NORTH CHICAGO, Ill. and
BUDAPEST, Hungary, March 11, 2022 /PRNewswire/ -- AbbVie (NYSE:
ABBV) and Gedeon Richter Plc. ('Richter') today announced a new
co-development and license agreement to research, develop and
commercialize novel dopamine receptor modulators for the potential
treatment of neuropsychiatric diseases. The collaboration is based
on the results of preclinical research carried out by Richter and
includes several new chemical entities selected for development.
AbbVie and Richter have collaborated for 15 years on Central
Nervous System (CNS) projects, including globally launched products
such as cariprazine (VRAYLAR® /
REAGILA®).
"In collaboration with Richter, we will continue to build on our
research that seeks to provide additional insights into our
understanding of cariprazine's clinical pharmacology and explore
novel chemistry to identify new dopamine receptor modulators," said
Tom Hudson, MD, senior vice
president, R&D, chief scientific officer, AbbVie. "AbbVie
is committed to driving progress and finding solutions for patients
living with complex neuropsychiatric conditions."
"I am very pleased to extend our existing co-operation under
this new collaboration with AbbVie as it opens the way towards new
products that could help alleviate the debilitating psychiatric and
cognitive symptoms of many neuropsychiatric conditions, leading to
an improved quality of life for patients suffering from these
conditions around the world," said Gábor Orbán, CEO of Richter. "I
greatly value AbbVie's capabilities in the field of development and
commercialization of drugs acting on the Central Nervous System and
we are looking forward to entering this collaboration on new
therapeutic options for patients and doctors."
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, 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.
The transaction is expected to close in the second quarter of
2022, subject to the satisfaction of customary closing conditions,
including applicable regulatory approvals.
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.
About 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, in
China and in Latin America. Having reached a market
capitalization of EUR 4.4 billion
(USD 5.0 billion) by the end of 2021,
Richter's consolidated sales were approximately EUR 1.8 billion (USD 2.1
billion) 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.
VRAYLAR (cariprazine) U.S. Uses and Important Safety
Information1
INDICATIONS AND USAGE
VRAYLAR is a prescription medicine used in adults:
- to treat schizophrenia
- 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
disorder (bipolar depression)
It is not known if VRAYLAR is safe and effective in
children.
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.
Antidepressants may increase suicidal thoughts or actions in
some children and young adults within the first few months of
treatment and when the dose is changed. Depression and other
serious 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 an 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)
-
Impaired judgment, thinking, and motor skills: 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
HDL-cholesterol
- 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. 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/clinical-and-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
were difficulty moving or slow movements, tremors,
uncontrolled body movements, restlessness and feeling like you need
to move around, sleepiness, nausea, vomiting, and indigestion.
These are not all
possible side effects of VRAYLAR.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit http://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.
Please click here for Full Prescribing
Information and Medication Guide for
VRAYLAR.
Globally, prescribing information varies; refer to the
individual country product label for complete information.
References:
- VRAYLAR (cariprazine) [package insert]. Madison, NJ: Allergan USA, Inc.
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.
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SOURCE AbbVie