Thursday, May 9, 2024

A Year On, Teva CEO Richard Francis Celebrates Progress in 'Pivot to Growth' Plan

(5/8, Fraiser Kansteiner, Fierce Pharma) ...In about a year after launching a revamp strategy under CEO Richard Francis, Teva has managed to return its generics business to growth, secure approvals for a pair of high-profile biosimilars and chart market gains with its star branded treatment, Austedo, in Huntington's disease. "If you look at where we've delivered our results, it's where we focused our efforts," Francis said in an interview with Fierce Pharma on Wednesday... Full

Teva Hits Five-Year High After Q1 Results

(5/8, Shiri Habib-Valdhorn, Globes) ...As the US generics market recovers Teva Pharmaceutical Industries Ltd. ended the first quarter of 2024 with revenue of $3.81 billion, up 4.3% from the first quarter of 2023, and above the analysts' expectations of $3.73 billion...Teva president and CEO Richard Francis said, "In 2024 Teva is off to a good start, with global revenues of $3.8 billion showing growth of 5% in local currency terms compared to Q1 2023, fueled by robust growth in our generics business across all regions, and continued growth of our innovative brands AUSTEDO and AJOVY."... Full

Teva Shares Continue to Surge, Climb to Highest Mark in More Than Five Years On Q1 Results

(5/8, Sophie Shulman, CTech) ...Teva recorded revenues of $3.8 billion in the first quarter of 2024, a growth of 5% compared to the corresponding quarter and slightly above analysts' expectations. At the same time, adjusted earnings stood at 48 cents per share, slightly below market expectations... Full

Teva Pharma's Turnaround Story: How A Key Win Helped It Clinch A Five-Year High

(5/8, Allison Gatlin, Investor's Business Daily) ...Teva stock surged to a five-year high Wednesday after the company beat first-quarter expectations and unveiled promising results from its schizophrenia treatment study...There's a huge unmet medical need for a long-acting version of olanzapine, Teva Chief Executive Richard Francis told Investor's Business Daily...[Evercore ISI analyst Umer Raffat) says the long-acting version of olanzapine could be a $1 billion product for Teva... Full

Teva Stock Is Powering Ahead as Schizophrenia News Offsets Mixed Earnings

(5/8, Josh Nathan-Kazis, Barron's) ...Shares of Teva Pharmaceutical Industries were climbing yet again on Wednesday after the company announced positive results in a trial of a schizophrenia medicine...For investors, the question isn't so much about how the company's legacy generic drug business is doing now, but how its pipeline of new medicines might do in the coming years. From that perspective, the results in the trial of TEV-‘749, the schizophrenia medicine, is bigger news than last quarter's results... Full

Teva Pharmaceutical's Stock Climbs As Schizophrenia Treatment Shows Promise

(5/8, Eleanor Laise, MarketWatch) ...Teva Pharmaceutical Industries Ltd.'s American depositary receipts jumped more than 6% premarket Wednesday after the company reported first-quarter sales that topped expectations and released positive late-stage trial data on a schizophrenia treatment...Teva is also looking to take a slice of the market from two high-profile blockbuster drugs, AbbVie Inc.'s rheumatoid arthritis drug Humira and Johnson & Johnson's psoriasis treatment Stelara... Full

Teva Hits a Five-Year High On Schizophrenia Trial Win, Q1 Beat

(5/8, Dulan Lokuwithana, Seeking Alpha) ...Teva Pharmaceutical ADRs reached the highest level since 2019 after the generic drugmaker reported better than expected Q1 2024 revenue on Wednesday, alongside a positive update from a Phase 3 trial for its schizophrenia therapy, TEV-‘749...CEO Richard Francis noted that growth in Teva's generics business along with continued growth in the company's innovative brands, such as Austedo and Ajovy, fueled topline growth...Jefferies analyst Glen Santangelo attributed the stock reaction to the revenue beat and the trial results... Full

Teva Pharma ADRs Climb 12% On 1Q Rev Beat, Schizophrenia Candidate Study Results

(5/8, Denny Jacob, Dow Jones) ...The Tel Aviv-based pharmaceutical company logged better-than-expected revenue in its first quarter as it benefited from sales of its generic products in major markets. Revenue was fueled by continued growth of brands including Austedo and Ajovy, said Chief Executive Richard Francis... Sub. Req'd

Teva Misses Q1 Profit Estimates, Touts Phase III Schizophrenia Win

(5/8, Tyler Patchen, BioSpace) ...Teva Pharmaceuticals missed analysts' first-quarter 2024 profit expectations on Wednesday, while reporting a 5% increase in revenues in local currency terms. The company also provided late-stage results for its injectable schizophrenia candidate, which met the primary endpoint in a Phase III trial... Full

Uzedy Partners Teva and MedinCell's Latest Long-Acting Schizophrenia Candidate Notches Phase 3 Win

(5/8, Zoey Becker, Fierce Pharma) ...After bringing slow-release schizophrenia drug Uzedy to market last year, Teva and France's MedinCell are using the same playbook for a similar candidate. With a phase 3 win, the duo is on their way to striking gold twice. Where Uzedy used MedinCell's SteadyTeq technology to provide a controlled release of risperidone, which Johnson & Johnson first marketed as Risperdal in the 90s, TEV'749 does the same with olanzapine... Full

Researchers Announce Positive Efficacy Results for Long-Acting Subcutaneous Olanzapine Injection

(5/8, Lauren Biscaldi, MS, Drug Topics) ..."These encouraging results from the efficacy portion of our phase 3 SOLARIS trial demonstrate the potential of TEV-749 to be an effective long-acting treatment for schizophrenia," said Eric Huges, MD, PhD, executive vice president of Global R&D and Chief Medical Officer at Teva... Full

Teva Exits Japanese Generics With Plan To Sell Local Business

(5/9, David Wallace, Generics Bulletin) ...Teva is exiting the Japanese generics market, putting its local generics business up for sale in a process that the Israeli generics giant expects to close within the next 12 months. Quietly announcing the decision during the firm's first-quarter results call, chief financial officer Eli Kalif explained that "as part of Teva's ‘Pivot to Growth' strategy, we have decided to divest our generic business in Japan, which is part of Teva's International Markets segment."... Global Sub. Full

Teva to Close Additional Manufacturing Sites As it Enters Next Phase of 'Pivot to Growth'

(5/8, Nicole DeFeudis, Endpoints News) ...The company's restructuring has involved manufacturing site closures, a shift away from some lower-margin generics, and more recently, plans to sell off its API unit. The first quarter of 2024 marked Teva's fourth consecutive quarter of revenue growth, CEO Richard Francis told investors on Wednesday, as he looks toward the next phase in the strategy. "We continue to optimize our manufacturing network," Francis told Endpoints News. "Outside of that, I don't see significant restructuring at this point in time."... Full

Teva Pharma (TEVA) PT Raised to $18 at BofA Securities

(5/9, StreetInsider.com) ...BofA Securities analyst Jason Gerberry raised the price target on Teva Pharma to $18.00 (from $16.00) while maintaining a Buy rating. The analyst comments "We raise our TEVA PO to $18 (from $16) following positive Phase 3 SOLARIS trial update for the Olanzapine LAI [long-acting injectable] and a broadly solid 1Q update. SOLARIS confirmed TEV-749 is an effective, once-monthly LAI version of olanzapine that looks clinically differentiated (in large TAM).”... Sub. Req'd

Teva Price Target Raised to $20 from $17 at Barclays

(5/9, The Fly) ...Barclays raised the firm's price target on Teva to $20 from $17 and keeps an Overweight rating on the shares post the Q1 report. The analyst says Teva's turnaround continues with compelling growth across Austedo, Ajovy and generics. The firm believes the company is in the "early innings of a long growth phase."... Full

Teva: Sustained Revenue Growth Amid Financial Strain (Rating Downgrade)

(5/9, Stephen Ayers, Seeking Alpha) ...Teva's Q1 earnings show continued momentum, with a 5% increase in total revenue and a jump in gross profit. The Company's blockbuster drugs, Austedo and Ajovy, continue to show robust growth and contribute to the company's revenue. TEVA's current ratio fell below 1, with debt management challenges and an operating loss from impairment adjustments. Teva is a "Hold" due to increased risk and price growth exceeding 50% since December... Full

QULIPTA™ (Atogepant) Now Approved by Health Canada for the Preventive Treatment of Chronic Migraine in Adults

(5/8, AbbVie) ...AbbVie announced today that Health Canada has approved QULIPTA (atogepant) for the prevention of migraine in adults who have at least four migraine days per month.1 QULIPTA is the first and only oral, small-molecule calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) approved to prevent both episodic and chronic migraine... Full

Sandoz ‘Surfs The Biosimilars Wave' Despite US Natalizumab Delay

(5/8, David Wallace, Generics Bulletin) ...Sandoz has delivered another quarter of growth on the back of booming biosimilars sales – and in spite of flat turnover from small-molecule generics that stemmed from a decline in North America. However, all is not plain sailing in biosimilars either, with Sandoz revealing a delay to its Tyruko (natalizumab) rival to Tysabri in the US stemming from US Food and Drug Administration queries over John Cunningham virus testing for the product... Global Sub. Full

Japan's Takeda Pharma to Restructure After Annual Profit Slump

(5/9, Rocky Swift, Reuters) ...Japan's Takeda Pharmaceutical announced a restructuring on Thursday after annual profit slid by more than half following the loss of patent protection of major sellers. Japan's biggest drugmaker said it will incur restructuring costs of about 140 billion yen ($899 million) this fiscal year as part of a plan to optimise its workforce, cut costs and strengthen technology... Full

Celltrion Q1 Net Profit Down 87.6 pct

(5/9, Kim Na-young, Yonhap News) ...Celltrion Inc., a major South Korea biopharmaceutical company, said Thursday its net profit plunged 87.6 percent from a year earlier, after the company's merger with its sales and marketing affiliate...Despite strong sales, the company said its net profit decreased due to effects deriving from its merger with Celltrion Healthcare in December, including bigger inventory and amortization of intangible assets. But Celltrion's sales surpassed 700 billion won for the first time in the first quarter mainly thanks to rising demand for its biosimilar infliximab products for autoimmune diseases in Europe... Full

Dr Reddy's Enters US With Second Oracea Generic

(5/8, David Wallace, Generics Bulletin) ...Dr Reddy's has become the second firm to compete in the US generic doxycycline market, announcing the launch of its doxycycline 40mg capsules, representing a fresh rival to Galderma's Oracea... Global Sub. Full

Cordavis Report Outlines Strategies for Biosimilar Development, Access in the US Health Care Market

(5/8, Skylar Jeremias, The Center For Biosimilars) ...A new report from Cordavis, a CVS Healthspire company, outlined current challenges with the development and commercialization of biosimilars in the US, as well as how the organization is working to expand access and affordability of these products...The present report explained how biosimilars help improve affordability of treatments and showcased how Cordavis' focus on manufacturing biosimilars is improving patient access and bringing innovation to the US health care system... Full

India's Alembic Pharma Posts Higher Q4 Profit On Strong N.America Sales

(5/9, Kashish Tandon, Reuters) ...Indian generic drugmaker Alembic Pharma reported a 17% rise in fourth-quarter profit on Thursday, driven by strong sales, especially in the key North American market...Indian generic drugmakers like Dr. Reddy's Laboratories, Cipla and Sun Pharmaceutical have been benefitting from price recovery in the U.S. market as well as strong sales, especially of their copycat versions of Bristol-Myers Squibb's blockbuster cancer drug Revlimid. On Tuesday, Dr Reddy's beat fourth-quarter profit estimates, boosted by strong U.S. sales of its generic version of Revlimid... Full

Alembic Pharma Gets USFDA Nod for Five Drugs in Over a Month

(5/9, CNBC TV 18) ...Alembic Pharmaceuticals Ltd on Thursday, May 9, said it received approvals from the United States Food and Drug Administration from April 1 to May 8, to launch five drugs. The USFDA clearances include both tentative and final approvals, the drug maker said in a stock exchange filing... Full

USFDA Issues Form 483 with 1 Inspectional Observation to Cipla's Kurkumbh Unit

(5/8, Press Trust Of India) ...Pharma major Cipla Ltd on Wednesday said it has received one inspectional observation in Form 483 from the US health regulator for its manufacturing facility at Kurkumbh in Maharashtra. As per the US Food and Drug Administration, Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that may constitute violations of the Food Drug and Cosmetic Act and related Acts... Full

Inside CVS Caremark's Move That Broke Humira's Hold On The Market

(5/8, Lydia Ramsey Pflanzer, Endpoints News) ...Joshua Fredell, Caremark's vice president and head of PBM and specialty product, told Endpoints News in an interview that Caremark began testing out biosimilar versions of Humira on its formulary at the start of 2023. But because the biosimilars weren't in a preferred position on the formulary, they weren't chosen over Humira. That didn't change, even when some biosimilars became preferred in September. "There needs to be a bigger catalyst for the change," Fredell said... Full

ViiV Healthcare And Medicines Patent Pool Celebrate 10-Year HIV Collaboration

(5/8, Urte Fultinaviciute, Generics Bulletin) ...Marking 10 years of "groundbreaking" voluntary licensing agreements for human immunodeficiency virus treatments, ViiV Healthcare and Medicines Patent Pool have announced a fruitful milestone. The collaboration, which started in 2014, has distributed more than 1 billion packs of generic dolutegravir-based medicines to 24 million people with HIV in 128 low- and middle-income countries. This means that over 90% of people on antiretroviral treatment in these countries are estimated to be on DTG-based regimens, the MPP stated... Global Sub. Full

Jazz Pharma to Fight FDA in Court Over Rival Sleep Drug Approval

(5/9, Nyah Phengsitthy, Bloomberg Law) ...Jazz Pharmaceuticals PLC will take to the US District Court for the District of Columbia to argue its case against the Food and Drug Administration on whether the agency violated the Orphan Drug Act when it approved Avadel CNS Pharmaceuticals LLC's Lumryz, a rival product of Jazz's narcolepsy drug Xywav... Sub. Req'd

Pfizer Agrees to Settle More than 10,000 Zantac Cancer Suits

(5/8, Jef Feeley, Bloomberg) ...Pfizer Inc. has agreed to settle more than 10,000 cases accusing it of hiding the cancer risks of its Zantac heartburn drug, according to people familiar with the deal, the biggest of the litigation...The deal is likely to reassure investors, who have seen other Zantac makers, including GSK Plc and Sanofi, sign settlements. Concerns about the drugmakers' exposure to Zantac suits helped wipe out about $45 billion in combined market value in the summer of 2022. The shares have since recovered and have risen on news of the earlier deals... Full

New PRI Brief: JAMA Study Justifying Drug Price Controls Deeply Flawed, Patient Health Jeopardized if Findings Implemented

(5/8, The Center for Medical Economics and Innovation) ...A new brief released today by the Center for Medical Economics and Innovation at the nonpartisan Pacific Research Institute analyzes a Journal of the American Medical Association study cited by Sen. Bernie Sanders (I-Vermont) to justify drug price controls, finding it was deeply flawed and would put patients at risk of losing access to cutting-edge medications if implemented. "Sen. Sanders uses a flawed analysis to promote price controls on innovative drugs, which would jeopardize the health of those living with serious illnesses if implemented," said Dr. Wayne Winegarden, director of PRI's Center for Medical Economics and Innovation and the brief's co-author... Full

House Panel Marks Up Bill to Require PBMs to Use a Flat Fee in Medicare

(5/8, Lia DeGroot, Endpoints News) ...The bill would require PBMs that contract with Medicare to "de-link" PBM compensation from the price of medications and instead charge a flat fee for their services. The measure has drawn pushback from the Pharmaceutical Care Management Association, which lobbies on behalf of PBMs...Rep. John Larson (D-CT) on Wednesday spoke out against the PBM provision at the markup, raising concerns that the bill will ultimately lead to higher costs for Medicare beneficiaries... Full

Joe Grogan: Congress Wants A Better Value. So Why Are They Eliminating Performance Based Payment?

(5/8, PCMA) ...The House Ways and Means Committee will vote today on legislation that will include a so-called "delinking" policy in Medicare. Joe Grogan, visiting senior fellow at the USC Schaeffer Center and former domestic policy adviser under the previous administration, asked Members of Congress a critical question in an op-ed published in Townhall: Congress wants a better value. So why are they eliminating performance based payment? In the piece, Grogan explores proposals in Congress that consider prohibiting performance-based incentives for pharmacy benefit companies successfully securing savings for patients and taxpayers... Full

Public Officials Seek Greater Oversight of Prescription Drug Middlemen

(5/8, Dilpreet Raju, Capitol News Illinois) ...As state lawmakers hold hearings targeting the role of pharmacy benefit managers – an influential arm in how the health insurance industry prices prescription drugs – multiple state agencies are considering how to better regulate the industry...Local pharmacy owners testified at recent committee hearings that they are being squeezed by PBMs through the price of acquiring drugs wholesale and dispensing them, often at no profit or even at a loss. Over 40 percent of local pharmacies in Illinois – about 300 locations – have closed since 2013, according to the National Community Pharmacists Association... Full

Editorial: To Save Local Pharmacies, State Must Rein in the Middlemen

(5/9, Pittsburgh Post-Gazette) ...PBMs claim that their aggressive tactics translate to big savings for their clients, and that spread pricing covers the cost of their services. If that's true, they should have no issues opening up their books for the public to take a look. The future of access to essential medicines depends on it. People's health, even their lives, depend upon it... Full

Officials Release Draft Legislation Aimed at Prescription Drug Shortage Issues

(5/8, Kennedy Ferruggia, Pharmacy Times) ...A draft legislative proposal was recently released by Senate Finance Committee Chair Ron Wyden, D-Ore, and Ranking Member Mike Crapo, R-Idaho, that addressed recurrent economic issues that have led to shortages of generic medications, including chemotherapy drugs and ADHD medications. Researchers from the American Society of Health-system Pharmacists began tracking national drug shortages as early as 2001. The data show that ongoing and active shortages are currently at the highest number (323) since January 2001... Full

The End of Drug Shortages Begins with Data Transparency

(5/8, Vicki Cookson, Pharma Phorum) ...Lack of data transparency across the supply chain is a core challenge for regulators and suppliers of all sizes. It prevents insights into supply fluctuations and their root causes. Decreased access to global compliance and quality data for the active pharmaceutical ingredients and finished drugs manufactured offshore has only compounded supply risks. Between 2020 and 2022, FDA's five-year backlogs for offshore API facility inspections have increased from 30% to 80%, and the agency is pivoting to remote and other inspection formats... Full

Sen. Rick Scott: Passing the AMERICAN DRUGS Act Will Cut U.S. Reliance On Communist China

(5/8, U.S. Senator of Florida Rick Scott) ...Senator Scott's AMERICAN DRUGS Act will create a strong incentive for companies to invest in domestic pharmaceutical production; address the ongoing and prevent future drug shortages; and shift away from reliance on Communist China. Currently, about 90% of drugs dispensed at U.S. pharmacies are generic drugs that overwhelmingly come from Communist China and India. Senators Mike Braun and J.D. Vance are cosponsors of the legislation... Full

Exclusive: Lawmakers Consider Limiting How Long Existing WuXi Contracts Can Continue

(5/9, Jared Whitlock, Endpoints News) ...House members want drugmakers to end their existing contracts with WuXi AppTec and other Chinese firms by 2032, two sources told Endpoints News...The proposed clause could intensify drugmakers' searches for WuXi alternatives. It can take eight years, and sometimes longer, to switch manufacturers, companies reported in a recent survey conducted by the trade group Biotechnology Innovation Organization, or BIO... Full

Califf Grilled On Avian Flu, Drug Shortages, and Adcomms During Senate Appropriations Hearing

(5/8, Joanne S. Eglovitch, Regulatory Focus) ...US Food and Drug Administration Commissioner Robert Califf told a Senate Appropriations subcommittee on Wednesday that he needs lawmakers' help "filling in the holes" in the pharmaceutical supply chain to address drug shortages and outlined steps the agency is taking to address the recent avian flu outbreak in dairy cattle... Full

Switching Between Biosimilars and Their Reference Counterparts with Dr. Sarah Yim

(5/8, U.S. Food & Drug Administration) ...Welcome to "Q&A with FDA," where we aim to answer some of the most frequently asked questions that we've received from the public. My name is Dr. Sara Roach, and today we will be discussing biosimilar drug products, switching between biosimilars and their reference or brand name counterparts, and safety outcomes associated when switching. Here with me today is Dr. Sarah Yim, Director of the Office of Therapeutic Biologics and Biosimilars in the FDA's Center for Drug Evaluation and Research... Full

Rx Advertising: Interchangeability Doesn't Mean Clinical Superiority To Other Biosimilars, FDA Says

(5/8, Sarah Karlin-Smith, Generics Bulletin) ...Updated draft guidance on promotion of biologic reference products, biosimilars and interchangeable biosimilars offers another indication of the US's push to do away with the interchangeability designation. Assertions that an interchangeable biosimilar offers safety and effectiveness advantages over a biosimilar without the designation likely will be dinged by the US Food and Drug Administration as misleading promotion, the agency cautioned in a new guidance update... Global Sub. Full

Wisconsin PDAB Bill Fails, Dems Vow To Reintroduce

(5/8, Luke Zarzecki, Jessica Karins, InsideHealthPolicy) ...Wisconsin Democrats plan to reintroduce a bill that would have created a prescription drug affordability board in the state next session, after the bill failed again this year. It comes after Virginia's governor, a Republican, vetoed similar legislation, saying it was the wrong approach to dealing with high health care costs... Sub. Req'd

The Hell of Drug Pricing Boards

(5/9, James K. Glassman, Maryland Matters) ...Nine other states have set up these Pharmaceutical Drug Affordability Boards, and there is a growing realization that they do a lot more harm than good. Maybe that's not hell, but for the victims of PDABs — that is, millions of patients — losing access to the right medicines will mean needless suffering with no gain in affordability... Full

Highlights from RAPS Euro Convergence 2024, Another Record-Breaking Event for RAPS in Europe

(5/8, Ryan Conners, Regulatory Focus) ...RAPS Euro Convergence is the most comprehensive regulatory affairs conference in Europe. It's a gathering that focuses on the latest developments in healthcare products in Europe and beyond — medical devices, IVDs, pharmaceuticals, and AI and software — in an environment dedicated to regulatory excellence... Full

Euro Convergence: Regulators Discuss Device Availability, AI Act, Lessons from Pharma

(5/8, Ferdous Al-Faruque, Regulatory Focus) ...Representatives of European regulators and health authorities offered assurances that the recent Artificial Intelligence Act (AI Act) is compatible with the Medical Device Regulation, that they are working to ensure product availability in the region, and other pressing topics during a panel discussion and Q&A at the 2024 RAPS Euro Convergence conference... Full

Patients ‘Aggressive' and ‘Spitting at Staff' Over Drug Shortages, Says New Report

(5/9, James Halliwell, Chemist + Druggist) ...The new report, published today (May 9), said that the worsening situation with medicine shortages has led to patients taking their frustrations out on pharmacy staff, including spitting at them and leaving them breaking down "in tears" or anxiously "walking on eggshells" for the rest of the day. Some 84% of pharmacy staff questioned by CPE said patients had become "aggressive" when informed about delays or incomplete prescriptions due to medicine shortages... Full

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