Wednesday, December 18, 2024

Teva's 10-Year Turnaround Takes Shape with Stunning Trial Results

(12/18, Sophie Shulman, CTech) ...Teva's recent momentum has extended beyond Duvakitug. The company has now reported seven consecutive quarters of growth, prompting credit rating agencies to upgrade its debt from junk status. Teva's revenue forecast for 2024 has been revised upward to $16.5 billion, signaling further stability and optimism for the pharmaceutical giant's long-term recovery... Full

Sanofi, Teva Look to 'Next Frontier' in IBD Treatment After TL1A Antibody Hits Mark in Midstage Trial

(12/17, Fraiser Kansteiner, Fierce Biotech) ...The trial outcome could represent the "next frontier" in UC and CD treatment, Sanofi's head of research and development, Houman Ashrafian, M.D., Ph.D., said in a statement. Meanwhile, Teva's global R&D chief and chief medical officer, Eric Hughes, M.D., Ph.D., said the results "exceeded our expectations." With the new findings in hand, Sanofi and Teva are now plotting a phase 3 study for duvakitug, pending talks with regulators... Full

Teva Jumps Sharply On Bowel Disease Drug Results

(12/17, Shiri Habib-Valdhorn, Globes) ...Teva reported that the trial for Dukaviyug, which it is developing with Sanofi, met its endpoints in ulcerative colitis and Crohn's disease, the most common forms of inflammatory bowel disease. Teva Pharmaceutical Industries Ltd. share price opened 20% higher on Wall Street after the Israeli company reported positive results of a Phase 2b clinical trial for Dukavitug, which it is developing together with Sanofi, for the treatment of ulcerative colitis (UC) and Crohn's disease (CD)... Full

Teva Shares Soar On Early Bowel Disease Drug Data

(12/19, Josh Nathan-Kazis, Barron's) ...While there are a number of medicines on the market to treat the diseases, Teva called duvakitug "potentially best-in-class" in a presentation on Tuesday morning...The trial results come on what seems to be the tail end of a long, slow recovery for Teva. After many years of underperformance, as the company labored under an immense debt load, things seem to be turning around for the drugmaker. The stock was up 58% this year as of the end of the day on Monday. Teva has been de-emphasizing its generic drug business, one of the largest in the world, in favor of developing and selling its own medicines. That strategy seems to be working out... Full

Teva, Sanofi Say IBD Treatment Achieved Higher Remission at Trial

(12/17, Dean Seal, Dow Jones) ...Teva Pharmaceuticals and Sanofi report that the latest trial of their jointly developed treatment for inflammatory bowel disease met its primary endpoints. The companies said Tuesday that patients with ulcerative colitis who were treated with duvakitug achieved a higher rate of clinical remission compared with a placebo group... Full

Teva Catapults 26%, Hitting A Six-Year High, After Scoring A Win With Sanofi-Tied Drug

(12/17, Allison Gatlin, Investor's Business Daily) ...Evercore ISI analyst Umer Raffat noted the placebo-adjusted responses to Teva's drug were better than the same for Merck's and Roche's. Merck's drug topped the placebo by 25%, while Roche's beat the nondrug by 18% to 23%, depending on the dosage. Teva's was 16% to 27% better than the placebo... Full

Teva Price Target Raised to $25 from $23 at BofA

(12/17, The Fly) ...BofA raised the firm's price target on Teva to $25 from $23 and keeps a Buy rating on the shares. The price target increase reflects the strong Phase 2 update for duvakitug as a treatment for inflammatory bowel disorders, the analyst tells investors in a research note. The firm now forecasts nominal peak sales of roughly $2B, with Teva booking half the profits, based on the strength of the data and the emerging product profile... Full

Teva Price Target Raised to $28 from $25 at Barclays

(12/18, The Fly) ...Barclays analyst Balaji Prasad raised the firm's price target on Teva to $28 from $25 and keeps an Overweight rating on the shares. The firm says Duvakitug with a 27% delta clinical remission for ulcerative colitis and 35% delta endoscopic response for Crohn's disease reflects a best in class efficacy profile. The data further validate Teva's pivot to growth strategy, the analyst tells investors in a research note... Full

Ontario Family Says Drug-Maker Helped Them Find Epilepsy Medication Amidst Ongoing Shortage

(12/17, CityNews Everywhere) ...Following our story on the Teva-Clobazam shortage, the family says the drug-maker reached out to help them find enough medication to get through the shortage. The Canadian Epilepsy Alliance wants Teva Pharmaceuticals to help others as well... Full

Pfizer's Message to Investors: The Ship is Steadying in 2025 (Even if Washington is Turbulent)

(12/17, Max Bayer, Endpoints News) ...What it's not projecting is much growth. Its revenue next year will be $61 billion to $64 billion, the company said Tuesday — the same range it's projecting to close out 2024...As part of the announcement, CEO Albert Bourla said that new CSO Chris Boshoff, who formerly directed all of Pfizer's oncology work, will team up with chief strategy and innovation officer Andrew Baum "to ensure that we focus our R&D investments on the most impactful opportunities." He said more would be revealed about the effort "in the coming months."... Full

Medicare Part D Redesign: Pfizer's Catastrophic Phase Discounts Will Total $1.5Bn In 2025

(12/17, Cathy Kelly, Pink Sheet) ...Pfizer expects the new 20% discount in the catastrophic phase of the Medicare Part D benefit will lower its 2025 revenue $1.5bn. The hit will be offset to a relatively limited extent by increased sales expected from the $2,000 annual out-of-pocket spending limit for beneficiaries that also will be added to Part D next year. Pfizer's forecast demonstrates the "push and pull" of the two policies under the Part D redesign and that product mix will determine the net impact on individual companies... Global Sub. Full

Dong-A ST Wins European Approval for Stelara Biosimilar IMULDOSA

(12/18, Kim Ji-hye, Korea Biomedical Review) ...Dong-A ST said Wednesday that its Stelara biosimilar, IMULDOSA (project name DMB-3115, ingredient: ustekinumab), has received marketing authorization from the European Commission (EC)... Full

Celltrion's Crohn's Treatment Set for February U.S. Release

(12/18, Lee Jae-Lim, Korea JoongAng Daily) ...Celltrion's Steqeyma, a biosimilar that references Johnson & Johnson's blockbuster monoclonal antibody Stelara, received approval from the U.S. Food and Drug Administration (FDA) to target market release in February, the Korean drugmaker said Wednesday... Full

Fresenius Kabi Launches Generic Epinephrine Injection in U.S.

(12/17, Contract Pharma) ...Fresenius Kabi's Epinephrine Injection, USP, is now available in the United States as the first generic version of Epinephrine in a 1mg/1mL vial for U.S. customers... Full

Eli Lilly's Alzheimer's Treatment Approved in China

(12/17, Gursimran Kaur, Reuters) ...China's medical regulator has approved Eli Lilly's treatment for early Alzheimer's, providing patients with another option after Eisai and Biogen's Leqembi received approval in January, the company said late on Tuesday. China is the fourth major market in which the treatment, sold under the brand name Kisunla, has received approval after the United States, Japan and the UK, Lilly said in a statement. Like Leqembi, Lilly's Kisunla is designed to clear an Alzheimer's-related protein called beta-amyloid from the brain... Full

Sun Gets Two-Year Jump On Zubsolv IP With Patent-Litigation Deal

(12/17, Dean Rudge, Generics Bulletin) ...Sun Pharma will be able to launch in September 2030 its generic version of Orexo's Zubsolv (buprenorphine/naloxone) sublingual tablets for the treatment of opioid use disorder in the US, under the terms of a patent-litigation settlement agreement that the Indian firm has brokered with the originator following four years of litigation... Global Sub. Full

Judge Advances LA County Opioid Crisis Lawsuit Against Prescription Drug Middlemen

(12/17, Hillel Aron, Courthouse News Service) ...A public nuisance lawsuit filed by Los Angeles County against two pharmacy benefit managers — middlemen in the chain between drug makers and insurance companies — cleared its first major legal hurdle on Tuesday, when a Los Angeles Superior Court judge declined to dismiss the complaint...At a hearing on Tuesday for their request to dismiss, attorneys for the PBMs argued that even if the facts in the complaint were true, they still hadn't done anything wrong... Full

How a Duty to Spend Wisely On Worker Benefits Could Loosen PBMs' Grip On Drug Prices

(12/18, Arthur Allen, KFF Health News) ...Ann Lewandowski knows all about pharmacy benefit managers, or PBMs, the companies that shape the US drug market. Her job as a policy advocate at Johnson & Johnson was to tell patient and physician groups about the PBMs' role in high drug prices. Armed with that knowledge, Lewandowski filed a potentially groundbreaking lawsuit in February. Rather than targeting the PBMs, however, she went after a big company that uses one — her own employer, Johnson & Johnson... Full

Health Extenders Package Cements PBM, Generic Drug Transparency & Drug Patenting Reforms

(12/17, Gabrielle Wanneh, Inside Health Policy) ...The back and forth between Republicans and Democrats over the scope of health extenders and offsets to include in Congress' upcoming continued resolution has resulted in bipartisan agreement on a package that includes long-sought reforms to pharmacy benefit managers' practices in Medicare, Medicaid and the commercial market, as well as measures to streamline the generic drug approval process and rein in brand drug makers' use of so-called patent thickets to delays generic and biosimilar competition... Sub. Req’d

PBM Reform is Part of Congress' End of Year Bill

(12/17, Denise Myshko, Formulary Watch) ...The proposed bill as currently written includes changes to Medicare and Medicare and some important measures intended to increase transparency into PBM business practices. Patrick Cooney, president of the lobbying group The Federal Group, said the big surprise is that the PBM provisions will reach affect how the industry deals with its commerical customers. "We've expected changes, but the new element is PBM reform," he said in an interview. "Congress is also going to institute private insurance reforms for PBMs."... Full

Biden Admin's Last Part D Rule Also Has Generic Drug Exclusion Comments, Prescription Payment Plan Tweaks

(12/17, Leslie Small, Pink Sheet) ...In the proposed rule, CMS said it would begin reviewing Part D plan formularies and utilization practices to see if programs include incentives to reduce costs, as well as offered suggestions for implementing the new Medicare Prescription Payment Plan. Although the provision aimed at broadening coverage of anti-obesity medications garnered the most attention, the Biden administration's last Medicare Advantage and Part D rule was full of under-the-radar provisions for the prescription drug benefits space... Global Sub. Full

PCMA Statement On Released Text Of Continuing Resolution

(12/17, PCMA) ..."The inclusion of costly, unvetted health care provisions in the released text of the year-end spending package would be disastrous for America's employers, patients, families, and taxpayers..."This bill does nothing to lower costs, nothing to improve pharmacy access, nothing to benefit patients. And that is because Congress is choosing to release 1,547 pages of new text hours before a vote, leaving no time to thoroughly review the provisions that will have serious consequences for our health care system. We urge Congress to put America's patients, employers, and seniors over Big Pharma's profits and reject this far overreaching health care package."... Full

CSRxP: Passage of Cornyn-Blumenthal and Q1/Q2 Reforms Would Be Positive Steps Toward Holding Big Pharma Accountable for Patent Abuse

(12/17, The Campaign for Sustainable Rx Pricing) ..."CSRxP commends Congressional leaders for including these bipartisan, market-based solutions to hold Big Pharma accountable for gaming the system to extend monopolies and keep drug prices high," said CSRxP executive director Lauren Aronson. "We encourage the full Congress to swiftly pass Cornyn-Blumenthal and Q1/Q2 reforms as positive first steps toward cracking down on Big Pharma's anti-competitive tactics and fostering greater competition in the marketplace to lower prices for consumers."... Full

Medicare's Drug Price Negotiation Program: The Disproportionate Impact On Small Molecules

(12/16, Rahel Ehrenberg, IQVIA) ...The IRA's MFP applicability begins at 9 years for small molecules, 4 years earlier than biologics. For small molecule products launched from 2005 to 2009, this 4-year difference accounts for a third of average sales revenues over the first 13 years. Lifetime sales revenues are even more backloaded for first-in-class medicines. The substantial reduction in expected revenues resulting from the IRA's MFP applicability at 9 years disincentivizes investment in small molecule drug development... Full

PIC/S Offers Guidance On Remote Inspections

(12/17, Joanne S. Eglovitch, Regulatory Focus) ...The Pharmaceutical Inspection Co-operation Scheme (PIC/S) recently released two documents aimed at creating a harmonized approach for planning, conducting, and following up on remote and hybrid inspections among its members. The documents also highlight important factors for assessing whether certain high-risk facilities are unsuitable for remote evaluations... Full

Deputy Commissioner Bumpus Announces Departure from FDA

(12/17, Joanne S. Eglovitch, Regulatory Focus) ...Namandjé Bumpus, the US Food and Drug Administration's (FDA) principal deputy commissioner and second in command, will be leaving the agency at the end of the year, according to an internal email reviewed by Focus...FDA Commissioner Robert Califf announced the news in an email to staff on Tuesday. Califf credits Bumpus for her "enormous contributions across the agency," noting that she "had an extraordinary impact on the growth, effectiveness and overall success of the agency."... Full

'A Nightmare': Why Hundreds of Vital Drugs Are in Short Supply

(12/17, Louise Bryne, RTE) ...In two years there has been a 30% increase in drug shortages in Ireland, statistics from the Health Products Regulatory Authority (HPRA) show...Breathing nebulisers, steroid creams, ADHD medications and blood pressure drugs are among 444 drugs currently on the HPRA's Medicine Shortages List. Among them is Daktarin, an anti-fungal medication used to treat fungal skin and mouth infections; the blood pressure medication Telmisartan; and Ipramol which is used to treat chronic breathing difficulties... Full

CDA Thiruvarur to Enter into Sale of Generic Medicines to Combat Threat of Generic and Discount Pharmacies

(12/18, Pharmabiz.com) ...Prior to the launch of the government sponsored subsidized generic pharmacy network scheme, ‘Mudhalvar Marunthagam' (chief minister's pharmacy) in Tamil Nadu, the Thiruvarur district Chemists and Druggists' Association (CDA Thiruvarur), an affiliate of the Tamil Nadu Pharma Traders Association (TN PTA), has decided to enter into sale of generic versions of all brands through their retail outlets... Full

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