Teva Pharmaceutical Indus Azioni (NYSE: TEVA)

Ultime notizie per Teva Pharmaceutical Indus (NYSE:TEVA) Azioni

Teva Pharmaceutical Indus

Teva Pharmaceutical Industries, based in Israel, is the leading generic drug manufacturer in the world. Teva derives half of its sales from North America and makes up a high-single-digit percentage of the total number of generic prescriptions in the US. It also has a significant presence in Europe, Japan, Russia, and Israel. Besides generics, Teva has a portfolio of innovative medicines and biosimilars in three main therapeutic areas: central nervous system with Copaxone, Ajovy, and Austedo; respiratory with Qvar and ProAir; and oncology with Truxima, Herzuma, and Bendeka/Treanda. Teva also sells active pharmaceutical ingredients, offers contract manufacturing services, and owns Anda, a US-based generic and specialty drug distributor.

Teva Pharmaceutical Industries Limited American Depositary Shares

Teva Pharmaceutical Industries Ltd

TEVA PHARMA IND ADR REP 1 ORD

TEVA PHARM INDUS LTD ORD by Teva Pharmaceutical Industries Ltd.

TEVANO SYS HLDGS INC by Tevano Systems Holdings Inc.

Tevano Systems Holdings Inc

On Thursday, Amicus Therapeutics&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/FOLD#NASDAQ">FOLD</a>) announced that it has entered into a License Agreement with Teva Pharmaceuticals Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/TEVA#NYSE">TEVA</a>).
The <a target="_blank" href="https://www.benzinga.com/pressreleases/24/10/g41376664/amicus-therapeutics-announces-settlement-of-galafold-migalastat-patent-litigation-with-teva" rel="noreferrer noopener">agreement resolves</a> the patent litigation brought by Amicus in response to Teva&#8217;s Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of Galafold (migalastat) 123mg capsules before the expiration of the applicable patents.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/10/41295664/teva-pays-450m-to-resolve-alleged-kickback-price-fixing-schemes" rel="noreferrer noopener">Teva Pays $450M To Resolve Alleged Kickback, Price-Fixing Schemes</a>.
Galafold is a medication for Fabry disease, a rare genetic disorder caused by the buildup of a type of fat called globotriaosylceramide in the body&#8217;s cells.
Under the terms of the Agreement, Amicus will grant Teva a license to market its generic version of Galafold&nbsp;in the&nbsp;United States&nbsp;beginning on January 30, 2037, if approved by the FDA and unless certain limited circumstances customarily included in these types of agreements occur.
The parties will terminate all ongoing Hatch-Waxman litigation between Amicus and Teva regarding Galafold patents pending in the U.S. District Court for the District of Delaware.
The litigation will continue against Aurobindo&nbsp;as the remaining active party, and the litigation stay remains in place for Lupin.
Price Action: TEVA stock is up 0.47% at $18.11, and FOLD stock is up 12.4% at $11.81 at last check Thursday.
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Amicus Therapeutics Settles Patent Lawsuit Teva Pharmaceuticals Over Generic Version Of Its Rare Genetic Disorder Drug

This Agreement resolves the patent litigation brought by Amicus in response to Teva&#39;s Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of GALAFOLD&nbsp;(migalastat) 123mg capsules prior to expiration of the applicable patents.
Pursuant to the terms of the Agreement, Amicus will grant Teva a license to market its generic version of GALAFOLD&nbsp;in the&nbsp;United States&nbsp;beginning on January 30, 2037, if approved by the U.S. Food and Drug Administration (FDA) and unless certain limited circumstances customarily included in these types of agreements occur.
In accordance with the Agreement, the parties will terminate all ongoing Hatch-Waxman litigation between Amicus and Teva regarding GALAFOLD&nbsp;patents pending in the U.S. District Court for the District of Delaware. The litigation will continue against Aurobindo1&nbsp;as the remaining active party and the litigation stay remains in place for Lupin.

Amicus Therapeutics Enters License Agreement With Teva, Resolving Galafold Patent Litigation; No Terms Disclosed

Teva Pharmaceuticals Industries Ltd (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/TEVA#NYSE">TEVA</a>) has agreed to a $450 million settlement with the U.S. government to resolve allegations that they violated the Anti-Kickback Statute (AKS) and the <a target="_blank" href="https://www.benzinga.com/general/biotech/24/09/40801368/teva-announces-80m-settlement-to-baltimore-city-continues-opioid-litigation-against-other-compani" rel="noreferrer noopener">False Claims Act (FCA)</a>.
The settlement stems from claims that Teva engaged in two unlawful kickback schemes, impacting Medicare and the pricing of essential drugs.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/09/40957505/eli-lilly-fights-183m-medicaid-fraud-judgment-cites-reasonable-interpretation-of-medicaid-rules" rel="noreferrer noopener">Eli Lilly Fights $183M Medicaid Fraud Judgment, Cites Reasonable Interpretation Of Medicaid Rules</a>.
This resolution includes $225 million in criminal penalties that Teva USA previously paid as part of a deferred prosecution agreement with the Department of Justice.
The first kickback <a target="_blank" href="https://www.justice.gov/opa/pr/drug-maker-teva-pharmaceuticals-agrees-pay-450m-false-claims-act-settlement-resolve-kickback" rel="noreferrer noopener">scheme</a> involved allegations that Teva violated the AKS by covering Medicare patients&#8217; copays for the multiple sclerosis drug Copaxone between 2006 and 2017.
During this period, Teva is accused of coordinating with third parties, including a specialty pharmacy and two supposedly independent copay assistance foundations, to direct donations to cover patients&#8217; Copaxone copays.
According to federal prosecutors, these actions were prohibited by the AKS and caused false claims to be submitted to Medicare as Teva simultaneously raised the drug&#8217;s price.
The second scheme alleges that Teva USA conspired with other generic drug manufacturers to fix the prices of pravastatin, a cholesterol-lowering drug, clotrimazole, and tobramycin, two additional generics.
The Justice Department had previously secured a deferred prosecution agreement with Teva USA, where the company admitted to participating in price-fixing activities.
The settlement is part of a broader initiative against price-fixing and kickbacks in the pharmaceutical industry.
According to Joshua S. Levy, Acting U.S. Attorney for the District of Massachusetts, Teva&#8217;s manipulation of the charitable foundation process violated the AKS and undermined Medicare&#8217;s copay system. His office has played a central role in these enforcement actions, returning over $1 billion to Medicare since 2017.
This settlement is the largest among a series of cases targeting pharmaceutical companies that unlawfully paid patient copays through third-party foundations.
The Justice Department has secured over $1 billion from these companies and reached settlements with four foundations and a specialty pharmacy.
Price Action: TEVA stock is down 0.34% at $17.35 at last check Friday.
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Teva Pays $450M To Resolve Alleged Kickback, Price-Fixing Schemes

<a href="https://www.justice.gov/opa/pr/drug-maker-teva-pharmaceuticals-agrees-pay-450m-false-claims-act-settlement-resolve-kickback" title="https://www.justice.gov/opa/pr/drug-maker-teva-pharmaceuticals-agrees-pay-450m-false-claims-act-settlement-resolve-kickback">https://www.justice.gov/opa/pr/drug-maker-teva-pharmaceuticals-agrees-pay-450m-false-claims-act-settlement-resolve-kickback</a>

'Drug Maker Teva Pharmaceuticals Agrees to Pay $450M in False Claims Act Settlement to Resolve Kickback Allegations Relating to Copayments and Price Fixing' - DOJ

Teva Pharmaceutical Indus (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/TEVA#NYSE">TEVA</a>) has outperformed the market over the past 5 years by 6.31% on an annualized basis producing an average annual return of 20.33%. Currently, Teva Pharmaceutical Indus has a market capitalization of $19.92 billion. 
Buying $100 In TEVA: If an investor had bought $100 of TEVA stock 5 years ago, it would be worth $261.22 today based on a price of $17.58 for TEVA at the time of writing.
<h3>Teva Pharmaceutical Indus's Performance Over Last 5 Years</h3>
<img src="https://www.benzinga.com/files/images/story/2024/1728572432_0.png" alt="comp_fig" />
Finally -- what's the point of all this? The key insight to take from this article is to note how much of a difference compounded returns can make in your cash growth over a period of time.
This article was generated by Benzinga's automated content engine and reviewed by an editor.

Here's How Much $100 Invested In Teva Pharmaceutical Indus 5 Years Ago Would Be Worth Today

The FDA&#39;s anticipated decision and EMA&#39;s expected opinion are anticipated in the second half of 2025.

Teva Says FDA Has Accepted, And The European Medicines Agency Has Validated, Applications For TVB-009P, A Biosimilar Candidate To Prolia

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US State Of Georgia's Supreme Court Reinstates Abortion Ban That Was Blocked By Lower Court

On Wednesday, the U.S. Department of Health and Human Services (HHS), working via the Centers for Medicare &amp; Medicaid Services (CMS), released final guidance for the second cycle of the <a href="https://www.benzinga.com/general/health-care">Medicare Drug Price Negotiation Program</a>.
This initiative <a target="_blank" href="https://www.cms.gov/newsroom/press-releases/hhs-releases-final-guidance-second-cycle-historic-medicare-drug-price-negotiation-program" rel="noreferrer noopener">aims</a> to provide lower drug prices starting in 2026 and 2027.
It also ensures that people with Medicare can access these negotiated prices, expanding on the groundwork laid in the first cycle of negotiations.
The first round of negotiations focused on 10 specific drugs. Medicare recipients should save approximately $1.5 billion in out-of-pocket costs when the new prices take effect in 2026.
By February 2025, CMS will select up to 15 additional drugs for the second round of negotiations. The selected drugs will undergo negotiations in 2025, with new prices becoming effective in 2027.
They include: 
<ul>
<li>Novo Nordisk&#8216;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVO#NYSE">NVO</a>) diabetes drug, <a href="https://www.benzinga.com/general/biotech/24/08/40534249/novo-nordisks-ozempic-might-be-among-2027-medicare-price-negotiation-targets">Ozempic,</a></li>
<li>Pfizer Inc.&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) cancer drugs Ibrance and Xtandi</li>
<li>GSK Plc&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>) asthma treatment Trelegy Ellipta</li>
<li>Teva Pharmaceutical Industries Ltd.&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/TEVA#NYSE">TEVA</a>) Huntington&#8217;s disease drug Austedo, and</li>
<li>Abbvie Inc.&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/ABBV#NYSE">ABBV</a>) irritable bowel syndrome treatment Linzess.</li>
</ul>
CMS plans to improve patient-focused engagement during the second cycle of negotiations. It will also organize roundtable events and town hall meetings in 2025.
As Medicare Open Enrollment approaches on Oct. 15, beneficiaries can expect more cost-saving measures in the coming years. That includes a $2,000 annual cap on out-of-pocket drug costs starting in January 2025.
These changes build on other provisions of the Inflation Reduction Act, which was signed by President Joe Biden on Aug. 16, 2022. The legislation included a $35 monthly cap on insulin and free recommended vaccines for adults covered under Medicare Part D.
Monday, the U.S. Department of Health and Human Services (HHS) announced that Medicare enrollees will benefit from reduced prices on 54 drugs through Medicare Part B, effective from Oct. 1, 2024, to Dec. 31, 2024. Some Medicare beneficiaries could see daily savings ranging from $1 to as much as $3,854 on drugs included <a href="https://www.benzinga.com/general/biotech/24/10/41127143/us-hhs-reveal-cost-savings-for-54-prescription-drugs-including-novartis-cancer-drug-ozempic-could" target="_blank" rel="noreferrer noopener">in the rebate program</a>.
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Medicare Drug Price Negotiation Program Gets Final Guidance For Second Cycle, $1.5B Savings Expected

<ul>
<li>The expansion of the strategic partnership reinforces the solid foundation of the collaborative efforts that commenced in April 2024</li>
<li>The collaboration supports Teva's Pivot to Growth strategy and adds to the company's biosimilar portfolio</li>
<li>Both companies reaffirm their shared commitment to making high-quality, affordable treatments accessible to patients worldwide &nbsp;</li>
</ul>
TEL AVIV, ISRAEL and MADRID, Oct. 03, 2024 (GLOBE NEWSWIRE) -- Teva Pharmaceuticals International GmbH, a subsidiary of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) and mAbxience, a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma, today announced a new global licensing agreement for the development of an anti PD-1 oncology biosimilar candidate. This marks the second agreement between the two companies, reinforcing the solid foundation of the collaborative efforts that commenced in April 2024.
The global agreement to develop an additional oncology biosimilar further strengthens the alliance between Teva and mAbxience, underscoring the shared goal to provide cost-effective, high-quality biosimilar treatments that address critical unmet needs in oncology care. By leveraging each company's unique expertise and resources, the collaboration continues to drive innovation and accessibility in healthcare to create solutions for patients worldwide.
The licensing agreement includes exclusive rights for multiple markets, including Europe and the United States, and aligns with mAbxience's strategy for global expansion. The collaboration reflects Teva's progress advancing its Pivot to Growth strategy by adding a new biosimilar to the company's broad portfolio of biosimilars, through focused partnerships and business development efforts.

Teva And mAbxience Expand Strategic Partnership To Include An Additional Oncology Biosimilar Candidate; Both Companies Reaffirm Their Shared Commitment To Making High-Quality, Affordable Treatments Accessible To Patients Worldwide

Shares of Teva Pharmaceutical Industries (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/TEVA#NYSE">TEVA</a>) on Tuesday the launch of the first and only generic version of Sandostatin LAR Depot (octreotide acetate for injectable suspension) in the U.S.
Teva's new generic drug is used to treat acromegaly—a condition characterized by excessive growth hormone—and severe diarrhea in patients with carcinoid syndrome, a complication of certain cancers. With annual sales of $826 million for the brand-name version of Sandostatin LAR Depot as of July 2024, the new generic option is expected to provide more affordable treatment to patients.
Ernie Richardsen, SVP of U.S. Commercial Generics at Teva, expressed optimism about the launch, stating, "This first-to-market launch showcases Teva&#8217;s expertise in bringing complex generics to market. We are not only sustaining a generics powerhouse but also bringing value to patients and healthcare systems."
What Else: Iran&#8217;s <a href="https://www.benzinga.com/etfs/broad-u-s-equity-etfs/24/10/41120592/iran-set-to-launch-ballistic-missile-attack-against-israel-report">missile attack</a> on Teva&#8217;s home country of Israel may have also be impacting the stock today. 
TEVA Price Action: Teva shares were down by 2.6% at $254.81 according to <a href="https://pro.benzinga.com/dashboard">Benzinga Pro.</a>
<figure class="wp-block-image size-large is-resized"><a href="https://www.benzinga.com/pro/?utm_source=BZprocontent100124&amp;t=be2bearmibe3na1"><img loading="lazy" decoding="async" width="1024" height="550" src="https://editorial-assets.benzinga.com/wp-content/uploads/2024/10/01132741/TEVA-1024x550.png" alt="" class="wp-image-575213" style="width:658px;height:auto" srcset="https://editorial-assets.benzinga.com/wp-content/uploads/2024/10/01132741/TEVA-1024x550.png 1024w,https://editorial-assets.benzinga.com/wp-content/uploads/2024/10/01132741/TEVA-300x161.png 300w,https://editorial-assets.benzinga.com/wp-content/uploads/2024/10/01132741/TEVA-768x412.png 768w,https://editorial-assets.benzinga.com/wp-content/uploads/2024/10/01132741/TEVA.png 1056w" sizes="(max-width: 1024px) 100vw, 1024px" /></a></figure>
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Image Via Shutterstock.

Teva Launches Generic Version Of Sandostatin In The US

<ul>
<li>This first-to-market launch showcases Teva's proven strengths in complex generic formulations and enhances Teva's strategic goal of sustaining a generic powerhouse. &nbsp;</li>
<li>Octreotide acetate for injectable suspension is indicated to treat acromegaly and severe diarrhea for carcinoid syndrome.</li>
</ul>
PARSIPPANY, N.J., Oct. 01, 2024 (GLOBE NEWSWIRE) -- Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), announced today the launch of the first and only generic version of Sandostatin&#xAE;1 LAR Depot, in the United States.
Octreotide acetate for injectable suspension (the generic version of Sandostatin&#xAE; LAR Depot) is indicated to treat acromegaly and severe diarrhea for carcinoid syndrome. Please see the below for more information.

Teva Announces Launch Of The First And Only Generic Version Of Sandostatin LAR Depot, In The U.S.

Teva Pharmaceutical Indus (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/TEVA#NYSE">TEVA</a>) has outperformed the market over the past 5 years by 6.63% on an annualized basis producing an average annual return of 20.77%. Currently, Teva Pharmaceutical Indus has a market capitalization of $19.95 billion. 
Buying $1000 In TEVA: If an investor had bought $1000 of TEVA stock 5 years ago, it would be worth $2,544.03 today based on a price of $17.61 for TEVA at the time of writing.
<h3>Teva Pharmaceutical Indus's Performance Over Last 5 Years</h3>
<img src="https://www.benzinga.com/files/images/story/2024/1727724615_0.png" alt="comp_fig" />
Finally -- what's the point of all this? The key insight to take from this article is to note how much of a difference compounded returns can make in your cash growth over a period of time.
This article was generated by Benzinga's automated content engine and reviewed by an editor.

$1000 Invested In Teva Pharmaceutical Indus 5 Years Ago Would Be Worth This Much Today

Truist Securities raised the price target for Corcept Therapeutics Incorporated (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CORT#NASDAQ">CORT</a>) and cites continued momentum in Korlym sales more than a decade after launch amid increasing competition and says it &#8220;is impressive and difficult to ignore.&#8221;
Korlym (mifepristone) is a prescription medicine used to treat high blood sugar (hyperglycemia) caused by high cortisol levels in the blood (hypercortisolism) in adults with endogenous Cushing syndrome who have type 2 diabetes mellitus or glucose intolerance and who cannot have surgery or for whom surgery has failed.&nbsp;
Cushing syndrome is&nbsp;a hormonal disorder that occurs when the body has too much cortisol, a hormone that helps the body respond to stress.&nbsp;
Truist analyst notes approximately 20K Cushing&#8217;s disease (pituitary adenoma) patients in the U.S., of which ~10K are adequately managed with surgical resection of the pituitary adenoma.
Medical management is recommended for the remaining 10K. Therefore, there&#8217;s still significant room for growth, with just ~2,000 hypercortisolism patients currently on Korlym.
In June, Teva Pharmaceuticals Inc.&nbsp;(NYSE:<a class="ticker" href="https://www.benzinga.com/stock/TEVA#NYSE">TEVA</a>) reportedly sued Corcept Therapeutics, accusing it of a monopoly on Korlym.
The lawsuit, filed in federal court in San Francisco, alleges that Corcept and its sole distributor, Optime Care, engaged in anti-competitive practices <a target="_blank" href="https://www.benzinga.com/24/06/39339275/concerpt-therapeutics-shares-are-trading-lower-what-you-need-to-know" rel="noreferrer noopener">to stifle competition</a>.
In May,&nbsp;Corcept Therapeutics announced that the GRACE Phase 3 trial of&nbsp;relacorilant&nbsp;in patients with hypercortisolism (Cushing&#8217;s syndrome)&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/24/05/39039282/why-mid-cap-corcept-therapeutics-stock-trading-higher-on-tuesday" rel="noreferrer noopener">met its primary endpoint</a>.
The company is conducting a Phase 3 GRADIENT trial for relacorilant with enrolled adrenal adenoma patients to strengthen the case for treating patients whose hypercortisolism was driven by adrenal adenoma.
Data from GRACE and GRADIENT studies will form a part of the FDA application submission. The analyst says, &#8220;GRADIENT is well-powered for success.&#8221;
Truist notes that Corcept Therapeutics can achieve around $3 billion in total revenue within five years.
The analyst highlights that management emphasized that once relacorilant is approved, almost all existing patients on Korlym would be converted to relacorilant.
With increased market penetration of relacorilant in Cushing&#8217;s from 16% to 25% in 2033, Truist raised the price target from $65 to $76, <a target="_blank" href="https://www.benzinga.com/quote/CORT/analyst-ratings" rel="noreferrer noopener">with a Buy rating</a>.
Price Action: CORT stock is up 5.19% at $46.21 at the last check on Monday.
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Corcept Therapeutics' Commercial Drug Korlym Sales Impress Despite Increased Competition, Analyst Boosts Price Forecast

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today presented data informing clinical strategies for switching patients to UZEDY&#xAE;, an extended-release injectable suspension of risperidone for subcutaneous use every one or two months for the treatment of schizophrenia in adults, from a once-monthly subcutaneous injection of Perseris&#xAE; (RBP-7000). The results were presented during the 37th Annual European College of Neuropsychopharmacology (ECNP) Congress taking place between September 21-24, 2024, in Milan, Italy.
Schizophrenia is a complex medical condition that may require switching from an oral option or between different long-acting injectable options during the patient treatment journey. These data further clinical understanding of optimal treatment strategies when switching to UZEDY from Perseris&#xAE;.
"Schizophrenia patients and healthcare providers rely on evidence-based studies that can help inform their treatment decisions. That is why Teva is dedicated to building on our commitment to neuroscience and schizophrenia and helps provide these clinical insights on UZEDY switching strategies, along with its role in long-acting treatment options," said Eric Hughes, MD, PhD, Executive Vice President of Global R&amp;D and Chief Medical Officer at Teva. "Up to 80% of schizophrenia patients experience multiple relapses in the first five years, making switching treatments a common experience in the search for optimal treatment. With UZEDY, Teva is building a robust portfolio of research that can help determine if and when it may be the right long-acting option."
In a population pharmacokinetic (PopPK) analysis, simulations were conducted to predict pharmacokinetic (PK) exposures when switching to UZEDY 4-6 weeks after the last injection of once-monthly RBP-7000. The simulation models indicated that switching to UZEDY 4 weeks after the last dose of once-monthly RBP-7000 resulted in comparable PK properties of UZEDY at both the initial exposure and steady state. Comparable doses included UZEDY at 100 mg (once-monthly dosing) or 200 mg (once-every-two-months dosing) to 120 mg of once-monthly RBP-7000.1
Any switching strategy should be determined by clinicians on an individual patient basis, considering factors such as patient preference, scheduling convenience and potential tolerability issues or risk of symptom breakthrough.
"Every person living with schizophrenia has unique treatment needs and preferences that may also evolve over time. For my patients, I encourage discussion around key factors like treatment adherence, dosing frequency, symptom control, and rate of relapse which inform what treatment option may be the most appropriate," said Christoph Correll, MD, Professor of Psychiatry at the Zucker School of Medicine, Hempstead, NY. "For healthcare providers, there is also a significant knowledge gap in the available clinical data on switching patients between the various LAI treatment options, which have differing pharmacokinetic properties and dosing considerations. Insights from studies like these are crucial for researchers and clinicians like myself, as they help us become more informed and better serve our patients."
Additional key data being presented at ECNP 2024 included new quantitative results from the ADVANCE (Attitudes Driving Regional Differences in LAI Antipsychotic Utilization for Schizophrenia Among HCPs, Patients and Caregivers) surveys, including:
<ul>
<li>Among 447 people living with schizophrenia and 375 caregivers, most common patient-reported reasons for accepting an LAI (n=331) were improvement of symptoms/condition with LAIs (68%, n=224), recommendation by their HCP (65%, n=214) and ease of using LAIs versus oral antipsychotics (57%, n=189).1</li>
<li>Patients also reported using LAIs due to fewer side effects versus oral antipsychotics (38%, n=127) and to help prevent hospitalization (20%, n=67).1</li>
<li>Caregivers (n=229) reported that patients accepted LAIs based on ease of use versus oral antipsychotics (78%, n=178), to help prevent hospitalization (62%, n=143) and perception that LAIs would work better for improving condition/symptoms (62%, n=143).1</li>
<li>Among a sample of 791 HCPs from 8 different countries, most HCPs reported that the primary reason for recommending an LAI to a patient was nonadherence to oral medication, with the exception of South Korea where the most common reason was that an LAI would be more efficacious than oral.1</li>
<li>The primary reasons cited for not recommending an LAI were patient clinical characteristics and the lack of an available LAI formulation of the patient's current oral treatment, except for China and South Korea, where the primary reasons were LAI cost to patient and LAI product not marketed, respectively.</li>
</ul>

Reported Saturday, Teva Unveils Data on UZEDY Injection Switching Strategy for Schizophrenia Treatment at ECNP

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced new positive efficacy, safety and tolerability results for Phase 3 Subcutaneous Olanzapine Extended-Release Injection Study (SOLARIS) trial evaluating TEV-‘749 in adult patients diagnosed with schizophrenia. In the study, TEV-‘749 met the primary endpoint, demonstrating significant improvements in the Positive and Negative Syndrome Scale (PANSS)&nbsp;total score from baseline to week 8, as well as key secondary endpoints with improvements in both the Clinical Global Impression-Severity (CGI-S) scale and the Personal and Social Performance (PSP) scale score, compared to placebo at week 8. Additionally, SOLARIS (Period 1) and Phase 1 safety results demonstrated no incidence of post-injection delirium/sedation syndrome (PDSS) in participants taking TEV-‘749 to date.1 The overall safety profile was consistent with other oral acting olanzapine options. These data were presented during the 37th Annual European College of Neuropsychopharmacology (ECNP) Congress taking place between September 21-24, 2024, in Milan, Italy.
Schizophrenia is a complex medical condition that may require switching from oral options or between different long-acting injectable (LAI) options during the patient treatment journey. These data demonstrate the potential role of TEV-‘749 as an LAI treatment option for schizophrenia patients taking daily oral olanzapine or other antipsychotic medications. Currently, the only long-acting olanzapine treatment option for schizophrenia carries a risk for PDSS, the sudden and unexpected onset of delirium or sedation when medication is released too quickly into the blood after receiving an intramuscular injection of long-acting olanzapine.1
"Teva is dedicated to building on its commitment to neuroscience by developing new long-acting injectable treatment options like TEV-‘749 that may help address unmet needs in schizophrenia for patients and healthcare providers," said Eric Hughes, MD, PhD, Executive Vice President of Global R&amp;D and Chief Medical Officer at Teva. "PDSS is a major barrier to the utilization of intramuscular olanzapine LAIs that exists today, and our SOLARIS findings fuel the continued development of TEV-‘749."
With nearly 30 years of clinical and real-world use, olanzapine is one of the most commonly prescribed 2nd generation oral antipsychotics for schizophrenia around the world. Its efficacy and safety profiles are well established.
"Developing a long-acting olanzapine formulation that poses potentially no risk of PDSS is crucial in preventing these dangerous episodes that otherwise limit the use of olanzapine to daily oral options," said Christoph Correll, MD, Professor of Psychiatry at the Zucker School of Medicine, Hempstead, NY. "With no PDSS observed in the SOLARIS trial to date, these data add to the growing body of evidence that TEV-‘749 may one day serve as an important treatment option for patients and healthcare providers who rely on olanzapine and also have needs or preferences that require a long-acting option."
Period 1 of the SOLARIS study is an 8-week, randomized, double-blind, placebo-controlled trial in patients aged 18-64 years diagnosed with schizophrenia, followed by an open-label safety period of up to 48 weeks (Period 2). Efficacy results from Period 1 of the SOLARIS study show that by week 8:
<ul>
<li>TEV-‘749 met its primary endpoint across all three dosing groups, with statistically significant mean differences in the change in PANSS total scores from baseline to week 8 of -9.71 points, -11.25 points, and -9.69 points versus placebo for the high (531 mg, corresponding to 20 mg/day of oral olanzapine), medium (425 mg, corresponding to 15 mg/day of oral olanzapine), and low (318 mg, corresponding to 10 mg/day of oral olanzapine) dose groups, respectively (all P&lt;0.0001).1</li>
<li>TEV-‘749 treatment significantly improved CGI-S scale scores across all three dosing groups, with reductions of -0.47 points (high), -0.61 points (medium), and -0.53 points (low) versus placebo from baseline to week 8 (all P&lt;0.0001).1</li>
<li>TEV-‘749 treatment significantly improved PSP scale scores across all three dosing groups, with increases of 4.93 points (high), 3.15 points (medium), and 4.63 points (low) versus placebo from baseline to week 8 (all P&lt;0.02).1 &nbsp;</li>
</ul>
The systemic safety profile of TEV-‘749 was consistent with other approved formulations of olanzapine, with no new safety signals identified. Additional safety and tolerability results from Period 1 (917 active injections) through week 8 of the SOLARIS study show that:
<ul>
<li>There were no reported cases of PDSS.1</li>
<li>Treatment-emergent adverse events that occurred more often in patients receiving TEV-‘749 versus placebo included weight increase (35% [173/500] versus 8% [13/167]), injection site induration (13% [64/500] versus 2% [4/167]), injection site pain (10% [50/500] versus 4% [7/167]) and injection site erythema (10% [48/500] versus 1% [1/167]).1</li>
<li>Serious adverse events and discontinuations due to adverse events were reported in 1% (7/500) and 3% (16/500) of patients treated with TEV-‘749, respectively, and in 2% (3/167) and 3% (5/167) of patients treated with placebo, respectively.1 &nbsp;</li>
</ul>
Also presented at ECNP 2024, results from the Phase 1 study of TEV-'749 show similar safety and tolerability results, including no reports of PDSS events. Additionally, a presented pre-clinical study suggests that the subcutaneous route of administration and formulation characteristics of TEV-'749 appear to greatly reduce the hypothesized risk of PDSS occurrence for patients receiving the treatment.
The long-term safety of TEV-‘749 and incidence of PDSS are also being evaluated in the SOLARIS open-label study (Period 2), with safety data topline readout expected in the first half of 2025.
TEV-‘749 utilizes SteadyTeq&#x2122;, a copolymer technology proprietary to Medincell that provides a controlled steady release of olanzapine.
TEV-‘749 is an investigational once-monthly subcutaneous LAI of the 2nd generation antipsychotic olanzapine and is not approved by any regulatory authority for any use, and its safety and efficacy are not established.

Reported Saturday, Teva's New Schizophrenia Treatment TEV-749 Meets Key Endpoints in Phase 3 Study

Reported Earlier, Teva Pharmaceutical Disclosed That A New Analysis Revealed That Deutetrabenazine Treatment Of Patients With Tardive Dyskinesia (TD) Was Associated With Long Term Improvement Of TD Symptoms

Teva Pharmaceutical Indus (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/TEVA#NYSE">TEVA</a>) has outperformed the market over the past 5 years by 5.93% on an annualized basis producing an average annual return of 19.42%. Currently, Teva Pharmaceutical Indus has a market capitalization of $20.48 billion. 
Buying $1000 In TEVA: If an investor had bought $1000 of TEVA stock 5 years ago, it would be worth $2,403.05 today based on a price of $18.08 for TEVA at the time of writing.
<h3>Teva Pharmaceutical Indus's Performance Over Last 5 Years</h3>
<img src="https://www.benzinga.com/files/images/story/2024/1726507872_0.png" alt="comp_fig" />
Finally -- what's the point of all this? The key insight to take from this article is to note how much of a difference compounded returns can make in your cash growth over a period of time.
This article was generated by Benzinga's automated content engine and reviewed by an editor.

If You Invested $1000 In This Stock 5 Years Ago, You Would Have $2,400 Today

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North Dakota Judge Overturns State's Abortion Ban, Making Abortion Legal In The State

UnitedHealth Group Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/UNH#NYSE">UNH</a>) reportedly announced on Tuesday that it will remove AbbVie Inc.&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/ABBV#NYSE">ABBV</a>) blockbuster drug Humira from some of its preferred reimbursement lists starting January 1, 2025. The company will recommend lower-cost biosimilar versions instead.
This move is part of a larger trend in the U.S. pharmaceutical market, as health plans seek to cut costs by promoting alternatives to high-priced drugs.
Also Read: <a target="_blank" href="https://www.benzinga.com/government/24/07/39695378/ftc-investigation-uncovers-anti-competitive-practices-by-handful-of-pharmacy-benefit-managers-includ" rel="noreferrer noopener">FTC Investigation Uncovers Anti-Competitive Practices By Handful Of Pharmacy Benefit Managers, Including CVS Health, UnitedHealth</a>.
Reuters highlights that Amgen Inc&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AMGN#NASDAQ">AMGN</a>) Amjevita, managed by its pharmacy benefits unit, Optum Rx, is among the biosimilars covered under UnitedHealth&#8217;s lists for commercial health plans.
With this decision, Optum becomes the last of the three largest U.S. pharmacy benefit managers (PBMs) to exclude Humira.
Cigna Corporation (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/CI#NYSE">CI</a>) announced last month that it would remove Humira from some of its lists in 2025, following a similar decision by CVS Health Inc&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/CVS#NYSE">CVS</a>) Caremark unit in April.
CVS&#8217;s action led to a swift shift, with more patients transitioning to Sandoz Group AG&#8217;s (OTC:<a class="ticker" href="https://www.benzinga.com/stock/SDZNY#OTC">SDZNY</a>) (OTC:<a class="ticker" href="https://www.benzinga.com/stock/SDZXF#OTC">SDZXF</a>) biosimilar version of Humira in just three weeks than in the previous 15 months combined.
Cigna plans to cover biosimilars like Boehringer Ingelheim&#8217;s Cyltezo, Simlandi from Teva Pharmaceutical Industries Ltd (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/TEVA#NYSE">TEVA</a>), and Alvotech&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ALVO#NASDAQ">ALVO</a>) products, including an unbranded version of Sandoz&#8217;s Hyrimoz, as replacements for Humira.
UnitedHealth noted that patients would still have access to Humira until the FDA designates the preferred biosimilars as interchangeable with the original drug, per the report. The FDA is expected to make this designation in 2025.
Despite the growing competition, AbbVie has managed to retain a dominant share of the U.S. Humira market throughout 2023. This has been achieved through favorable negotiations with PBMs, even as biosimilar alternatives from companies like Pfizer Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) entered the market.
As per a Reuters report, Humira has still managed to retain over 80% of its patients even after facing lower-priced rivals in the&nbsp;<a target="_blank" href="https://www.benzinga.com/news/large-cap/24/04/38468317/arthritis-patients-cignas-evernorth-to-offer-humira-biosimilar-at-no-out-of-pocket-cost" rel="noreferrer noopener">U.S. over the past year</a>.
Following their launch last year, pharmacy benefit managers largely influenced patient access, with minimal incentive for doctors to switch to <a target="_blank" href="https://www.benzinga.com/general/biotech/24/06/39228916/abbvies-arthritis-drug-humira-retains-market-dominance-despite-biosimilar-competition-challenges-" rel="noreferrer noopener">these alternatives</a>.
In May, Cantor Fitzgerald said AbbVie had positioned itself to absorb Humira biosimilar erosion and achieve modest <a target="_blank" href="https://www.benzinga.com/analyst-ratings/analyst-color/24/05/38899905/abbvie-is-successfully-positioned-to-absorb-humira-biosimilar-erosion-analyst" rel="noreferrer noopener">operational revenue growth</a>.
Price Action: UNH stock is down 2% at $587.07 at last check Wednesday.
Photo via Shutterstock
Disclaimer: This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.
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UnitedHealth Follows Competitors, Replaces Humira with Lower-Cost Biosimilars

The City of Baltimore, led by Mayor Brandon M. Scott, reached an $80 million settlement with Teva Pharmaceuticals Industries Ltd (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/TEVA#NYSE">TEVA</a>) to resolve claims against the company for its role in the city&#8217;s opioid epidemic.
Under the agreement, Teva will pay an initial $35 million by the end of 2024, with the remaining amount due by July 1, 2025.
Also Read: <a target="_blank" href="https://www.benzinga.com/analyst-ratings/analyst-color/24/09/40754258/jp-morgan-shows-most-interest-in-teva-organon-as-specialty-pharma-sector-exhibits-s" rel="noreferrer noopener">JP Morgan Shows Most Interest In Teva, Organon As Specialty Pharma Sector Exhibits Signs Of Stability</a>.
The <a target="_blank" href="https://mayor.baltimorecity.gov/news/press-releases/2024-09-09-city-baltimore-reaches-80-million-deal-teva-pharmaceuticals-resolve" rel="noreferrer noopener">settlement</a> is part of Baltimore's broader litigation strategy against opioid manufacturers and distributors.
Previous settlements with AbbVie Inc&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/ABBV#NYSE">ABBV</a>) Allergan, CVS Health Corp (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/CVS#NYSE">CVS</a>), and Cardinal Health Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/CAH#NYSE">CAH</a>) have brought in $322.5 million in total recoveries.
The ongoing legal battle will proceed to trial on Sept. 16 against the remaining defendants, who were responsible for more than half of the opioids distributed in Baltimore.
Mayor Scott emphasized the city's decision to opt out of the national Teva settlement, which would have yielded only $11 million over 13 years. Instead, the new agreement brings in more than seven times that amount in under a year.
Baltimore secured more than three times the funds it would have received from global settlements.
Baltimore will dedicate $5 million to education and outreach about the 988 crisis helpline, $3 million to the Penn North Recovery Center and $2 million to BMore Power.
Additional funds will be administered following the framework detailed in the executive order to address the ongoing epidemic.
In July, Teva announced topline results from its Phase 3 SPACE study evaluating the efficacy of Ajovy (fremanezumab) for the prevention of episodic migraine in children and adolescent <a href="https://www.benzinga.com/general/biotech/24/07/39843370/tevas-migraine-treatment-found-effective-for-children-as-young-as-6" target="_blank" rel="noreferrer noopener">patients aged 6-17</a>.
The trial met its primary endpoint with Ajovy achieving a statistically significant superior efficacy over 12 weeks of treatment compared to placebo.
TEVA Price Action: Teva stock is down 1.43% at $17.55 at last check Tuesday.
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Photo: Ralf Liebhold via Shutterstock

Teva Announces $80M Settlement To Baltimore: City Continues Opioid Litigation Against Other Companies

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Teva agrees to pay $425M to settle Copaxone kickback case: DOJ

In a report released today, Ashwani Verma from UBS maintained a Buy rating on Teva Pharmaceutical (TEVA – Research Report), with a price target of ...

Teva Pharmaceutical (TEVA) Receives a Buy from UBS

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Press Releases

Teva to Present at the Morgan Stanley 22nd Annual Global Healthcare Conference

Teva to Present at the Bank of America 2024 Global Healthcare Conference

New Data Provide Treatment Insights into Options for Switching Adult Patients Diagnosed with Schizophrenia to UZEDY® (risperidone) Extended-Release Injectable Suspension from Perseris® (RBP-7000)

Teva Presents New Phase 3 Efficacy, Safety and Tolerability Data from SOLARIS Trial Evaluating TEV-'749 (olanzapine) as a Once-Monthly Subcutaneous Long-Acting Injectable for Adult Patients Diagnosed with Schizophrenia

Teva Announces Long Term Efficacy and Safety of Deutetrabenazine in European Patients with Debilitating Movement Disorder Tardive Dyskinesia

As Fentanyl Crisis Escalates, Abuse-Deterrent Formulations to Zero in on the Rising Epidemic of Opiate Abuse

Teva to Host Conference Call to Discuss Third Quarter 2024 Financial Results at 8 a.m. ET on November 6, 2024

Teva Announces Launch of the First and Only Generic Version of Sandostatin® LAR Depot (octreotide acetate for injectable suspension), in the U.S.

Teva and mAbxience Expand Strategic Partnership to include an additional Oncology Biosimilar Candidate

Teva Prolia® (Denosumab) Biosimilar Candidate is Accepted for Review by U.S. FDA and EU EMA

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