Thursday, April 25, 2024

Alvotech Highlights Lack Of Simponi Rivals As It Delivers Golimumab Results

(4/24, David Wallace, Generics Bulletin) ...Alvotech has just become the first company to announce positive topline results from a confirmatory clinical study for a proposed golimumab rival to Simponi and Simponi Aria – and moreover, the firm sees limited competition from other biosimilars on the horizon...[Alvotech CEO Robert] Wessman said Alvotech would "intend to file marketing applications for AVT05 in major global markets this year, which adds to the continued diversification of our portfolio and further demonstrates the capabilities of our biosimilar-dedicated platform." The firm is already partnering on the product with firms such as Teva in the US, Advanz Pharma in Europe and Fuji Pharma in Japan... Global Sub. Full

FDA Approves Amneal's Naloxone Hydrochloride Nasal Spray As An OTC Treatment for Opioid Overdose

(4/24, Don Tracy, PharmExec.com) ...Amneal Pharmaceuticals announced that the FDA has approved its OTC Naloxone Hydrochloride nasal spray for use in counteracting opioid overdoses. As a generic of Narcan, this nasal spray has also been shown to neutralize overdoses caused by heroin, fentanyl, and prescription opioids. With Naxolone officially available, the company stated that this action provides another affordable option to prevent overdoses, which causes more death in people under the age of 50 years than any other cause... Full

Xbrane Assembles The Troops As FDA Says No To Lucentis Biosimilar

(4/24, Dean Rudge, Generics Bulletin) ...Xbrane Biopharma was riding the crest of a wave with the EU launch of its biosimilar to Lucentis, following years of toil and investment. However, plans to roll out the product in the US will have to be pushed back – likely – into the middle of 2025, following a US FDA complete response letter... Global Sub. Full

Copycats Take Bite Out of AbbVie's Best-Selling Humira Drug

(4/25, Oliver Barnes and Oliver Roeder, Financial Times) ..."CVS has put their stake in the ground that they're going to create a marketplace where one [biosimilar] manufacturer is rewarded," said Jon Martin, head of Organon's US biosimilar arm, which produces Humira competitor Hadlima. "I think that you're going to see other PBMs gradually get to that place because if they want competitive market dynamics, they have to start to reward biosimilars." Two Humira biosimilars — from Organon in collaboration with Samsung Bioepis and Teva Pharmaceuticals working with Alvotech — earlier this year became the first to be granted interchangeable status by the US Food and Drug Administration, which lets pharmacists substitute them for Humira without consulting patients. If interchangeable biosimilars were added to the formularies of the big PBMs next year, that would boost competition, Martin predicted... Full

Sanofi Profit Slips On Generic Competition and Currency Effects

(4/25, Ludwig Burger, Reuters) ...Sanofi's first-quarter operating income fell 14.7% as currency effects and cheap competition to its multiple sclerosis drug Aubagio outweighed rising sales of anti-inflammatory drug Dupixent, the French drugmaker said on Thursday...Analysts have said the recent market debuts of drugs including Beyfortus, to protect infants against a common respiratory infection, are indicative of the company's medium-term earnings prospects. Quarterly sales of Beyfortus came in at a better than expected 182 million euros... Full

Despite Oncology Cutbacks, Sanofi isn't Out of the Game Yet with Early Assets

(4/25, Amber Tong, Endpoints News) ...Sanofi is keeping an early pipeline of oncology projects even as it axed clinical-stage programs and reallocated resources to immunology, CEO Paul Hudson told reporters Thursday morning. Hudson also said that the French pharma is not expecting a significant impact from the US legislation targeting Chinese service providers given the "grandfather nature" of existing relationships... Full

Following Lower-Than-Expected Profits, Evotec Plans to Cut Costs, Completes CEO Search

(4/24, Lei Lei Wu, Endpoints News) ...Evotec announced a "reset" to its business plan as it reported financial results Wednesday, following a year in which many contract drug manufacturers have struggled...While Evotec's 2023 sales were in line with expectations, profits were lower than what Wall Street projected because of higher-than-anticipated costs, according to Jefferies analyst Benjamin Jackson. However, the company's biologics unit did better than anticipated... Full

Roche's Vabysmo Shows No Sign of Slowdown After Regeneron and Bayer's Launch of Eylea HD

(4/24, Kevin Dunleavy, Fierce Pharma) ...In the first quarter of 2024, Vabysmo racked up revenue of 847 million Swiss francs ($927 million), which was up 108% year over year and demolished the analyst consensus of 750 million Swiss francs. It also was a huge leap sequentially from sales of 594 Swiss francs in the fourth quarter of last year...In a conference call on Wednesday, Roche's pharma CEO Teresa Graham said the company has not seen any sales impact on Vabysmo since the start of this month... Full

Roche Unruffled by China Bill As it Looks to Grow Roots in the Region

(4/24, Ayisha Sharma, Endpoints News) ...Roche on Wednesday morning said it has "minor exposure" from the Biosecure Act, adding that it is making strides in China's pharma and diagnostics markets. "We've really worked on diversifying our supply chain and this is helping us now, so that we have multiple partners to work with across the world and we can absolutely adhere to those changes in legislation, should they come," CEO Thomas Schinecker said on a media call. In contrast, Novartis on Tuesday said it is working to shift its CRO collaborations "over time" to prepare for risks if Biosecure moves forward... Full

AstraZeneca Leaps After Smashing First-Quarter Forecasts

(4/25, Eva Mathews, Maggie Fick, Reuters) ...AstraZeneca sailed past market expectations for quarterly revenue and profit on Thursday, boosted by demand for its blockbuster drugs and steady sales from partnered medicines and sending its shares up over 5%. Oncology, the Anglo-Swedish drugmaker's top business, delivered a 26% jump in first-quarter sales to $5.12 billion... Full

Merck Raises 2024 Profit Forecast On Strong Cancer, HPV Drugs Sales

(4/25, Patrick Wingrove, Reuters) ...Merck & Co on Thursday raised its annual profit and revenue forecast on the back of strong sales for its blockbuster cancer drug Keytruda and human papillomavirus vaccine Gardasil. The New Jersey-based drugmaker said it expected earnings of $8.53 and $8.65 per share, up from its previous prediction of $8.44 to $8.59, and sales of $63.1-$64.3 billion for the year... Full

Formycon Reports Audited Annual Results for the Financial Year 2023 – Looking Back On a Successful Operative Year and Exceeded Guidance

(4/25, Formycon AG) ..."The growth rates prove it: biosimilars are on a successful path worldwide. And Formycon is not only part of this process, but we are on our way to become a driving force step by step. In 2023, we reached all the operational milestones we had set and therewith laid the foundations for a successful and profitable future...Our goal is to consolidate our position as one of the few pure-play biosimilar developers and to further expand this position in a dynamic growth environment" explained Dr. Stefan Glombitza, CEO of Formycon AG... Full

Takeda is Fourth Big Company to Leave BIO Since December

(4/24, John Wilkerson, STAT Plus) ..."Takeda decided not to renew its membership with the Biotechnology Innovation Organization at the end of March 2024, aligned with the end of Takeda's Fiscal Year," a company spokesperson said. Pfizer, UCB, and WuXi AppTech also recently ended their membership with the trade group, though the circumstances of WuXi's departure were unusual...The loss of members coincides with a drop in lobbying spending by BIO. The trade group spent $1.76 million in the first quarter of this year, down 27% from $2.43 million during the first quarter of last year... Sub. Req'd

McKinsey Under Criminal Investigation Over Opioid-Related Consulting

(4/24, Alexander Gladstone, The Wall Street Journal) ...The Justice Department is conducting a criminal investigation into consulting firm McKinsey related to its past role in advising some of the nation's largest opioid manufacturers on how to boost sales. Federal prosecutors are also probing whether McKinsey or any of its employees may have obstructed justice in relation to records of its consulting services for opioid producers, according to people familiar with the investigation, which has been ongoing for several years... Sub. Req'd

McKinsey Faces US Criminal Probe Over Opioids Work, Sources Say

(4/24, Mike Spector, Nate Raymond and Chris Prentice, Reuters) ...McKinsey & Co is under criminal investigation in the United States over allegations that the consulting firm played a key role in fueling the opioid epidemic, with federal prosecutors homing in on its work advising OxyContin maker Purdue Pharma and other drugmakers, three people familiar with the matter said...The Justice Department is also investigating whether McKinsey conspired to commit healthcare fraud when its consulting work for companies selling opioids allegedly resulted in fraudulent claims being made to government programs such as Medicare, they said... Full

Big Pharma's ROI for Drug R&D Saw 'Welcome' Rebound in 2023: Report

(4/25, James Waldron, Fierce Biotech) ...A brief uptick in the internal rate of return (IRR) during the COVID-19 pandemic appeared to be an anomaly, with the long-term trend reasserting itself in 2022 to produce a IRR of just 1.2%, the lowest in the 14 years Deloitte has been monitoring the scene. But the 2023 figures are now in, and they suggest the picture isn't as bleak as feared. In fact, the IRR jumped up to a healthy 4.1% last year, according to the April 25 report. The authors branded this a "welcome sign of improvement."... Full

This Is What a Miracle Drug Looks Like. And It Only Costs $5 to Make.

(4/24, David Wallace-Wells, The New York Times) ...A single month's worth of Ozempic or Wegovy is today priced at around $1,000 or more...A month of doses can be manufactured for less than $5, which means that American customers are paying a 200-fold markup or more, with many of them paying it out of pocket. That suggests one additional way that semaglutide could reshape American health and health care: The price of marginal production has never determined American medication costs, but the sheer magnitude of Ozempic demand may force a belated reckoning with the mess of U.S. drug pricing... Sub. Req'd

Walgreens Will Build Out Specialty Pharmacy Business, Leaning into Drug and Therapy Services

(4/25, Lydia Ramsey Pflanzer, Endpoints News) ...In addition to setting up a cell and gene therapy facility, Walgreens is taking its existing specialty pharmacy-related businesses, like community pharmacies that are located near or inside a health system, and putting them all into one division: Walgreens Specialty Pharmacy. Ideally, the rebranded specialty pharmacy business can better work with enterprise partners like health plans, pharma and providers as a competitor to PBM-owned specialty pharmacies... Full

Exclusive: Optum is Shutting Down its Virtual Care Business

(4/24, Ngai Yeung, Endpoints News) ...UnitedHealth Group's Optum is shutting down its virtual care business, Endpoints News has learned. Known as Optum Virtual Care, the business provides online urgent and primary care visits and prescription refills, and was a major part of Optum's push into telehealth services in 2021, as Covid-19 accelerated the industry's adoption of virtual services. The shutdown raises questions about how UnitedHealth is thinking about its virtual strategy... Full

Sanders Launches Investigation into ‘Unacceptable' Diabetes, Weight Loss Drug Prices

(4/24, Sarah Fortinsky, The Hill) ...Sen. Bernie Sanders (I-Vt.), chair of the Senate Health, Education, Labor, and Pensions Committee, on Wednesday launched an investigation into the "outrageously high prices" of Novo Nordisk's respective diabetes and weight loss drugs, Ozempic and Wegovy... Full

US Senate Committee Investigates Pricing of Novo's Ozempic and Wegovy

(4/24, Christy Santhosh and Pratik Jain, Reuters) ...Senator Bernie Sanders, chair of the Senate Committee on Health, Education, Labor and Pensions, sent a letter to Novo's CEO seeking more information on U.S. prices for the two drugs, which are higher than the prices in other countries. The committee also asked Novo if it will substantially reduce both the list price and the net price of both the drugs, and why the company was charging a higher price for the weight loss drug Wegovy than Ozempic, which contains the same compound... Full

Sen. Sanders Launches Probe of Novo's Wegovy and Ozempic Pricing

(4/24, Nicole DeFeudis, Endpoints News) ...A Novo spokesperson told Endpoints News on Wednesday that it "remains committed to working with policymakers to advance solutions to support access and affordability for all patients." "It's easy to oversimplify the science that goes into understanding disease and developing and producing new treatments, as well as the intricacies of U.S. and global healthcare systems. However, the public debate doesn't always take into account this extremely complex reality," the spokesperson said... Full

Sanders Demands Pricing, Sales Data For Novo Nordisk's Lucrative GLP-1 Drugs

(4/24, Maaisha Osman, InsideHealthPolicy) ...Sanders asks the company to share a broad spectrum of information on the drugs, including a detailed breakdown of prices and sales for the blockbuster semaglutide drugs, internal communications about pricing and patents, and information about research and development costs. A spokesperson for Novo told Inside Health Policy the company agrees that "access to these important treatments is essential for patients in Medicare, Medicaid and the commercial markets."...The Pharmaceutical Research and Manufacturers of America (PhRMA) accuses Sanders of targeting Novo to "advance a personal political agenda," while giving a free pass to pharmacy benefit managers... Sub. Req'd

Novo Nordisk Probed by Senate Committee on Weight-Loss Drug Prices

(4/24, Ben Glickman, Dow Jones) ...Novo Nordisk said in a statement it agreed that it was important to give patients access to Ozempic and Wegovy..."Novo Nordisk remains committed to working with policymakers to advance solutions to support access and affordability for all patients, and we reiterated this commitment in our conversation with Chairman Sanders." Sanders requested Novo Nordisk turn over detailed information on pricing, sales and insurance coverage for the drugs, as well as communications related to pricing and the product... Full

Medicaid Saved When Switching to Interchangeable Insulin Glargine

(4/24, Denise Myshko, Managed Healthcare Executive) ...The introduction of an interchangeable biosimilar insulin glargine saved $60.6 million for Medicaid programs between the fourth quarter of 2021 and the fourth quarter 2022, or about 5% of Medicaid spending on insulin glargine, according to a poster presented at the recent annual meeting of the Academy of Managed Care Pharmacy in New Orleans... Full

AMCP Posters Tackle Interchangeability and Medicaid, Factors Driving Biosimilar Access

(4/24, Skylar Jeremias, The Center For Biosimilars) ...A poster examining the impact of the first interchangeable biosimilar for insulin glargine on spending and utilization of state Medicaid programs found the interchangeability label helped reverse a declining market share for insulin glargine biosimilars, helping to generate significant savings for the programs. However, the researchers noted that utilization of biosimilars varied widely across states, suggesting the need for more biosimilar education and financial incentives to promote their adoption. Additionally, 4 states, and Puerto Rico, completely restrict interchangeability... Full

Pharma Can Pursue Claims Against Providers For 340B Duplicate Discounts In Medicaid Managed Care, HRSA Says

(4/24, Cathy Kelly, Pink Sheet) ...Manufacturers can pursue claims against 340B hospitals and other providers when they provide rebates in the Medicaid managed care program for drugs already purchased at a 340B discount, the Health Resources and Services Administration stated in its final rule on the 340B administrative dispute resolution (ADR) process...President and CEO Maureen Testoni told the Pink Sheet that under the law, any issues regarding duplicate discounts in Medicaid managed care should be resolved between manufacturers and the states and not involve providers in the ADR process... Sub. Req'd

Insurance Data: PBM Reform Has No Material Impact On Premiums

(4/24, Nick McGee, PhRMA) ...A first-of-its-kind analysis found no evidence a new law requiring insurance companies and their pharmacy benefit managers (PBM) to share rebates with patients has an impact on premiums...The findings reaffirm other research that has shown sharing rebates directly with patients would have minimal impact on premiums. But the savings can be huge for some patients. This is certainly welcome news for people who need lifesaving cures and treatments, and it's welcome news for lawmakers pushing this reform forward, even in the face of myths and scare tactics... Full

Independents Outshine PBMs in Manufacturers' Exclusive Specialty Pharmacy Networks

(4/24, Adam J. Fein, Ph.D., Drug Channels) ...Today, we examine how manufacturers' specialty networks contribute to this concentration. In DCI's exclusive analysis below, we show that specialty pharmacies affiliated with pharmacy benefit managers play an outsized role in manufacturer-designated dispensing networks... Full

Shortages of Generic Drugs Can't Be Blamed Solely On Group Purchasing Organizations

(4/25, James B. Rebitzer and Robert S. Rebitzer, STAT) ...Today, however, generic drugs seem to be a victim of their success. Important categories of drugs — from antibiotics to chemotherapies to saline solution — experience persistent shortages and inadequate quality. Why? Prices have dropped so low that manufacturers don't have the resources to produce adequate quantities of drugs or ensure compliance with quality standards. Such shortages are becoming a feature of the generic pharmaceutical industry... Full

White House Plan To Curb Drug Shortages Doesn't Address Generics' Quality

(4/24, Arthur L. Kellermann, Forbes) ...Drug shortages are at an all-time high. The White House rolled out a plan earlier this month intended to sharply reduce future shortages of essential medicines, such as antibiotics and cancer drugs...The plan does not encourage, much less require, U.S. wholesalers and pharmacy benefits managers (the powerful middlemen in the drug supply chain) to source the generic drugs they buy from manufacturers that consistently produce high-quality products. This is surprising, since quality concerns cause more drug shortages than all other factors combined. In her interview with Bloomberg, Tanden explained that the Administration did not want to undermine the FDA's role as the "arbiter of the quality of drugs."... Full

Biosimilars Haven't Always Yielded Lower Out-Of-Pocket Costs for Patients, Study Finds

(4/24, Ed Silverman, STAT Plus) ...Two years after biosimilars became available in the U.S., a higher proportion of patients using brand-name biologics were paying out-of-pocket costs, which were also, on average, 12% higher than before, according to a recent study. In addition, patients who used biosimilars often did not pay lower out-of-pocket costs than those who were given brand-name biologic medicines... Sub. Req'd

Drug and Biotech Companies Join Lobbying Push On China Bill As Scrutiny of WuXi Continues

(4/24, Jared Whitlock and Lia DeGroot, Endpoints News) ...The list of companies that have registered to lobby on the legislation includes many of the biggest names in biopharma, such as Vertex, Amgen, Takeda, AstraZeneca, BeiGene and GSK, services and testing companies including Illumina, Danaher and Thermo Fisher, and advocacy groups for the drug industry, academic centers and other groups...Other major drugmakers that have partnered with WuXi entities — including Amgen and GSK, according to corporate records and news articles — also registered to lobby on Biosecure but declined to comment... Full

Mary Beth Clarke, CDER Exec Programs Office Director And Generic User Fee Shepherd, Will Retire

(4/24, Derrick Gingery, Pink Sheet) ...Clarke helped launch GDUFA I and negotiate GDUFA II, chaired the CDER Executive Committee and oversaw many other programs in the US FDA's drugs center. Mary Beth Clarke, the long-time US Food and Drug Administration official who helped usher in the generic drug user fee era, is set to retire...Gil Roth, president of the Pharma and Biopharma Outsourcing Association, said Clarke's presence still was felt throughout GDUFA III talks even though she was not present... Sub. Req'd

FDA To Drug Makers: Don't Imply Reference Drugs, Interchangeables Superior To Biosimilars

(4/24, Jessica Karins, InsideHealthPolicy) ...FDA warns drug makers in a new draft guidance not to imply in their promotional and advertising materials that reference drugs are superior to their biosimilars, or that interchangeable biosimilars are clinically distinct from other biosimilars. The warning that such statements could be "false or misleading" comes as the Biden administration takes regulatory steps to increase use of biosimilars, and asks Congress to remove the distinction between biosimilars with interchangeability status and those without... Sub. Req'd

FDA's Biologics Chief Peter Marks Previews Accelerated Approval Guidance

(4/24, Zachary Brennan, Endpoints News) ...The FDA's Center for Biologics Evaluation and Research is planning to release some crucial guidance soon for CRISPR and gene therapy developers on platform technologies, accelerated approvals for rare diseases, and potentially in the "not-too-distant future," a platform technology guidance specifically for genome editing, CBER Director Peter Marks said Tuesday in an Alliance for a Stronger FDA webinar... Full

Changes To EU Pharma Reform: More Questions Than Answers?

(4/24, Ian Schofield, Pink Sheet) ...In the first of a series of articles on the future direction of the EU pharmaceutical reform proposals, the Pink Sheet looks at the new uncertainties created for the drug industry after the European Parliament voted through a series of amendments in the area of regulatory data protection. The proposed reform of the EU pharmaceutical legislation passed a major hurdle after it was Okd by the European Parliament earlier this month, but there is still a long way to go before it is approved by the member states and finally adopted... Sub. Req'd

EU Approves New Antibiotic to Tackle Rise of Superbugs

(4/22, Ian Johnston and Michael Peel, Financial Times) ...The EU has approved a new antibiotic for serious illnesses such as pneumonia and urinary tract infections, marking a step forward in the drive to combat the growing resistance of "superbugs" to existing drugs. Emblaveo, marketed in Europe by US pharmaceutical company Pfizer, combines two existing medicines to tackle so-called Gram-negative bacteria that are among the leading drug-resistance threats... Sub. Req'd

Big Opportunity For Indian Drugmakers as 24 Mega-Seller Drugs Set to Lose Patent by 2030: Govt Study

(4/25, Himani Chandna, News 18) ...From global mega-seller arthritis and cancer drugs, Humira and Keytruda, to popular asthma inhaler Symbicort, 24 major blockbuster drugs are set to lose their patents by 2030, according to a study by the Department of Pharmaceuticals. Overall drugs worth annual sales of more than $250 billion or Rs 20.75 lakh crore are set to lose patent protection by 2030, opening a huge market for generic drug makers across the globe, especially in India... Full

Centre Expands Committee Participation to Usher in Drugs Pricing Reforms

(4/24, Somrita Ghosh, Mint) ...The department of pharmaceuticals has decided to expand the committee to oversee efforts to reform drug and medical device pricing by bringing in more industry participants, according to an order issued by it. As per the order seen by Mint, it has invited at least seven industry associations to the committee that has been tasked with striking a balance between pricing and availability of essential medicines, while offering incentives to the industry to foster growth and exports... Full

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