Janssen R&D Ireland Share Participation Scheme

SAN FRANCISCO, Dec. 28, 2022 /PRNewswire/ -- If you purchased Atripla®, Biktarvy®, Complera®, Descovy®, Evotaz®, Genvoya®, Odefsey®, Prezcobix®, Stribild®, Symtuza®, Truvada®, or Viread®, a class action lawsuit may affect your rights. If you are a member of one or both classes, your legal rights will be affected whether you act or don't act, so please read this notice carefully. You must decide whether to remain a member of the class(es) or to exclude yourself from the class(es). A class action lawsuit is pending in the United States District Court for the Northern District of California (the "Court") involving the antiretroviral products Atripla, Biktarvy, Complera, Descovy, Evotaz, Genvoya, Odefsey, Prezcobix, Stribild, Symtuza, Truvada, and Viread ("Products"). The lawsuit claims that Gilead Sciences, Inc., Gilead Holdings, LLC, Gilead Sciences, LLC, and Gilead Sciences Ireland UC ("Gilead"), and Johnson & Johnson, Janssen Products LP, and Janssen R&D Ireland ("Janssen") (collectively, "Defendants") engaged in allegedly anticompetitive conduct that caused certain consumers and third-party payors to pay too much for certain of the Products . Defendants deny any wrongdoing. PLEASE NOTE: No one is claiming that any of these products is unsafe or ineffective. WHO IS INCLUDED IN THE CLASSES? The Court has certified three Damages Classes and three Injunctive Classes in this lawsuit (the "Classes"). The Damages Classes are made up of third-party payors ("TPPs") only (i.e., not individual consumers); the Injunctive Classes are made up of both TPPs and consumers. Damages Classes : The Truvada Class: All entities in the United States that indirectly purchased, paid, and/or provided reimbursement for some or all of the purchase price of Truvada, and/or its AB-rated generic equivalent sold by Teva Pharmaceutical Industries Ltd. or its affiliates, in the Specified States1 for consumption by their members, employees, insureds, participants, or beneficiaries, other than for resale, during the period February 1, 2018 through May 31, 2021; The Atripla Class: All entities in the United States that indirectly purchased, paid, and/or provided reimbursement for some or all of the purchase price of Atripla, and/or its AB-rated generic equivalent sold by Teva Pharmaceutical Industries Ltd. or its affiliates, in the Specified States for consumption by their members, employees, insureds, participants, or beneficiaries, other than for resale, during the period February 1, 2018 through July 31, 2021; and The Complera Class: All entities in the United States that indirectly purchased, paid, and/or provided reimbursement for some or all of the purchase price of Complera in the Specified States for consumption by their members, employees, insureds, participants, or beneficiaries, other than for resale, during the period February 1, 2018 through September 27, 2022. Excluded from the Truvada, Atripla, and Complera Classes are: (a) Defendants and their officers, directors, management, employees, subsidiaries, or affiliates; (b) All federal and state government entities, except for cities, towns, municipalities, or counties with self-funded prescription drug plans; (c) Fully insured health plans, i.e., plans for which the insurer bears 100% of the risk for the reimbursement obligations to members; and (d) Pharmacy Benefit Managers. Injunctive Classes : The Evotaz Injunctive Class: All persons or entities in the United States who indirectly purchased, paid, and/or provided reimbursement for some or all of the purchase price of Evotaz for consumption by themselves, their families, or their members, employees, insureds, participants, or beneficiaries, other than for resale, during the period May 14, 2015 through September 27, 2022; The Prezcobix Injunctive Class: All persons or entities in the United States who indirectly purchased, paid, and/or provided reimbursement for some or all of the purchase price of Prezcobix for consumption by themselves, their families, or their members, employees, insureds, participants, or beneficiaries, other than for resale, during the period May 14, 2015 through September 27, 2022; and The cART Foundation Drug Injunctive Class: All persons or entities in the United States who indirectly purchased, paid, and/or provided reimbursement for some or all of the purchase price of a cART Foundation Drug2 for consumption by themselves, their families, or their members, employees, insureds, participants, or beneficiaries, other than for resale, during the period May 14, 2015 through September 27, 2022. Excluded from each of the Injunctive Classes are: (a) Defendants and their officers, directors, management, employees, subsidiaries, or affiliates; (b) All federal and state government entities, except for cities, towns, municipalities, or counties with self-funded prescription drug plans; (c) Fully insured health plans, i.e., plans for which the insurer bears 100% of the risk for the reimbursement obligations to members; (d) Pharmacy Benefit Managers; and (e) The Judges in this case and any members of their immediate families. Additionally, excluded from the cART Foundation Drug Injunctive Class are natural persons who have filed a claim for personal injury against any of the Defendants or Bristol-Myers Squibb Company or E. R. Squibb & Sons, L.L.C., alleged to be caused by the consumption of a tenofovir-containing product. YOUR RIGHTS AND OPTIONS Your options depend on whether you are a member of one of the Damages Classes or a member of one of the Injunctive Classes. If you are a member of one of the Damages Classes, you have the right to exclude yourself from (to opt out of) the Damages Classes no later than March 15, 2023. Details on how to request exclusion can be found at . If you do nothing, you will remain a member of the class(es) and be bound by the outcome of this lawsuit, whether by a settlement or by a judgment rendered for or against the Defendants. If you are a member of one of the Injunctive Classes, you cannot exclude yourself from the Class. The deadlines contained in this notice may be amended by Court Order, so check the website for any updates. A trial is scheduled for March 27, 2023 and any updates will be provided on the website. FOR MORE INFORMATION AND A CLAIM FORM Visit Call 1-877-388-1751 Source: Hagens Berman Sobol Shapiro LLP, Hilliard & Shadowen LLP, and Durie Tangri LLP 1 The "Specified States" for each of the Damages Classes are: Alabama, Arizona, California, Connecticut, Florida, Hawaii, Iowa, Kansas, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Hampshire, New Mexico, New York, North Carolina, North Dakota, Oregon, Rhode Island, South Dakota, Tennessee, Utah, Vermont, West Virginia, Wisconsin, and the District of Columbia. 2 For the purposes of this class definition a cART Foundation Drug is any of one or more of: Atripla, Biktarvy, Complera, Descovy, Genvoya, Odefsey, Stribild, Symtuza, Truvada, and Viread. SOURCE Hagens Berman Sobol Shapiro LLP, Hilliard & Shadowen LLP, and Durie Tangri LLP

The EMA is handing out a new recommendation surrounding J&J and AbbVie’s cancer drug Imbruvica and some medicines containing terlipressin. On Friday, the EMA’s safety committee (PRAC) stated that it has taken new measures to reduce the risk of respiratory failure and sepsis when medicines containing terlipressin that are used to treat people with hepatorenal syndrome (HRS-1), particularly for patients with advanced acute-on-chronic liver disease or advanced kidney failure. Healthcare officials should consider giving medicines containing terlipressin on a drip as it may reduce any side effects as well as monitoring any patients for signs of reparatory failure, according to the committee. This move stems from the safety committees’ review of a clinical trial involving patients with HRS-1 which showed that those treated with these medicines were more likely to experience and possibly die from reparatory disorders within 90 days than those with a placebo. However, limitations were noted in the data including differences in how terlipressin was used in the trials compared to the actual clinical space. But combining this with data on hand convinced the PRAC to take new measures. The medicines are available in most EU member states under several names including glypressin, terlipressin acetate and variquel. However, that is not the only medicine that the EMA is raising concerns about. It is also letting healthcare providers know of an increased risk of serious and deadly cardiac arrhythmias and cardiac failure with the use of Imbruvica. While the drug from J&J and AbbVie is meant to treat people with blood cancers, the EMA said that patients with “advanced age” may be at a greater risk of cardiac events that may be fatal. The PRAC is advising that an evaluation of cardiac history should be conducted before starting treatment. Patients that are at risk should be assessed before treatment starts and possible alternatives may be considered and should not be given to anyone with onset or worsening of grade two cardiac failure or grade three cardiac arrhythmias. Brian Kenney, the global therapeutic area and cross-sector oncology communication leader at Janssen R&D, said in an email to Endpoints News the company had recently updated the Imbruvica SmPC to provide further information for healthcare professionals about monitoring and managing patients with cardiac risks along with specific guidance related to dose modifications for patients. “We continually monitor patient safety and, working closely with the EMA, update our label guidance accordingly as additional clinical trial data and real-world experience is accumulated. We are confident in the benefit/risk profile of Imbruvica, which has been used to treat more than 250,000 patients worldwide with complex B-cell blood cancers,” Kenney said in the email. Imbruvica is a major drug for J&J and AbbVie, when data on the BTK inhibitor was revealed at ASCO in June, it kept a rare and aggressive form of cancer back, in combination with two other drugs, for more than six years, however, investigators did not see a significant difference in overall survival. Last month , it also won approval in a pediatric population as it netted approval as a second-line treatment for chronic graft versus host disease (cGVHD) in children one year and older.

Johnson & Johnson on Tuesday unveiled a new research and development facility in San Francisco, aiming to grow its presence in one of the top biotechnology hubs in the U.S.J&J has had a presence in the city for years. In 2013, the pharmaceutical company opened up the California Innovation Center, hoping to build ties with scientists and entrepreneurs. Two years later, it broadened another startup-focused initiative, expanding its JLABS program to South San Francisco.The new facility, a 200,000-square-foot campus located in Brisbane, Calif., has a broader scope. It is meant to be the main site for J&Js R&D in the San Francisco Bay Area, said James Merson, the site head of the campus and leader of infectious disease work at its Janssen subsidiary.According to Merson, the campus will bring three major J&J units and their existing employees under one roof: Janssen R&D, J&J Technology and J&J Innovation. The site can hold up to 400 workers, and people began relocating from their previous work sites in San Francisco last month, he said. The campus will work on gene and RNA therapies as well as experimental treatments for infectious and retinal diseases. Itll also focus on digital health and data science, the company said in a statement.Having all of the groups in one facility will help the companys divisions collaborate and develop innovative medicines faster and more efficiently, Merson said.The new campus is also meant to expand J&Js contact with academic institutions and entrepreneurs, serving as an additional arm to invest in new research and partner with emerging companies.Merson wouldnt specify how much money J&J put into the facility. '