Generalized anxiety disorder

The agreement focuses on the discovery, co-development and licensing of new targets that could address neuropsychiatric conditions. Credit: wavebreakmedia/Shutterstock. AbbVie has entered a collaboration with Hungary-based pharmaceutical company Gedeon Richter to develop new treatments for neuropsychiatric conditions. The agreement focuses on discovering, co-developing and licensing new targets to address these conditions. The partnership leverages almost two decades of successful collaboration on central nervous system projects. It has already led to the delivery of products such as cariprazine (VRAYLAR/REAGILA) and the development of the investigational drug candidate ABBV-932, aimed at treating bipolar depression and generalised anxiety disorder. VRAYLAR is a prescription therapy designed to work alongside antidepressants in adults, treating major depressive disorder, manic or mixed episodes associated with bipolar I disorder, and schizophrenia. The new agreement’s terms include preclinical and clinical research and development activities, with costs shared by both parties. Richter will receive a $25m upfront cash payment, with potential additional future payments tied to development, regulatory and commercial milestones. The company is eligible to receive royalties based on sales. AbbVie discovery research senior vice-president and global head Jonathon Sedgwick stated: “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. “We are excited to expand our longstanding and successful partnership with Richter to help address the complex needs of these patients.” While AbbVie will hold commercialisation rights worldwide, Richter retains rights within its traditional markets, including geographic Europe, Russia, other Commonwealth of Independent States (CIS) countries and Vietnam. Gedeon Richter CEO Gábor Orbán said: “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.” The US Food and Drug Administration (FDA) recently approved AbbVie‘s VYALEV (foscarbidopa and foslevodopa) to treat motor fluctuations in adults with advanced Parkinson’s disease.

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 . • 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 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 . Follow @abbvie on LinkedIn, Facebook, Instagram, X (formerly Twitter), and YouTube. About Gedeon Richter Gedeon Richter Plc. (), 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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Seaport has developed a platform called Glyph designed to enhance efficacy and reduce the side effects of potential drug candidates. The original research behind the platform came from Monash University in Australia. Potential medications developed using Glyph are absorbed like fats in the diet through the lymphatic system. The Series B adds to Seaport’s $100 million Series A round that was announced ​ in April, alongside the launch of the company, meaning they now have $325 million in total funding. The round was led by General Atlantic and had several new investors including T. Rowe Price Associates, Inc., Foresite Capital, Invus, Goldman Sachs Alternatives, and CPP Investments. The original investors in Seaport also contributed to the Series B including ARCH Venture Partners, Sofinnova Investments, Third Rock Ventures, and co-founder PureTech Health. American entrepreneur Daphne Zohar is both a co-founder and CEO of Seaport. Zohar was previously co-founder and CEO of PureTech Health, which was launched almost 20 years ago. Since then, PureTech has developed 29 therapeutic candidates across a range of different indications, three of which have FDA approval. PureTech has also launched several successful spin-out companies including Karuna Therapeutics, which was acquired ​ by BMS earlier this year and was behind the successful development and recent approval ​ of the schizophrenia drug Cobenfy (KarXT). Zohar was also a co-founder of Karuna. “Seaport is advancing novel therapeutics that have proven clinical efficacy but had previously been held back by an issue we can now address with our Glyph platform,” said Zohar in a press statement. googletag.cmd.push(function () { googletag.display('text-ad1'); }); “This financing enables the important clinical work that brings us another step closer to delivering new medicines to make a difference in the lives of patients and their families.” The quest for better psychiatry medicines ​ Seaport is hoping to use its oversubscribed fundraising rounds to create better psychiatric drugs that are more effective, last longer and have fewer side effects than those currently on the market. The Glyph platform allows previously discovered potential neuropsychiatric therapies, that may have been abandoned due to adverse events, or poor absorption, or similar, to have a new lease of life, as well as new potential drug candidates. “The development of important new neuropsychiatric medicines is often halted due to poor drug-like properties or unacceptable tolerability, challenges that our Glyph platform can now uniquely address,” said Steve Paul, co-founder and Board Chair at Seaport. “For instance, xanomeline was an effective drug that faced tolerability challenges, but once resolved, led to the FDA approval of Cobenfy for schizophrenia. With Glyph, we believe each of Seaport’s programs could create similar life-changing value for patients.” Seaport currently has three candidate medicines in its pipeline. The most advanced, SPT-300 is a prodrug of allopregnanolone being developed to treat major depressive disorder with or without anxious distress. Allopregnanolone has been shown to quickly reverse the symptoms of depression and anxiety, but previously was only effective in an intravenous format. Seaport has developed an oral version of this candidate, which is now at phase 2b. The other two candidates are at an earlier stage and include SPT-320, a novel prodrug of agomelatine soon to enter phase 1 studies for the treatment of generalized anxiety disorder and SPT-348, a prodrug of a non-hallucinogenic neuroplastogen in development for the treatment of mood and other neuropsychiatric disorders.