Latest news with #VEGF
Business Wire
10-07-2025
- Health
- Business Wire
First Patient Dosed in XyloCor Therapeutics' Phase 2b EXACT-2 Trial Evaluating XC001 for the Treatment of Coronary Artery Disease
KING OF PRUSSIA, Pa.--(BUSINESS WIRE)--XyloCor Therapeutics, a clinical-stage biopharmaceutical company focused on developing novel therapies for cardiovascular disease, announced the first patient has been dosed in the Phase 2b EXACT-2 trial, designed to evaluate its gene therapy candidate XC001 (encoberminogene rezmadenovec) in individuals with coronary artery disease and refractory angina. XC001 is an adenoviral vector-based gene therapy encoding for vascular endothelial growth factor (VEGF), uniquely designed as a one-time catheter-based treatment to reduce cardiac ischemia by creating new blood vessels in the heart and thereby reducing episodes of chest pain and improving patient ability to perform everyday activities. This percutaneous administration approach, injecting directly into the heart muscle, allows XC001 to achieve higher gene expression levels locally in the heart while minimizing systemic vector circulation and associated side effects. 'Initiating the EXACT-2 trial is an important milestone as we continue to develop XC001 for the treatment of refractory angina in patients who have exhausted available treatment options and have a debilitating quality of life,' said Albert Gianchetti, President and CEO of XyloCor. 'Building on the positive results from EXACT-1, we are now focused on advancing the EXACT-2 trial to bring this potentially transformative treatment to patients as quickly as possible.' EXACT-2 is a Phase 2b, multicenter, randomized, double-blind study in 100 patients with refractory angina to evaluate the safety and efficacy of a one-time gene therapy with XC001, delivered using the Extroducer ® Infusion Catheter System, an endocardial delivery catheter designed to inject advanced therapies directly into the heart in a simple injection procedure in the cardiac catheterization lab. Additional information can be found here. The first patient was dosed by Timothy Henry, MD, at The Christ Hospital Health Network in Cincinnati, OH. 'After seeing the convincing results from the EXACT-1 trial, we were eager to participate in EXACT-2,' commented Dr. Timothy Henry, a cardiovascular interventionist and the Lindner Family Distinguished Chair in Clinical Research and Medical Director of The Carl and Edyth Lindner Center for Research at The Christ Hospital. 'We believe that XC001 delivered through the Extroducer ® Infusion Catheter System will maintain the accuracy of delivery of XC001 to the heart and improve the safety over the surgical administration approach used in EXACT-1.' The XC001 Phase 1/2 EXACT-1 trial results supported the transformative, disease-modifying potential of XC001 to reduce cardiac ischemia, reduce anginal symptoms and improve the quality ‑of ‑life for cardiac patients who have no other treatment options. The results demonstrated the potential for XC001 to be safely administered and achieve durable clinical improvements, including increases in exercise duration, decrease in ischemic burden as measured by Positron Emission Tomography (PET) imaging and a reduction in angina frequency. Notably, 93% of patients in the trial entered with chest pain so severe that it markedly limited daily activities, whereas at six months 43% reported no chest pain with ordinary activities. XC001 was well tolerated in the patient population and there were no serious adverse events related to the study drug. XyloCor is also initiating a second clinical trial this year – a double-blind Phase 2 trial of XC001 as an adjunctive treatment to coronary artery bypass graft surgery (CABG). About XC001 XC001 is designed to reduce cardiac ischemia by creating new blood vessels in the heart that will bypass diseased blood vessels and improve blood flow. By restoring blood flow, chest pain associated with refractory angina may decrease, potentially improving patients' quality of life by enabling them to engage in daily physical activities that would otherwise cause pain. XC001 is designed to avoid toxicity issues observed with other gene therapies through a strategy of one-time, local administration and delivery through an adenoviral vector. This approach allows XC001 to achieve higher gene expression in the heart while minimizing systemic vector circulation and associated side effects. About Extroducer® Infusion Catheter System The Extroducer® Infusion Catheter System is a first-in-class endovascular delivery device which enables direct-to-tissue drug delivery. The Extroducer® addresses a significant unmet need in the field of novel therapies, enabling targeted delivery of a wide range of treatment modalities to otherwise hard to reach tumors and organs. Using standard fluoroscopy equipment and routine interventional radiology approaches, the Extroducer provides access to hard-to-reach tissues by safely penetrating the vessel wall and delivering payload directly to the target location, or inside the heart ventricle. Smartwise received U.S. Food and Drug Administration (FDA) clearance under 510(k) for the Extroducer® delivery catheter in June 2022. In 2024, XyloCor entered into a licensing agreement with SmartWise, a unit of SmartCella, to deliver XC001 via the Extroducer® Infusion Catheter System. About Chronic Refractory Angina In the United States, coronary artery disease is a leading cause of death and disability. Chronic angina pectoris occurs when the heart muscle does not receive sufficient oxygen, resulting in chest pain. This is usually due to atherosclerotic plaques that block the coronary arteries. Refractory angina is a growing problem that occurs in patients with chronic angina who are symptomatic despite optimal medical therapy and are no longer eligible for mechanical interventions like percutaneous coronary intervention (PCI) and coronary artery bypass gracing (CABG). These patients currently have no treatment options and are frequently highly symptomatic, which severely impacts their quality of life, and may exacerbate comorbidities and cause further deterioration of their health status. Refractory angina results in significant consumption of healthcare resources, including visits to the emergency department as a result of patients' chest pain. About XyloCor XyloCor Therapeutics, Inc. is a private, clinical-stage biopharmaceutical company developing potential best-in-class gene therapies to transform outcomes for patients with cardiovascular disease. The Company's lead product candidate, XC001, is in clinical development for use in patients with coronary artery disease and refractory angina for whom there are no treatment options. XyloCor has a second preclinical investigational product, XC002, in the discovery stage, being developed for the treatment of patients with cardiac tissue damage from heart attacks. The company, which was co‑founded by Ronald Crystal, MD, and Todd Rosengart, MD, has an exclusive license from Cornell University. For more information, visit About SmartCella SmartCella, founded in 2014, is a global biotech company pioneering the future of targeted therapies through delivery solutions and advanced therapy development. SmartCella combines novel delivery platforms, such as the Extroducer® (an endovascular delivery device that enables direct injection to hard-to-reach organs and tumors), with cutting-edge development and manufacturing of cell therapies. For more information, visit
Time Business News
07-07-2025
- Health
- Time Business News
Stem Cell Ramsey NJ: Non-Surgical PRP Therapy Healing
For residents of Ramsey, NJ, seeking effective, non-surgical solutions for pain relief and tissue repair, Platelet-Rich Plasma (PRP) therapy is a game-changer. This regenerative treatment, offered at Pain Relief Experts, harnesses the body's natural healing mechanisms to address chronic pain, joint injuries, and more. By focusing on stem cell recruitment and tissue regeneration, PRP therapy provides a safe, minimally invasive alternative to surgery for Bergen County residents. Platelet-Rich Plasma (PRP) therapy is a cutting-edge regenerative treatment that uses a patient's own blood to promote healing. The process involves extracting a small blood sample, processing it in a centrifuge to concentrate the platelets, and injecting the platelet-rich plasma into the affected area. These platelets release growth factors that stimulate tissue repair, reduce inflammation, and enhance stem cell recruitment, making PRP therapy a powerful tool for natural healing. In Ramsey, NJ, PRP therapy is gaining popularity as a non-surgical alternative for conditions like osteoarthritis, tendonitis, and sports injuries. Unlike traditional treatments that may only mask symptoms, PRP therapy addresses the root cause of pain by promoting the body's natural repair processes. At Pain Relief Experts, our Ramsey clinic offers personalized PRP therapy to help Bergen County residents regain mobility and vitality without invasive procedures. The effectiveness of PRP therapy lies in its ability to activate the body's healing mechanisms, particularly through stem cell recruitment. Platelets contain growth factors, such as platelet-derived growth factor (PDGF), transforming growth factor-beta (TGF-β), and vascular endothelial growth factor (VEGF), which play a critical role in tissue regeneration. These growth factors: Recruit Stem Cells : PRP signals stem cells to migrate to the injury site, where they differentiate into specialized cells to repair damaged tissue. : PRP signals stem cells to migrate to the injury site, where they differentiate into specialized cells to repair damaged tissue. Promote Collagen Synthesis : Growth factors stimulate the production of collagen, strengthening tendons, ligaments, and cartilage. : Growth factors stimulate the production of collagen, strengthening tendons, ligaments, and cartilage. Enhance Blood Flow : PRP encourages angiogenesis, the formation of new blood vessels, to improve circulation and accelerate healing. : PRP encourages angiogenesis, the formation of new blood vessels, to improve circulation and accelerate healing. Reduce Inflammation: The anti-inflammatory properties of PRP alleviate pain and swelling, improving function in the affected area. This scientific foundation makes PRP therapy an ideal choice for Ramsey, NJ residents seeking a non-biologic, autologous treatment that leverages their body's own resources. By focusing on stem cell recruitment, PRP therapy supports long-term healing without the risks associated with surgery or synthetic drugs. For residents of Ramsey, NJ, PRP therapy offers a unique combination of safety, efficacy, and convenience. Here are the key reasons why PRP therapy is a preferred choice for natural healing in Bergen County: PRP therapy eliminates the need for invasive surgeries, reducing risks such as infections, scarring, and extended recovery periods. The procedure involves a simple blood draw and targeted injections, making it a practical option for busy Ramsey residents. Because PRP therapy uses your own blood, it minimizes the risk of allergic reactions or complications. This non-biologic approach ensures compatibility and aligns with the body's natural healing processes, making it a safe choice for stem cell Ramsey NJ treatments. PRP therapy is effective for a wide range of conditions, including: Osteoarthritis : Reduces joint pain and promotes cartilage repair in knees, hips, and shoulders. : Reduces joint pain and promotes cartilage repair in knees, hips, and shoulders. Tendon Injuries : Accelerates healing for conditions like tennis elbow, Achilles tendonitis, and rotator cuff injuries. : Accelerates healing for conditions like tennis elbow, Achilles tendonitis, and rotator cuff injuries. Ligament Sprains : Supports recovery from sprained or torn ligaments. : Supports recovery from sprained or torn ligaments. Muscle Strains : Speeds up healing for muscle tears and sports injuries. : Speeds up healing for muscle tears and sports injuries. Chronic Pain: Addresses persistent pain that resists conventional treatments. Unlike surgical interventions, which may require weeks or months of downtime, PRP therapy allows patients to resume normal activities within days. This is particularly appealing for active individuals in Ramsey, NJ, who want to maintain their lifestyles. At Pain Relief Experts, our Ramsey clinic tailors PRP therapy to each patient's unique needs. Our experienced physicians conduct thorough consultations to assess eligibility and develop customized treatment plans for optimal outcomes. PRP therapy is a versatile treatment that addresses a variety of musculoskeletal and chronic pain conditions. At Pain Relief Experts, we use PRP therapy to treat: Osteoarthritis : PRP injections reduce inflammation and stimulate cartilage regeneration, providing relief for arthritic joints. : PRP injections reduce inflammation and stimulate cartilage regeneration, providing relief for arthritic joints. Tendonitis : Conditions like patellar tendonitis, tennis elbow, and plantar fasciitis respond well to PRP, which promotes tendon repair. : Conditions like patellar tendonitis, tennis elbow, and plantar fasciitis respond well to PRP, which promotes tendon repair. Ligament Injuries : PRP supports the healing of sprained or torn ligaments, common in athletes and active individuals. : PRP supports the healing of sprained or torn ligaments, common in athletes and active individuals. Chronic Back Pain : Targeted PRP injections address damaged spinal tissues, alleviating persistent lower back pain. : Targeted PRP injections address damaged spinal tissues, alleviating persistent lower back pain. Sports Injuries: From muscle strains to joint injuries, PRP therapy helps Ramsey residents recover faster and return to their active lifestyles. If you're unsure whether PRP therapy is right for your condition, our Ramsey, NJ clinic offers consultations to evaluate your needs and recommend the best treatment options. At Pain Relief Experts, we prioritize patient comfort and precision throughout the PRP therapy process. Here's what to expect when you visit our Ramsey, NJ clinic for stem cell Ramsey NJ treatment: Consultation: Our physicians review your medical history, symptoms, and goals to determine if PRP therapy is suitable for you. Blood Draw: A small sample of your blood is collected, similar to a routine blood test. PRP Preparation: The blood is processed in a centrifuge to isolate the platelet-rich plasma, ensuring a high concentration of growth factors. Injection: Using advanced imaging, such as ultrasound, our physicians inject the PRP into the targeted area with precision. Post-Treatment Care: Patients receive detailed aftercare instructions to optimize healing. Most can resume normal activities within a day or two. The entire procedure is completed in a single visit, typically lasting under an hour, making it a convenient option for Ramsey residents. PRP therapy is suitable for a wide range of patients, particularly those who: Have not found relief from traditional treatments like physical therapy or medications. Prefer non-surgical options to avoid the risks and downtime of surgery. Seek a natural, autologous approach to healing. Experience chronic pain or injuries affecting joints, tendons, ligaments, or muscles. However, PRP therapy may not be appropriate for patients with certain conditions, such as blood disorders or active infections. During your consultation at Pain Relief Experts, our physicians will evaluate your eligibility and discuss the best treatment options for your needs. Pain Relief Experts is a trusted provider of PRP therapy in Ramsey, NJ, offering unparalleled expertise and patient-centered care. Here's why Bergen County residents choose us: Experienced Physicians : Our team specializes in regenerative medicine, ensuring safe and effective PRP treatments. : Our team specializes in regenerative medicine, ensuring safe and effective PRP treatments. Advanced Technology : Our Ramsey clinic uses state-of-the-art equipment for precise PRP preparation and delivery. : Our Ramsey clinic uses state-of-the-art equipment for precise PRP preparation and delivery. Personalized Approach : We tailor treatments to each patient's unique condition and goals, maximizing results. : We tailor treatments to each patient's unique condition and goals, maximizing results. Convenient Location: Located in Ramsey, NJ, our clinic is easily accessible to Bergen County residents, with flexible scheduling to accommodate busy lifestyles. If you're ready to explore a non-surgical, natural solution for pain relief and tissue repair, PRP therapy at Pain Relief Experts is the answer. Our Ramsey, NJ clinic is dedicated to helping Bergen County residents achieve lasting relief through innovative regenerative treatments. Don't let pain hold you back—contact us today to schedule your personalized consultation and discover how PRP therapy can transform your health. Schedule your appointment now or call Pain Relief Experts to learn more about stem cell Ramsey NJ solutions. PRP therapy uses a patient's own blood to create a concentrated platelet solution, which is injected into the injured area to promote healing. The platelets release growth factors that stimulate tissue repair and enhance stem cell recruitment. Yes, PRP therapy is safe because it uses your own blood, minimizing the risk of adverse reactions. At Pain Relief Experts, our Ramsey, NJ clinic follows strict protocols to ensure patient safety. PRP therapy is effective for osteoarthritis, tendonitis, ligament injuries, muscle strains, and chronic pain. It's an ideal solution for Ramsey residents seeking non-surgical treatment options. Results vary by individual and condition. Some patients notice improvement within weeks, while others may require months to experience full benefits. Multiple sessions may be recommended. The procedure involves minimal discomfort, similar to a standard injection. Our physicians use advanced imaging to ensure precise injections, and local anesthesia may be used for added comfort. The number of sessions depends on the condition's severity and the patient's response. Some Ramsey patients achieve relief after one session, while others may need two to three sessions. Insurance coverage for PRP therapy varies. Contact your provider to confirm coverage, and our Ramsey clinic can assist with payment options during your consultation. Pain Relief Experts offers experienced physicians, advanced technology, and personalized care in a convenient Ramsey, NJ location. We are committed to helping Bergen County residents achieve lasting pain relief through PRP therapy. PRP therapy is transforming the landscape of non-surgical healing for Ramsey, NJ residents, offering a safe and effective solution for pain relief and tissue repair. By leveraging stem cell recruitment and the body's natural healing mechanisms, PRP therapy provides long-lasting results without the risks of surgery. At Pain Relief Experts, we are proud to serve Bergen County with cutting-edge regenerative treatments tailored to your needs. Contact us today to schedule your consultation and take the first step toward a pain-free, active lifestyle with stem cell Ramsey NJ solutions. TIME BUSINESS NEWS
Associated Press
30-06-2025
- Health
- Associated Press
Ashvattha Therapeutics Presents Positive Interim Phase 2 Results for Subcutaneous Migaldendranib Treatment for DME and Wet-AMD at 2025 MaculArt Meeting
Monthly subcutaneous migaldendranib shows favorable safety with sustained efficacy through 24 weeks in patients with DME and wet-AMD Novel subcutaneous delivery may offer a more patient-friendly alternative to intravitreal injections, with the potential to significantly reduce treatment burden REDWOOD CITY, Calif., June 30, 2025 (GLOBE NEWSWIRE) -- Ashvattha Therapeutics ('Ashvattha'), a clinical-stage company advancing a new class of nanomedicine therapeutics that traverse tissue barriers to selectively target and reprogram activated cells in regions of inflammation, today announced interim results from its ongoing Phase 2 study of subcutaneous (subQ) migaldendranib (MGB) for the treatment of diabetic macular edema (DME) and neovascular age-related macular degeneration (wet-AMD). The data were presented at the MaculArt Meeting, June 29 – July 1, 2025 in Paris. MGB represents a potential alternative to current standard of care, which requires patients to receive intravitreal injections every 4 to 12 weeks in a clinical setting. MGB is a first-in-class subcutaneously administered candidate being developed for convenient, at-home monthly treatment of DME and wet AMD, aiming to reduce treatment burden while avoiding systemic side effects. Unlike current anti-VEGF therapies that require repeated intravitreal injections directly into the eye, subcutaneously (subQ) administered MGB provides a unique mechanism of action of normalizing vascular endothelial growth factor (VEGF) expression in activated macrophages, microglia and retinal pigment epithelial cells in the retina. By reducing VEGF expression, MGB reduces the need for anti-VEGF intravitreal injections improving patient adherence. Key Phase 2 Interim Results (24-week data): Data presented in the presentation titled ' Subcutaneous Migaldendranib (MGB) for the Treatment of Neovascular Age-Related Macular Degenerations and Diabetic Macular Edema: Interim Results of Chronic Dosing Phase 2 Study' showed that subQ MGB demonstrated promising safety and tolerability in both DME and wet-AMD patients in the first 24 weeks of treatment. The study used more conservative supplement criteria compared to other recent clinical studies, with rescue anti-VEGF injections given when central subfield thickness increased above baseline, rather than the >75 μm increase from lowest value used in other studies. The interim analysis included 19 subjects who completed 24 weeks (11 wet AMD, 8 DME). Results: These interim results support MGB's potential in decreasing the need for supplemental intravitreal injections of anti-VEGF, suggesting a potential new treatment pathway for patients. End of study results will be presented at an upcoming conference. 'These results demonstrate a potential paradigm shift in the treatment of DME and wet-AMD patients,' said Jeff Cleland, PhD, CEO of Ashvattha Therapeutics. 'The interim Phase 2 data support the potential of subcutaneous MGB to offer patients a convenient, once-monthly alternative to frequent eye injections. By targeting inflammation and fluid accumulation in both eyes with a single systemic dose, we may be able to significantly reduce treatment burden and improve quality of life. We look forward to advancing this novel treatment for DME and wet-AMD and to bringing a new treatment forward for patients who need it most.' These data were also presented at the Clinical Trials at the Summit, June 21, 2025, in Las Vegas. About Ashvattha Therapeutics Ashvattha Therapeutics is advancing a new class of clinical-stage nanomedicine therapeutics that traverse tissue barriers to selectively target and reprogram activated cells only in regions of inflammation. Our targeted nanomedicine approach seeks to redefine precision medicine, empowering a new standard of care across ophthalmology, neurology, oncology, and inflammation. Ashvattha Therapeutics was founded by Kannan Rangaramanujam, Sujatha Kannan, and Jeff Cleland and incubated by Natural Capital. For more information, visit: Media ICR Healthcare [email protected] Investor Relations Aman Patel, CFA & Adanna G. Alexander, PhD ICR Healthcare [email protected]
Business Upturn
27-06-2025
- Business
- Business Upturn
Biocon subsidiary gets Health Canada nod for YESAFILI
By Aman Shukla Published on June 27, 2025, 09:19 IST Biocon Biologics Ltd. (BBL), a subsidiary of Biocon Ltd., has received a Notice of Compliance from Health Canada for YESAFILI™ (aflibercept), marking a significant milestone in the company's global biosimilars journey. The regulatory approval, granted on June 26, 2025, makes YESAFILI the first biosimilar to EYLEA® (aflibercept) to be approved in Canada. The product will be available in both vial and prefilled syringe forms (2 mg/0.05 mL), with its commercial launch set for July 4, 2025. YESAFILI is a vascular endothelial growth factor (VEGF) inhibitor designed to treat several serious eye conditions. These include neovascular (wet) age-related macular degeneration (AMD), diabetic macular edema (DME), and visual impairment due to macular edema caused by retinal vein occlusion (CRVO and BRVO), as well as myopic choroidal neovascularization (myopic CNV). The approval is backed by a robust data package encompassing analytical, nonclinical, and clinical studies. Health Canada concluded that YESAFILI matches EYLEA in quality, safety, and effectiveness, with no clinically meaningful differences. This milestone not only reinforces Biocon Biologics' capabilities in developing high-quality biosimilars but also enhances patient access to affordable treatment options in Canada. Ahmedabad Plane Crash Aman Shukla is a post-graduate in mass communication . A media enthusiast who has a strong hold on communication ,content writing and copy writing. Aman is currently working as journalist at
Business Upturn
23-06-2025
- Business
- Business Upturn
European Medicines Agency Recommends Market Approval of AVT06, Alvotech's Proposed Biosimilar to Eylea® (aflibercept)
REYKJAVIK, Iceland and LONDON, June 23, 2025 (GLOBE NEWSWIRE) — Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide and Advanz Pharma, a UK headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease medicines in Europe, today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human use (CHMP) adopted a positive opinion recommending approval for AVT06, Alvotech's proposed biosimilar to Eylea® (aflibercept 2 mg). Based on a positive recommendation by CHMP, biosimilar medicines can be approved by the European Commission for marketing in the European Economic Area, that includes the 27 member states of the European Union, in addition to Norway, Iceland and Lichtenstein. 'CHMP's positive opinion takes us a step closer to being able to market our proposed biosimilar in Europe, which is excellent news for patients and their caregivers. Alvotech looks forward to increasing access to this vital biologic treatment for eye disorders,' said Joseph McClellan, Chief Scientific Officer of Alvotech. Advertisement 'We are pleased with the CHMP's positive opinion, which marks an important milestone in our mission to bring high-quality, specialist medicines to patients across Europe,' said Nick Warwick, Chief Medical Officer of Advanz Pharma. The CHMP opinion recommends granting of a marketing authorization for AVT06 intended for the treatment of adults with neovascular (wet) age-related macular degeneration (AMD), visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO), visual impairment due to diabetic macular oedema (DME) and visual impairment due to myopic choroidal neovascularisation (myopic CNV). Alvotech is responsible for the development and commercial supply of the proposed biosimilar. Advanz Pharma is responsible for registration and has exclusive commercialization rights for most countries in Europe. In 2024, global sales of Eylea® were about US$9 billion, and one third of these sales were in Europe [1]. In January 2024 Alvotech announced positive top-line results from a confirmatory clinical study with AVT06 (AVT06-GL-C01) comparing the efficacy, safety, and immunogenicity of the proposed biosimilar to Eylea® in patients with neovascular (wet) AMD. The study met its primary endpoint, with results demonstrating therapeutic equivalence between Alvotech's biosimilar candidate and Eylea® [2]. Alvotech is also developing AVT29, a proposed biosimilar to Eylea® HD, a higher dose (aflibercept 8 mg) aflibercept. Advanz has licensed the distribution rights from Alvotech for both biosimilar candidates, for the same territory. About AVT06 (aflibercept) AVT06 is a recombinant fusion protein and a biosimilar candidate to Eylea® (aflibercept), which binds vascular endothelial growth factors (VEGF), inhibiting the binding and activation of VEGF receptors, neovascularization, and vascular permeability [3]. AVT06 is an investigational product and has not received regulatory approval in any country. Biosimilarity has not been established by regulatory authorities and is not claimed. Sources [1] Global Data and IQVIA [2] Agostini, H. (2025). A randomized, double-masked parallel-group, multicenter clinical study evaluating the efficacy and safety of the biosimilar candidate AVT06 compared to the reference product aflibercept in participants with neovascular age-related macular degeneration. Expert Opinion on Biological Therapy, 1–15. [3] Use of trademarks Elyea® is a registered trademark of Regeneron Pharmaceuticals Inc. and Bayer AG. About Alvotech Alvotech is a biotech company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high quality, cost-effective products, and services, enabled by a fully integrated approach and broad in-house capabilities. Alvotech's current pipeline includes eight disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer. Alvotech has formed a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa and the Middle East. Alvotech's commercial partners include Teva Pharmaceuticals, a US affiliate of Teva Pharmaceutical Industries Ltd. (US), STADA Arzneimittel AG (EU), Fuji Pharma Co., Ltd (Japan), Advanz Pharma (EEA, UK, Switzerland, Canada, Australia and New Zealand), Cipla/Cipla Gulf/Cipla Med Pro (Australia, New Zealand, South Africa/Africa), JAMP Pharma Corporation (Canada), Yangtze River Pharmaceutical (Group) Co., Ltd. (China), DKSH (Taiwan, Hong Kong, Cambodia, Malaysia, Singapore, Indonesia, India, Bangladesh and Pakistan), YAS Holding LLC (Middle East and North Africa), Abdi Ibrahim (Turkey), Kamada Ltd. (Israel), Mega Labs, Stein, Libbs, Tuteur and Saval (Latin America) and Lotus Pharmaceuticals Co., Ltd. (Thailand, Vietnam, Philippines, and South Korea). Each commercial partnership covers a unique set of product(s) and territories. Except as specifically set forth therein, Alvotech disclaims responsibility for the content of periodic filings, disclosures and other reports made available by its partners. For more information, please visit . None of the information on the Alvotech website shall be deemed part of this press release. About Advanz Pharma Partner of choice in specialty, hospital, and rare disease medicines. Advanz Pharma is a global pharmaceutical company with the purpose to improve patients' lives by providing and enhancing the specialty, hospital, and rare disease medicines they depend on. Our headquarters are in London, UK. We have commercial sales in more than 90 countries globally and have a direct commercial presence in more than 20 countries, including key countries in Europe, the US, Canada, and Australia, a Centre of Excellence in Mumbai, India, as well as an established global distribution and commercialization partner network. Advanz Pharma's product portfolio and pipeline comprises innovative medicines, biosimilars & specialty generics, and originator brands. Our products cover a broad range of therapeutic areas, including hepatology, rheumatology, gastroenterology, anti-infectives, critical care, endocrinology, oncology, CNS, and, more broadly, rare disease medicines. Our ambition is to be a partner of choice for the commercialization of specialty, hospital, and rare disease medicines in Europe, Canada, and Australia. In line with our ambition, we are partnering with biopharma and development companies to bring medicines to patients. We can only achieve this due to our dedicated and highly qualified employees, acting in line with our company values of entrepreneurship, speed, and integrity. Alvotech Forward Looking Statements Certain statements in this communication may be considered 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements generally relate to future events or the future financial or operating performance of Alvotech and may include, for example, Alvotech's expectations regarding future growth, results of operations, performance, future capital and other expenditures, competitive advantages, business prospects and opportunities including pipeline product development, future plans and intentions, results, level of activities, performance, goals or achievements or other future events, regulatory review and interactions, the satisfactory responses to the FDA's inspection findings and resolution of other deficiencies conveyed following the re-inspection of Alvotech's manufacturing site, the potential approval, including for AVT02, AVT04, and the product candidates in scope of the partnership with Advanz, by the FDA and other regulatory agencies and commercial launch of its product candidates, the timing of the announcement of clinical study results, the commencement of patient studies, regulatory applications, approvals and market launches, and the estimated size of the total addressable market of Alvotech's pipeline products. In some cases, you can identify forward-looking statements by terminology such as 'may', 'should', 'expect', 'intend', 'will', 'estimate', 'anticipate', 'believe', 'predict', 'potential' or 'continue', or the negatives of these terms or variations of them or similar terminology. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Alvotech and its management, are inherently uncertain and are inherently subject to risks, variability, and contingencies, many of which are beyond Alvotech's control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: (1) the ability to reach development milestones under commercial partnership agreements including the partnership with Advanz; (2) the ability to raise substantial additional funding, which may not be available on acceptable terms or at all; (3) the ability to maintain stock exchange listing; (4) changes in applicable laws or regulations; (5) the possibility that Alvotech may be adversely affected by other economic, business, and/or competitive factors; (6) Alvotech's estimates of expenses and profitability; (7) Alvotech's ability to develop, manufacture and commercialize the products and product candidates in its pipeline; (8) the ability of Alvotech or its partners to respond to inspection findings and resolve deficiencies to the satisfaction of the regulators; (9) actions of regulatory authorities, which may affect the initiation, timing and progress of clinical studies or future regulatory approvals or marketing authorizations; (10) the ability of Alvotech or its partners to enroll and retain patients in clinical studies; (11) the ability of Alvotech or its partners, including Advanz, to gain approval from regulators for planned clinical studies, study plans or sites; (12) the ability of Alvotech's partners to conduct, supervise and monitor existing and potential future clinical studies, which may impact development timelines and plans; (13) Alvotech's ability to obtain and maintain regulatory approval or authorizations of its products, including the timing or likelihood of expansion into additional markets or geographies; (14) the success of Alvotech's current and future collaborations, joint ventures, partnerships or licensing arrangements, including the partnership with Advanz; (15) Alvotech's ability, and that of its commercial partners, including Advanz, to execute their commercialization strategy for approved products; (16) Alvotech's ability to manufacture sufficient commercial supply of its approved products; (17) the outcome of ongoing and future litigation regarding Alvotech's products and product candidates; (18) the potential impact of the ongoing COVID-19 pandemic on the FDA's review timelines, including its ability to complete timely inspection of manufacturing sites; (19) the impact of worsening macroeconomic conditions, including rising inflation and interest rates and general market conditions, war in Ukraine and global geopolitical tension, and the ongoing and evolving COVID-19 pandemic on the Alvotech's business, financial position, strategy and anticipated milestones; and (20) other risks and uncertainties set forth in the sections entitled 'Risk Factors' and 'Cautionary Note Regarding Forward-Looking Statements' in documents that Alvotech may from time to time file or furnish with the SEC. There may be additional risks that Alvotech does not presently know or that Alvotech currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. Nothing in this communication should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. Alvotech does not undertake any duty to update these forward-looking statements or to inform the recipient of any matters of which any of them becomes aware of which may affect any matter referred to in this communication. Alvotech disclaims any and all liability for any loss or damage (whether foreseeable or not) suffered or incurred by any person or entity as a result of anything contained or omitted from this communication and such liability is expressly disclaimed. The recipient agrees that it shall not seek to sue or otherwise hold Alvotech or any of its directors, officers, employees, affiliates, agents, advisors, or representatives liable in any respect for the provision of this communication, the information contained in this communication, or the omission of any information from this communication. Advanz Pharma Forward Looking Statements Certain statements in this press release are forward-looking statements. These statements may be identified by words such as 'anticipate', 'expectation', 'belief', 'estimate', 'plan', 'target', 'project', 'will', 'may', 'should' or 'forecast' and similar expressions, or by their context. Although Advanz Pharma believes that these assumptions were reasonable when made, by their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial consequences of the plans and events described herein. Actual results may differ from those set forth in the forward-looking statements as a result of various factors (including, but not limited to, future global economic conditions, changed market conditions affecting the industry, intense competition in the markets in which Advanz Pharma operates, costs of compliance with applicable laws, regulations and standards, diverse political, legal, economic and other conditions affecting Advanz Pharma's markets, and other factors beyond the control of Advanz Pharma. Neither Advanz Pharma nor any of its directors, officers, employees, advisors, or any other person is under any obligation to update or keep current the information contained in this press release or revise any forward-looking statements, whether as a result of new information, future events or otherwise. You should not place undue reliance on forward-looking statements, which speak of the date of this press release. Statements contained in this press release regarding past trends or events should not be taken as a representation that such trends or events will continue in the future. No obligation is assumed to update any forward-looking statements. The information contained in this press release is provided as at the date of this document and is subject to change without notice. MEDIA CONTACTS Alvotech Global Communications and Investor Relations Benedikt Stefansson [email protected] Advanz Pharma Global Corporate Communications Courtney Baines [email protected] Disclaimer: The above press release comes to you under an arrangement with GlobeNewswire. Business Upturn takes no editorial responsibility for the same.
