Janssen Products LP

PHILADELPHIA, June 17, 2024 /PRNewswire/ -- Berger Montague PC is pleased to announce that on June 13, 2024, a jury unanimously found Johnson & Johnson subsidiary Janssen Products, LP liable for illegal off-label promotion and marketing of two of its HIV/AIDS-treatment drugs, in violation of the federal False Claims Act and state False Claims Acts. The jury of eight unanimously agreed that Janssen was responsible for defrauding Medicare, Medicaid and the AIDS Drug Assistance Program. The jury found that Janssen caused 159,574 false claims for reimbursement to be submitted to the government for its drugs, Prezista and Intelence, and awarded single damages of $120,004,736 on the federal False Claims Act violations and $30,001,184 on the state False Claims Act violations. The False Claims Acts provide for mandatory trebling of damages and the imposition of civil penalties ranging from $5,500-$11,000 per false claim. Once finalized, the total judgment against Janssen will likely exceed $1 billion, after a final determination by the Court. This judgment will represent one of the largest False Claims Act jury verdicts in history. The historic jury verdict is the culmination of over a decade's long battle against the billion-dollar pharmaceutical company Janssen. In 2012, Berger Montague, on behalf of its two whistleblower-clients, Jessica Penelow and Christine Brancaccio, filed the case United States ex rel. Penelow v. Janssen Products, LP, Civil A. No. 12-07758 in the District of New Jersey. The False Claims Act allows private citizen whistleblowers (known as "Relators" under the law) to bring claims on behalf of the government when the government is defrauded. The government declined to intervene in the case. However, as is permitted under the law, Relators and their attorneys decided to litigate on their own. According to Sherrie R. Savett, Chair of the False Claims Act, Qui Tam & Whistleblower Department at Berger Montague, "We believed in our clients and their serious allegations of fraud, and we were willing to devote significant resources over the years to the litigation of this case and eventual trial, even without the direct involvement of the government. We defeated Janssen's motion to dismiss the case in 2017, defeated its motion for summary judgment in 2021, and ultimately prevailed at trial." The jury trial commenced on May 6th in the United States Court for the District of New Jersey in Trenton before the Honorable Zahid N. Quraishi. Berger Montague's Sherrie Savett, Joy Clairmont, Michael Fantini and William Ellerbe partnered with lead trial counsel Pete Marketos, Josh Russ, Andrew Wirmani, Adam Sanderson and Whitney Wendel from Reese Marketos LLP of Dallas, Texas. During trial, Relators presented substantial evidence of a nationwide scheme carried out by Janssen from 2006 through 2014 to market and promote Prezista and Intelence off-label, for uses not approved as safe and effective by the Food and Drug Administration (FDA) and for uses not medically reasonable and necessary. Relators, who worked as sales representatives at Janssen, as well as five other former Janssen employees, testified that the management of the company orchestrated the scheme to promote the drugs off-label in order to increase sales of the two drugs that had limited FDA-approved indications. Berger Montague partner, Joy Clairmont, commented, "It has been a long and difficult process for our courageous whistleblower clients, and we are thrilled to finally see their claims against Janssen vindicated at trial." If you are a whistleblower seeking representation concerning a potential qui tam / whistleblower / False Claims Act case, please contact Berger Montague. About Berger Montague Berger Montague is a national law firm focusing on complex civil litigation in federal and state courts throughout the United States. For over half a century, Berger Montague has played lead roles in consequential, precedent-setting cases and has recovered over $60 billion for its clients and the classes they have represented. Berger Montague is headquartered in Philadelphia and has offices in Chicago, Minneapolis, San Diego, San Francisco, Toronto, Wilmington, Del., and Washington, D.C. Contact: Sherrie R. Savett, 267-979-8995, [email protected] . SOURCE Berger Montague

The fixed-dose combination of PREZCOBIX/REZOLSTA is a collaborative effort between Janssen R&D Ireland and Gilead. Credit: Dmytro Zinkevych/ Shutterstock. Johnson & Johnson (J&J) has filed a supplemental new drug application (sNDA) with the US Food and Drug Administration (FDA) seeking expanded approval for the use of its HIV-1 therapy, PREZCOBIX  (darunavir/cobicistat), in children aged six years and above. Recommended Buyer's Guides Buyer's Guide Leading Guide to Compliance Software for the Pharmaceutical Industry Buyer's Guide Top Guide for Drug Delivery Systems Approval is being sought for PREZCOBIX use in paediatric patients weighing a minimum of 25kg. In Europe, the company has submitted applications to the European Medicines Agency for the paediatric use of the medication, marketed as REZOLSTA. Approval of the applications would enable PREZCOBIX/REZOLSTA to be administered to both adults and paediatric patients from the age of six years. A new paediatric formulation has been developed, featuring a lower dose tablet (darunavir 675mg/cobicistat 150mg) making it easier for children to swallow. See Also: The tiny pills that may send shockwaves across immunology Roche’s PI3K inhibitor secures breakthrough status in breast cancer The applications are supported by data from a clinical study, sponsored by Janssen Research & Development (R&D), which indicated that the new combination tablet is bioequivalent to the individual doses of darunavir and cobicistat. A Phase II/III clinical trial by Gilead Sciences has established the efficacy, safety and tolerability of cobicistat-boosted darunavir in treating younger children with HIV-1. PREZCOBIX/REZOLSTA combines darunavir, an HIV-1 protease inhibitor, with cobicistat, a CYP3A inhibitor that enhances the pharmacokinetics of the therapy, allowing for once-a-day dosing. The therapy is currently approved for use in adults and adolescents weighing a minimum of 40kg without resistance mutations to darunavir. Darunavir is marketed by Janssen Products as PREZISTA in the US, and cobicistat, developed by Gilead Sciences, is sold as TYBOST. The fixed-dose combination of PREZCOBIX/REZOLSTA is a collaborative effort between Janssen R&D Ireland and Gilead. Johnson & Johnson infectious diseases and vaccines and global public health R&D global therapeutic area head Penny Heaton stated: “We are proud of this latest step in our years of work to ensure that some of the youngest people living with HIV have access to different treatment regimens that can work for them. “If approved, this medicine could offer healthcare providers a new treatment option that ensures weight-appropriate dosing to better meet the needs of young people living with HIV.” The latest development comes after Johnson & Johnson gained the global rights to Numab Therapeutics’ investigational first-in-class antibody, NM26 for atopic dermatitis.

TITUSVILLE, N.J., July 28, 2023 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking to expand the indication of EDURANT® (rilpivirine) to include the treatment of HIV-1 infection in children weighing 10 kg or more. A parallel Marketing Authorization application has also been submitted to the European Medicines Agency (EMA) in support of a type II variation and line extension for expanded pediatric use in Europe. These applications reflect Janssen’s longstanding commitment to address the needs of adults, adolescents and children affected by the global HIV epidemic.If the new applications are approved, EDURANT®, a product of Janssen Sciences Ireland Unlimited Company, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, could be administered to younger pediatric patients via standard 25 mg tablets or new 2.5 mg tablets for oral dispersion that were developed to aid administration and weight-adjusted dosing for children. “We’ve been working to fight HIV for decades and are proud to have helped bring forward nine medicines for people living with HIV,” said Penny Heaton, M.D., Global Therapeutic Area Head, Infectious Diseases and Vaccines, Janssen Research & Development, LLC. “These filings are the latest example of our longstanding work to make different treatment options available to meet the diverse needs of people living with HIV.”The expanded pediatric applications are supported by data from the Phase 2 PAINT (NCT00799864) and PICTURE (NCT04012931) studies, which showed that EDURANT®, in combination with other antiretroviral therapies, effectively maintains or suppresses the virus in treatment-experienced and treatment-naive pediatric patients, respectively. Given these data, Janssen is seeking an expanded indication to allow use in treatment-naïve children (with HIV-1 RNA <100,000 copies/mL) and treatment-experienced virologically suppressed children (with HIV-1 RNA <50 copies/mL) weighing 10 kg or more.The expansion of the EDURANT® indication would mark the latest step forward in Janssen’s efforts to make its HIV medicines available to young people living with HIV. In 2022, the FDA approved the world’s first long-acting injectable HIV-1 treatment option for adolescents 12 years of age and older. This regimen consists of Janssen’s long-acting rilpivirine and ViiV Healthcare’s long-acting cabotegravir and requires as few as six treatments per year.Johnson & Johnson’s Commitment to HIVIn addition to driving innovation in HIV care, Johnson & Johnson also works with vulnerable communities on the global frontlines of the HIV epidemic, and has supported collaborative initiatives like Positively Fearless, the DREAMS Partnership and the MenStar Coalition. We also support the New Horizons Collaborative, which is working to address the unmet needs of HIV treatment-experienced children, adolescents and young adults in sub-Saharan Africa.To learn more about Johnson & Johnson’s commitment to combating HIV, please visit jnj.com/HIV.About EDURANT®EDURANT is a human immunodeficiency virus type 1 (HIV-1) specific, nonnucleoside reverse transcriptase inhibitor (NNRTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-naïve patients 12 years of age and older and weighing at least 35 kg with HIV-1 RNA less than or equal to 100,000 copies/mL. Limitations of Use:EDURANT is indicated in combination with VOCABRIA (cabotegravir), for short-term treatment of HIV-1 infection in adults and adolescents 12 years and older and weighing at least 35 kg who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.Please see full Prescribing Information for important safety information.Important Safety InformationWho should not take EDURANT®?Do not take EDURANT® if you also take:What should I tell my healthcare provider before taking EDURANT®?Before taking EDURANT®, tell your healthcare provider about all your medical conditions, including if you:Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.Some medicines interact with EDURANT®. Keep a list of your medicines to show your healthcare provider and pharmacist when you get a new medicine. You can ask your healthcare provider or pharmacist for a list of medicines that interact with EDURANT®.Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take EDURANT® with other medicines.How should I take EDURANT®?What are the possible side effects of EDURANT®?EDURANT® can cause serious side effects including:Stop taking EDURANT® and get medical help right away if you develop a rash with any of the following signs or symptoms:Liver problems. People with a history of hepatitis B or C virus infection or who have certain liver function test changes may have an increased risk of developing new or worsening liver problems during treatment with EDURANT®. Liver problems have also happened during treatment with EDURANT® in people without a history of liver disease. Your healthcare provider may need to do tests to check your liver enzymes before and during treatment with EDURANT®. Call your healthcare provider right away if you develop any of the following signs or symptoms of liver problems:Depression or mood changes. Tell your healthcare provider right away if you have any of the following symptoms:Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider right away if you start having any new symptoms after starting your HIV-1 medicine.The most common side effects of EDURANT® include depression, headache, trouble sleeping (insomnia), and rash.This is not a complete list of all side effects. If you experience these or other symptoms, contact your healthcare provider right away.You are encouraged to report side effects of prescription drugs to the FDA. www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Janssen Products, LP, at 1-800-JANSSEN (1-800-526-7736).Please read the full Product Information for EDURANT® and discuss any questions you have with your healthcare provider.About the Janssen Pharmaceutical Companies of Johnson & JohnsonAt Janssen, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular, Metabolism & Retina; Immunology; Infectious Diseases & Vaccines; Neuroscience; Oncology; and Pulmonary Hypertension.Learn more at http://www.janssen.com and follow us at http://www.twitter.com/JanssenGlobal and www.twitter.com/JanssenUS. Janssen Sciences Ireland Unlimited Company and Janssen Research & Development, LLC are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.Cautions Concerning Forward-Looking StatementsThis press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding rilpivirine and other treatments for HIV. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Sciences Ireland Unlimited Company, Janssen Research & Development, LLC, the Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 1, 2023, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.###© Janssen Therapeutics, Division of Janssen Products, LP