVie's 2023 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, and specifically declines, to release publicly any
revisions to forward-looking statements as a result of subsequent
events or developments, except as required by law.
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SOURCE AbbVie