Thursday, November 7, 2024

Teva Pharmaceutical Sees More Growth in 2025 After Strong Q3

(11/6, Steven Scheer, Reuters) ...Teva recorded double-digit sales growth in generic drugs as well as in sales of its trio of key branded medicines. "2025 will be a bit of more of the same - more innovative growth, the ability to continue our generics performance, but also then start to add up our biosimilar business," Chief Executive Richard Francis told Reuters after the results were issued. He did not provide specific numbers... Full

Teva's Generics and Biosimilars Fuel Another Booming Quarter

(11/6, Kevin Dunleavy, Fierce Pharma) ...Those under the impression that Francis' "Pivot to Growth" strategy—which he introduced in May of 2023—would follow the familiar blueprint of other pharma giants were mistaken. Though Teva's primary goal was to beef up its innovative products portfolio, there was no de-emphasis on generics and biosimilars. "Our third pillar (of Pivot to Growth) was about creating a sustainable generics powerhouse," Francis said in an interview with Fierce Pharma on Wednesday. "In no way were we in a sense stepping away from generics."... Full

Teva Reports Seventh Straight Quarter Of Growth

(11/6, Shiri Habib-Valdhorn, Globes) ...The Israeli pharmaceutical company has again raised 2024 revenue guidance, this time to $16.1-16.5 billion. Teva Pharmaceutical Industries Ltd. ended the third quarter with $4.33 billion revenue and non-GAAP earnings per share of $0.69, beating the analysts' consensus, which had forecast $4.12 billion revenue and $0.66 per share... Full

Teva Soars with Double-Digit Growth in Q3, Raises Annual Forecast

(11/6, Sophie Shulman, CTech) ...This marks the seventh consecutive quarter of growth for Teva, prompting the company to raise its annual forecast once again. Teva now expects annual revenues of $16.1 to $16.5 billion. The improved outlook is largely attributed to the stronger-than-expected performance of its new drug, Uzedy, which is projected to generate $100 million this year, compared to previous forecasts of $80 million. Launched earlier this year, Uzedy is designed to treat schizophrenia... Full

Teva Retreats, Sacrificing A Breakout, Despite Its Third-Quarter Beat And Raise

(11/6, Allison Gatlin, Investor's Business Daily) ...Teva stock plunged Wednesday — sacrificing an earlier breakout — despite beating Wall Street's third-quarter expectations and raising its guidance...But Chief Executive Richard Francis remained upbeat. "This is a new Teva now," he told Investor's Business Daily. "We talked about pivotal growth 18, 20 months ago. People thought it was a story. They thought it was fiction. I think people are seeing now, after several quarters of growth, that this is not fiction, this is a plan we're executing."... Full

Teva Pharm CEO Says Will Work Productively With Trump Administration

(11/6, Steven Scheer, Reuters) ...Teva Pharmaceutical Industries expects to work productively with the incoming Trump administration in the United States, chief executive Richard Francis said on Wednesday...He said, though, it wouldn't be clear until after Donald Trump takes office what his healthcare and pharmaceutical policies will be. Francis also said that he expects 2025 to be "more of the same" for the company, with growth in branded drugs, continuing growth in its generics drugs business, plus more sales of biosimilars... Full

Biotech and Pharma Executives On What Trump and RFK Jr. Could Mean for the Industry

(11/6, Allison DeAngelis, Matthew Herper, Andrew Joseph, Jason Mast, and Ed Silverman , STAT Plus) ...If there's one thing you'd ask the new administration to do differently, what would it be? [Richard Francis, CEO of Teva Pharmaceutical] "The U.S. could benefit from access that's made available in a more simplistic fashion. This goes for generics and biosimilars. It hasn't happened as quickly as it should have. It goes through this slightly distorted system of PBMs and payers. It's nothing I can't control, but we need changes, because if access were to happen more quickly, it would benefit everyone."... Sub. Req’d

Phase 3 Data Shows TEV-‘749 Injection Improves Social Function in Schizophrenia

(1/6, Chelsie Derman, HCP Live) ...TEV-‘749 significantly improved social functioning and quality of life in schizophrenia patients, meeting primary efficacy endpoints in the SOLARIS trial. The safety profile of TEV-‘749 was comparable to existing oral olanzapine formulations, with no increased risk of PDSS...TEV-‘749 and risperidone offer promising long-acting injectable options for schizophrenia, potentially reducing the burden of daily oral medication adherence... Full

Biocon's Growth Rides On FDA Site Inspection Outcomes After Muted Q2

(11/6, Urte Fultinaviciute, Generics Bulletin) ...Despite the biosimilars business reporting increased quarterly sales, further success for Biocon depends on the outcome of the US Food and Drug Administration's site inspections, analysts say. Biocon Biologics reported sales of INR21.8bn ($259.2m) in Q2 FY2025, which was an 11% year-on-year increase. It was the only segment out of Biocon's three divisions to report income growth in the quarter, accounting for 59% of Q2 revenues... Global Sub. Full

Biogen Celebrates As EPO Upholds Tecfidera Patent

(11/6, Dave Wallace, Generics Bulletin) ...Biogen has notched up another victory in its attempts to keep generic versions of its Tecfidera (dimethyl fumarate) brand off the market in Europe. The European Patent Office's opposition division has upheld the validity of the firm's European patent EP2,653,873, which expires in February 2028...As a result, generic versions sold by Accord Healthcare, Mylan, Neuraxpharm, Polpharma and Teva in the EU had to be pulled from the market after the European Commission revoked their centralized marketing authorizations... Global Sub. Full

Celltrion Sets Sights On 2030 With Expanded Biosimilar Portfolio, Market Reach

(11/6, Skylar Jeremias, The Center For Biosimilars) ...Currently, Celltrion USA has 6 biosimilars (infliximab, rituximab, trastuzumab, adalimumab, bevacizumab, on the US market, as well as Zymfentra, a novel product that allows for the subcutaneous administration of its infliximab biosimilar (Inflectra, Remsima). In international markets, Zymfentra is marketed as a biosimilar under the name Remsima SC.2 By 2030, Celltrion said that it plans to have 12 immunology products, 7 oncology offerings, and 3 products for other therapeutic areas... Full

Hikma Reiterates Outlook On Strong Trading

(11/7, Abigail Townsend, ShareCast) ...Hikma said it had seen strong trading across all three of its units - injectables, branded and generics - this year. In particular, its injectables business benefited from the acquisition of Danish rival Xellia, which completed in September. It is expected to contribute revenues of around $20m this year... Full

Indian Drugmaker Alembic Pharma Misses Q2 Profit View as US Sales Growth Slows

(11/7, Nishit Navin, Reuters) ...Indian drugmaker Alembic Pharmaceuticals reported a smaller-than-expected rise in second-quarter profit on Thursday, hurt by a slowdown in the U.S. market amid pricing pressure...U.S. generics sales grew 5%, but slowed down from an 18% rise in the previous quarter... Full

Gilead 3rd-Quarter Results Beat Wall Street Estimates, Raises Outlook

(1/6, Deena Beasley, Reuters) ...Gilead Sciences reported third-quarter financial results that handily beat Wall Street expectations on Wednesday as sales climbed 7%, leading the drugmaker to raise its outlook for full-year earnings...Due to "the strength of our overall business model ... we're increasing our 2024 guidance across every metric," Gilead Chief Executive Officer Daniel O'Day told Reuters... Full

Amgen Aims To Enter GLP-1 Market With Different Drug Approach

(11/6, Maaisha Osman, InsideHealthPolicy) ...Pharmaceutical company Amgen Inc. says the GLP-1 drug for weight loss it is developing will set itself apart from rival Novo Nordisk and Eli Lilly drugs by addressing the root causes of obesity. The company aims to achieve less frequent dosing for patients and combat related conditions like obstructive sleep apnea and atherosclerotic disease... Sub. Req’d

Advent Mulls €5 Billion Sale of Generic Drugmaker Zentiva

(11/7, Dinesh Nair, Swetha Gopinath and Pamela Barbaglia, Bloomberg) ...Advent is working with Goldman Sachs Group Inc. and boutique adviser PJT Partners Inc. to explore options for the business that it acquired in 2018, the people said, asking not to be identified as the matter is private. The business is likely to draw interest from other buyout firms and financial investors who are keen to expand in the sector, the people said... Full

Drugs for Unmet Needs and Those from Experienced Companies Had the Best Chance for Successful Launches in 2023: Report

(11/6, Kevin Dunleavy, Fierce Pharma) ...According to Trinity's report: "Moving the Needle: Lessons from the 2023 Launch Class," Skyclarys supports one of the key findings of the 2023 analysis, which held that several companies—both big and small—had successful launches of drugs that address an unmet need. Trinity defines a successful launch as one in which sales exceed analyst expectations... Full

With Trump's Return, Pharma Trades Disagreeable Knowns For Uncertainty

(11/6, Jessica Merrill, Pink Sheet) ...The election of Republican Donald Trump as the next president of the US could suggest a smoother road ahead for pharmaceutical manufacturers on drug pricing policy and mergers and acquisitions. But an administration friendlier to pharma is not a guarantee and Trump's bombastic rhetoric and disruptive leadership style will add a high degree of uncertainty for industry in Washington DC... Global Sub. Full

Fate Of IRA Negotiations Uncertain After Trump Election Victory

(11/6, Gabrielle Wanneh, InsideHealthPolicy) ...President-elect Donald Trump has won a second term without articulating a concrete plan for how he would lower prescription drug costs in America, placing Biden administration policies to rein in high drug prices, including Medicare drug price negotiations under the Inflation Reduction Act, on shaky ground. Trump is expected to revive some policies from his first term, while others will likely fall by the wayside... Sub. Req’d

FTC Under Trump Likely to Maintain PBM Focus But M&A Oversight May Moderate

(11/6, Cathy Kelly, Pink Sheet) ...The FTC will maintain and could heighten its scrutiny and enforcement of PBMs during a second Trump Administration. But the commission likely will be more flexible in its attitude toward biopharma mergers and acquisitions, which is expected to facilitate more consolidation in the industry. The FTC's interest in discouraging patent gaming by brand drug firms also may continue in the next administration... Global Sub. Full

More M&A, or a Shake-Up at the FDA? Pharma Braces for Trump's Return to the White House

(11/6, Zoey Becker, Fierce Pharma) ...The president-elect's "concepts of a plan" regarding healthcare haven't been laid out yet, but he has a few options on the table. There's a chance he could move to revive his Most Favored Nation drug pricing policy that died out quickly after attracting lawsuits, or he could look to Project 2025, a controversial 922-page policy proposal by The Heritage Foundation, for a few ideas... Full

US FDA's Drug Approval Norms Could Be Upended In Second Trump Term

(11/7, Sarah Karlin=Smith, Pink Sheet) ...Despite the recent anti-vaccine rhetoric in the final weeks of the Trump campaign, pulling an established safe and effective product off market would be difficult. But there's little to stop political interference in approvals and it is unclear Trump and his base would care about violating them... Global Sub. Full

Robert F. Kennedy Jr., Foe of Drug Makers and Regulators, Is Poised to Wield New Power

(11/6, Sheryl Gay Stolberg, Rebecca Davis O'Brien, The New York Times) ...Some have speculated that Mr. Trump will make him a "health czar" inside the White House, to guide the president on public health matters; a person familiar with the transition said Mr. Kennedy was at Mar-a-Lago on Wednesday and spoke with Trump insiders about the public health agenda...Now that Republicans will control the Senate, Mr. Kennedy could theoretically win confirmation for any one of a number of top health jobs: secretary of Health and Human Services, commissioner of the Food and Drug Administration or director of the Centers for Disease Control and Prevention... Sub. Req’d

GSK CEO Emma Walmsley On the New Trump Administration, Trust, AI and China

(11/6, Drew Armstrong, Endpoints News) ...Despite the rise of a vaccine skeptic in the campaign of US presidential election winner Donald Trump, GSK CEO Emma Walmsley believes her company can work "constructively" with the incoming administration..."We've worked very successfully with that administration, including through Covid," Walmsley told Endpoints News at the Financial Times' Global Pharma and Biotech Summit in London. Walmsley spoke on stage Wednesday with Executive Editor Drew Armstrong about vaccines, changing US policy, the global relationship with China, and how artificial intelligence will reshape workforces... Full

Blue Shield Of California Push For Cheaper Biosimilars Could Disrupt Market

(11/6, Joshua P. Cohen, Forbes) ...Bloomberg reports that BSC struck a deal with Evio Pharmacy Solutions, which is owned by BSC and other Blue-branded health carriers. Unlike a PBM, BSC will pay Evio a flat fee to negotiate directly with drug manufacturers rather than a payment calculated based on the drug's price... Full

Industry Groups Spar Over FDA's Proposed Compounding Survey

(11/6, Joanne S. Eglovitch, Regulatory Focus) ...The Outsourcing Facilities Association (OFA) has called for more transparency in US Food and Drug Administration (FDA) inspections and in the development of the 503B bulk drug substances list, which lists drugs substances for which there is or isn't a clinical need for compounding. The Pharmaceutical Research and Manufacturers of America (PhRMA), on the other hand, urged greater FDA oversight of compounding by outsourcing facilities... Full

FDA Q&A: Addressing Biosimilar Safety, AI in Drug Development, and Supply Chain Challenges

(11/6, Skylar Jeremias, AJMC) ...As the US unravels the results from the presidential election, a Q&A with an anonymous FDA spokesperson discusses efforts to reduce misinformation about biosimilars, emphasizing education and experience to build confidence in their safety. The FDA is also collaborating with international regulators to streamline biosimilar development and reduce costs, aiming to enhance global competition and accessibility. To build public trust, the FDA continues to educate the public on the rigorous approval process for biosimilars, ensuring they meet high safety standards... Full

California Voters Say Yes to Restrictions Around 340B Spending

(11/6, Nicole DeFeudis, Endpoints News) ...According to unofficial results, 51.5% of voters said yes to the measure, which calls for rules that limit how certain entities can spend revenue from the program. 340B was established in 1992 to provide discounts to health systems and hospitals serving low-income patients. But supporters of the California ballot measure have argued that some entities use "a legal loophole to game the system."... Full

Medicines for Ireland unveils General Election Manifesto

(11/7, Medicines for Ireland) ...Chairperson of MFI, Paul Neill said "As we approach a critical juncture in Ireland's healthcare landscape, we must prioritise the accessibility and affordability of essential medicines. Our manifesto outlines a clear path to achieving this by addressing the barriers to early market entry for generics and biosimilars. By implementing these reforms, we can ensure that Irish patients have timely access to the treatments they need, while also delivering significant cost savings to the State."... Full

‘New Era' To Begin For UK's ILAP In 2025, With Focus On ‘Transformative' Drugs

(11/6, Ian Schofield, Pink Sheet) ...The UK's Innovative Licensing and Access Pathway (ILAP) is to enter a "new era" when it is relaunched at the beginning of 2025 with tighter entry criteria to ensure it is more closely focused on "potentially transformative" medicines, according to the drugs regulator, the MHRA... Global Sub. Full

‘Pharma City to Be Ready for Units to Set Up Shop in 1 Year'

(11/7, The Times of India) ...After declaring the Telangana govt's intention to scrap Hyderabad's Green Pharma City project earlier this year during BioAsia 2024, industries and IT minister Duddilla Sridhar Babu on Wednesday said infrastructure development on the project is moving rapidly, with industries expected to begin setting up shop there within a year. The minister said five major pharma companies—Dr Reddy's Laboratories, Aurobindo Pharma, Hetero, Laurus Labs, and MSN Pharmaceuticals—have already committed to significant investments in the upcoming 19,000-acre project, which is being touted as India's answer to China's humongous scale... Full

NPPA Asks Companies to Cut Prices of Three Cancer Drugs Post Tax Relief

(11/7, Teena Thacker, The Economic Times) ...In a move aimed at providing relief to cancer patients, the National Pharmaceutical Pricing Authority (NPPA) has directed drug manufacturers to reduce the maximum retail price (MRP) of three crucial cancer drugs. This directive follows the government's decision to exempt Trastuzumab Deruxtecan, Osimertinib, and Durvalumab from Customs duty and reduce GST rates on these medications... Full

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