Tuesday, April 2, 2024

Teva, Viatris Win New Chance to Challenge J&J Schizophrenia Drug Patent

(4/1, Blake Brittain, Reuters) ...Teva Pharmaceutical and Viatris convinced a U.S. appeals court on Monday to revive their challenges to a patent covering a blockbuster Johnson & Johnson schizophrenia drug, giving them a new chance to clear a path to launch cheaper generic versions of the medicine...A Teva spokesperson said the company was pleased with the decision and looks forward to "providing this important low-cost medication to patients as soon as possible."... Full

Teva and Viatris Revives Chance to Dispute J&J's Schizophrenia Drug Patent

(4/1, Nilanjana Basu, Seeking Alpha) ...JNJ sued Mylan, now part of Viatris and Teva over patent infringement concerns for proposed generic versions of the drug in 2018 and 2019. In the 2021 ruling, U.S. District Judge Claire Cecchi said that Teva could not prove the invalidity of of JNJ's patent, covering a dosing regimen for Invega Sustenna. The panel at the Federal Circuit, on Monday, however overturned the 2021 ruling, sending back the case to New Jersey. This decision could give a new opportunity to Teva and Viatris to find more affordable generic versions of the drug... Full

CAFC Sends Janssen Schizophrenia Treatment Claims Back to District Court for New Obviousness Analysis

(4/2, Eileen McDermott, IPWatchdog) ...On appeal, Teva said the district court's obviousness analysis was legally flawed, including with respect to its analysis of secondary considerations. In particular, Teva said the district court improperly required Teva to show that the prior art recited dosing regimens for the general population of patients, or a generalized dosing regimen, when the claims were not directed to a generalized dosing regimen. The CAFC agreed and said the relevant claims reference "a" patient, rather than the patient population generally or a certain percentage of the patient population... Full

Obviousness and Pharmaceutical Method of Treatment Claims

(4/1, Dennis Crouch, Patentlyo) ...In the ensuing Hatch-Waxman litigation, Teva stipulated to infringement but challenged the patent on obviousness and indefiniteness grounds. Following a bench trial Judge Cecchi (D.N.J.) rejected Teva's invalidity defenses, and Teva appealed. On appeal, Judge Prost authored a unanimous opinion affirming the district court's indefiniteness determination but vacating and remanding on obviousness. Overall, this is a bad case for pharmaceutical formulary patents... Full

Teva Snares Up to $150M in Abingworth Funding to Propel Late-Stage Asthma Rescue Inhaler

(4/1, Eric Sagonowsky, Fierce Pharma) ...Monday, Teva and Abingworth revealed that they have entered a clinical collaboration agreement to advance TEV-'248, a dual-action combination of an inhaled corticosteroid and a short-acting beta-agonist (ICS/SABA). In a release, the companies said the prospect could become the first ICS/SABA for both the adult and pediatric patient population... Full

Carlyle's Abingworth Will Help Fund Teva's Phase 3 Asthma Rescue Inhaler

(4/1, Kyle LaHucik, Endpoints News) ...The inhaler could work for adults and children, Teva has said. It combines the "two most widely used molecules," which are fluticasone propionate and albuterol sulfate. The Israel-based pharma in January touted a $2.5 billion potential market. If the multi-dose, dry powder inhaler secures FDA approval, Teva would make fixed payments to Abingworth as well as payments based on sales, the companies said... Full

Teva and Launch Therapeutics Collaborate for Dual-Action Asthma Rescue Inhaler Respiratory Program

(4/1, Nilanjana Basu, Seeking Alpha) ...Under agreement, Launch Therapeutics will have the lead role in the operational execution and management of the planned clinical trials, focused on accelerating Teva's ICS-SABA clinical research program. Teva will retain primary responsibility for manufacturing, regulatory interactions in the U.S., and commercialization... Full

Teva Puts a Face On Tardive Dyskinesia in Latest Austedo XR Spots

(4/1, John Newton, MM+M) ...To help patients and HCPs recognize TD, Teva created two spots focused on "Kate" and "Dan," characters who have TD. The pair are shown on their journey from TD interfering with their daily activities to walking steadily with an orange travel mug filled with hot coffee in hand..."We obviously wanted to take the learnings from our first campaign and apply them here," says Nina DeLucia, director of consumer brand marketing with Teva, whose team led the Austedo campaign. "Some of those were that patients wanted to see something that felt real, authentic and relatable in terms of what they were seeing within the ad itself. Both ads are meant to show people what TD is and to put a name to it so folks can say, ‘That's something that I might have.'"... Full

Amneal Targets Limited US Ciprodex Pool With FDA Approval

(4/2, Adam Zamecnik, Generics Bulletin) ...The FDA has granted approval to Amneal's ciprofloxacin/dexamethasone otic suspension ANDA product, referencing Ciprodex, adding a further drug to the company's portfolio as the firm continues its strategic shift to complex generics...Amneal's key R&D focus remains on injectables and inhalable products...One notable opportunity for Amneal is its generic version of Teva's ProAir (albuterol sulfate). ProAir currently finds itself at the center of a patent dispute between Amneal and Teva, which originated with Teva alleging that Amneal's proposed generic infringes certain of its patents... Global Sub. Full

Biocon And Zentiva Hail Milestone Liraglutide Approval In UK

(4/2, David Wallace, Generics Bulletin) ...Biocon Limited and Zentiva have celebrated receiving a frontrunning approval for generic liraglutide after the UK Medicines and Healthcare Products Regulatory Agency endorsed the partners' 6mg/ml solution for injection in pre-filled pen. The firms underlined that the approval represented the "first generic liraglutide approved in a major regulated/ICH [International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use] market."... Global Sub. Full

Bora Completes Upsher-Smith Takeover

(4/2, David Wallace, Generics Bulletin) ...Bora Pharmaceuticals has completed its takeover of Upsher-Smith from Sawai, with the acquisition opening up new US opportunities for the Taiwanese company including providing the firm with its first US manufacturing sites...Upsher-Smith boasts a "diversified portfolio of 48 generic products" along with manufacturing facilities in Plymouth and Maple Grove, Minnesota... Global Sub. Full

French Pharma Major Sanofi Plans First-in-Class Drug Launches in India

(4/2, Neethi Rojan, Money Control) ...French pharmaceutical giant Sanofi India is gearing up for a series of first-in-class drug launches in the Indian market this year, according to a statement from a top company official. Rodolfo Hrosz, Managing Director of Sanofi India Limited, told Moneycontrol in an interview that the company has planned these launches from June onwards...Among the significant launches planned are Soliqua, a pre-mix insulin, and Rezurock, a medication for bone marrow transplants...Additionally, Sanofi aims to introduce other groundbreaking medications, including Dupixent for Atopic Dermatitis in adults, Xenpozyme, the only approved therapy for late-onset Pompe disease, Beyfortus for RSV, and TZIELD, which has shown promise in slowing type 1 diabetes in clinical trials... Full

Lupin Bags Tentative USFDA Nod for Migalastat Capsules

(4/1, Ruchika Sharma and Dr. Kamal Kant Kohli, Medical Dialgues) ...Global pharma major Lupin Limited has announced that it has received tentative approval from the United States Food and Drug Administration for its Abbreviated New Drug Application for Migalastat Capsules, 123 mg, to market a generic equivalent of Galafold Capsules, 123 mg of Amicus Therapeutics US LLC... Full

Kukje Pharma to Sell Celltion's Eylea Biosimilar Exclusively

(4/2, Yang Hyeon-su, Korea Biomedical Review) ...Under the agreement, Celltrion will exclusively provide Kukje Pharma with domestic marketing rights to CT-P42. Upon completing the Ministry of Food and Drug Safety's approval process, Kukje Pharma will assume domestic sales and distribution of CT-P42...Eylea's annual global market sales are about $1.3 billion (1.75 billion won), and its domestic market sales are about 97 billion won. Its sales are growing as the number of patients with macular degeneration has recently increased... Full

Pfizer Korea and Hanlim MS to Co-Market Enbrel Following Xeljanz

(4/2, Korea Biomedical Review) ...Pfizer Korea said Tuesday that the company has signed an agreement with Hanlim MS to co-market Enbrel (etanercept), the first anti-tumor necrosis factor (TNF)-a inhibitor approved for treating rheumatoid arthritis. Through this agreement, the two companies will collaborate on various activities, from marketing to sales, to enable more patients to benefit from Enbrel treatment. In particular, Pfizer Korea and Hanlim MS plan to further strengthen their synergies in the inflammatory and immunologic diseases business by expanding the scope of their partnership with this agreement... Full

Eisai, Biogen's Injectable Leqembi Delayed as FDA Asks for More Data

(4/1, Angus Liu, Fierce Pharma) ...The FDA has required additional three-month immunogenicity data for subcutaneous Leqembi given at a maintenance dose of 360 mg weekly, Eisai and Biogen said Monday...The subcutaneous delay is a "technicality," William Blair analysts said in a Monday note to clients. Still, this will push back a potential filing to the second half of 2024—or even longer if the FDA denies it the fast-track designation, the team noted... Full

Eisai Submits sBLA to USFDA for its Key Drug to Treat Early Alzheimer's Disease

(4/2, Financial Express) ...BioArctic AB‘s partner Eisai has announced that the company has submitted a supplemental Biologics License Application (sBLA) for its drug Leqembi to the US Food and Drug Administration... Eisai was recently informed by the FDA that a Fast Track designation specific for the SC formulation is needed to receive rolling review. Following the guidance, Eisai submitted a request for Fast Track designation for the SC formulation and will initiate a rolling submission should the FDA grant this designation. The Fast Track designation will be determined within 60 days from the March 2024 submission... Full

Galderma Loses Drug Patent Dispute, Claims Dubbed as Speculation

(4/1, Christopher Yasiejko, Bloomberg Law) ...A federal judge ruled that Lupin Ltd.‘s generic version of Galderma Laboratories LP's Oracea doesn't infringe two patents for the rosacea treatment, and said Galderma's infringement theory "masquerades speculation as science.". Judge Stephanos Bibas said he found no evidence that Lupin's copy of Oracea, whose active ingredient is doxycycline, is equipped with an immediate-release dose and smaller delayed-release portion... Sub. Req'd

Net Prices for Medicines Fell Considerably in 2023's Last Quarter, Mostly Thanks to Humira Biosimilars

(4/1, Ed Silverman, STAT Plus) ...The net prices that health plans paid for medicines — after subtracting rebates, discounts, and fees — fell by 2.8% in last year's fourth quarter, the largest decline ever measured by SSR Health, a research firm that tracks the pharmaceutical industry and its pricing trends. A key reason for the big drop — which dwarfed the 0.4% decline seen at the same time a year earlier — was pricing pressure on the Humira treatment for rheumatoid arthritis and psoriasis... Sub. Req'd

Industry Wants to Avoid Surprises in Remote Regulatory Assessments

(4/1, Mary Ellen Schneider, Regulatory Focus) ...As the US Food and Drug Administration refines its guidance for conducting remote regulatory assessments, industry is seeking assurances that the agency will provide advance notice for mandatory assessments and discuss observations before taking regulatory action...The Pharmaceutical Research and Manufacturers of America asked the agency to add language in the guidance about providing an opportunity for discussion in advance of mandatory RRAs, ensuring that any record requests are "appropriately tailored" and outlining how the agency will provide feedback after the review of submitted records... Full

FDA Finalizes Guidance On Electronic Submission of BA/BE Adverse Event Reports to FAERS

(4/1, Joanne S. Eglovitch, Regulatory Focus) ...The US Food and Drug Administration has finalized guidance that spells out how generic drug manufacturers can electronically submit expedited individual case safety reports for serious adverse events from bioavailability (BA)/bioequivalence and (BE) studies that are exempt from investigational new drug requirements... Full

PhRMA, Infusion Centers Appeal Texas Court's Dismissal Of IRA Case

(4/1, Gabrielle Wanneh, InsideHealthPolicy) ...The Pharmaceutical Research and Manufacturers of America, Global Colon Cancer Association and National Infusion Center Association are seeking to revive their case against CMS' Medicare drug price negotiation program following a Texas court's dismissal of the lawsuit in February. The groups recently filed an appeal of the decision, arguing there's good cause for the Fifth Court of Appeals to expedite their appeal due to ongoing and irreparable harm from the negotiations, the appeal's inclusion of "purely legal questions" and the lack of opposition from the government, according to the March 22 motion... Sub. Req'd

In Lowellville, Brown Fights to Lower Cost of Insulin

(4/1, U.S. Senator for Ohio Sherrod Brown) ...Today, U.S. Senator Sherrod Brown (D-OH) joined pharmacist Ray Carlson, R.Ph., owner of RC Outsourcing and RC Compounding Services, as well as Ohioans Mike and Kathleen Heinzer, to discuss his fight to lower insulin prices for Ohioans. During the event, Brown highlighted how the $35 monthly cap on the cost of insulin, made possible by the Inflation Reduction Act that Brown helped write and pass, has helped lower costs for Ohioans on Medicare. He also discussed his continuing push to cap the price of insulin at $35 for all Americans... Full

As PBMs Help Reduce NC Drug Costs, Drug Companies Push Congress to Regulate

(4/1, Christy Lewis, The Carolina Journal) ...Too many North Carolinians suffer from the high cost of prescription drugs. Fifty-four percent of Tar Heels say they struggle to afford the medication they need. Over 30% say they skip taking their prescription drugs to save money. North Carolina's drug costs problems are only expected to get worse. Pharmacies throughout the state are experiencing substantial supply shortages of cheaper generic medications this year. Fewer generic drugs in stock means higher prices for consumers...Members of Congress are trying to convince Sens. Ted Budd and Thom Tillis to support the PBM Transparency Act, a bill that will sick government regulators on entities called pharmacy benefit managers at the behest of the nation's largest drug companies... Full

EU's Pharma Legislative Reforms 'Will Scare Investment Away,' Astellas Executive Says

(4/1, Zachary Brennan, Endpoints News) ...Beginning April 10, members of the European Parliament are scheduled to debate and vote on the legislative overhaul at a plenary session. The new regulation and directive are meant to make Europe a more attractive destination for R&D. And while there's a lot in the package to be thankful for, Claus Zieler, chief commercial officer at Astellas and board representative of industry group EFPIA, told Endpoints News in an interview on Monday that the lowering of the data protection period to six months less than what pharma companies currently enjoy is a non-starter... Full

‘Unsavoury' Practices: Pharma Will Need To Be More Transparent On CME Expenses In India

(4/1, Anju Ghangurde, Pink Sheet) ...India's revised code for marketing practices includes US Sunshine Act-like requirements converging with tax laws and puts the spotlight on continuing medical education initiatives, where pharma will need to display funding/expenditure data on their website. The Pink Sheet talks to experts on the implications and also new requirements on brand reminders and drug samples...Arunish Chawla, secretary, department of pharmaceuticals, India's Ministry of Chemicals and Fertilizers, in an interview with CNBC-TV18 on April 1, was reported as saying that the new code is mandatory and quasi-statutory. "A reputational play is the best defence against unethical marketing practices – that's what the code tries to achieve," Chawla emphasized... Sub. Req'd

Reputation Key to Curbing Unethical Marketing, ‘Name and Shame' Policy Just the Beginning: Pharma Secy

(4/1, Timsy Jaipuria, CNBC TV18) ...The Uniform Code on Pharmaceutical Marketing Practices will curb pharmaceutical companies from extending personal benefits to healthcare professionals or their family members...Chawla held a comprehensive meeting on Monday with stakeholders to discuss the implementation of the recently notified Uniform Code for Pharmaceutical Marketing Practices 2024. The meeting included representatives from various Pharma associations, which Chawla highlighted as pivotal for enforcing the code... Full

From Paracetamol to Amoxycillin, Samples of 58 Commonly-Used Drugs Fail Quality Test; CDSCO Issues Alert

(4/1, Sushmita Panda, Financial Express) ...According to the list, some of the major companies whose samples have been flagged include Glenmark Pharmaceuticals, Micro Labs, Sun Pharmaceuticals, Glenmark Lifesciences, and Alkem Laboratories. The Central Drugs Standard Control Organisation has issued an alert against 58 samples of commonly used medicines as they failed the latest drug safety alert issued by the drug regulator in March... Full

India's Greenfield Bulk Drugs Drive Amidst Shift from China

(4/2, The Pharma Letter) ...The Indian pharmaceutical sector is poised for a substantial makeover with the inauguration of 27 greenfield plants dedicated to manufacturing bulk drugs. These plants signify a pivotal shift in India's pharmaceutical landscape and an in-your-face statement to the heavy import dependence on China, reports The Pharma Letter's India correspondent...Dr Arunish Chawla, Secretary of the Department of Pharmaceuticals, said India's drug industry has grown by 12% every year for the last 10 years. He also pointed out that with the PLI scheme, India plans to make around 1800 medicines and 22 bulk drugs... Sub. Req'd

Gujarat Pharma Majors Maintain Growth Momentum

(4/2, Pharmabiz.com) ...The pharma & healthcare segment captured domestic as well as international market with higher approvals from highly regulated authorities. Despite stiff competition from international players and the challenges faced in the US, Gujarat-based pharma majors have maintained momentum...The market capitalisation of Sun Pharma touched Rs. 3,88,803 crore on March 28, 2024 and that of Zydus Lifesciences, Torrent Pharma and Alembic Pharma also increased to Rs. 1,01,151 crore, Rs. 88,030 crore and Rs. 19,309 crore respectively... Full

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