Wednesday, June 26, 2024

Teva Settles Tax Dispute in Israel with $750 Mln Payment

(6/25, Christy Santhosh, Reuters) ...Teva Pharmaceutical Industries has entered into a deal with the Israel Tax Authority to resolve all pending litigation related to taxes payable for the years from 2008 to 2020, the drugmaker said on Tuesday... Full

Teva Pharmaceuticals to Pay $750 Million to Resolve Israeli Tax Litigation

(6/25, Dean Seal, Dow Jones) ...Teva has also agreed to pay an additional 5% to 7% in corporate taxes if it pays dividends on or repurchases its equity interests, up to a maximum of about $500 million. The company doesn't expect the settlement to impact its full-year financial guidance... Sub. Req'd

Teva Agrees $750M Israel Tax Authority Settlement

(6/25, Ela Levi-Weinrib, Globes) ...Teva reported that the amount includes $500 million in corporation tax on historical profits, which the company saw as exempt as part of the Law for the Encouragement of Capital Investment. The company will pay an additional $250 million in corporation tax that was disputed...Teva said, "This allows Teva to end this historical income tax issue, and to continue to focus on its commitment to the health of patients and on the continued implementation of its "Pivot to Growth" strategy."... Full

Teva to Pay $750M to Clean Slate with Israeli Tax Authorities

(6/25, Anna Bratulic, FirstWorld Pharma) ...Teva on Tuesday announced an agreement with the Israel Tax Authority, resolving all pending litigation tied to a long-standing tax dispute that spans over a decade. The settlement, which covers the company's taxable years from 2008 to 2020, will see Teva pay out a total of $750 million in installments over the next five years... Full

Teva Settles $750 Million Tax Dispute with Israeli Authorities

(6/25, Sophie Shulman, CTech) ...Teva CEO Richard Francis continues to address the issues he inherited from his predecessors, and this time it is also aligned with the needs of the Israeli Ministry of Finance. The pharmaceutical giant announced a settlement with the Tax Authority, agreeing to pay $750 million, or about NIS 3 billion, for tax assessments covering the period from 2008 to 2020. Although this seems like a significant amount, it is only a third of the state's original demand from the company... Full

Teva to Pay $750M to Resolve Israel Tax Disputes

(6/25, Nicole DeFeudis, Endpoints News) ...The recent settlement "allows Teva to end this historical income tax issue," the company said in a news release, while bringing attention back to its "pivot to growth" strategy. That strategy has involved manufacturing site closures, a shift away from lower-margin generics, and focusing more attention on its innovative portfolio... Full

Teva Agrees to Fork Over $750M to Close the Book On Years of Tax Litigation in Israel

(6/25, Zoey Becker, Fierce Pharma) ...CEO Richard Francis' "Pivot to Growth" strategy involves leaning on innovative medicines while expanding Teva's pipeline and sustaining its generics business with "high-value opportunities." The plan appears to be coming along, as Teva enjoyed a 6% sales increase in 2023 to $15.8 billion. This year, Teva expects its annual revenues to come in between $15.7 and $16.3 billion... Full

‘Skinny Jabs': Weight-Loss Drugs Set for New Boom As Generic Versions Emerge

(6/25, Nicola Davis and Julia Kollewe, The Guardian) ...Medicines that enable dramatic weight loss are likely to experience a new boom in uptake, experts have said, as the first generic versions hit the market this week at a lower cost than the original drugs...While such treatments are available to some patients on the NHS, private access is expensive, and recent shortages have made them hard to get hold of. But change is afoot. Patents for Victoza and Saxenda have expired, according to Novo Nordisk. As a result, other drugmakers are working on generic versions. Israel's Teva Pharmaceutical Industries the world's largest generic drugmaker, launched a generic version of Victoza in the US on Monday... Full

Teva Readies First Generic Version of GLP-1 Drug Victoza in U.S.

(6/25, Brian Buntz, Drug Discovery & Development) ...In terms of pricing, Teva plans on charging $469.60 for the two pack and $704.40 for the three pack versions of the drug. "Teva looks forward to bringing our first to file Gx Saxenda to the market at the appropriate time, and will continue to evaluate future opportunities in this space," a spokesperson said... Full

'The Era of the GLP': Obesity Drugs' Next Play

(6/25, Erica Carbajal, Becker's Hospital Review) ...Following Novo Nordisk's blockbuster success with Ozempic and Wegovy, many drugmakers are focused on developing new iterations of weight loss drugs that could come with fewer side effects and drive down costs...Increasing competition in the weight loss drug arena could lead to more affordable medications and wider access, experts say. On June 24, Teva Pharmaceuticals launched the first authorized generic of Victoza, making it the first generic GLP-1 product available in the U.S... Full

11 Updates On GLP-1s

(6/25, Paige Twenter, Becker's Hospital Review) ...On June 24, Teva Pharmaceuticals began selling the country's first GLP-1 generic. The product, liraglutide, is a generic for Novo Nordisk's Type 2 diabetes therapy Victoza. Teva did not immediately answer Becker's questions about the generic's list price... Full

Celltrion Scores Domestic Nod for Xolair Biosimilar

(6/25, Kim Chan-hyuk, Korea Biomedical Review) ...Celltrion said Monday that it won the nod from the Ministry of Food and Drug Safety for Omlyclo Prefilled Syringe Injection. The approval comes one year after the company applied for it in June 2023. Omlyclo is an antibody biopharmaceutical with the same composition as the original drug, Xolair of Novartis, and its domestic indications are allergic asthma and chronic idiopathic urticaria. Xolair is a blockbuster product with global sales of about 5 trillion won ($3.6 billion) in 2023, and was recently approved in the U.S. for an additional food allergy indication... Full

Takeda To Keep Pushing for China Biotech Partnerships, CEO Says

(6/25, Akemi Terukina and Natsuko Katsuki, Bloomberg) ...Takeda Pharmaceutical Co. will keep up efforts to forge partnerships with Chinese biotech companies, as the drugmaker scouts for promising drug candidates to bolster its pipeline, Chief Executive Officer Christophe Weber said..."China is becoming a source, a country where there is innovation," Weber said, adding that it's Takeda's fastest-growing business. "That was not the case 10 years ago. We are seeing more attractive innovation and research in China, and that's why we identify this potential partnering."... Sub. Req'd

Kidswell And Chiome Team Up On Biosimilar Development

(6/25, Adam Zamecnik, Generics Bulletin) ...The Japanese companies Kidswell Bio Corporation and Chiome Bioscience have announced a business alliance agreement aimed at the co-development of new biosimilars, in an effort to stand out in a domestic market focused on small-molecule drugs. According to the two businesses, many Japanese pharmaceutical companies have focused their resources on R&D in small-molecule drugs instead of biopharmaceuticals, which led to delays in the local development... Global Sub. Full

FDA Again Rejects AbbVie's Continuous Infusion Therapy for Parkinson's

(6/25, Max Gelman, Endpoints News) ...Regulators turned away ABBV-951, a 24-hour infusion therapy to treat advanced Parkinson's disease, AbbVie said Tuesday morning. Back in March 2023, the FDA issued a CRL, requesting more information about the product's infusion pump device...The drug was conceived as another option for Parkinson's patients before potentially facing deep brain stimulation surgery, trial investigator Robert Hauser told Endpoints News. Individuals with advanced disease sometimes undergo such surgery because the effectiveness of levodopa and carbidopa wanes over time... Full

Biogen's RoActemra Biosimilar Tofidence Approved by EC to Treat Arthritis and COVID-19

(6/25, Emily Kimber, PMLive) ...Biogen's Tofidence (tocilizumab), a biosimilar referencing Roche's RoActemra, has been approved by the European Commission to treat certain forms of arthritis and COVID-19. The intravenously administered monoclonal antibody, developed by Bio-Thera, has been approved to treat moderate-to-severe active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis... Full

US Advisers to Consider RSV Shots as GSK Looks to Keep Market Lead

(6/26, Michael Erman, Reuters) ...A committee of outside experts to the U.S. CDC are set to vote on whether to expand the age group of adults who should receive respiratory syncytial virus (RSV) vaccines this year, as GSK battles rival Pfizer and new entrant Moderna to keep its top position in the market... Full

Lilly Partners with OpenAI to Develop Medicines for Drug-Resistant Bacteria

(6/25, Christy Santhosh, Reuters) ...Eli Lilly said on Tuesday it will collaborate with OpenAI to leverage its generative AI to develop antimicrobials that can be used to treat drug-resistant bacteria...The partnership supports Lilly's earlier commitment, which started in 2020 when it pledged $100 million to the AMR Action Fund. The fund was launched to help struggling antibiotic makers tackle the threat of antibiotic-resistant bacteria... Full

Samsung Bioepis Releases 2024 Sustainability Report, Highlighting Progress in Accessibility and R&D Innovation

(6/25, Samsung Bioepis) ...Report highlights key progress and achievements across three pillars: access to medicines, R&D innovation, and product quality and patient safety. 430,000 patients have been treated with Samsung Bioepis' biosimilars across 40 countries in 2023. In 10 countries, our biosimilars have created social impact worth approximately 2.5 trillion KRW (1.9 billion USD) in 2023. The company reaffirms its commitment to achieving Net Zero by 2050 as part of the global effort to tackle climate change; company's first report on Task Force on Climate-Related Financial Disclosures to be released in second half of 2024... Full

Glenmark Recalls 114 Batches of Low Potassium Drug in the US Over Potentially Deadly Hyperkalemia Risk

(6/25, Fraiser Kansteiner, Fierce Pharma) ...Glenmark Pharmaceuticals on Tuesday said it's recalling 114 batches of 750mg potassium chloride extended-release capsules thanks to failed dissolution of the product. Failed dissolution of the capsules could cause patients to develop heightened potassium levels, also known as hyperkalemia, which can result in irregular heartbeat. That side effect can potentially in turn lead to cardiac arrest... Full

US Appeals Court Revives Amarin Heart-Drug Patent Lawsuit Over Hikma Generic

(6/25, Blake Brittain, Reuters) ...Amarin Pharma convinced a U.S. appeals court on Tuesday to resurrect a patent infringement lawsuit over Hikma Pharmaceuticals' generic version of Amarin's cardiovascular drug Vascepa...The decision is the Federal Circuit's latest to grapple with "skinny labels," which allow generic drugmakers to avoid patent lawsuits if their drug's label omits infringing uses of the brand-name drug it replicates. An Amarin spokesperson declined to comment on the decision. Hikma's attorney and spokespeople did not immediately respond to requests for comment... Full

How Pfizer, Bristol Myers Squibb and Johnson & Johnson Are Confronting Patent Cliffs

(6/26, Ben Hargreaves, BioSpace) ...The pharmaceutical industry is facing a sizable patent cliff, with hundreds of billions in sales at risk as more than 190 products lose exclusivity between 2022 and 2030. The industry has faced large-scale patent cliffs before, including in 2016, when many major sellers, such as Crestor (rosuvastatin) and Glivec (imatinib), went off-patent. However, while the 2016 patent cliff was projected to erode $100 billion in brand-name sales, the current expirations will put over $300 billion sales at risk between 2023 and 2028, Eduardo Schur, EY US health sciences & wellness commercial strategy and R&D lead, told BioSpace... Full

Authors Spotlight Long-Term Solutions to Ensure Biosimilar Market Sustainability

(6/25, Skylar Jeremias, The Center For Biosimilars) ...The development and marketing costs for biosimilars are significantly influenced by pricing and procurement practices that cause rapid price erosions. An IQVIA report highlighted that nearly one-third of high-sales biologics losing exclusivity in the next decade lack biosimilar candidates. Additionally, the same report found that the European Union could miss out on a minimum of €15 billion in cost savings from a lack of biosimilars for biologics about to lose exclusivity, which could have implications for overall treatment cost efficiency gains and medication availability... Full

Drugmakers Dig in Their Heels Amid FTC's Latest Patent Crackdown. What Happens Next?

(6/25, Angus Liu, Fierce Pharma) ...The eight pharma companies that face FTC's challenges against patents in the FDA's Orange Book have opted not to remove any of them, according to a Fierce Pharma review of an FDA document. These include all 17 patents for Novo Nordisk's popular GLP-1 diabetes med Ozempic that have landed in the antitrust authority's crosshairs...Diabetes injectable drugs and inhalers for asthma and chronic obstructive pulmonary disease from AstraZeneca, Boehringer Ingelheim, Novartis, Teva, Covis Pharma and Amphastar Pharmaceuticals are also involved in the FTC's latest campaign. Altogether, the agency is contesting more than 300 so-called "junk" listings at the FDA... Full

PhRMA-Backed Report Finds IRA Will Lead To 12% Cost Increase For Part D Enrollees

(6/25, Gabrielle Wanneh, InsideHealthPolicy) ...A new analysis commissioned by the Pharmaceutical Research and Manufacturers of America found the new Medicare Part D drug price negotiation program could raise out-of-pocket costs in 2026 for 3.5 million seniors because formulary placement will require they pay copays instead of coinsurance, meaning they won't fully benefit from the new out-of-pocket limit in Part D... Sub. Req'd

The IRA Could Lead to Higher Out-Of-Pocket Costs for 3.5 Million Medicare Patients in 2026

(6/25, Nicole Longo, PhRMA) ...Instead of seeing their out-of-pocket costs decline, many seniors and people with disabilities may have to dig even deeper into their pockets to afford the medicines they need because of the IRA's drug pricing provisions. Rather than continue with misguided policies, Congress and the administration should prioritize strengthening the Part D program and tackling system-wide abuses by insurers and PBMs to ensure patients have consistent and affordable access to medicines... Full

PhRMA Statement on CMS' Initial Price-Setting "Offer" to Biopharmaceutical Companies

(6/25, PhRMA) ..."This report is further evidence the IRA's new drug pricing scheme will have significant unintended consequences for millions of Medicare Part D patients," said PhRMA president and CEO Stephen J. Ubl. "Some people will be shocked when they see their out-of-pocket costs go up as a result of this law, which is the exact opposite of what many policymakers claimed would happen." The higher out-of-pocket costs are a result of the way the IRA's drug pricing provisions interact with the new out-of-pocket cap in Medicare Part D... Full

Conservative Groups Push to Roll Back Drug Price Law

(6/25, Peter Sullivan, Axios) ...An array of conservative groups is calling on GOP leaders to roll back the drug pricing provisions of the Inflation Reduction Act and seeking to elevate the issue on the party's agenda for the next Congress...The groups portray the Medicare drug price negotiations as heavy handed and economically ruinous. "History shows that price controls never achieve their stated ends and the IRA's price controls are further evidence," the letter states. "Basic economics dictates that imposing price controls on one class of products will simply force manufacturers to stop producing or investing in those products."... Sub. Req'd

Senate Finance Committee Bill Addressing Drug Shortages Would Provide Long Overdue Relief from Penalties Hurting Generic Drug Market

(6/25, AAM) ...While prescription drug shortages are multi-faceted, the issue continues to vex the American health care system, despite efforts from stakeholders to mitigate the problem. A range of experts from across the political divide have agreed that unsustainably low prices for generic drugs is contributing to the challenge. For instance, FDA Commissioner Califf recently said, "We essentially have two drug industries in the U.S. There's the innovator industry, where the prices are too high, and then there's the generics industry, where a lot of the prices are too low."... Full

Key Lawmaker Sees Growing Drug Shortages As National Security Threat

(6/25, Yash Roy, The Hill) ...Today, supplies of more than 300 commonly used drugs in the U.S. are experiencing shortages. That's compared to supplies of maybe 40 or 50 commonly used drugs in the U.S. experiencing shortages 20 years ago, according to Rep. Larry Bucshon (R-Ind.), vice chair of the House Energy and Commerce Subcommittee on Health. The shortages, combined with the U.S.'s increased independence on foreign nations for critical drug ingredients, represent a national security issue he and other congressional lawmakers hope to address, Bucshon — who will retire at the end of the year — said during a panel discussion with The Hill... Full

Keeping Pharmacy Shelves Filled, Solutions to Address Drug Shortages: Watch Live

(6/25, The Hill) ...In the first quarter of 2024, there were a record 323 drugs in short supply in the U.S., according to the American Society of Health-System Pharmacists and the University of Utah. Chemotherapy, ADHD medication, generics and injectables top the list of drugs that can be the hardest to source...Join The Hill for a special discussion on the pharmaceutical supply chain as we convene government leaders, supply chain experts, healthcare providers and physicians to discuss the collective goal of preventing drug shortages and, when they are unavoidable, mitigating their impact on patients... Full

The Interchangeables Are A-Changin': New FDA Guidance Proposes Eliminating Switching Studies Requirements

(6/26, Sara W. Koblitz, FDA Law Blog) ...Effectively, all biosimilars could be interchangeable with the right explanation, which leaves questions of whether the distinction between a regular biosimilar and an interchangeable biosimilar is necessary at all. Given that FDA asked Congress specifically to do away with the line between interchangeable biosimilars and other biosimilars in its recent Budget Request, this Guidance should not come as much of a surprise... Full

Some States Say They Can't Afford Ozempic and Other Weight Loss Drugs

(6/25, Oliver Whang, The New York Times) ...Over the past year, states have been trying, amid rising demand, to determine how far to extend coverage for public employees. Connecticut is on track to spend more than $35 million this year through a limited weight-loss coverage initiative. In January, North Carolina announced that it would stop paying for weight-loss medications after forking out $100 million for them in 2023 — 10 percent of its spending on prescription drugs... Sub. Req'd

New Study Reveals Discrepancies in Drug Pricing by Pharmacy Benefit Managers, Costing Employers and Hurting Pharmacies in Washington State

(6/25, Washington State Pharmacy Association) ..."This data paints a stark picture that Washington pharmacists know all too well - most PBMs and their affiliates are raking in massive profits from a manipulative drug pricing system, leaving patients and providers to bear the brunt," said Jenny Arnold, PharmD, BCPS, Chief Executive Officer of WSPA... Full

Arkansas Files Opioid Epidemic Lawsuit Against PBMs Optum, Express Scripts

(6/26, Noah Tong , Fierce Healthcare) ...Arkansas Attorney General Tim Griffin revealed the state is filing a lawsuit against pharmacy benefit managers Optum and Express Scripts for their role in the state's ongoing opioid epidemic. In the lawsuit, the state argues the PBMs negotiated deals with opioid manufacturers and exploited rebates, all while failing to protect consumers as they financially benefited... Full

European Solutions To European Problems – Securing The Supply Of Critical Medicines

(6/26, David Wallace, Generics Bulletin) ...European solidarity and dialogue will be key as the region seeks to secure its supply of critical medicines, says Victor Mendonça, board member of Medicines for Europe. In an exclusive interview, he speaks to Generics Bulletin about what can be done to strengthen Europe's supply chain without "one country's solution being another country's problem."... Global Sub. Full

European Alliance Should Lead To Critical Medicines Act, Says Industry

(6/26, David Wallace, Generics Bulletin) ...Also speaking at the conference, Philippe Drechsle – vice-president of portfolio for Teva and a member of Medicines for Europe's executive board – warned that if European generic medicines were a patient, then "the patient is sick." "In the last 10 years," Drechsle told delegates, "26% of generic medicines, 33% of antibiotics and 40% of cancer drugs have disappeared from at least one European market."...The answer to overcome shortages law with "complementary local and EU policy reforms," Drechsle suggested. At national level, he said, new pricing models were needed that were more adapted to individual countries pricing systems... Global Sub. Full

Acceptability Of RWD Must Be Decided On Case-By-Case Basis, Says EU Expert

(6/25, Vibha Sharma, Pink Sheet) ...The former head of the European Medicines Agency's Data Analytics and Methods Task Force says sponsors should engage early with regulators to get feedback on the suitability of real-world data for a regulatory application. However, industry suggests developing a fitness-for-purpose framework with specific criteria to determine when RWD may be appropriate... Sub. Req'd

U.K. Pharma Increasingly Violates Voluntary Industry Marketing Codes, and Probes Are Taking Longer

(6/25, Ed Silverman, STAT Plus) ...Pharmaceutical companies in the U.K. have increasingly violated a voluntary industry marketing code but complaints are also taking longer to review, according to a new analysis. As a result, the researchers argue that the growing number of infractions and inadequate policing are harming public health due to unsafe or unethical business practices... Sub. Req'd

Indian Pharmaceutical Industry Moving Ahead from Generics to Biosimilars and MedTech

(6/26, ANI) ..."From generics, we are now moving very fast into biosimilars. We are moving equally fast in MedTech. And you will see that in the years to come, this industry will grow rapidly further, and most independent market-based research firms project the Indian pharma and MedTech industry as the industry with the best and the most glowing future," said Arunish Chawla, Secretary, Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers to ANI... Full

Russia Will Speed Up Process of Launching Generics of Original Drugs

(6/25, The Pharma Letter) ...Russia will speed up the process of launching generics of original drugs that have been withdrawn from the market by their producers in a move to ensure better security of the country in its pharmaceutical sector, reports The Pharma Letter's local correspondent. According to the first deputy chairman of the State Duma Committee on Health Protection, Fedot Tumusov, it is important to begin preparations for the launch of generics of original drugs in the Russian market even before the end of their patent protection... Sub. Req'd

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