Tuesday, January 16, 2024

Vanda Slams US Federal Circuit In Teva, Apotex Hetlioz Supreme Court Petition

(1/16, Dean Rudge, Generics Bulletin) ...Serial litigator Vanda Pharmaceuticals has followed through on its pledge to take its patent-infringement loss to Teva and Apotex over its Hetlioz sleep-disorder brand all the way to the US Supreme Court...At the end of 2022, Delaware district judge Colm Connolly found in favour of Teva and Apotex on their challenges to four Hetlioz method-of-treatment patents, which have expiry dates ranging from January 2033 to July 2035... Global Sub. Full

Teva Pharma (TEVA) PT Raised to $14 at BofA Securities Following US Generics Segment Review

(1/12, StreetInsider.com) ...BofA Securities analyst Jason Gerberry raised the price target on Teva Pharma to $14.00 (from $13.00) while maintaining a Buy rating. The analyst commented, "Based on our review of TEVA's US generics segment, we believe TEVA can achieve low-SD growth even excluding contributions from two wildcards (Korlym and Humira-IC) and zero contribution from undisclosed launch candidates.”... Full

Why Big Pharma Led By Merck, Sanofi, Teva Are Pouring Billions Into A New Immunology Space

(1/12, Allison Gatlin, Investor's Business Daily) ...Companies believe blocking TL1A could have a profound impact on, initially, ulcerative colitis and Crohn's disease. But experts say it could reach far beyond stomach diseases and into arthritis, skin conditions and lung diseases. Teva Chief Executive Richard Francis believes the company's TL1A drug could be a "multibillion-dollar blockbuster. That could help soften the expected financial blow from soon-to-expire patents protecting some of the industry's biggest moneymakers... Full

Lupin Kicks Off 2024 With Major US Generics Launches

(1/15, David Wallace, Generics Bulletin) ...Lupin has begun 2024 by notching up multiple US approvals and launches, including introducing an exclusive generic version of Prolensa and challenging Chantix. Lupin has kicked off the new year with multiple US launches and approvals, chief among them its introduction of the first generic rival to Bausch + Lomb's Prolensa (bromfenac) 0.07% ophthalmic solution, for which the Indian firm will enjoy 180-day first-to-file exclusivity... Global Sub. Full

Lupin Reports Three USFDA Approvals in Less Than a Week

(1/15, Sriram Lyer, CNBC TV 18) ...This is third new launch announced by the company in the last one week. The stock jumped over 86% in the last one year, thanks to whole host of new launches and the easing pressure on profit margin. The US Food and Drug Administration has approved Propranolol Hydrochloride Extended-Release Capsules (the generic version of Inderal sold by Minnesota-based ANI Pharmaceuticals) made by Lupin, the company said in a filing to the stock exchanges... Full

Organon Expects 2028 ‘Tidal Wave' For Biosimilars

(1/15, David Wallace, Generics Bulletin) ...Organon CEO Kevin Ali provided a detailed overview of the firm's biosimilars strategy at the J.P. Morgan Healthcare Conference last week, looking ahead to competition on Opdivo and Keytruda in 2028; highlighting nearer-term launches of denosumab and pertuzumab; and providing a breakdown of the firm's experiences in the competitive US adalimumab market... Global Sub. Full

Coherus: Ophthalmologists Have Been ‘Burned Time And Again'

(1/12, Dean Rudge, Generics Bulletin) ...Coherus BioSciences revealed that it has shipped nearly 200,000 doses of its Lucentis biosimilar Cimerli, as it pondered from where to grab further market share in 2024 at the J.P. Morgan Annual Healthcare Conference. Coherus BioSciences says it is "very pleased" with the progress of its Formycon-partnered Cimerli (ranibizumab-eqrn) biosimilar to Genentech's Lucentis in the US, insisting that the company's 190,000 doses shipped since launch and 30% volume share is "really important for ophthalmologists, because ophthalmologists have been burned time and again by novel agents that come on the market."... Global Sub. Full

Amgen Hit With US Eylea Suit Ahead Of Looming Biosimilar Date

(1/12, Dean Rudge, Generics Bulletin) ...Regeneron is continuing to keep the pressure on would-be biosimilar sponsors for its mammoth Eylea (aflibercept) brand, suing biosimilar sponsor Amgen for alleged patent infringement on the back of a recent favorable verdict over Biocon. Weeks after Amgen confirmed that its proposed biosimilar to Eylea (aflibercept) had been accepted for filing by the US Food and Drug Administration, the California-based firm has been sued for patent infringement by originator Regeneron, in a bid to put the kibosh on Amgen's ambitions ahead of Eylea's regulatory exclusivity expiring in May... Global Sub. Full

Jazz Beats Cipla's Bid to Knock 20 Epidiolex Patents From Suit

(1/12, Christopher Yasiejko, Bloomberg Law) ...A federal judge rejected Cipla Ltd.'s arguments that 20 patents for Jazz Pharmaceuticals Plc's epilepsy treatment Epidiolex are unenforceable, finding Jazz didn't lie to the US Patent and Trademark Office when it filed applications as a "small entity." Judge Michael E. Farbiarz, in an opinion issued Thursday in the US District Court for the District of New Jersey, tossed a set of counterclaims from a case over several generic-drug makers' proposed copies of Epidiolex. He called arguments by Cipla, its InvaGen Pharmaceuticals Inc. unit, and API Pharma Tech LLC—which supplies the active ingredient in their generic version of the drug—"not persuasive."... Sub. Req'd

Korean Biosimilars of Humira Step Up Offensives in Domestic Market

(1/15, Yang Hyeon-su, Korea Biomedical Review) ...Korean drugmakers will likely intensify marketing activities for their biosimilars of AbbVie's autoimmune disease treatment Humira (adalimumab) this year, government and business officials said on Monday. According to the Ministry of Food and Drug Safety, Samsung Bioepis has decided to focus on supplying only the high-concentration formulation of its Humira biosimilar, Adalloce, in Korea... Full

Biotech and Pharma Companies Are Betting On a Promising Class of Cancer Drugs to Drive Growth

(1/14, Annika Kim Constantino, CNBC) ...During the four-day event, the biotech and pharmaceutical industry signaled its enthusiasm for antibody-drug conjugates, or ADCs, which deliver a cancer-killing therapy to specifically target and kill cancer cells and minimize damage to healthy ones. Meanwhile, standard chemotherapy is less selective – it can affect both cancer cells and healthy cells. Johnson & Johnson last week announced a $2 billion acquisition of ADC-developer Ambrx Biopharma to beef up its existing pipeline of ADCs, which some researchers believe could be heralding a "new era" for cancer treatment... Full

CAR-T Hype Faces Infrastructure Reality Check

(1/15, Angus Liu, Fierce Pharma) ...Six CAR-T therapies targeting either CD19 or BCMA have reached the U.S. market to treat various blood cancers. Impressive efficacy data, wide reimbursement acceptance, earlier-line approvals and steady production expansions have fueled blockbuster revenue predictions. But drug developers and Wall Street may have underestimated the bottlenecks from the healthcare infrastructure needed to deliver a cell therapy, Leerink Partners analyst Daina Graybosch, Ph.D., warns... Full

JPMorgan's Investor Conference Brings Pharma Firepower, But Health Services Quiet

(1/12, Claire Rychlewski, Axios) ...The JPMorgan Health Care Conference ended with more than $10 billion in deal announcements, setting a bullish tone for pharma and biotech M&A in 2024. Yes, but: There was a notable lack of large-scale deal announcements in any health sector outside of pharma. What they're saying: "JPM is a really good microcosm of the way that we talk about health care, where drugs are like 10 cents of every health care dollar but they're 90 percent of our conversation," a JPM veteran and PR adviser to several health care companies told Axios' Caitlin Owens... Sub. Req'd

Battleground GLP-1s: After Chinese Firms, Glenmark Debuts Liraglutide; More Coming

(1/12, Anju Ghangurde, Generics Bulletin) ...After China, India sees the arrival of a biosimilar to Novo Nordisk's Victoza at a sharp discount, while action also appears to be heating up for the Danish firm's high-flying GLP-1, semaglutide, in both markets...Globally, Teva, Viatris and Sandoz have settled their patent dispute in the US pertaining to liraglutide with Novo Nordisk, setting the stage for anticipated biosimilar competition in June this year. Pfizer, which had in July 2020 joined an inter parties review by Mylan (now Viatris) against a formulation patent covering Victoza, is also not expected to launch a generic version of Victoza until June 2024... Global Sub. Full

Lilly's Direct-to-Consumer GLP-1 Service Likely Doesn't Threaten PBMs

(1/15, Peter Johnson, Pink Sheet) ...In terms of the reimbursement impact, the LillyDirect approach is comparable to existing patient assistance and coupon programs, one expert tells AIS Health, a division of MMIT. "I think Lilly is, appropriately for their shareholders, establishing this channel so that they're taking down an access barrier for people without insurance" that covers GLP-1s, says Dan Mendelson, CEO of Morgan Health, JP Morgan Chase Co.'s health care consulting and venture capital arm. "If this is the next iteration of the classic patient assistance program that these drug companies run, I certainly understand it."... Sub. Req'd

Dr Kirollos Hanna Talks Chemotherapy Shortage Challenges and Solutions

(1/15, Hayden E. Klein, AJMC) ...Kirollos S. Hanna, PharmD, BCPS, BCOP, FACCC, director of pharmacy services at Minnesota Oncology, spoke with The American Journal of Managed Care® (AJMC®) about chemotherapy shortages and what Minnesota Oncology does to work around the resulting challenges while identifying which patients need access to the drugs most... Full

New Congressional Bill Would Thwart Patent Thickets in Order to Speed Generic Drugs to Market

(1/12, Ed Silverman, STAT Plus) ...In the latest bid to lower the cost of medicines, a new bill was introduced in Congress that would make it harder for pharmaceutical companies to use numerous patents in order to thwart generic competition. The legislation, which was introduced in both the House and the Senate, addresses the use of so-called patent thickets. This refers to a widely used tactic in which a drug company obtains numerous patents — sometimes, numbering in the dozens — to protect its monopoly on a medicine even though some of the patents do not represent novel or innovative improvements... Sub. Req'd

Arrington Leads Bipartisan Effort to Address Patent Thickets and Increase Competition in the Prescription Drug Market

(1/12, Representative Jodey Arrington) ...Today, Representative Jodey Arrington (TX-19) led a bipartisan, bicameral group of lawmakers, including Representatives Doggett, Pfluger, Dingell, Issa and Jayapal and Senators Braun and Welch in introducing legislation to lower prescription drug costs by addressing patent gamesmanship...New research shows that the thickets used by certain branded pharmaceutical companies are duplicative, and fail to make substantial improvements to the original drug. This practice delays competition and keeps drug prices high for hardworking American families. The newly introduced bill would curb the practice of patent thicketing, bringing much-needed competition to the domestic biosimilars market and increasing access to lower cost treatments and cures... Full

Medicare Patients On Pricey Drugs Are Saving Big This Year

(1/15, Liz Essley Whyte, The Wall Street Journal) ...Medicare patients lining up to fill pricey prescriptions at the pharmacy counter this year will realize some good news: For the first time, there is a ceiling on how much they will pay in 2024 for their Part D drugs. Changes brought about by the 2022 Inflation Reduction Act mean that people on Part D plans now pay no more than roughly $3,300 on drugs annually—a number that could shift a bit based on whether they take brand or generic medications. In 2025, that cap will change again to a flat $2,000... Sub. Req'd

The New NIH Director is Walking a Tightrope On Biden's Drug Pricing Vision

(1/16, Sarah Owermohle, STAT Plus) ..."Our relationship with the pharmaceutical industry, with the industry overall, is really, really critical," Director Monica Bertagnolli told STAT in an interview. "It's very difficult, if you can imagine, to implement something broadly that is as effective as we want it to be."...The tightrope laid by Sanders and Biden is just one of the myriad challenges facing Bertagnolli in the first few months of her tenure. The longtime oncologist and former National Cancer Institute director, the second woman to ever lead thhe NIH, is also facing a storm of questions from Congress around coronavirus research, foreign lab oversight, and how it spends money — particularly as Republicans look to cut costs across the government... Sub. Req'd

Despite Lawsuits, NJ Drugmakers Take Part in Medicare Negotiations

(1/15, Kimberly Redmond, NJBIZ) ...Despite suing the Biden administration over a controversial new government program aimed at reducing the cost of prescription drugs for older Americans, New Jersey's biggest pharmaceutical companies are taking part in price-setting negotiations...While the administration argues that the price adjustments will save taxpayers $160 billion by reducing how much Medicare pays for drugs through negotiation and inflation rebates, the pharmaceutical industry maintains the program will curtail profits and ultimately compel drugmakers to scale back development of groundbreaking new treatments... Full

New House Drug Shortage Bills Beef Up Data, Require 6-Month Pediatric Drug Reserve

(1/12, Maaisha Osman, InsideHealthPolicy) ...House lawmakers on Friday (Jan.12) floated two bills aimed at stemming drug shortages by fixing cracks in the drug supply chain: the bipartisan Mapping America's Pharmaceutical Supply Act would require that HHS update its essential medicine list and create a database to track drugs in various steps of the supply chain; the Democratic Pediatric Cancer Drug Supply Act of 2024 would require that HHS create a six-month reserve supply of essential pediatric cancer drugs... Sub. Req'd

Reps. Eshoo, DeGette, Schrier Introduce Bill to Ensure Stable Supply of Pediatric Cancer Drugs

(1/12, Congresswoman Anna G. Eshoo) ...U.S. Reps. Anna G. Eshoo (D-CA), Ranking Member of the Energy and Commerce Health Subcommittee, Diana DeGette (D-CO) and Kim Schrier (D-WA) introduced the Pediatric Cancer Drug Supply Act of 2024, legislation to ensure the United States maintains a stable supply of essential pediatric cancer drugs. The Pediatric Cancer Drug Supply Actof 2024 directs the U.S. Department of Health and Human Services (HHS) to establish a program to create a reserve supply of essential pediatric cancer drugs. Through this program, HHS will contract with eligible drug manufacturers to produce a stockpile of the most essential pediatric cancer drugs... Full

PhRMA, Eli Lilly, Other Drug Companies Push Back On FDA's Draft Guidance About Communicating Off-Label Use

(1/12, Lia DeGroot, Endpoints News) ...Big Pharma is pushing back on draft guidance published by the FDA this fall that aims to clarify how drugmakers can communicate with healthcare providers about the unapproved use of approved medications...Eli Lilly said the draft guidance is a step forward that could help ensure that the FDA doesn't impede a firm's ability to engage in constitutionally-protected speech. But the company also voiced several concerns with the guidance, disagreeing with the agency's interpretation of the First Amendment... Full

US FDA Resists Proposals For Mideast Presence To Boost Pharmaceutical Imports From Allies

(1/12, Bowman Cox, Pink Sheet) ...Legislation is brewing that could establish agency posts in Abraham Accords countries to help unleash their potential to supply pharmaceuticals to the US and reduce its dependence on China. But the FDA has not warmed to the idea. The US Food and Drug Administration may be losing a battle against its enlistment in efforts to wage peace in the Mideast by turning the region into a pharmaceutical manufacturing hub that protects Americans from overdependence on cheap drugs from China... Sub. Req'd

Florida GOP Lawmakers Turned to Maine Democratic Leader to Discuss Drug Pricing Plan

(1/15, Jacob Ogles, Florida Politics) ...Drew Gattine, a senior policy fellow for the National Academy for State Health Policy, spoke on Jan. 8 to the House Health & Human Services Committee. He was one of two expert witnesses invited there to discuss international drug reference pricing. It's an issue Gattine has discussed in front of state Legislatures across the country, including Connecticut, Minnesota and North Dakota...Notably, in January Florida had a Canadian drug import program approved by the Food and Drug Administration. Support for such policy had not historically broken across clear party lines. Gattine discussed how various states have handled pricing issues... Full

Florida's Plan to Import Cheaper Drugs from Canada Faces Pushback — from Canada

(1/12, Berkeley Lovelace Jr., NBC News) ...The plan to allow Florida to import cheaper prescription drugs from Canada is already facing outrage from Canadians who claim it could make their own drug supply shortages worse. And experts in the U.S. have doubts the program will ever help people in Florida get a cost break on medications for conditions like heart disease and diabetes..."The U.S. needs to solve its own drug pricing problem, and not rely on other countries to do it for them," said Dr. Joel Lexchin, a professor emeritus at the School of Health Policy and Management at York University in Toronto... Full

Editorial: Like Canada, U.S. Should Control Drug Prices

(1/15, Sun Sentinel) ...The FDA's belated approval comes with informational and safety requirements that Florida should not have too much trouble fulfilling. The question, rather, is what might happen in Canada to thwart the savings, as much as $150 million a year, that Florida hopes to gain by purchasing cheaper drugs in Canada for Medicaid, its prison hospitals and programs run by the Department of Children and Families. (Individual consumers are already able to order prescriptions from Canada.) Canada, whose entire population of 38.9 million is only 71% larger than Florida's, is concerned that sizeable purchases by Florida might lead to shortages and higher prices there... Full

NHS Medicines Shortage Putting Lives at Risk, Pharmacists Warn

(1/14, Daniel Boffey, The Guardian) ...An unprecedented medicines shortage in the NHS is endangering lives, pharmacists have said, as unpublished figures reveal that the number of products in short supply has doubled in two years. A treatment for controlling epileptic seizures was the latest to be added on Wednesday to a UK drugs shortage list that includes treatments for conditions ranging from cancer to schizophrenia and type 2 diabetes. Causes of the crisis are thought to include the plummeting purchasing value of the pound since the Brexit referendum, which reduces the NHS's ability to source medicines abroad, and a government policy of taxing manufacturers... Full

U.K. Drug Shortages ‘Worse Than Ever' As Brexit Continues To Bite

(1/15, Katherine Hignett, Forbes) ...British pharmacists are struggling to get their hands on certain medicines for cancer, epilepsy, diabetes and menopause as drug supply issues intensify in the country. The number of drug products in short supply nearly doubled from start of 2022 to the end of last year, data obtained by the British Generic Manufacturers Association show. Around 50 drugs were on a shortage list kept by the government in January 2022, compared with nearly 100 in mid-December 2023... Full

Swissmedic Updates Guidances On API, Fast-Track Pathway, and More

(1/15, Ferdous Al-Faruque, Regulatory Focus) ...Swissmedic has made updates to several of guidances related to active pharmaceutical ingredients, temporary authorization, products that receive fast-track authorization, and other documents how it authorizes products under the Therapeutic Products Act. The agency said it updated its guidance on APIs to reflect its thinking on how complex or heterogenous APIs are reviewed before being allowed on the market... Full

U.S.-India Partnership Boosts Trade and Supply Chains, Says Mukesh Aghi

(1/14, Nivedita Mukherjee, The Sunday Guardian) ...As geopolitically aligned nations, India-US are focused on finding ways to streamline trade partnership and integrate India into the global supply chains: Mukesh Aghi, President & Chief Executive Officer of the US-India Strategic Partnership Forum to the Sunday Guardian... Full

AZ's Migraine Drug Zomig in Short Supply Due to Hoarding

(1/12, Kim Chan-hyuk, Korea Biomedical Review) ...According to the Ministry of Food and Drug Safety, AstraZeneca reported a shortage of Zomig 2.5mg on Thursday...This is the third shortage in just three months. According to AstraZeneca, the previous supply shortage of Zomig has led to continuous stockpiling, causing another shortage since Jan. 2. AstraZeneca expects the supply to resume next Wednesday, adding that the ongoing shortage is not expected to cause a significant effect on patient care... Full

Japan Review/Outlook: Pricing Tweaks Considered After Year Of Change

(1/16, Lisa Takagi, Pink Sheet) ...After a year of revising and opening up its regulations for new drugs in 2023, Japan is aiming to add more reimbursement pricing premiums for innovative medicines in 2024, while cautiously discussing other detailed revisions to regulations and the pricing system...However, this will be balanced by ongoing efforts to contain the rise in overall reimbursement costs under the national health insurance scheme, most notably through continued direct price controls... Sub. Req'd

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