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European Medicines Agency Recommends Marketing Approval of Gobivaz®, Alvotech's Proposed Biosimilar to Simponi® (golimumab) with Advanz Pharma as Commercialization Partner
Globenewswire· 2025-09-22 08:30
Core Viewpoint - Alvotech and Advanz Pharma announced a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use recommending approval for Gobivaz®, a biosimilar to Simponi® (golimumab), which is used to treat chronic inflammatory diseases [1][4]. Company Overview - Alvotech is a global biotech company focused on developing and manufacturing biosimilar medicines, aiming to be a leader in the biosimilar space with a pipeline that includes eight disclosed biosimilar candidates targeting various diseases [9]. - Advanz Pharma is a UK-based global pharmaceutical company specializing in specialty, hospital, and rare disease medicines, with a commercial presence in over 90 countries [11]. Product Details - Gobivaz® is proposed in two formulations: 50 mg/0.5 mL and 100 mg/mL, intended for treating rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, and juvenile idiopathic arthritis [4]. - The product is still under EMA regulatory review, with a final decision pending from the European Commission [4]. Clinical Study Results - Alvotech previously announced positive top-line results from a clinical study comparing the efficacy, safety, and immunogenicity of its biosimilar candidate AVT05 with Simponi® in patients with moderate to severe rheumatoid arthritis [6]. - A pharmacokinetic study also showed positive results for AVT05 compared to Simponi® in healthy adult participants [6]. Strategic Partnership - Alvotech is responsible for the development and commercial supply of Gobivaz®, while Advanz Pharma holds exclusive rights for commercialization in Europe [5].
Alvotech Announces Marketing Approval in Japan of Three New Biosimilars
Globenewswire· 2025-09-19 11:45
Core Viewpoint - Alvotech has received marketing approval for three new biosimilars in Japan, expanding its product offerings and addressing the growing demand for cost-effective biologic medicines [1][2][5] Group 1: New Product Approvals - Fuji Pharma has received marketing approval for three biosimilars: AVT03 (biosimilar to Ranmark®), AVT05 (biosimilar to Simponi®), and AVT06 (biosimilar to Eylea®) [1][2][3][4] - AVT05 is noted as the first golimumab biosimilar approved for sale in major markets globally [1] - AVT03 is approved for treating bone lesions due to multiple myeloma or metastases of solid tumors [2] - AVT05 is approved for treating Rheumatoid Arthritis in patients who have not responded sufficiently to conventional treatments [3] - AVT06 is approved for treating Age-related Macular Degeneration and other eye conditions [4] Group 2: Strategic Partnerships and Market Expansion - The partnership with Fuji Pharma was established in November 2018, and they successfully launched the first biosimilar to Stelara® in May 2024 [5] - Alvotech has licensed commercial rights in Japan to Fuji Pharma for two additional biosimilar candidates currently under development [5] Group 3: Company Overview - Alvotech is focused on developing and manufacturing biosimilar medicines, aiming to be a global leader in the biosimilar space [7] - The company has a pipeline that includes eight disclosed biosimilar candidates targeting various diseases, including autoimmune disorders and cancer [7] - Alvotech has formed strategic commercial partnerships to enhance its global reach, including collaborations with companies in the US, Europe, Japan, and other regions [7]
Here's How ALVO's Commercial Partnerships Are Driving Top-line Growth
ZACKS· 2025-09-18 14:36
Core Insights - Alvotech (ALVO) differentiates itself in the biosimilar market by utilizing partnerships as its primary commercial model, focusing on distribution alliances rather than building its own sales infrastructure [1] - The company's product revenues increased over 200% year-over-year in the first half of 2025, reaching nearly $205 million, driven by its immunology biosimilars marketed through partnerships [2] - Alvotech's partnerships also provide diversified income streams beyond product sales, contributing to a more stable cash position [3] Revenue Growth - In H1 2025, Alvotech's product revenues surged to nearly $205 million, with significant contributions from its immunology biosimilars Simlandi and Selarsdi, marketed by Teva Pharmaceuticals in the U.S. and Stada in the EU [2][7] - The company maintains a full-year revenue guidance of $600 million to $700 million for 2025, supported by the rapid sales growth of its biosimilars [2] Strategic Partnerships - Alvotech has established agreements with companies like Teva, Dr. Reddy's Laboratories, and Advanz Pharma, which include upfront and milestone payments, enhancing its cash flow stability [3] - Recent partnerships have expanded Alvotech's pipeline into new therapeutic areas, including ophthalmology, neurology, and oncology, with new biosimilar candidates in development [4][5] Market Position and Valuation - Alvotech's shares are currently trading at a premium to the industry, with a price-to-sales (P/S) ratio of 3.23 compared to the industry average of 2.12 [9] - The company's earnings per share (EPS) estimates for 2025 and 2026 have seen significant improvements in the past month [10]
Is it the Right Time to Retain Abbott Stock in Your Portfolio?
ZACKS· 2025-09-18 14:06
Core Insights - Abbott has shown strong growth and market share gains in its Nutrition business, with a focus on adult nutrition products and a strategic emphasis on biosimilars in its Established Pharmaceuticals division [1][3][10] - The Diabetes Care segment is benefiting from the success of the FreeStyle Libre continuous glucose monitoring system, which has achieved global leadership and is expanding with new FDA-approved products [5][6] - Macroeconomic challenges and currency fluctuations pose potential risks to Abbott's financial performance [1][12][13] Nutrition Business Performance - Abbott's Nutrition business reported 3.4% organic growth in Q2 2025, driven by a 6.6% increase in Adult Nutrition sales [4][9] - The strong demand for Ensure and Glucerna brands supports the growth in Adult Nutrition, while Pediatric Nutrition remains robust in the U.S. with the Similac brand leading the market [4][9] Diabetes Care Segment - Sales of the FreeStyle Libre CGM system exceeded $1.9 billion in Q2 2025, reflecting a 19.6% organic growth, with U.S. sales rising nearly 26% [6][9] - The introduction of new over-the-counter CGM systems marks a significant expansion opportunity for Abbott in the U.S. market [5] Established Pharmaceuticals Division - Abbott's EPD achieved 7.7% organic growth in Q2 2025, with a focus on branded generics in emerging markets [11] - The division is well-positioned for sustainable growth, with a five-year CAGR of 8% and plans for biosimilar launches starting in 2026 [10][11] Financial Performance and Market Position - Abbott's market capitalization stands at $231.06 billion, with an earnings yield of 3.9%, significantly higher than the industry average of 0.2% [2] - The company has outperformed the industry, with a 17.5% stock price increase over the past year compared to a 0.3% decline in the industry [2]
12 Cheap Healthcare Stocks to Buy Now
Insider Monkey· 2025-09-15 11:35
Core Viewpoint - The healthcare industry is currently facing significant challenges, with large-cap pharmaceutical companies particularly affected, leading to a poor performance compared to the market [2][3]. Group 1: Industry Challenges - The healthcare sector has only outperformed the market during downturns over the last decade, indicating a troubling trend [2]. - The current dynamics in the healthcare industry are described as the worst experienced in decades, with managed care and pharmaceuticals identified as the main contributors to market pressures [3]. Group 2: Investment Opportunities - A methodology was employed to identify cheap healthcare stocks, focusing on companies with a market capitalization above $2 billion and a forward P/E ratio below 15 [5]. - The article lists 12 healthcare stocks deemed attractive for investment, based on their valuation metrics and growth potential [6]. Group 3: Company Highlights - **Bausch Health Companies Inc. (NYSE:BHC)**: - Forward P/E Ratio: 1.45, recognized for strategic acquisitions and pipeline developments, particularly in hepatology [7]. - Recent acquisition of DURECT Corporation valued at $63 million upfront, with potential milestone payments of up to $350 million, enhancing its portfolio for alcoholic hepatitis [8]. - Key pipeline assets include larsucosterol and rifaximin SSD, with significant market potential in addressing hospitalizations for alcoholic hepatitis [9][10]. - **Organon & Co. (NYSE:OGN)**: - Forward P/E Ratio: 2.73, focused on women's health and biosimilars, expanding its market presence since spinning off from Merck [11]. - Recent FDA approvals for biosimilars BILDYOS and BILPREVDA, aimed at improving access to osteoporosis and bone cancer treatments [12]. - The company is pivoting towards biosimilars as a growth engine while maintaining focus on women's health and dermatology [13]. - **Viatris Inc. (NASDAQ:VTRS)**: - Forward P/E Ratio: 4.40, formed from the merger of Mylan and Pfizer's Upjohn division, focusing on generics and specialty pharmaceuticals [14]. - FDA approval of a generic iron sucrose injection, reflecting a strategic entry into the intravenous iron market with significant sales potential [15]. - Positive late-stage trial results for several pipeline assets, reinforcing the company's growth strategy and upcoming product launches [16][17].
生物医疗-一图胜千言-A picture is worth a thousand words
2025-09-08 06:23
Summary of Key Points from the Conference Call Industry Overview - The conference call focuses on the **Biopharma** industry in **North America** with a comprehensive analysis of the **US drug market** as per **IQVIA Rx** data [1][6]. Core Insights - The **Total Prescription Year-over-Year (YoY) growth** for the week ending **August 29, 2025**, was reported at **+1.7%**, a decrease from **+2.3%** the previous week and **+2.6%** over the past 12 weeks [1][2]. - The **rolling 4-week TRx YoY** change was **+2.3%**, while the **rolling 12-week TRx YoY** was **+2.6%** [2]. - The **Extended Unit (EUTRx)** weekly YoY growth was **+2.0%**, indicating stronger performance compared to the overall TRx YoY [2]. Company-Specific Developments - **Bristol Myers Squibb (BMY)**: The drug **Cobenfy** for schizophrenia was approved on **September 26, 2024**. The current weekly scripts are approximately **2,210**, up from **2,160** the previous week. To meet the 2025 consensus expectations, Cobenfy needs to achieve **~129K TRx** at a net price of **~$1,200** [3]. - **Vertex Pharmaceuticals (VRTX)**: The drug **Journavx** for acute pain was approved on **January 30, 2025**. Current scripts are around **7,280**, with hospital scripts making up about **35%** of total scripts. To achieve projected sales of **$78 million**, approximately **349K total scripts** are needed [4]. - **Gilead Sciences (GILD)**: The drug **Yeztugo** was approved on **June 18, 2025**. The latest total TRx is approximately **470**, up from **390** the previous week. Projections for achieving consensus estimates for the second half of 2025 are discussed, with a focus on gross-to-net pricing adjustments [5]. Market Trends and Comparisons - A comparison of launches between **GILD's Yeztugo**, **Descovy**, and **Apretude** is provided, highlighting the uptake among different patient groups and the anticipated growth trajectory [5][9]. - The **GLP-1 franchise** from **Eli Lilly** shows significant growth, with **Mounjaro** and **Zepbound** experiencing **+66%** and **+233%** YoY growth respectively [20][23]. Additional Insights - The call includes a detailed analysis of **key products** and their respective YoY performance, with notable declines in some established drugs like **Humira** (-39%) and growth in others like **Skyrizi** (+44%) [20]. - The **COVID vaccine** tracking and **biosimilar adoption** analysis are also mentioned, indicating ongoing trends in the pharmaceutical landscape [12][28]. Conclusion - The conference call provides a comprehensive overview of the current state of the biopharma industry in North America, highlighting both challenges and opportunities for key players in the market. The data reflects a mixed performance across various drugs, with some experiencing significant growth while others face declines.
TEVA Stock Up More Than 19% in a Month: Buy, Sell or Hold the Stock?
ZACKS· 2025-09-04 15:31
Core Viewpoint - Teva Pharmaceutical Industries Limited's stock has increased by 19.4% in the past month, driven by mixed second-quarter results where earnings estimates were beaten but sales fell short [1][2]. Group 1: Financial Performance - Teva's second-quarter results showed a 1% decline in sales on a constant currency basis, primarily due to lower sales in its global generics business [1][11]. - The company reported strong sales growth for its three innovative branded drugs: Austedo, Ajovy, and Uzedy, which collectively saw a 26% year-over-year increase in sales during the second quarter [2][3]. - Teva's U.S. generics/biosimilars business rose by 15% in 2024, although sales were nearly flat in the first half of 2025 due to lower revenues from specific generic products [12][14]. Group 2: Product Performance - Austedo sales increased by 29% in the first half of 2025, reaching $891 million, with expectations of annual revenues exceeding $2.5 billion by 2027 [4]. - Ajovy sales rose by 34% in the first half of 2025 to $117 million, with anticipated growth from patient expansion and international launches [5]. - Uzedy, launched in May 2023, achieved sales of approximately $117 million in 2024 and saw a 134% increase to $93 million in the first half of 2025 [6]. Group 3: Pipeline and Future Outlook - Teva aims to generate over $5 billion in revenues from its branded products by 2030 [8]. - The company has a promising pipeline for branded drugs, including olanzapine and duvakitug, with plans for phase III trials and new drug applications in 2025 [7]. - Teva plans to double its global biosimilars sales by 2027, with several new launches expected [13]. Group 4: Market Position and Valuation - Teva's stock is currently trading at a price/earnings ratio of 7.11, which is lower than the industry average of 11.26, indicating an attractive valuation [19]. - Despite a 14.8% decline in stock price year-to-date, the company is experiencing stock price appreciation due to improved growth prospects and a robust pipeline [16][25]. Group 5: Strategic Initiatives - The company is optimizing operations for efficiency, aiming for an adjusted operating margin of 30% by 2027 through cost savings and growth in branded drugs [24]. - Recent credit outlook upgrades from Fitch, Moody's, and S&P reflect improved growth prospects for Teva [25].
AMGN Up Almost 14% YTD: Should You Buy, Sell or Hold the Stock?
ZACKS· 2025-08-26 13:10
Core Insights - Amgen's stock has increased by 13.5% year-to-date, outperforming the industry, sector, and S&P 500 Index [1][9][10] Revenue Drivers - Key medicines such as Repatha, Evenity, and Blincyto, along with newer products like Tavneos and Tezspire, are driving sales growth, compensating for declines in oncology biosimilars and mature products like Enbrel [4][7][10] - Revenues increased by 9.4% in the first half of 2025 due to rising patient demand for innovative medicines [6] - Rare disease drugs from the acquisition of Horizon Therapeutics are also contributing to revenue growth [7] Pipeline Developments - Amgen is focusing on the obesity candidate MariTide, which is in phase III studies, and has shown promising results in clinical trials [12][14] - Additional indications for existing drugs like Kyprolis and Uplizna are being evaluated, with potential approvals expected to drive further growth [8][10] Biosimilars Performance - New biosimilars launched in 2025, including Wezlana and Pavblu, generated significant sales, contributing to a total of $1.4 billion from biosimilars in the first half of 2025 [18][20] - Amgen's biosimilars have accumulated nearly $12 billion in sales since their first launch in 2018, enhancing top-line growth [20] Competitive Landscape - Sales of key drugs Prolia and Xgeva are expected to decline due to biosimilar competition following patent expirations [22] - Pricing pressures and competitive challenges are impacting sales of some products, particularly Otezla and Lumakras [23] Valuation and Estimates - Amgen's shares are trading at a price/earnings ratio of 13.53, lower than the industry average of 14.85, indicating reasonable valuation [24] - Consensus estimates for earnings per share have increased for 2025 and 2026, reflecting positive sentiment [27][29]
AcariaHealth Sparks Innovation at 2025 Healthcare Advocate Summit with Hackathon and Expert Panels
Prnewswire· 2025-08-26 12:40
Core Insights - AcariaHealth is showcasing its innovative approach to specialty pharmacy solutions at the 2025 Healthcare Advocate Summit with a unique "Reimagine Access" Hackathon and expert sessions [1][6]. Group 1: Event Highlights - The "Reimagine Access" Hackathon will take place on September 2, 2025, focusing on real-world access challenges in healthcare, encouraging participants to brainstorm actionable solutions [2]. - An expert panel on biosimilars and market disruption is scheduled for September 4, 2025, where AcariaHealth leaders will discuss trends and payer mandates, along with a video highlighting the role of Provider Experience Managers [3]. - A roundtable discussion on the Medicare Prescription Payment Plan (M3P) will conclude the summit on September 5, 2025, providing an interactive platform for attendees to ask questions [5]. Group 2: Company Commitment - AcariaHealth emphasizes the importance of seamless access to care, aiming to reshape specialty pharmacy through innovation, advocacy, and compassion [6]. - The company is dedicated to supporting patients with complex conditions by leveraging its expertise and the resources of Centene Corporation, the largest Medicaid managed care organization [8].
Alvotech appoints Patrik Ling as VP of Investor Relations Scandinavia
Globenewswire· 2025-08-20 10:05
Company Overview - Alvotech is a global biotech company focused on the development and manufacture of biosimilar medicines for patients worldwide [5] - The company aims to be a leader in the biosimilar space by delivering high-quality, cost-effective products and services through a fully integrated approach [5] - Alvotech has two approved biosimilars, Humira® (adalimumab) and Stelara® (ustekinumab), marketed in multiple global markets [5] - The current development pipeline includes nine disclosed biosimilar candidates targeting various conditions such as autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer [5] Recent Developments - Patrik Ling has joined Alvotech as VP Investor Relations Scandinavia, based in Stockholm [1] - Ling has over 25 years of experience in the life-science industry, previously serving as a Senior Equity Analyst at DNB Carnegie [2] - His expertise in both pharmaceuticals and finance is expected to enhance Alvotech's efforts to broaden its shareholder base in Scandinavia [3] Strategic Focus - Alvotech is expanding its portfolio of products and has established a new base of R&D operations in Sweden [4] - The company emphasizes the importance of biosimilars in meeting the growing demand for high-quality biologics and controlling healthcare costs [4] - Alvotech has formed strategic commercial partnerships to enhance its global reach and leverage local expertise across various markets, including the US, Europe, Japan, China, and parts of South America, Africa, and the Middle East [5]