Friday, May 10, 2024

Teva Schizophrenia Drug Phase III Results Excite Analysts

(5/9, Shiri Habib-Valdhorn, Globes) ...If the drug reaches the market it could significantly contribute to Teva's results. Evercore ISI analyst Umer Raffat believes that sales could amount to more than $1 billion annually, which would enhance Teva's EBITDA. He says that Teva's story today is significantly different than several years ago. UBS believes that annual sales of Olanzapine could reach $875 million by 2030...Jefferies' analysts think that Teva's share is undervalued and its current price attributes little credit to its product pipeline, probably due to Teva's history in recent years... Full

Teva Price Target Raised to $18 from $16 at BofA

(5/9, The Fly) ...BofA raised the firm's price target on Teva to $18 from $16 and keeps a Buy rating on the shares following a positive Phase 3 SOLARIS trial update for the Olanzapine long-acting injectable, or LAI, and what the firm calls "a broadly solid 1Q update." The firm exited Q1 more confident Teva can deliver results near the top end of its 2024 guidance, the analyst tells investors... Full

Teva Pharma (TEVA) PT Raised to $16 at Goldman Sachs

(5/10, StreetInsider.com) ...Goldman Sachs analyst Nathan Rich raised the price target on Teva Pharma to $16.00 (from $11.00) while maintaining a Neutral rating... Sub. Req'd

Ozempic, Inhalers, In The Crosshairs As FTC Goes After Hundreds More ‘Junk Patents'

(5/9, Dean Rudge, Generics Bulletin) ...The FTC has sent fresh warning letters to a number of high-profile brand manufacturers, including further action against Israeli generics giant Teva, after its initial challenge to more than 100 patent listings in November bore fruit with the delisting of US Food and Drug Administration Orange Book listed patents...According to the 10 warning letters sent by the FTC, the drugs named for potential improper patent listings are...Teva's AirDuo (fluticasone/salmeterol) and ArmonAir (fluticasone) Respiclick and Digihaler family of products, and QVAR RediHaler (beclomethasone)... Global Sub. Full

Celltrion USA's Adalimumab-Aaty Biosimilar to HUMIRA® Now Available at Low Wholesale Acquisition Cost

(5/9, Celltrion USA) ...Celltrion USA announced today that adalimumab-aaty, the company's high-concentration (100 mg/mL) and citrate-free formulation biosimilar to HUMIRA ® (adalimumab), is now available at a low wholesale acquisition cost. Adalimumab-aaty will be priced as WAC list price at an 85% discount to the current WAC list price of HUMIRA. Adalimumab-aaty is also available from Celltrion USA under the brand name YUFLYMA®, which launched in July 2023 and is available at a 5% discount to the current WAC list price of HUMIRA... Full

Celltrion Marks Largest Quarterly Sales in Q1 Thanks to Biosimilar Growth

(5/10, Lee Han-soo, Korea Biomedical Review) ...Celltrion said it recorded consolidated first-quarter sales of 737 billion won ($538 million), marking a significant 23.3 percent increase from the same period last year, thanks to strong biosimilar sales...Looking forward, Celltrion explained that it is focusing on securing a future pipeline of biosimilars for blockbuster drugs like Stelara (CT-P43), Actemra (CT-P47), Eylea (CT-P42), Xolair (CT-P39), and Prolia (CT-P41). The company plans to increase its biosimilar portfolio from six to eleven by 2025... Full

Amneal Announces $272.5M Opioid Settlement Amid Positive Q1 Earnings

(5/9, Adam Zamecnik, Generics Bulletin) ...Amneal Pharmaceuticals has agreed to an opioid drug settlement worth over $270m that will resolve cases linked to the company's role in the US opioid epidemic filed by different jurisdictions in the nation...Other large players in the generics space such as Teva Pharmaceuticals also faced their share of litigation linked to their alleged role in fuelling the epidemic...Beyond news of its settlement, the company reported an 18% growth in net revenue in Q1, from $558m in the first quarter of 2023 to $659m this year...Amneal's revenues from generics rose by 14% on the back of strong performance in complex generics, oncology biosimilars, and new launches... Global Sub. Full

Viagra Maker Viatris Misses Revenue Estimates On Weak Demand for Older Drugs

(5/9, Sneha S K and Sruthi Narasimha Chari, Reuters) ...Drugmaker Viatris narrowly missed first-quarter revenue estimates on Thursday, hurt by weak sales for its older drugs such as cholesterol medication Lipitor and Norvasc for high blood pressure. Net sales in its branded drugs unit, which makes up two-thirds of the company's total revenues, also fell 4.5% to $2.31 billion...On Thursday, CEO Scott Smith said the company has completed the divestiture of its women's healthcare business, while the API unit's divestiture will close imminently... Full

As Vyvanse Generics Bite, Takeda Sets Out On $900M Restructuring Plan

(5/9, Zoey Becker, Fierce Pharma) ...In response to rapidly declining profits and the downfall of ADHD drug Vyvanse, Takeda is planning to throw 140 billion Japanese yen ($899 million) toward a company-wide restructuring campaign...Now, with the overhaul in the works and 2024 marking the last year of "significant" generic headwinds for Vyvanse, Takeda said it expects to bring total profit to 225 billion yen ($1.4 billion) this fiscal year, which ends in March 2025... Full

Drugmaker Abbott India Posts Q4 Profit Rise On Higher Sales

(5/9, Kashish Tandon, Reuters) ...Indian drugmaker Abbott India reported a 24% rise in fourth-quarter profit on Thursday, as strong sales outpaced the impact of government pricing caps on certain medicines...Revenues of drugmakers such as Abbott India and GlaxoSmithKline Pharma India, which get most of their business from India, have been impacted after the inclusion of some of their drugs in the government's essential medicines list in September 2022, making them susceptible to price caps...Abbott, which is a unit of U.S. healthcare firm Abbott Laboratories, has been trying to mitigate the impact of pricing curbs by driving up sales and cutting back on expenses... Full

India's Cipla Open to Partnering with Eli Lilly to Market Their Obesity Drugs, CEO Says

(5/10, Rishika Sadam and Kashish Tandon, Reuters) ...Cipla is open to partnering with U.S. drugmaker Eli Lilly to market its blockbuster obesity treatment drugs in India, the company's CEO said on Friday. 'Absolutely and always open...we value our partnership with Lilly tremendously and I think the two companies are culturally aligned," Cipla's Global CEO Umang Vohra said in response to a Reuters query... Full

Strides Pharma Rises 3% After US FDA Approves Hypocalcemia Drug

(5/10, Business Standard) ...The rise came after the company announced that the United States Food and Drug Administration has approved its Sevelamer carbonate tablets 800 mg...With a market size estimated at $181 million according to IMS data, the approval of Sevelamer Carbonate tablets strengthens Strides Pharma's position in the Sevelamer portfolio... Full

Waverley Waves Goodbye To Generics As It Relinquishes ANDAs

(5/10, David Wallace, Generics Bulletin) ...Canada's Waverley Pharmaceuticals says it is stepping away from the generics market in order to concentrate entirely on novel drug development, after competitive pressures – including multiple rivals and deep price discounts – thwarted the firm's generics ambitions...Meanwhile, in the UK Waverley "has been awarded a few tenders," the firm noted, "but the prices are so low that it is next to impossible to make a profit."... Global Sub. Full

Pfizer Puts 74 Swiss Jobs On Chopping Block as it Folds Seagen into its Cancer Operations

(5/9, Fraiser Kansteiner, Fierce Pharma) ...Pfizer, which completed its $43 billion buyout of antibody-drug conjugate specialist Seagen in December, has made the "difficult decision" to propose another round of staff reductions and role changes at the newly acquired company, a Pfizer spokesperson told Fierce Pharma Thursday... Full

Regeneron's Cell Medicines Chief is Crafting a New Cell Therapy 'Secret Sauce'

(5/9, Annalee Armstrong, Fierce Biotech) ...Over the next year, Gregory said the focus is on driving toward the inflection points for the original 2seventy pipeline. That includes the dual-targeted CAR T cell therapy bbT369 in B-cell non-Hodgkin lymphoma, SC-DARIC33 in acute myeloid leukemia, a MUC16-targeted CAR-T for ovarian cancer, a MAGE-A4 TCR program in solid tumors and therapies aimed at automimmune indications and several unnamed targets. Longer term, the company will work in Regeneron's biologics, so antibodies and bispecifics, as well as some that haven't been disclosed yet... Full

Xbrane and Stada Partner with Valorum Biologics to Commercialize Ranibizumab Biosimilar Candidate in the US

(5/10, Xbrane Biopharma AB) ...Partners Xbrane Biopharma AB and STADA have entered into an exclusive licensing agreement with US biosimilars specialist Valorum Biologics for their ranibizumab biosimilar candidate. Under the terms of the agreement, leading Swedish biosimilar developer Xbrane and Germany-based specialty pharma, generics and consumer healthcare company STADA are responsible for completing the regulatory approval process for the ranibizumab candidate, which was developed under the Xlucane name. Xbrane is responsible for commercial manufacturing and supply... Full

Moderna's First Vaccine Was a Big Hit. Its Second Is a Let Down

(5/9, Gerry Smith, Bloomberg) ...The forthcoming RSV shot, expected to get US regulatory approval this month, is Moderna's first chance to show the versatility of mRNA technology to more effectively treat and prevent a range of illnesses from the flu to cancer. It will be the first mRNA product for something other than Covid. Yet the vaccine doesn't clearly perform any better than what's already on the market. Early signs from clinical trials suggest that Moderna's shot wears off faster than offerings from GSK Plc and Pfizer Inc. Analysts only expect it to bring in $340 million in revenue this year — less than half of what competitors made off their RSV vaccines last year and a tiny fraction of Moderna's Covid shot revenue... Full

Innovent Says Next-Gen GLP-1 Drug from Lilly Beats Top Diabetes Med in Phase 3 China Study

(5/9, Amber Tong, Endpoints News) ...A next-generation GLP-1 candidate from Eli Lilly has outdone an older Lilly drug in a Phase 3 trial involving Chinese patients with diabetes, Lilly partner Innovent announced late Wednesday. The candidate, mazdutide, was "superior compared with dulaglutide," the active ingredient in Trulicity, for glycemic control after 28 weeks of treatment, Innovent reported... Full

Drug Shortages: What to Do When You Can't Get Your Medicine

(5/9, Lois M. Collins, Deseret News) ...Few people in the country know more about drug shortages than Erin Fox, associate chief pharmacy officer at University of Utah Health...Most of the drugs with shortage status are hospital drugs — typically "really old generic products." They're cheap and frequently prescribed for patients in the hospital. The very low price is a large part of the problem, she said. "The prices are very, very low in part because the FDA tells us that all generic products are equal. And the only thing left for those companies to compete on is price. Over time they just undercut each other to try to get market share."... Full

Q&A: Biosimilar Access, Pricing in the Spotlight

(5/9, Lauren Biscaldi, MS, Drug Topics) ...Lakesha Farmer, Senior Director, Strategic Accounts, ION Oncology Practice Network at Cencora, sat down with Drug Topics at AXS24, the Asembia Specialty Pharmacy Summit, to discuss the biosimilar adoption, access, and pricing... Full

Warren, Sanders, Merkley Slam Chamber of Commerce for Opposition to Biden Administration's Proposal to Boost Competition, Lower Drug Prices

(5/9, Senator Elizabeth Warren) ...Senator Elizabeth Warren (D-Mass.), Bernie Sanders (I-Vt.), and Jeff Merkley (D-Ore.) wrote to the Chamber of Commerce (Chamber) expressing concern and demanding an explanation for the organization's opposition to the Biden Administration's proposal to boost competition and lower drug prices for American families and businesses by allowing agencies to consider price when deciding to exercise their "march-in rights" under the Bayh-Dole Act... Full

Cancer Drug Price-Cutting Pitch Mulled by HHS as Industry Waits

(5/10, Ian Lopez, Bloomberg Law) ...Astellas Pharma's blockbuster cancer drug Xtandi is a prime candidate for the Biden administration to try seizing drug patents to lower its cost. That's the argument Knowledge Ecology International and other interest groups are making to the Department of Health and Human Services, adding that under the proposed approach, the government would also be off the hook for paying the drugmaker royalties... Sub. Req'd

CMS Stands Firm On Key Terms Driving Rx Price Negotiation Selection

(5/9, Gabrielle Wanneh, InsideHealthPolicy) ...CMS' new draft guidance on how it will pick the next round of Part D drugs for price negotiation stands firm on the agency's interpretation of what constitutes a "qualifying single source drug" and what constitutes "bona fide marketing" of generic and biosimilar alternatives, despite industry arguments to the administration and the courts that the definitions are flawed... Sub. Req'd

Janssen's Stelara May Be Medicare Price Negotiation Savings Star

(5/9, Cathy Kelly, Pink Sheet) ...Research replicating the process that the Centers for Medicare and Medicaid Services is using to set Medicare prices for 10 selected drugs suggests that Janssen Pharmaceuticals Inc.'s Stelara will yield the greatest level of savings, UC San Diego researcher and pharmacy professor Inmaculada Hernandez reported...Stelara's "maximum fair price" in Medicare Part D will primarily be based on the 60% minimum discount applicable to the drug under the Inflation Reduction Act, the researchers believe... Sub. Req'd

Patent Bill Would Hike Drug Prices, Cut Access, Senators Warned

(5/9, Annelise Gilbert, Bloomberg Law) ...Pharmaceutical companies would be able to drive drug prices to "unjustifiable heights" and prevent competition from more affordable generic drugs if Congress passes a pending patent bill, public interest advocates cautioned Senate Judiciary leaders. The proposed Promoting and Respecting Economically Vital American Innovation Leadership Act, or PREVAIL Act, would prohibit patients and consumers from challenging patents' validity and raise evidentiary standards to make it more difficult to cancel wrongly granted patents... Sub. Req'd

Justice Department 'Upping its Game' On Healthcare Antitrust Enforcement with New Task Force

(5/9, Heather Landi, Fierce Healthcare) ...The task force, called HCMC for short, will guide the division's enforcement strategy and policy approach in healthcare, including by facilitating policy advocacy, investigations and, where warranted, civil and criminal enforcement in healthcare markets, the agency said in a press release. The task force will consider "widespread competition concerns" shared by patients, healthcare professionals, businesses and entrepreneurs, including "issues regarding payer-provider consolidation, serial acquisitions, labor and quality of care, medical billing, healthcare IT services and access to and misuse of health care data," the DOJ said... Full

Industry's Sudden Decoupling from Chinese CDMOs Could Harm Millions of Patients, BIO Warns Lawmakers

(5/9, Angus Liu, Fierce Pharma) ...As a biosecurity crackdown on certain Chinese pharma service providers gains momentum in Washington, the industry trade group Biotechnology Innovation Organization is warning U.S. lawmakers that an abrupt decoupling could harm millions of patients. BIO sent that message to lawmakers on Capitol Hill on Wednesday, along with other findings from a recent survey of its biopharma members. In sum, the survey results showcase the industry's deep reliance on Chinese contract biomanufacturing organizations... Full

BIO Seeks ‘Substantial Runway' To Shift Away From China As Momentum For Manfacturing Bill Grows

(5/9, M. Nielsen Hobbs, Pink Sheet) ...Association CEO John Crowley tells the Pink Sheet that a survey which found decoupling from China could be disruptive underscores the need to do so because having the supply chain ‘tied up with a global adversary is profoundly worrying to all of us.'..."We cannot immediately decouple," Crowley said. "We would do great harm to patients to biomedical research, and we'd actually undermine national security. … It needs to be that reasonable period of time. And as the survey showed, that's up to eight years for many of our member companies."... Sub. Req'd

Top FDA Officials Discuss PDUFA Hiring, Rapid Communication, and International Collaboration Efforts

(5/9, Joanne S. Eglovitch, Regulatory Focus) ...Peter Marks, director of the US Food and Drug Administration's Center for Biologics Evaluation and Research, said his center is doing a "pretty good job" of filling positions under the current Prescription Drug User Fee Act agreement at a meeting sponsored by the Friends for Cancer Research and Parker Institute for Cancer Immunotherapy in Washington, DC on Monday... Full

Government Price-Setting Boards: Why Minnesota Needs to Take a Better Approach

(5/9, Reid Porter, PhRMA) ...We agree, out-of-pocket costs for patients are too high. As we've said before, patients need help affording their medicines. Unfortunately, organizations backed by the insurance industry — have lobbied for state lawmakers to embrace so-called prescription drug affordability boards. It's no surprise that their path provides government bureaucrats the power to set prices for innovative medicines without addressing insurer and PBM roles in determining prescription drug costs... Full

Vermont Senator Peter Welch Criticizes Growing Profits for Pharmaceutical Companies Outlined in New Report

(5/9, Pat Bradley, WAMC) ...Following a report issued Tuesday showing record profits from drug companies, Vermont Senator Peter Welch and Michigan Congresswoman Debbie Dingell, both Democrats, are calling for change. On Tuesday Protect Our Care, a Washington, D.C.-based group that advocates for affordable health care, issued its quarterly Greed Watch report. It found that in the first three months of this year, the 15 largest pharmaceutical companies reported nearly $173 billion in revenue and $29 billion in net profits... Full

New State Bill Would Allow Pharmacists to Tell Patients About Less Expensive Medication Options

(5/9, Alexis Marigny, WBRZ) ...Rep. Chad Brown (D-Plaquemine) proposed a bill — HB 509 — allowing pharmacists to tell patients about less expensive medication options. It would also forbid pharmacy benefit managers from interfering with insurance rates based on discounts available to some patients... Full

‘Don't Cut Corners' If You Want To Succeed, EMA Orphan Drug Head Tells Sponsors

(5/9, Eliza Slawther, Pink Sheet) ...Pharmaceutical companies developing drugs for rare diseases should use the European Medicines Agency's scientific advice and protocol assistance services to avoid delays during the assessment of their marketing authorization applications, according to the EMA's head of orphan medicines, Kristina Larsson... Sub. Req'd

Are Managed Entry Agreements The Answer To EU Market Access For ATMPs?

(5/9, Francesca Bruce, Pink Sheet) ...Managed entry agreements may have a role to play in in addressing the market access problem that advanced therapies present, but they will not be a panacea, especially as more of these high-priced products are approved over the coming years, according to speakers at the Cell and Gene Therapy Meeting On the Med, organized by the Alliance For Regenerative Medicine... Sub. Req'd

Czech Ministry Proposes Changes in Medicines Price Setting Approach

(5/9, Aneta Zachová, Euractiv) ...The Czech Health Ministry has introduced amendments to the public insurance law to enhance healthcare accessibility and ensure sustainable medical treatment costs – a move welcomed by Czech pharmaceutical companies. The legislative change aims to bolster the resilience of the pharmaceutical market and improve drug availability... Full

Brazil Pursues Regulatory Reliance Strategy For GMP Inspections

(5/9, Francesca Bruce, Pink Sheet) ...Brazil's medicines regulator, ANVISA, has published new rules setting out procedures for using good manufacturing practice inspections and certification processes carried out by foreign authorities deemed to be equivalent regulatory bodies. The move is part of a drive by ANVISA to exploit regulatory reliance as a means of ensuring high-quality medicines get to Brazilian patients... Sub. Req'd

Novartis Slammed for Discrediting Industry As 'Very Concerned' Panel Finds Fault with Entresto Files

(5/9, Nick Paul Taylor, Fierce Pharma) ...Novartis' Entresto team has earned the ire of the PMCPA. For the third time in 12 months, the U.K. drug promotion watchdog has found the Swiss drugmaker's actions have brought discredit upon the pharma industry. The case centers on two third-party documents that physicians could download from a Novartis portal. Neither text was written by Novartis... Full

Partnering for Biosimilar Security: India's Role in US Health Care Savings, Supply Chain Stability

(5/9, Skylar Jeremias, The Center For Biosimilars) ...Indian pharmaceutical companies are responsible for providing a substantial proportion of drugs to US residents, with Indian companies supplying 4 of every 10 prescriptions filled in the US in 2022, according to a new report from IQVIA...Overall, medicines from Indian companies generated $1.3 trillion in savings to the US health care system between 2013 and 2022, $219 billion of which were accumulated in 2022 alone... Full

Global Healthcare Partners and Indian Pharma Companies: Making Medicines Affordable

(5/10, Dr. Anil Gulati, Express Pharma) ...Dr Anil Gulati, Chairperson and CEO, Pharmazz highlights that our country plays a pivotal role in delivering quality-certified medications at significantly lower costs, with its dominance in generic medicine production, resilience amidst the COVID-19 pandemic, leadership in vaccine manufacturing, and collaborative efforts in research and development... Full

Korean Neurologists Express High Expectations for AbbVie's Migraine Drug Aquipta

(5/10, Lee Han-soo, Korea Biomedical Review) ...AbbVie's oral calcitonin gene-related peptide receptor antagonist, Aquipta, was recently launched in Korea as a preventive treatment for adult migraines, addressing unmet patient needs through its convenience and short half-life. During a press conference at Andaz Seoul Gangnam on Friday, AbbVie Korea shared Aquipta clinical findings and the current state of migraines in Korea... Full

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