Thursday, August 1, 2024

Teva Pharma CEO: Majority of Momentum Came From Innovative Business, Not GLP-1s

(7/31, CNBC) ...Richard Francis, Teva Pharma CEO, joins 'Money Movers' to discuss how much of the company's momentum is around its generic obesity drug, the market's excitement around its GLP-1 drug, and much more... Full

Teva Posts Impressive Q2 Results, Ups 2024 Revenue Forecast

(7/31, Sophie Shulman, CTech) ...Teva reported stronger-than-expected results for the second quarter of 2024, ending the quarter with revenues of $4.2 billion and earnings of 61 cents per share. This surpassed forecasts, which had predicted revenues of $4.05 billion and earnings of 55 cents per share...Teva increased marketing expenses by 9% in line with CEO Richard Francis' strategy to shift toward growth... Full

Teva Boosts Forecasts as Sales of Generics, Huntington's Disease Drug Jump

(7/31, Bhanvi Satija and Michael Erman, Reuters) ...Teva Pharmaceutical Industries raised its annual forecasts on Wednesday, banking on strong demand for its cheaper copycat medicines, including a GLP-1 generic, and branded treatment for Huntington's disease. The drugmaker has been looking to launch six biosimilars by 2027, which, along with its branded medicines, is expected to drive growth..."We're well set for this (Simlandi) to generate some performance in third and fourth quarters of this year," CEO Richard Francis said on a post-earnings call... Full

Teva Rides Growth Momentum Through Q2, Boosts '24 Sales Outlook

(7/31, Eric Sagonowsky, Fierce Pharma) ...During the second quarter of the year, Teva grew sales 11% in local currency terms to $4.2 billion. The performance comes after the company reported a 5% revenue increase during the first quarter...Now, after releasing second-quarter results for 2024, Teva has raised its annual revenue guidance to a new range of $16 billion to $16.4 billion. The forecast adds $300 million to the low end of the company's prior guidance of $15.7 billion to $16.3 billion... Full

Teva Pharma Flirts With Breakout As Generic Drugs Drive Beat-And-Raise

(7/31, Allison Gatlin, Investor's Business Daily) ...Chief Executive Richard Francis credited generic drugs and Austedo for the strong second-quarter showing. Austedo treats movement disorders tardive dyskinesia and chorea associated with Huntington's disease... Full

Teva Factored IRA's Next Round of Negotiations into its Growth Plans

(7/31, Nicole DeFeudis, Endpoints News) ...Teva will soon move into the next phase of its "pivot to growth" strategy, which has involved manufacturing site closures, a shift away from some lower-margin generics, and plans to sell off its API unit in the first half of 2025. Francis told Endpoints News that the company is "in the thick of" that process with its API unit, but declined to provide further detail...Teva landed in hot water with the FTC earlier this month, when the agency launched a civil investigation into a group of drug patents it said are improperly listed in an FDA database. Without going into much detail, Francis told Endpoints that Teva stands behind its patents, and has no intention to pull them from the database, also known as the Orange Book... Full

Teva Raises Guidance As Generics Enjoy Solid Growth In Q2

(8/1, David Wallace, Generics Bulletin) ...President and CEO Richard Francis summarized that "we've done six quarters of growth, and we continue to believe we will be returning to growth and have the opportunity to continue on that journey, because of the work we're doing and the results we're seeing with [innovative brands] Austedo (deutetrabenazine), Uzedy (long-acting injectable risperidone), Ajovy (fremanezumab) and also the generics business as well as the biosimilar pipeline starting to come through."... Global Sub. Full

Teva's Generics Business Drives Revenue Growth to $4.2B

(7/31, Molly Huth, MM+M) ...Of note, Teva said it expects results of duvakitug, which had an accelerated development timeline, in Q4. "We are also showing significant progress in on our late-stage innovative pipeline, underscored by the acceleration of the development timeline of duvakitug (Anti-TL1A), with top-line results now expected in the fourth quarter of 2024, and full data expected next year," Francis added... Full

Teva Price Target Raised to $22 from $21 at Barclays

(8/1, The Fly) ...Barclays analyst Balaji Prasad raised the firm's price target on Teva to $22 from $21 and keeps an Overweight rating on the shares. The company's Q2 beat was led by Austedo, the analyst tells investors in a research note... Full

Dr Reddy's Dishes On Denosumab, Abatacept Filings Amid ‘Steady' Q1

(7/31, Dean Rudge, Generics Bulletin) ...Dr Reddy's has provided key expected dates for movement on its slate of pending biosimilars, as it continues to drive towards a meaningful impact from biosimilars in key markets in 2026/27. Dr. Reddy's Laboratories expects to launch its Alvotech-partnered proposed denosumab biosimilar by the end of calendar 2026, as the Indian firm guides towards spending 20% of its research and development budget on biosimilar products: a strategy it calls "very, very important activity for us."... Global Sub. Full

Cipla Signals Deal Appetite, Readies New Growth Avenues In Mental Health, Obesity

(8/1, Anju Ghangurde, Generics Bulletin) ...Cipla's managing director and global CEO, Umang Vohra, indicated that company expects to diversify beyond key areas such as lung leadership, antimicrobial resistance and wellness, into the mental health and obesity segments...In response to a query from Generics Bulletin sister publication Scrip at a media interaction, Vohra said that the efforts in mental health will be driven by a mix of the licensing as well as the firm's own portfolio. Epilepsy and migraine are also some of the areas that the company is working on. "They're not full-scale psychiatry. I think that will follow later," Vohra added... Global Sub. Full

Indian Drugmaker Sun Pharma Beats Q1 Profit Expectations

(8/1, Rishika Sadam and Kashish Tandon, Reuters) ...The Mumbai-based company's net profit rose 40% to 28.36 billion rupees ($339 million) in the three months ended June 30, beating analysts' average estimate of 24.78 billion rupees, according to LSEG data. Revenue, however, missed analysts' estimates as generic drugmakers continue to take the hit of lower pricing of drugs in the competitive U.S. market...Most of India's generic drugmakers derive a significant share of revenue from the United States, where lower drug prices amid stiff competition have been weighing on companies' margins... Full

Moderna Reins in 2024 Sales Forecast, Expects Very Low EU Vaccine Revenue

(8/1, Patrick Wingrove, Reuters) ...Moderna on Thursday cut its 2024 sales forecast for COVID-19 and respiratory syncytial virus vaccines by up to 25%, or $1 billion, as it expects very low sales to the EU, sending the shares of vaccine maker down nearly 11% before the bell...The company said it now expects to make between $3 billion and $3.5 billion in sales for the year following discussions with EU officials over COVID-19 vaccine contracts for the bloc. Moderna Chief Financial Officer James Mock told Reuters it had yet to secure a joint purchasing agreement with the EU, although it was still in discussions... Full

GSK's Weak Vaccine Sales Eclipse Brighter Annual Forecast

(7/31, Ashleigh Furlong, Bloomberg) ...GSK has streamlined its portfolio under Chief Executive Officer Emma Walmsley, spinning off its consumer business to shore up vaccine development. The launch of a shot for respiratory syncytial virus in the US last year saw the company secure a larger portion of the market than rival Pfizer Inc. However, expectations for the vaccine's continued growth have been stymied by lack of a US recommendation for use of the shot in younger age groups... Full

Amneal To Deliver On Three 505(b)(2) Injectables Promise In 2024

(8/1, Urte Fultinaviciute, Generics Bulletin) ...The US Food and Drug Administration has approved Amneal's new presentation of potassium phosphates in 0.9% sodium chloride injection intravenous ready-to-use bags...Amneal teased about its plans to launch two to three 505(b)(2) injectables each year going forward during the firm's Q4 and full-year 2023 earnings call in March, as the firm continued to shift towards a more complex product portfolio... Global Sub. Full

Takeda Defends Alzheimer's Pact, TYK2 Potential as Restructuring is in 'Full Swing'

(7/31, Kyle LaHucik, Endpoints News) ...In its quarterly update on Wednesday, Takeda executives said the Japan-based pharma giant's $900 million restructuring is in "full swing" as the pipeline has been reconfigured to focus on late-stage hopefuls. Layoffs have hit multiple units in recent months, but leadership defended the drugmaker's recent Alzheimer's pact with AC Immune and remained upbeat on its mega-bet in the TYK2 space in response to analysts' questions about underperformance from competitors... Full

Lundbeck leaves Trintellix to Partner Takeda in the US, Opting for Royalties as it Focuses Efforts On Rexulti

(7/31, Zoey Becker, Fierce Pharma) ...Ending promotional efforts for Trintellix in the U.S. will allow Lundbeck to "fully reallocate" resources to support "other growth opportunities," including antipsychotic Rexulti, Lundbeck said in a release. With two years left until Trintellix loses U.S. patent protection at the end of 2026, Lundbeck will receive a fixed, undisclosed royalty rate based on net U.S. sales in 2025 and 2026. The writing was on the wall for Lundbeck's pivot to a Rexulti focus... Full

Sage Changes Main Endpoint in Huntington's Study Months Ahead of Readout

(8/1, Max Gelman, Endpoints News) ...Sage Therapeutics is altering the primary endpoint of a Phase 2 study for its drug candidate dalzanemdor in cognitive impairment associated with Huntington's disease, just months before trial results are expected...CMO Laura Gault said Sage made the decision after seeing that some aspects of HD-CAB were "directionally positive" in spite of the small difference in the topline result. Gault added that Sage also discussed the move with Huntington's patient organizations and other experts... Full

Sanofi to Invest 1.3 Bln Euros in New Insulin Plant in Frankfurt

(8/1, Friederike Heine, Reuters) ...French drugmaker Sanofi will invest 1.3 billion euros ($1.40 billion) in a new insulin production facility at its existing site in Frankfurt, where it makes insulin brand Lantus, the company said on Thursday. The investment will pave the way for the construction of a 36,000-square-metre facility that will replace Sanofi's current insulin production plant in Frankfurt's Hoechst district by 2029, the company said... Full

Novo Nordisk to Launch Weight-Loss Drug Wegovy in Australia this Month

(8/1, Jacob Gronholt-Pedersen, Reuters) ...Danish drugmaker Novo has launched its Wegovy weight-loss medicine in Australia, the drugmaker said on Thursday, making the hugely popular drug available in 12 countries...It is a market that analysts estimate could be worth up to $100 billion by the end of the decade... Full

Updated: Eisai Says Alzheimer's Drug Keeps Working After Three Years. But Weaknesses in Study Raise Questions

(7/31, Ryan Cross, Endpoints News) ...Now, the company claims it has new data to back that hypothesis. But the results unveiled Tuesday also raise questions about how the data in the study were analyzed, and if the results are really as strong as Eisai appears to be saying they are. "The value proposition of the anti-amyloid therapies is that they lead to the long-term benefit. What we've got at the moment is probably too marginal to be happy with, given the cost and side effects," Scott Ayton, a director at The Florey Institute of Neuroscience and Mental Health at the University of Melbourne, told Endpoints News in an interview... Full

Hong Kong's AMTA Settles Quickly On Upsher-Smith's Qudexy XR

(7/31, Dean Rudge, Generics Bulletin) ...A Hatch-Waxman case in Delaware stemming from AMTA Labs' proposed generic version of Upsher-Smith's Qudexy XR (topiramate) extended-release capsules has closed with a swift settlement. AMTA Labs has swiftly forged a patent-litigation settlement agreement in the US on undisclosed terms for Upsher-Smith's Qudexy XR (topiramate) extended-release capsules – several years after Glenmark debuted generic competition to the branded migraine headache prophylaxis and treatment for certain seizures... Global Sub. Full

Filgrastim Biosimilars Similarly Effective in Cancer Patients

(7/31, Leah Lawrence, Cancer Therapy Advisor) ...Two filgrastim biosimilars — filgrastim-aafi and filgrastim-sndz — are similarly effective in patients with solid tumors, according to research published in JCO Oncology Practice..."To date, there have been no head-to-head studies that assess outcomes of different filgrastim biosimilars for prophylaxis of severe neutropenia," the researchers wrote. "The findings of this real-world study may add to prescriber and patient confidence in use of different biosimilars in oncology practice. Future biosimilar-versus-biosimilar research should be conducted in treatment-experienced patients, for other indications, or with other G-CSF products."... Full

Can Biosimilars Repeat Success of Generics?

(8/1, Ayesha Siddiqui, BioSpectrum) ...The combination of many biologics coming off patent plus high biosimilar adoption rates paints a bright future for biosimilars, and their ability to have a dramatic impact on healthcare and the pharmaceutical industry in broadening access to a new class of impactful affordable medicines. Can biosimilars transform the industry like generics did? Let's find out... Full

ADHD Cases in Women Hit Record Level as TikTok Videos Raise Awareness

(7/31, Amy Borrett, Financial Times) ...A rising awareness of ADHD in young women driven by TikTok has seen prescriptions for the condition typically associated with boys hit record levels in England. In the first quarter of 2024, there were 19,400 women aged 25 to 34 prescribed medication for attention deficit hyperactivity disorder, more than five times as many patients as at the start of 2019, according to an FT analysis of NHS prescription data for England... Sub. Req'd

Drug Companies Confident Medicare Price Deals Won't Hit Bottom Lines

(8/1, Nathaniel Weixel, The Hill) ...AbbVie CEO Robert Michael said during a call last week the company has included in its forecasts an expected sales hit to Imbruvica, a leukemia drug developed with Johnson & Johnson. "We've come out and said that even with modeling that impact in, that we still expect to deliver on our long-term outlook," Michael said....Richard Francis, president and CEO of Teva, had a similar message Wednesday regarding the drug Austedo, which could be part of the next round of negotiations to take effect in 2027. The company has a $2.5 billion sales target for the drug in 2027, which he said includes any impact of the IRA negotiations... Full

IRA Drug Price Reductions Won't Hurt Biotech Innovation, Analyses Find

(7/31, Darren Incorvaia, Fierce Biotech) ...In a 2022 quarterly conference call, Merck CEO Robert Davis said the bill's reduction of drug prices would be "highly chilling on future innovation." But two new studies suggest these fears may be overblown...Big Pharma "can protect both their earnings and their pipeline with pretty straightforward reallocation of R&D to late-stage development [and] continued or increased licensing or acquisition of early-stage products," Fred Ledley, M.D., told Fierce Biotech in an interview... Full

Drugmakers, Medicare Conclude Talks to Slash Spiraling Costs

(8/1, Nyah Phengsitthy, Bloomberg Law) ...While Aug. 1 marks the end of the first cycle of talks, the Centers for Medicare & Medicaid Services is slated to announce the negotiated prices—dubbed the maximum fair prices—by Sept. 1. The prices will go into effect in January 2026. The pharmaceutical industry and Medicare beneficiaries are eagerly waiting to see how the negotiated prices will affect their bottom lines and pocketbooks as billions of dollars are at stake. Widely used blood thinners from Bristol Myers Squibb Co. and Johnson & Johnson, along with diabetes treatments from AstraZeneca PLC and Merck & Co., were among the drugs selected for price cuts... Full

Judge Rejects Novo Nordisk's IRA Case As Pricing Negotiations Conclude

(7/31, Nicole DeFeudis, Endpoints News) ...The judge stood behind those opinions on Wednesday, saying that Novo's participation in Medicare negotiations is voluntary. He also rejected additional arguments made by Novo Nordisk that the negotiation process violates the Constitution's due process clause and separation of powers. A Novo Nordisk spokesperson said Wednesday that the company is disappointed in the decision and intents to immediately appeal. "We believe the decision fails to appreciate the serious constitutional problems raised by the Inflation Reduction Act's unprecedented drug price control provisions," the spokesperson said... Full

3 Big Pharma Cancer Drugs Facing Inflation Penalties

(7/31, Amy Baxter, PharmaVoice) ...Big Pharma will need to pony up for some of its biggest price hikes. The industry expects invoices from the government later this year as a penalty for raising drug prices faster than the rate of inflation...The rebate program began last year, when Medicare required payment for 46 drugs. The latest round includes several blockbuster drugs from Big Pharma. While pharma companies are also grappling with price negotiations, here are three cancer treatments on the rebate list that pharma giants will need to account for... Full

Former Obama Health Official's Claim Cuban's Drug Company Won't Lower Brand Prices Draws Rebuke From Cuban

(7/31, Maaisha Osman, InsideHealthPolicy) ...Mark Cuban, founder of the Mark Cuban Cost Plus Drug Company, tells Inside Health Policy that a former Obama administration health care adviser's claim that Cuban's company is unlikely to lower prices patients pay for brand-name drugs is inaccurate. The former adviser opined that Cuban's main contribution is helping to alleviate the generic drug shortage, not lowering prices... Sub. Req'd

CMS Punts Part D Premium Announcement, Hopes New Demo Will Bring Down Rates

(7/31, Gabrielle Wanneh, InsideHealthPolicy) ...CMS has decided not to unveil preliminary Medicare Part D premiums as it normally does in July, hoping a new voluntary demonstration it unveiled Monday (July 29) will bring premiums down even though average plan bids more than doubled for next year. The agency announced the bid increases Monday and warned that based on that information, the base beneficiary premium could increase by $2.08 to $36.78 for Part D enrollees in 2025... Sub. Req'd

Booker Reintroduces Bill to Establish National Drug Pricing Agency to Lower Costs, Increase Access

(7/30, United States Senator Cory Booker) ...The bill would create an independent agency—the Bureau of Prescription Drug Affordability and Access—tasked with conducting reviews of drug prices and determining an appropriate list price. If companies don't comply with the Bureau-reviewed list price, the Secretary of Health and Human Services would allow other entities to produce the drug, thereby voiding the companies' government-granted exclusivity and ensuring patients have access to the drug at a lower and more reasonable price determined by the Bureau... Full

Durbin, Cassidy Introduce Legislation To Lower Drug Prices By Promoting Generic Competition

(7/31, United States Senator Dick Durbin) ...The Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act, would promote competition by removing barriers to Food and Drug Administration approval for lower-cost generic drugs. Many high-cost, brand-name drugs are shielded from competition because of the ability to obtain numerous additional patents to their product in an attempt to forestall generic competition. The REMEDY Act would crack down on these pharmaceutical monopolies and lower costs for patients... Full

CSRXP Applauds Reintroduction of Remedy Act in U.S. Senate

(7/31, The Campaign for Sustainable Rx Pricing) ..."Big Pharma's egregious abuse of the patent system extends monopolies and enables brand name drug companies' price-gouging," said CSRxP executive director Lauren Aronson. "We applaud Senators Durbin and Cassidy for reintroducing the REMEDY Act that would help crack down on Big Pharma's anti-competitive practice known as evergreening, in which sham patents are filed around blockbuster drugs to trigger automatic delays in approval for alternatives trying to enter the market."... Full

PBMs Aren't Opening Access to Lower-Cost Biosimilars. Reform is Needed Now

(8/1, Juliana M. Reed, STAT) ...The Biden administration, Congress, the Federal Trade Commission, and others need to do everything in their power to address the anti-competitive behaviors of the PBM monopoly and control over the medicines people can access. Time is of the essence: every day without reform deepens the affordability crisis for Americans dealing with a convoluted, misaligned system for their prescription drugs... Full

Scoop: Thune Says 340B Bill Coming This Week

(7/31, Victoria Knight, Axios) ..."It is being filed this week," Thune told Axios, adding that the legislation would be available publicly this week and will be called the "SUSTAIN Act." Thune previously said in June that the six senators in the working group were hopeful a draft would materialize by August recess. One health lobbyist told Axios the legislation will be rolled out tomorrow... Sub. Req'd

BsUFA FY 2025 Fees Announced

(7/31, Bob Pollock, Lachman Consultants) ...The base fee amount for the BsUFA program for FY 2025 is $51,058,823, which is adjusted for inflation (this year is calculated at 4.1881%); along with factoring in other required estimated expenses, this results in a total estimated collection amount of $56,012,000... Full

PDUFA Fees Announced for FY 2025

(7/31, Bob Pollock, Lachman Consultants) ...It is interesting that the magnitude of the application fee increases were much less for FY 2024 to 2025 than for FY 2023 to FY 2024, when the application fee requiring clinical data increased by $806,669 while applications not requiring clinical data were assessed at one-half of that fee increase... Full

Maryland PDAB Requests Information On Four Drugs For Cost Review

(7/31, Luke Zarzecki, InsideHealthPolicy) ...Maryland's Prescription Drug Affordability Board (PDAB) is requesting information by Aug. 26 for their cost review study process for Eli Lilly's Trulicity, Novo Nordisk's Ozempic, Boehringer Ingelheim's Jardiance and AstraZeneca's Farxiga...According to the state's PDAB statute, the cost review will determine whether the drug "has led or will lead to affordability challenges for the state health care system or high out-of-pocket costs for patients."... Sub. Req'd

Rob Gundermann: PBMs Are Under a Microscope and Patients Will Benefit from Changes

(7/31, WisPolitics) ...As Congress debates what to do next on prescription drug prices, it should follow Wisconsin's lead. PBMs need real reforms that delink fees from prices and that tie out-of-pocket expenses to the discount prices that PBMs actually pay. These companies, which have operated behind the curtains for too long, need to be put on center stage if there's any hope of lowering patient costs... Full

EU Medicines Network Strategy Extended To 2028 To Align With Pharma Reform

(7/31, Vibha Sharma, Pink Sheet) ...EU regulators have decided to update and extend to 2028 their existing five-year strategy, which contains detailed work plans for key priority areas and was originally scheduled to run until the end of 2025. The European Medicines Agency said that the strategy would now include two new topics: artificial intelligence and how to improve the EU's competitiveness. It added that the extension to 2028 was being put in place so that the strategy aligns with when the reformed EU pharmaceutical legislation is expected to be implemented... Sub. Req'd

EMA Awards Funding For Pan-African Drug Review Pilot

(7/31, Ian Schofield, Pink Sheet) ...A regulatory initiative underway in Africa is testing out continental-level assessments of new drug applications that its sponsors say could provide the foundations for a "robust and well-founded" African Medicines Agency. The European Medicines Agency has awarded a grant to a pilot program that is trialing procedures for the joint assessment of drug approval applications at continental level in Africa... Sub. Req'd

Access Generic Medicines Work-Sharing Initiative Operational Procedures Update

(8/1, Australian Government) ...The GMWSI is a work-sharing submission pathway for the coordinated assessment of generic applications that are filed with multiple Access Consortium agencies. The updates to the GMWSI Operational Procedures include information on the acceptability of reference/comparator products used in bioequivalence studies submitted with GMWSI applications. This includes details on which Access countries will accept a previously conducted BE study using a Foreign Comparator Product, and current regulatory requirements regarding the acceptance of FCPs... Full

Ireland launches New Clinical Trials Oversight Group to Attract Pharma Investment

(7/31, Brian Maguire, Euractiv) ...Ireland's Minister for Health, Stephen Donnelly, has announced the formation of a National Clinical Trials Oversight Group. The group is tasked with developing strategies to increase the number of clinical trials conducted in Ireland... Full

India's Cost-Effective Pharma Model Attracts Global Giants Amid Start-Up Surge

(7/31, The Pharma Letter) ...Start-ups in the Indian pharma sector have soared from 283 in 2021 to the current 1,397, underscoring the entrepreneurial spirit and innovative potential within the industry, reports The Pharma Letter's India correspondent. By providing a supportive ecosystem for innovation, the government's initiatives are creating a fertile ground for collaboration between domestic companies and multinational partners, said an official, accelerating drug discovery, and market access... Sub. Req'd

Russia to Provide Priority for Domestic Drugs for State Tenders

(8/1, The Pharma Letter) ...Domestic drugs and foreign drugs, the production of which is localized in Russia, will be given a priority when included in the list of vital and essential drugs (VED) and expensive drugs, according to a recent resolution signed by the Russian government, The Pharma Letter's local correspondent reports... Sub. Req'd

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