Wednesday, July 31, 2024

Teva Reports Strong Q2 Results, Raises 2024 Forecast

(7/31, Shiri Habib-Valdhorn, Globes) ...Teva's President and CEO Richard Francis said, "In the second quarter of 2024, we are encouraged by the positive momentum across each of the four pillars of our Pivot to Growth strategy. Teva's global revenues of $4.2 billion increased by 7% in U.S. dollars, or 11% in local currency terms compared to the second quarter of 2023, delivering strong growth driven mainly by our generics and innovative business, with AUSTEDO growing 32% in the US compared to Q2 2023."... Full

Teva 2Q Loss Narrows; Boosts FY24 Adj EPS View on Strong Generic, Branded Demand

(7/31, Rob Curran, Dow Jones) ...Teva Pharmaceuticals posted second-quarter adjusted earnings ahead of Wall Street estimates, and boosted the lower end of its 2024 adjusted earnings forecast on strong demand for both its generic and branded drugs...Generic drug sales, the core of Teva's business traditionally, rose 16% to $1.02 billion in the U.S, with particularly strong demand for a generic version of Bristol Myers Squibb's Revlimid cancer medication... Paid Sub. Req'd

Teva Gains After Lifting Outlook On YTD Performance

(7/31, Dulan Lokuwithana, Seeking Alpha) ...Shares of Teva Pharmaceutical gained in the premarket on Wednesday after the generic drugmaker reported better-than-expected Q2 2024 financials and raised its full-year outlook, citing YTD performance. Israel-based Teva reported $4.2B in revenue for the quarter, indicating ~7% YoY growth as its generics business expanded across all regions, generating ~$2.5B globally with ~9% YoY growth... Full

Teva Reports Q2 EPS 61c, Consensus 55c

(7/31, The Fly) ...Reports Q2 revenue $4.2B, consensus $4.06B. Richard Francis, Teva's President and CEO, said... "Teva's global revenues of $4.2 billion increased by 7% in U.S. dollars, or 11% in local currency terms compared to the second quarter of 2023, delivering strong growth driven mainly by our generics and innovative business, with AUSTEDO growing 32% in the U.S. compared to Q2 2023. We are also showing significant progress in on our late-stage innovative pipeline, underscored by the acceleration of the development timeline of duvakitug with top-line results now expected in the fourth quarter of 2024, and full data expected next year. With these robust results, we are raising our financial guidance for 2024."... Full

Teva Pharma (TEVA) Tops Q2 EPS by 6c; Raises Guidance

(7/31, StreetInsider.com) ..Teva Pharma reported Q2 EPS of $0.61, $0.06 better than the analyst estimate of $0.55. Revenue for the quarter came in at $4.2 billion versus the consensus estimate of $4.06 billion... Full

Teva Raises 2024 Revenue View $16M-$16.4M from $15.7M-$16.3M

(7/31, The Fly) ...Consensus $16.01M Sees AUSTEDO revenues of ~$1.6 billion; Adjusted EBITDA of $4.6 - $5.0 billion; Non-GAAP diluted EPS of $2.30 - $2.50, consensus $2.34... Full

Fresenius Beats Q2 View On Strong Unit Performance, Cost Savings

(7/31, Bartosz Dabrowski, Reuters) ...German healthcare group Fresenius beat second-quarter operating profit expectations on Wednesday, citing strong performance at its Kabi and Helios units, and progress in group-wide cost savings...Kabi reported a quarterly EBIT growth of 17%, helped by strong biopharma business, while EBIT at Helios increased by 19% due to strong operating performance in Spain... Full

GSK Shares Fall After Sales of Top Two Vaccines Disappoint

(7/31, Yadarisa Shabong, Maggie Fick, Reuters) ...British drugmaker GSK cut its forecast for 2024 vaccine sales on Wednesday after quarterly revenue from its blockbuster shingles and respiratory syncytial virus (RSV) jabs missed expectations, sending its shares lower... Full

Pfizer Tacks On $1B to 2024 Revenue Outlook Amid Cost-Cutting Drive

(7/30, Zoey Becker, Fierce Pharma) ...During the second quarter, Pfizer collected sales of $13.3 billion, a 2% uptick from last year's second quarter and a 3% boost operationally. Taking COVID products Comirnaty and Paxlovid out of the equation, operational revenue growth totaled 14%. Considering the company's total haul for the first half of this year is now up by 11% to $28 billion, Pfizer opted to crank up its full-year earnings outlook by $1 billion to reflect a "strong business performance," chief financial officer David Denton said on the second-quarter earnings call... Full

China Corruption Crackdown Hits Merck's Gardasil Sales, Spooking Investors

(7/30, Max Bayer, Endpoints News) ...China's recent effort to crack down on healthcare corruption has spurred a slowdown in Gardasil shipments, according to Merck CEO Rob Davis. On Tuesday, Davis told investors that China's corruption work led to criminal charges against "a senior scientific representative" related to a Covid-19 vaccine, impacting immunization efforts in the country. Neither the local official nor the vaccine product were mentioned by name, and the company declined to say more when asked in a follow-up email... Full

Amid EuroAPI's Restructuring, Production Woes at Italy Site Cause Steep Half-Year Sales Decline

(7/30, Zoey Becker, Fierce Pharma) ...During the first half of this year, EuroAPI saw a 9.6% decrease in net sales to 448.7 million euros ($485 million). In a release, the company said the slide was largely a result of a production suspension at its Brindisi, Italy, plant after an internal audit revealed quality control issues that were later confirmed to have stemmed from "malpractices at the local level."... Full

India's Mankind Pharma Misses Q1 Profit Expectations On Higher Costs

(7/31, Kashish Tandon, Reuters) ...Revenue from operations rose about 12% to 28.93 billion rupees, but expenses rose 15.5%...Mankind Pharma's June quarter profit was hurt by rising costs, mainly employee-related expenses, even as Indian drugmakers have been benefiting from strong domestic demand for their specialty drugs. The company, which makes anti-infectives and drugs for treating respiratory illnesses, also said that growth was partially impacted due to a delay in the flu season... Full

Roche's Vabysmo Challenges Eylea Dominance with Third European Indication

(7/30, Robert Barrie, Pharmaceutical Technology) ...The European Commission has approved Roche's Vabysmo (faricimab) for the treatment of retinal vein occlusion, adding a third indication for the company's blockbuster drug...GlobalData senior pharma analyst Sara Reci said: "If Roche's Vabysmo continues to provide promising sales figures for the foreseeable future, in addition to the company's anticipated re-launch of Susvimo and Suvsimo's label expansion, Roche will have put itself on track to becoming an industry leader within the ophthalmological space."... Full

Celltrion's Stelara Biosimilar Approved in Canada, Targeting 28 Trillion Won Global Market

(7/31, Choi Mun-hee, Business Korea) ...Celltrion announced on July 31 that it has received approval from Health Canada for its new drug submission for Steqeyma (development name CT-P43), a biosimilar developed for the treatment of autoimmune diseases, modeled after Stelara...With this approval, Celltrion has not only expanded its autoimmune disease treatment portfolio in the North American market but also strengthened its position. In addition to its existing tumor necrosis factor (TNF)-alpha inhibitors such as Zymfentra, Remsima, and Yuflyma, Celltrion can now extend its therapeutic range to include IL inhibitors... Full

Formycon And Bio-Thera Kick Off Trials For Keytruda Rivals

(7/30, David Wallace, Generics Bulletin) ...Formycon and Bio-Thera Solutions have revealed fresh updates on their planned biosimilar rivals to Keytruda (pembrolizumab), with both firms kicking off Phase III trials as development hots up for one of the biggest future targets for biosimilars. They join the likes of Alvotech, Amgen, Celltrion, Sandoz and Samsung Bioepis that already have versions of pembrolizumab in development... Global Sub. Full

Kashiv Finishes Patient Recruitment In Late Stage Xolair Biosimilar Trial

(7/30, Adam Zamecnik, Generics Bulletin) ...Kashiv Biosciences has completed patient enrollment for the Phase III trial of its Xolair (omalizumab) biosimilar ADL018, doubling down on the product's development after its recent licensing deal with Amneal Pharmaceuticals...This year, the company expects its biosimilars revenues to double to over $125m, while also anticipating a peak US biosimilar revenue of $200m in 2025... Global Sub. Full

Lupin Receives US FDA Tentative Marketing Approval for Generic Descovy Tablets

(7/31, Pharmabiz.com) ...Global pharma major Lupin Limited announced that it has received tentative approval from the United States Food and Drug Administration (FDA) under the US President's Emergency Plan for AIDS Relief (PEPFAR) for its Abbreviated New Drug Application for emtricitabine and tenofovir alafenamide tablets, 200 mg/25 mg, to market a generic equivalent of Descovy tablets, 200 mg/25 mg, of Gilead Sciences, Inc... Full

Zydus Lifesciences Receives Marketing Approval for Mamitra in Mexico

(7/31, IIFL Securities) ...Zydus Lifesciences has announced that Mamitra, a Trastuzumab biosimilar, has received marketing approval from COFEPRIS (Federal Commission for the Protection Against Sanitary Risk) in Mexico. This approval marks a significant milestone for Zydus as Mamitra will now be available in two strengths: 150 mg and 440 mg. The drug is intended for the treatment of patients with HER2 overexpressing metastatic breast cancer (MBC), HER2 overexpressing early breast cancer (EBC), and advanced gastric cancer... Full

Benefit of Eisai and Biogen's Alzheimer's Drug Increases Over Time, Studies Suggest

(7/30, Julie Steenhuysen, Reuters) ...The benefit of Eisai and Biogen's Alzheimer's drug Leqembi in patients with early-stage Alzheimer's appears to increase with continued use with no new safety issues, according to three-year data presented at an Alzheimer's meeting on Tuesday. In the companies' pivotal clinical trial, Leqembi reduced cognitive decline by 27% after 18 months - data that supported the drug's approval last year... Full

FDA Shoots Down Second Novartis Petition Seeking to Halt Entresto Generics

(7/30, Zachary Brennan, Endpoints News) ...The FDA said in its response that Novartis' latest citizen petition was similar to its first from 2021, and again explained why the Swiss drugmaker's call for the agency to refrain from approving generics isn't valid...In its most recent petition, Novartis called on the FDA to not approve any Entresto generics due to potential label discrepancies with the brand-name version. But the FDA said in its new response that Entresto's label was expanded in 2021 to include patients who could be categorized as having heart failure with preserved ejection fraction (HFpEF), and that indication can be carved out from generic labels... Full

Regulator Halts Import of GSK's Asthma Drug and Imposes a Fine

(7/30, Kim Chan-hyuk, Korea Biomedical Review) ...GlaxoSmithKline received two administrative penalties from the Ministry of Food and Drug Safety on July 19. The ministry imposed the penalties after GSK violated regulations by failing to report a change in the specifications of the main ingredient in a raw drug and confusing the drug's manufacturing number and expiration date... Full

Generic Drug Makers Continue Forging Ahead

(7/30, Sandra Levy, Drug Store News) ...Executives from several generics firms acknowledge that there are abundant challenges, but they also emphasize their commitment to accelerate innovation to best serve their customers and patients. The low price of many generic medicines has become a thorn in the side of the industry, and the consensus is that it has resulted in drug shortages... Full

Biotech API Manufacturing Market Growing Fast

(7/30, The Pharma Letter) ...The global market for biotech active pharmaceutical ingredient (API) manufacturing services is poised for significant growth, according to an analysis from Transparency Market Research. The trend is driven by the increasing demand for biologics, biosimilars, and other biopharmaceuticals, with an aging population one of the key factors at work... Paid Sub. Req'd

Drug Costs to Increase 3.8% Next Year: Vizient

(7/30, Alex Kacik, Modern Healthcare) ...Drug prices are expected to increase 3.81% next year, propelled by expensive cell and gene therapies and glucagon-like peptide agonists. The estimate from Vizient, a group purchasing organization, tops the company's 2024 drug cost growth projection of 3.42%. Vizient uses recent provider purchasing data to forecast what hospitals and health systems might pay for drugs after discounts and rebates... Paid Sub. Req'd

As Drug Shortages Abound, Columbus Drug Manufacturer Steps Up to Make Chemo Drugs for Kids

(7/31, Samantha Hendrickson, The Columbus Dispatch) ...STAQ Pharma, a Denver-based pharmaceutical supplier focusing on acute shortages in critical medications, announced the launch of its oncology drugs portfolio at its Columbus location Friday. The company, owned by hospitals around the country including Columbus-based Nationwide Children's, will manufacture the well-known chemotherapy drug methotrexate at its Hilltop facility. Methotrexate is used to treat cancers such as blood-born leukemias and non-Hodgkin's lymphoma in children... Full

Hospital Partnership and Penicillin Imports: The Latest On Mark Cuban Cost Plus Drug Company

(7/30, Will Maddox, D Magazine) ...The partnership is the first of its kind for Cost Plus, and CEO Dr. Alex Oshmyansky says the two organizations have been in talks for about a year before the launch. He says the plan is to meet every couple of weeks with CHS leadership to develop a larger drug portfolio for the system. Oshmyasnky, a trained radiologist and polymath, has long been working to disrupt what he calls a broken pharmaceutical system and fight against unnecessarily high drug prices. A cold email led to a partnership with Cuban and he now leads the only company founded by the former Mavericks owner that bears Cuban's name... Full

Amazon Expected $1 Billion Loss from Healthcare Biz for 2024: Document

(7/30, Eugene Kim, Business Insider) ...Overall, the 10-page document revealed Amazon wrestling with a challenging and complex new sector, while making tough decisions and steady progress. Although the company doesn't break out financials on the healthcare business, investors will be looking for signs of success when it reports results on Thursday...Amazon forecast overall healthcare revenue to climb 28% to $3.16 billion in 2024, according to the document from December. That was mostly thanks to Amazon Pharmacy, which was projected to generate $1.81 billion in 2024 sales, a 45% surge. One Medical, meanwhile, was anticipated to grow revenue by 10% to $1.34 billion... Full

Florida's RSV Season Has Started, and It's Coming Soon to the Rest of US. Here's a Primer.

(7/31, Sam Ogozalek, KFF Health News) ...Even in Florida, not many older adults have gotten the shot yet. That's telling for a place with a high concentration of seniors because, while the virus has traditionally been thought of as a childhood ailment that affects babies, older adults can suffer from it, too. And Florida, with its humid weather, is the nation's ground zero for RSV. Each year, infections typically start in Florida and the Southeast before spreading to other parts of the United States, according to the University of Florida's Emerging Pathogens Institute... Full

Pharma Damps Effects of First Drug Price Talks

(7/31, Maya Goldman, Axios) ...As drugmakers continue to try to overturn Medicare drug price negotiations in courts, they're telling Wall Street the negotiations won't materially affect their bottom lines in the short run..."It is what it is. It is the law of the land, and we are doing our best to make sure that we minimize any impact, particularly in the future," Pfizer CEO Albert Bourla said Tuesday in a call with analysts, during which the company adjusted full-year projections upward... Full

Medicare Negotiations for Lower Drug Prices Near the Finish Line

(7/30, Sydney Lupkin, NPR) ...Negotiating Medicare drug prices is something former President Donald Trump also talked about doing before walking the campaign promise back a few years ago. Here's what to know about the landmark update to the health care program for seniors... Full

Part D Redesign Pushes 2025 Bid Amounts Up As CMS Demo Aims To ‘Stabilize' PDPs

(7/30, Cathy Kelly, Pink Sheet) ...Medicare Part D plan bids for 2025 more than doubled on average from 2024, primarily reflecting a shift in government payments that are part of the Inflation Reduction Act's benefit redesign, which will be fully in effect next year, the Centers for Medicare and Medicaid Services announced July 29... Paid Sub. Req'd

The Next 340B Battle: Discount Duplication With Medicare Negotiated Prices

(7/30, Cathy Kelly, Pink Sheet) ...Manufacturers likely will have to determine when to provide a 340B discount on a drug assigned a Medicare negotiated price under CMS guidance. PhRMA anticipates the job will not be easy...CMS and HRSA should not take enforcement action against manufacturers if they do not "promptly" provide 340B discounts on drugs that also have Medicare negotiated prices despite "good faith efforts" at verification with hospital claims data, PhRMA says... Paid Sub. Req'd

Supreme Court Urged to Skip Review of Drug Benefit Middlemen Law

(7/30, Lauren Clason, Bloomberg Law) ...The US Supreme Court does not need to take up a federal appeals court's rejection of an Oklahoma law regulating the work of pharmacy benefit managers because the Tenth Circuit settled the questions of the case, the industry's lobby group argued in a Monday filing...PCMA countered Wednesday by saying the Tenth Circuit's decision was in line with the Supreme Court's ruling in Rutledge, and that Oklahoma's argument to the Supreme Court was based on how the appeals court characterized the law, not whether the law was preempted by federal statute... Paid Sub. Req'd

New Bill Echoes Calls For Federal Transition Away From Traditional PBM Model

(7/30, Gabrielle Wanneh, InsideHealthPolicy) ...Months after Mark Cuban of the Mark Cuban Cost Plus Drug Company suggested the Biden administration cut its current ties to top traditional pharmacy benefit managers and shift federal health programs to new contracts with PBMs operating under a more transparent business model, bipartisan legislation introduced last Tuesday (July 23) offers a similar solution that would implement a transparent model for pharmacy reimbursement across several federal health programs to combat current PBM practices... Paid Sub. Req'd

Wells Fargo Sued Over Drug Costs in Employee Health Plan

(7/30, John Tozzi, Bloomberg) ...A lawsuit filed in federal court in Minnesota Tuesday alleges that the country's fourth-largest bank squandered money in its health plan, sometimes causing workers to pay far more for medications than they would have if they'd paid cash. For example, the Wells Fargo plan paid almost $10,000 for a generic pill for multiple sclerosis that Wegmans pharmacies sold for $648, according to the complaint, driving up premiums and out-of-pocket costs... Full

AI Isn't Ready for Patent Office Policies, Pharma Group Says

(7/30, Jorja Siemons, Bloomberg Law) ...The US patent office shouldn't yet develop broad policy around the use of AI because the technology's use is still in its early stages, Pharmaceutical Research and Manufacturers of America said Monday. "Indeed, use of AI within the pharmaceutical industry is a recent phenomenon, and the use of such tools are highly experimental and fragmented," Vice President of IP and Law David E. Korn and Assistant General Counsel John E. Nappi said in comments to the PTO... Paid Sub. Req'd

Improving How CMS Defines "Unmet Medical Need" Under The IRA

(7/30, A. Alex Levine, Stacey Kowal, James D. Chambers, Health Affairs) ...Arriving at a comprehensive yet clear understanding of unmet medical need within the Medicare Drug Price Negotiation Program poses challenges. Yet, a workable and person-centered definition is crucial to anchoring treatment access and innovation to beneficiary need, increasing transparency for stakeholders, and prioritizing limited health care resources... Full

GDUFA User Fee Rates for FY 2025 – We Warned You!

(7/30, Bob Pollock, Lachman Consultants) ...The individual ANDA submission fee will be going up by $69,467 next year. Remember that October 1st (the beginning of FY 2025) is right around the corner; my guess is that the race to submit new ANDAs before the end of September is going to be a crowded field... Full

US FDA Corrects Errors, Limits PDUFA Application Fee Increase

(7/30, Derrick Gingery, Pink Sheet) ...The agency used a 10-year average with updated figures to calculate the FY 2025 PDUFA application fee and limit the impact of submission volatility, but still allowed GDUFA and BsUFA fees to skyrocket...Prescription drug application user fees will increase again in fiscal year 2025, although not as much as the previous year, while similar charges for generics and biosimilars will spike... Paid Sub. Req'd

Filing a New Drug with Clinical Data in 2025? FDA Sets Fee at $4.3M

(7/30, Zachary Brennan, Endpoints News) ...The FDA said Tuesday that companies filing new drug and biologics applications next year with clinical data will each have to pay a fee of $4.3 million, which is about $300,000 more than they're paying in 2024. For applications not requiring clinical data, the filing fee has risen consistently from $1.6 million in 2023 to $2 million in 2024. It will be $2.2 million in 2025. But the program fee, which is an annual fee for marketed drugs, will decline to $403,889 in 2025 from $416,734 in 2024... Full

Pharmacies Dwindle in RI Amid National Battle Over How Drugs Are Priced

(7/30, Eli Sherman, Tim White, WPRI) ...Mike Bladyga, public affairs director for the PBM industry's Pharmaceutical Care Management Association, also rejected the idea that they're responsible for pharmacies closing down. "It makes no sense that PBMs are putting pharmacies out of business," Baldyga told Target 12 in a statement. "There are many factors for pharmacy closures, however pharmacy benefit managers are supporting community pharmacies in rural areas through programs that increase reimbursements. Blaming PBMs for pharmacy closures is not based on the facts."... Full

EU To Launch New Platform For Tackling Shortages Of ‘Critical' Medicines In Health Crises

(7/30, Ian Schofield, Pink Sheet) ...The European Medicines Agency's new platform for monitoring medicine supply, demand and availability during health crisis situations is to go live for marketing authorization holders in November and for national regulators by the legal deadline of February 2025. The European Shortages Monitoring Platform will be used in three circumstances: for routine reporting of shortages of "critical" centrally authorized products, for crisis preparedness exercises, and in actual health emergencies... Paid Sub. Req'd

Government Schemes Bolster Startup Growth in India's Pharmaceutical Sector

(7/31, Express Pharma) ...The Government of India has rolled out several initiatives to boost startups, with a significant focus on the pharmaceutical sector. The Department of Pharmaceuticals recently launched the Scheme for Promotion of Research and Innovation in Pharma-MedTech sector (PRIP), which targets startups through its Component BIII. Out of 125 research projects identified in six priority areas, 50 are specifically designated for pharmaceutical startups... Full

Indian Pharma Locators Seen Stabilizing Supply of Medicine, PEZA Says

(7/30, Adrian H. Halili, Business World) ...The Philippine Economic Zone Authority (PEZA) said more Indian drugmakers establishing operations in economic zones hold the potential for addressing the shortage of essential drugs and medical devices. In a statement, PEZA Director General Tereso O. Panga said that the Philippines' increasing population and increased demand for medicine and healthcare services are "compelling reasons to localize production of drugs and medical devices."... Full

Singapore Experience Shows Benefits of Value-Driven Strategies in Generating Biosimilar Savings

(7/30, Skylar Jeremias, The Center For Biosimilars) ...Value-driven health care strategies in Singapore's public health care institutions have led to high biosimilar adoption rates, improving affordable access through reduced treatment costs and producing significant savings for the health care system, according to a study published in PharmacoEconomics... Full

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