Amneal Pharmaceuticals
🇺🇸United States
- Country
- 🇺🇸United States
- Ownership
- Public
- Established
- 1995-01-01
- Employees
- 7.7K
- Market Cap
- $2.6B
- Website
- http://www.amneal.com
Amneal Pharmaceuticals Reports Strong Q1 2025 Results with 5% Revenue Growth and Margin Expansion
• Amneal Pharmaceuticals reported Q1 2025 revenue of $695 million, a 5% year-over-year increase, with growth across all three business segments despite falling short of analyst expectations.
• The company's Parkinson's disease treatment CREXONT continues to gain market traction, with insurance coverage expanding from 30% to 60% of U.S. covered lives in just six months.
• Adjusted EBITDA increased 12% to $170 million, with adjusted diluted EPS rising 50% to $0.21, reflecting improved gross margins and operating expense leverage.
FDA Approves Brekiya: First DHE Autoinjector for Acute Migraine and Cluster Headache Treatment
• The FDA has approved Amneal Pharmaceuticals' Brekiya, the first and only dihydroergotamine (DHE) autoinjector for acute treatment of migraine and cluster headaches in adults.
• Brekiya provides patients with the same medication used in hospitals and emergency rooms in a convenient, self-administered form that requires no refrigeration, assembly, or priming.
• The approval addresses significant unmet needs, as headache is the fourth most common reason for ER visits, affecting approximately 39 million Americans with migraine and up to 1 million with cluster headache.
Amneal and Apiject Partner to Expand US-Based Sterile Injectable Manufacturing with Advanced BFS Technology
• Amneal Pharmaceuticals and Apiject Systems have formed a strategic collaboration to expand domestic production of sterile drug dosage forms using Blow-Fill-Seal technology at Amneal's Brookhaven, NY facility.
• The partnership will create approximately 200 high-quality jobs and establish manufacturing capacity for 250-300 million units annually, with potential to scale to over 400 million units of prefilled injectables, ophthalmics, and inhalation products.
• Apiject's innovative technology combines Blow-Fill-Seal manufacturing with precision injection molding to create sterile, single-dose prefilled injectors that offer advantages in scalability, cost-effectiveness, and supply chain efficiency over traditional glass vials.
Takeda Spotlights Three Late-Stage Readouts as Potential "Inflection Point" Amid Vyvanse Generic Competition
• Takeda Pharmaceutical is positioning three upcoming late-stage clinical trial readouts as a strategic "inflection point" to offset revenue losses from Vyvanse's generic competition.
• The Japanese pharmaceutical giant is focusing on new product launches and pipeline advancement to maintain growth momentum, with particular emphasis on rare disease and neuroscience therapeutic areas.
• Industry analysts view Takeda's pipeline strategy as critical for the company's long-term financial stability, as it navigates the challenging transition period of losing exclusivity for one of its top-selling medications.
Shionogi to Acquire Japan Tobacco's Pharmaceutical Subsidiaries for $1.1 Billion
• Shionogi & Co. plans to acquire Japan Tobacco's pharmaceutical subsidiaries Torii Pharmaceutical and Akros Pharma for ¥160 billion ($1.1 billion) to strengthen its global R&D capabilities.
• The acquisition, negotiated since early 2024, will proceed through a tender offer beginning June 18 with a share price of ¥6,350 to acquire at least 11.89% of the minority stake.
• This strategic move represents significant consolidation in the Japanese pharmaceutical sector and expands Shionogi's market presence amid increasing global competition.
FDA Approves Biocon Biologics' Bevacizumab Biosimilar JOBEVNE for Multiple Cancer Indications
• Biocon Biologics has received U.S. FDA approval for JOBEVNE (bevacizumab-nwgd), a biosimilar to Avastin, expanding its oncology portfolio to include a seventh FDA-approved biosimilar.
• JOBEVNE, a VEGF inhibitor that restricts tumor blood supply, is indicated for multiple cancer types including metastatic colorectal cancer, non-small cell lung cancer, glioblastoma, and several others.
• The approval follows comprehensive comparative studies confirming JOBEVNE's similarity to Avastin, with U.S. bevacizumab sales reaching approximately $2 billion in 2023, representing a significant market opportunity.
Jazz and Hikma to Pay $195M to Settle Antitrust Claims Over Narcolepsy Drug Xyrem
• Jazz Pharmaceuticals will pay $145 million to settle allegations of anti-competitive practices related to its narcolepsy drug Xyrem, while denying all wrongdoing in the class action lawsuit.
• Hikma Pharmaceuticals agreed to a separate $50 million settlement over claims it conspired with Jazz to delay the release of generic versions of Xyrem, forcing health plans to pay inflated prices.
• Plaintiffs alleged Jazz increased Xyrem's price by over 800% between 2007-2014 while maintaining market exclusivity through complex reverse payment agreements with generic manufacturers.
Amneal's CREXONT Shows Significant Sleep Quality Improvements in Parkinson's Disease Patients
• New Phase 3 RISE-PD study data reveals CREXONT (carbidopa/levodopa extended-release) significantly improved sleep quality in Parkinson's disease patients compared to immediate-release formulations, with a mean difference of -2.35 in PDSS-2 scores (p<0.0001).
• Patients treated with CREXONT were significantly more likely to wake up in an "On" state compared to those on immediate-release carbidopa/levodopa, addressing a critical need as sleep disturbances affect up to 80% of Parkinson's patients.
• The novel formulation combines immediate-release granules for rapid onset with extended-release pellets for sustained effect, potentially offering comprehensive symptom management throughout both day and night.
Amneal Launches Boruzu: First Ready-to-Use Bortezomib Injection for Multiple Myeloma Treatment
• Amneal Pharmaceuticals and Shilpa Medicare have launched Boruzu, the first ready-to-use bortezomib formulation for subcutaneous or intravenous administration in multiple myeloma and mantle cell lymphoma treatment.
• The innovative formulation eliminates reconstitution steps required with the reference product Velcade, potentially streamlining clinical workflow and reducing patient wait times.
• Boruzu represents Amneal's fourth 505(b)(2) injectable product launch in the past year, featuring a unique J-code to facilitate reimbursement as part of the company's strategy to build a portfolio of complex injectable products.
Federal Circuit Rules Against Teva's Orange Book Patent Listings for ProAir HFA Inhaler
• The U.S. District Court ordered Teva Pharmaceuticals to remove its ProAir HFA inhaler device patents from the FDA's Orange Book, ruling they don't meet statutory listing requirements.
• The Federal Circuit affirmed that patents must claim the drug's active ingredient to be Orange Book listable, rejecting Teva's argument that device component patents qualify.
• The case, sparked by Amneal Pharmaceuticals' generic challenge, has drawn attention from major pharma companies and the FTC, potentially impacting future drug-device patent listings.
Novel Antibiotic Gepotidacin Shows Promise for Drug-Resistant UTIs, Awaits FDA Review
• Gepotidacin represents the first potential new oral antibiotic for urinary tract infections in over 20 years, offering a novel mechanism that overcomes fluoroquinolone resistance.
• The drug demonstrates effectiveness against multi-drug resistant pathogens, including ESBL-producing bacteria, potentially reducing the need for hospitalization and IV antibiotics.
• Clinical trials show gepotidacin's twice-daily oral dosing helps minimize gastrointestinal side effects and QTC prolongation risks, making it a promising option for patients with limited treatment choices.
Bevacizumab Biosimilars Demonstrate Comparable Efficacy and Safety Profile to Avastin in Advanced NSCLC Study
• A comprehensive study of 1,058 NSCLC patients reveals bevacizumab biosimilars match the reference drug Avastin in overall response rates, with biosimilars achieving 27.41% compared to 29.79% for the original drug.
• The safety analysis shows similar adverse event profiles between biosimilars and the reference product, with only elevated hypertension risk noted in specific patient subgroups receiving high doses.
• Five FDA-approved bevacizumab biosimilars demonstrate potential for reducing healthcare costs while maintaining therapeutic effectiveness in treating advanced lung cancer.
FDA Approves Samsung Bioepis' Denosumab Biosimilars for Bone Health Conditions
• Samsung Bioepis receives FDA approval for OSPOMYV and XBRYK, biosimilar versions of denosumab (Prolia and Xgeva), expanding treatment options for bone health conditions.
• The biosimilars demonstrate comparable efficacy and safety profiles to the reference products, potentially offering more cost-effective alternatives for patients requiring denosumab therapy.
• These approvals mark a significant advancement in expanding access to critical bone health treatments while potentially reducing healthcare costs.
Amneal Pharmaceuticals Gains FDA Approval for Alzheimer's and Oncology Treatments
• Amneal Pharmaceuticals has received FDA approval for memantine/donepezil extended-release capsules, indicated for moderate to severe dementia of the Alzheimer's type.
• The FDA also approved Amneal's everolimus extended-release tablets for treating Tuberous Sclerosis Complex (TSC)-associated subependymal giant cell astrocytoma (SEGA).
• Amneal was granted tentative approval for rifaximin oral tablets for irritable bowel syndrome with diarrhea (IBS-D), pending resolution of ongoing litigation.
• The approval of these therapies expands Amneal's portfolio and addresses critical needs in dementia, oncology, and gastrointestinal disease.
GI Advances: FDA Approvals, Novel Research Shape Gastroenterology in Early 2025
• The FDA approved mirikizumab (Omvoh) for Crohn's disease, marking its second approval in IBD after ulcerative colitis, based on positive Phase 3 trial results.
• A tentative FDA approval was granted for a generic version of rifaximin for IBS-D, offering a potential cost-effective alternative pending the resolution of ongoing litigation.
• Ironwood initiated a rolling NDA submission for apraglutide, aiming to address short bowel syndrome by reducing dependence on parenteral support.
• Research indicates fecal microbiota transplantation (FMT) shows promise in treating type 1 diabetes and gastroenteropathy, improving patient quality of life.
Novel Drug Regimens Show Promise in Reducing Graft-versus-Host Disease After Stem Cell Transplants
• A novel drug regimen (SIR/CSP/PTCy) significantly reduced moderate to severe chronic graft-versus-host disease (cGVHD) to 1% compared to 28% with the SIR/CSP/MMF regimen.
• The SIR/CSP/PTCy regimen also improved one-year cGVHD-free relapse-free survival, showing 76% compared to 55% in the control group.
• A Phase I trial of itacitinib showed promising results in preventing severe graft-versus-host disease (GvHD) in half-matched stem cell transplants, with no grade 3 or 4 GvHD observed.
• Itacitinib, a JAK inhibitor, is being investigated for its potential to prevent GvHD when administered before stem cell transplantation, representing a new approach to managing this complication.
Durvalumab Gains Priority Review for Muscle-Invasive Bladder Cancer Treatment
• The FDA has granted priority review to durvalumab (Imfinzi) for muscle-invasive bladder cancer (MIBC), potentially expediting its approval.
• Phase 3 NIAGARA trial data supports the application, showing a 32% reduction in disease progression or recurrence with perioperative durvalumab.
• The Imfinzi regimen also demonstrated a 25% reduction in the risk of death, offering a significant survival benefit.
• Regulatory decisions are anticipated in the second quarter of 2025, with potential implications for MIBC treatment standards.
FDA Accepts Satsuma and SNBL's NDA Resubmission for STS101 Migraine Treatment
• The FDA has accepted for review Satsuma Pharmaceuticals and SNBL's resubmitted NDA for STS101, a dihydroergotamine nasal powder, for acute migraine treatment.
• The PDUFA date is set for April 30, 2025, offering hope for the nearly 40 million Americans suffering from migraine, especially women in their 20s to 40s.
• STS101 is designed for quick self-administration, leveraging a proprietary nasal delivery device for rapid DHE absorption and sustained plasma concentrations.
• The resubmission addresses FDA's previous concerns related to formulation, with no additional clinical trials requested, marking a significant step toward potential approval.
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