Wednesday, May 1, 2024

FTC Targets ‘Junk' Patent Listings On Ozempic and Other Drugs

(4/30, Liz Essley Whyte, The Wall Street Journal) ...The letters targeted what agency officials called "junk listings" on patents for 20 drug products, including diabetes drug Ozempic. Also on the list are inhalers and more diabetes treatments from AstraZeneca, Boehringer Ingelheim, Covis Pharma, GSK, Novartis Pharmaceuticals, Novo Nordisk, Teva Pharmaceutical Industries, Amphastar Pharmaceuticals and some of their subsidiaries..."At no time did Teva use these patent listings to stifle competition, prolong a monopoly, or price gouge patients," said a letter from the drugmaker to lawmakers concerning the matter. "To the contrary, robust patent listings are inherently pro-competitive."... Sub. Req'd

FTC Warns ‘Junk Patents' Could Make Drugs Like Ozempic Pricier—Here's How

(4/30, Ty Roush, Forbes) ...The FTC sent warning letters to 10 pharmaceutical companies—including Novo Nordisk, AstraZeneca, GlaxoSmithKline and Teva—disputing more than 300 "junk" patent listings across 20 different brand name products, the agency said Tuesday...Teva said it doesn't use patent listings to "stifle competitions, prolong a monopoly, or price gouge patients," adding it allows competitors to work around its patents. Teva also argued patent listings were "inherently pro-competitive" and a "critical aspect of the legal and regulatory landscape."... Full

Novo, Teva, AstraZeneca Issued FTC Warnings Over ‘Bogus' Patents

(4/30, Dulan Lokuwithana, Seeking Alpha) ...The Federal Trade Commissionsent warning letters to 10 drugmakers, including Novo Nordisk, Teva Pharmaceutical, and AstraZeneca, on Tuesday over questionable patent listings...It is the FTC's latest measure to improve generic drug competition. Similarly, in November, the agency notified companies such as AbbVie, AstraZeneca, GSK, and Teva, challenging some of their patent listings in the FDA's Orange Book... Full

FTC Targets More Drug Patents, Going After Obesity, Diabetes and Asthma Medications

(4/30, Drew Armstrong, Endpoints News) ...The latest round of letters were sent to AstraZeneca, Novo Nordisk, Boehringer Ingelheim, Covis Pharma, GSK, Novartis, Teva and Amphastar Pharmaceuticals, as well as a handful of subsidiaries. The patents targeted by the FTC include those for Novo's blockbuster diabetes drug Ozempic and GSK's Ellipta asthma products, among many others... Full

FTC Extends Warning Letters Over 'Junk' Patents To Ozempic And Other Drugs

(4/30, Maaisha Osman, InsideHealthPolicy) ...Other companies that received warnings Tuesday over asthma and COPD products are Boehringer Ingelheim, Covis Pharma, Glaxo-Smith Kline, Novartis Pharmaceuticals, Teva Pharmaceuticals and some of their subsidiaries...Seven of 10 companies FTC warned with its first round of letters in November chose to delist their patents on inhaler products from the Orange Book. Boehringer Ingelheim and AstraZeneca capped their inhaler prices but did not delist their patents. Teva did not cap its prices for inhaler products or delist its patents from the Orange Book, prompting FTC to take the issue to court in a bid to get Teva's patents removed... Sub. Req'd

FTC Challenges ‘Junk' Patents Held by 10 Drugmakers, Including for Novo Nordisk's Ozempic

(4/30, Annika Kim Constantino, CNBC) ...The agency sent letters to Novo Nordisk, AstraZeneca, Boehringer Ingelheim, Covis Pharma, GlaxoSmithKline, Novartis, Teva Pharmaceuticals, among others..."By filing bogus patent listings, pharma companies block competition and inflate the cost of prescription drugs, forcing Americans to pay sky-high prices for medicines they rely on," FTC Chair Lina Khan said in a release... Full

FTC Issues Warnings On ‘Junk' Patent Listings for Ozempic and Other Drugs

(4/30, Ed Silverman, STAT Plus) ...In its latest series of missives, the agency again sent letters to Boehringer Ingelheim, Teva, AstraZeneca and subsidiaries of GSK, although the disputed patents were listed for different asthma and COPD inhalers than those cited in the November letters. The newest batch of letters were also sent to Novo, Amphastar Pharmaceuticals, Norton, Covis Pharma and Novartis. A Teva spokeswoman declined to comment... Sub. Req'd

‘Skinny Labels' On Generic Medicines Saved Medicare $15 Billion Over a Recent Six-Year Period

(4/30, Ed Silverman, STAT Plus) ...But some consumer advocates and academics worry the maneuver may see limited use after the U.S. Supreme Court last year declined to hear an appeal of a complicated court case. In that case, Teva Pharmaceuticals, which won a "skinny label" approval to sell a generic version of a GSK heart drug, was found liable of "inducing" patent infringement based on product labeling and marketing to physicians. As a result, the U.S. Supreme Court threw into question whether generic companies can "carve out" uses for their medicines and supply Americans with cheaper alternatives to brand-name drugs... Sub. Req'd

Teva And Alvotech Confirm Quallent Deal On US Adalimumab

(4/30, David Wallace, Generics Bulletin) ...Teva and Alvotech have confirmed deductions that it is their recently-approved 100mg/ml adalimumab biosimilar that will be used by Cigna's Evernorth as part of a recently announced private-label deal involving Evernorth's Quallent Pharmaceuticals...Thomas Rainey – senior vice-president of US market access at Teva – said that the firm would "continue to be focused on creating cost savings across the healthcare system and providing affordable options, like the high-concentration interchangeable adalimumab, for patients who need them."... Global Sub. Full

What's Next? Five Things To Look Out For In May

(5/1, Dean Rudge, Generics Bulletin) ...Teva Awaits Irish Decision On Apixaban. The Court of Appeal in Ireland will this month conduct a hearing on the merits of an Irish composition-of-matter patent and related supplementary protection certificate shielding Bristol Myers Squibb's Eliquis (apixaban) blockbuster anticoagulant, after Ireland's High Court ruled it to be invalid. The court's decision was delivered in December last year in favor of generics manufacturer Teva... Global Sub. Full

Milestone Payments Fuel Growth For Formycon In 2023

(4/30, Adam Zamecnik, Generics Bulletin) ...Formycon reported an 83% growth in group revenue to €77.7m ($83.3m) in its 2023 fiscal year on the back of ramped up income from partnerships and milestone payments. Specifically, the company attributes this increase to receipt of several milestone payments sent by Fresenius Kabi as part of the companies' FYB202 (ustekinumab) biosimilar partnership deal... Global Sub. Full

Pfizer to Sell Covid and Migraine Drugs Directly to Consumers

(5/1, Oliver Barnes, Financial Times) ...Pfizer is developing an online platform for patients to order medicine including anti-Covid drug Paxlovid and a migraine nasal spray, according to people familiar with the matter, in the latest push by drugmakers to cut out industry middlemen and sell straight to consumers. The website, which is expected to launch later this year, would connect customers in the US with independent telehealth consultants to prescribe the medications, while a drug-dispensing partner would fill and ship the prescriptions, the people said... Full

Weight-Loss Drug Drives Eli Lilly to Raise 2024 Sales Forecast by $2 Billion

(4/30, Bhanvi Satija and Patrick Wingrove, Reuters) ...Explosive demand and increased manufacturing capacity for Eli Lilly's weight-loss drug Zepbound drove the company to raise its annual sales forecast by $2 billion on Tuesday, lifting its shares nearly 5%. Lilly said it expects significant production increases in the second half of the year for its obesity treatment and related diabetes drug Mounjaro, for which most doses are in shortage due to high demand... Full

GSK Raises Profit Outlook On Strong Vaccine, HIV Drug Sales

(5/1, Eva Mathews and Maggie Fick, Reuters) ...GSK raised its full-year profit forecast on Wednesday on strong demand for its common respiratory vaccine and specialty HIV medicines, though it expects sales growth to slow in the second half...Sales of recently launched products such as respiratory syncytial virus (RSV) vaccine Arexvy and bone marrow cancer therapy Ojjaara have been strong since the start of 2024, while asthma drug Trelegy also performed better than expected, GSK said... Full

Pfizer Lifts Profit View On Cost Cuts, Higher COVID Vaccine Demand

(5/1, Bhanvi Satija and Sriparna Roy, Reuters) ...Pfizer lifted its annual profit forecast, banking on cost cuts, a smaller-than-feared drop in sales for its COVID antiviral treatment and strong demand for pneumonia vaccine, sending its shares up about 2% before the bell on Wednesday. Shares of the U.S. drugmaker have lost 11% of their value this year on worries over its growth after the pandemic as billions of dollars in COVID vaccine and treatment sales evaporated... Full

Neurocrine Biosciences' Huntington's Disease Drug Gets FDA Approval

(4/30, Sruthi Narasimha Chari, Reuters) ...The U.S. Food and Drug Administration has approved the granule formulation of Neurocrine Biosciences' Ingrezza drug to treat movement disorders associated with Huntington's disease, the company said on Tuesday...Nadeau estimates that the drug has only been adopted by about 30,000 patients, indicating significant growth potential for Ingrezza. Israel-based Teva Pharmaceutical Industries' Austdedo is also approved to treat chorea stemming from Huntington's disease. Ingrezza recorded global sales of $1.84 billion in 2023 and the company expects the drug to generate overall sales in the range of $2.1 billion to $2.2 billion this year... Full

First Trial Over Zantac Cancer Claims Set to Begin in Chicago

(4/30, Brendan Pierson, Reuters) ...The first trial over claims that blockbuster heartburn drug Zantac, once sold by GSK and other companies, causes cancer is set to begin this week in Chicago...GSK and Boehringer Ingelheim are the only defendants in the trial, after other companies settled..."We are confident in our position based on the facts and science and look forward to presenting our case at trial," GSK said in a statement. "The totality of the scientific evidence, which includes numerous recently conducted epidemiological studies, points to only one conclusion: Zantac does not cause any type of cancer," Boehringer Ingelheim said in a statement... Full

The Importance of Biosimilars in Health Care

(4/30, Sree Chaguturu, MD, CVSHealth) ...A new report authored by Sree Chaguturu, MD, Executive Vice President and Chief Medical Officer, CVS Health, explains how biosimilar drugs help make treatments more affordable. It also showcases how Cordavis™, a CVS Health subsidiary focused on manufacturing high-quality biosimilars, is improving patient access to these life-changing treatments and bringing innovation to health care... Full

Dr Sophia Humphreys Provides Calls to Action to Ensure Biosimilar Market Sustainability

(4/30, Skylar Jeremias, The Center For Biosimilars) ...More strategies around market trend analysis, high-quality manufacturing, and patient education are needed to ensure market success and sustainability, according to Sophia Humphreys, PharmD, director of formulary management at Sutter Health...She touched on the US experience with adalimumab biosimilars, which have only obtained 2% share at the 1-year mark despite 10 products on the market. There was immense promise for these biosimilars to break into the reference product Humira's $21 billion annual revenue... Full

Expert Discusses Medication Access and Innovative Medication

(4/30, Pharmacy Times) ...Jon Mahrt, president of PBM and Chief Operating Officer at Optum Rx, discusses key challenges and strategies for improving patient access to medications. He covers the growth of GLP-1 drugs for diabetes and upcoming indications, highlighting the need for utilization management and supply chain strategies to meet demand. Ensuring drug affordability is also identified as critical, as 1 in 5 patients lose adherence due to cost... Full

GLP-1s Are Flipping the Script, Says Doug Long | 2024 Asembia

(4/30, Peter Wehrwein, Managed Healthcare Executive) ...For years, the growth in spending in specialty drugs relative to so-called traditional drugs has been a well-documented trend in U.S. drug expenditures and more-than-welcome news at the Asembia meeting, which is devoted to specialty drugs and pharmacy. Doug Long, MBA, has been one of the prime narrators of that story in his many presentations featuring a voluminous slide decks at the Asembia gatherings and other meetings... Full

Bristol Myers, Johnson & Johnson Plot Appeal After US Judge Dismisses IRA Lawsuits

(4/30, Kevin Dunleavy, Fierce Pharma) ...On Monday, a New Jersey federal judge tossed lawsuits by Bristol Myers Squibb and Johnson & Johnson, which questioned the constitutionality of the U.S. government requiring drugmakers to negotiate with Medicare on the pricing of their products... Full

JNJ, BMS's IRA Loss Is First Time Court Rejects Industry's First Amendment, Takings Claims

(4/30, Sarah Karlin-Smith, Pink Sheet) ...Janssen Pharmaceutical Cos. and Bristol Myers Squibb Company failed to convince a district court judge that the Inflation Reduction Act's drug price negotiation program violates the drug industry's First Amendment rights, the Takings Clause of the Fifth Amendment or the Unconstitutional Conditions Doctrine, per a summary judgement issued in favor of the government April 29... Sub. Req'd

Drug Companies Seek To Revive Rejected IRA Lawsuits

(4/30, Gabrielle Wanneh, InsideHealthPolicy) ...Drug makers aren't backing down despite another district court ruling Monday (April 29) against their efforts to delay Medicare drug price negotiation, with Bristol Myers Squibb and Johnson & Johnson swiftly appealing Monday's rulings in New Jersey, AstraZeneca the same day appealing a recent ruling against it in Delaware, and the drug lobby PhRMA and allied associations set to make a pitch in oral arguments Wednesday (May 1) for the 5th Circuit to revive a case recently dismissed by a Texas judge for lack of venue. Unless the industry can get at least one ruling in its favor, drug companies will have a hard time getting the Supreme Court to step in, a legal expert at Georgetown told Inside Drug Pricing... Sub. Req'd

NEWS: Sanders Responds to FTC's Efforts to Target ‘Junk' Ozempic Patents

(4/30, U.S. Senator for Vermont Bernie Sanders) ...[Bernie Sanders] Let me commend the Federal Trade Commission, under the leadership of Chair Lina Khan, for taking bold action today against the bogus patents Novo Nordisk has filed to prevent Americans struggling with diabetes from receiving a generic version of Ozempic at a much lower price. Novo Nordisk must not be allowed to make billions in profits by delaying generic competition for Ozempic by unlawfully filing junk patents that have nothing to do with the drug itself, but the injection pen... Full

CSRXP Applauds Expanded FTC Crack Down On Big Pharma's Sham Patents in the Orange Book

(4/30, The Campaign for Sustainable Rx Pricing) ..."CSRxP applauds the FTC for building on previous progress to hold Big Pharma accountable for abuse of the patent system that extends monopolies on blockbuster money-makers, blocks competition from more affordable alternatives and keeps prescription drug prices high," said CSRxP executive director Lauren Aronson. "The FTC's scrutiny of Big Pharma's sham patents around blockbuster GLP-1 weight loss drugs will be especially critical given the staggering costs these egregiously-priced products could impose on American patients and the U.S. health care system."... Full

NY Health Groups Sue Boehringer Ingelheim Over Inhaler Patents

(4/30, Nyah Phengsitthy, Bloomberg Law) ...The complaint filed Monday in the US District Court for the District of Connecticut by the 1199SEIU National Benefit Fund, Greater New York Benefit Fund, National Benefit Fund for Home Care Workers, and Licensed Practical Nurses Welfare Fund seeks injunctive relief on behalf of themselves and others who the lawsuit alleges paid for Boehringer's Combivent Respimat and Spiriva Respimat "at monopoly prices" long after the drugmaker's patents expired and "generic drugs should have entered the markets."... Sub. Req'd

First Do No Harm: US MedPAC Wrestles With Complexity Of Low-Cost Drug Pricing

(4/30, Michael McCaughan, Pink Sheet) ...The US Medicare Payment Advisory Commission is analyzing two of the lower-cost segments of the US medicine marketplace: generic drugs and the 340B brand discount program. In both cases, there is a picture of complexity and unintended consequences to rival higher cost segments... Sub. Req'd

Chairing Hearing, Warren Calls for Action to Address Drug Shortages, Guarantee Reliable, High Quality Care for Service Members and Their Families

(4/30, U.S. Senator Elizabeth Warren) ...Today, U.S. Senator Elizabeth Warren (D-Mass.), chair of the Armed Services Subcommittee on Personnel, led a hearing on the Department of Defense's efforts to ensure service members are receiving safe, effective medicines. Senator Warren, in her opening statement, expressed concern that DoD's overreliance on foreign drug manufacturers may pose risks to DoD's pharmaceutical supply chains and affect quality of care for service members... Full

Drug Makers Exposed to Antitrust Probes if Patent Cache Adopted

(5/1, Annelise Gilbert, Bloomberg Law) ...A proposed patent office depository for sealed settlements could expose pharmaceutical giants to antitrust scrutiny if investigators use it to identify which companies may have coaxed biosimilar makers to drop patent challenges to maintain exclusivity... Full

New Analysis: Accelerated Approval Pathway is Changing Lives in Underserved Communities

(4/30, Andrew Powaleny, PhRMA) ...Medicare beneficiaries from underserved communities with certain life-threatening diseases and few other options are gaining access to innovative medicines because of the accelerated approval pathway, according to a new analysis conducted by Avalere... Full

Board Trying to Lower Drug Costs Urges Marylanders to Help ‘Fill In' Info Gaps

(4/30, Danielle J. Brown, Maryland Matters) ...Before a state board can begin the process of determining if certain prescription drugs pose an affordability challenge to Marylanders, officials of the Prescription Drug Affordability Board are seeking feedback from patients, physicians and manufactures to provide additional context and first-hand experience about trying to afford medications treating HIV, eczema, and diabetes and other conditions... Full

EU Launches Critical Medicines Alliance But Prospect Of Act On Manufacturing Still Uncertain

(4/30, Francesca Bruce, Pink Sheet) ...Work on safeguarding the medicine supply chain should be accompanied by ambitious actions to ensure the future of the sector, including a new deal on competitiveness, says the pharmaceutical industry... Sub. Req'd

EMA Pilots Partnering With Companies To Gain Efficiencies In Preparing Drug Assessment Reports

(4/30, Vibha Sharma, Pink Sheet) ...The European Medicines Agency is inviting more drug sponsors to participate in a pilot it launched last year to reduce the time its regulatory reviewers spend on preparing assessment reports on initial marketing authorization applications (MAAs) by allowing companies to pre-fill these reports with factual data beforehand. The approach is expected to free up more time for the MAA assessors to better focus on the drug assessment itself, and could potentially speed up regulatory reviews... Sub. Req'd

MHRA Calls for More Prominent Warnings Neuropsychiatric Reactions with Montelukast

(4/30, The Pharma Letter) ...More prominent warnings are to be added to the package insert of montelukast (Singulair) in the UK, reminding patients and healthcare professionals that they should be alert to serious behavior and mood-related changes (neuropsychiatric reactions) associated with the treatment, said the UK's Medicines and Healthcare products Regulatory Agency... Sub. Req'd

Bolar Exemption India Files: Roche Blocks Alleged Infringer Of Evrysdi Patent

(4/30, Anju Ghangurde, Pink Sheet) ...More legal action in India that has the Bolar exception provision at its crux with Roche, in this instance warding off a local drug maker in the Evrysdi patent infringement case. Roche appears to have thwarted, at least for now, an alleged infringement attempt pertaining to the patents for its oral spinal muscular atrophy treatment Evrysdi (risdiplam) in India... Sub. Req'd

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