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iStock, White Bear Studio The Eylea franchise was in need of a win after an appellate court last week denied the pharma’s bid to block Amgen’s biosimilar from the U.S. Two investigational eye therapies, from Opthea Limited and UNITY Biotechnology, were unable to unseat Regeneron ’s blockbuster anti-VEGF therapy Eylea on Monday as the standard of care in two different ophthalmic indications. The news comes as Regeneron last week lost its court appeal to prevent Amgen’s biosimilar Pavblu from entering the U.S. market. In a March 15 note to investors, BMO Capital Markets analysts said the failed appeal “reads as a modest negative to Regeneron” and compounds the existing risk to its Eylea franchise. Presenting topline data from the Phase III COAST study, Australian biotech Opthea revealed that its investigational VEGF blocker sozinibercept failed to significantly outperform Eylea at improving vision in patients with wet age-related macular degeneration (AMD). At 52 weeks, best-corrected visual acuity (BCVA) in those treated with sozinibercept improved by 12.8 letters on average from baseline, while mean improvement in Eylea counterparts was 13.7 letters. Like Eylea, sozinibercept is designed to be injected into the eye and also works by binding VEGF, a protein involved in the formation of new blood vessels. Uniquely, however, sozinibercept targets the VEGF-C and VEGF-D subtypes (Eylea binds to VEGF-A and placental growth factor), which according to Opthea is highly expressed in patients receiving the standard VEGF-A therapies, in turn leading to leaky blood vessels that could ultimately also harm vision. Sozinibercept is Opthea’s only clinical candidate , and wet AMD is its most advanced indication. Monday’s Phase III stumble thus presents a financial problem for the biotech, which in its news release revealed that it “has been assessing its rights and obligations” to investors. Opthea could be on the hook for certain payments that “would have a material adverse impact on the solvency of the company,” it wrote. The biotech is in “active discussions” with its investors, trying to determine “whether there is a pathway that represents the best outcome for the company and its shareholders,” according to Monday’s release. Opthea has yet to reach a decision but is mulling over terminating the COAST trial or unmasking a separate wet AMD trial. Also on Monday, California-based UNITY Biotechnology announced that its investigational eye injection UBX1325 likewise fell to Eylea in patients with diabetic macular edema. Topline data from the Phase IIb ASPIRE study showed that UBX1325 improved visual acuity by more than five letters at 24 and 36 weeks versus baseline. These gains, according to UNITY, were “non-inferior” to Eylea at almost all time points through 36 weeks except at the average of weeks 20 and 24. At this time point, UBX1325 showed non-inferiority at an 88% confidence interval—just shy of the 90% prespecified threshold for the study’s primary endpoint. Despite missing its target, UNITY CEO Anirvan Ghosh sang an optimistic tune in a statement on Monday, noting that UBX1325 “showed robust vision improvements in a difficult to treat patient population.” The biotech will continue to advance the candidate into late-stage studies.

Feb. 18, 2025 -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for AVT06, Alvotech’s proposed biosimilar to Eylea® (aflibercept), a biologic used to treat eye disorders, including diseases which can lead to vision loss or blindness. The process to obtain regulatory approval is anticipated to be completed in the fourth quarter of 2025. "We are extremely pleased with this new step in the development of our biosimilar candidate to Eylea®, as better access will benefit patients and their caregivers," said Joseph McClellan, Chief Scientific Officer of Alvotech. "Our success in developing multiple biosimilar candidates in parallel for global markets, demonstrates the advantage of our fully integrated approach and broad in-house capabilities in both R&D and manufacturing." “We are delighted to share this latest biosimilar milestone with Alvotech for those living with retinal diseases,” said Thomas Rainey, Senior Vice President, U.S. Biosimilars at Teva. “This acceptance continues to build on our shared commitment to improving patient outcomes by offering cost saving and accessible options.” In addition to AVT06, which is a biosimilar candidate for Eylea® (aflibercept) 2 mg, Alvotech is currently also developing AVT29, a biosimilar candidate for Eylea® HD (aflibercept) 8 mg. Teva also holds commercialization rights for AVT29 in the U.S. Eylea® is a widely used biologic for the treatment of eye disorders, such as neovascular (wet) Age-related Macular Degeneration (AMD), macular edema, and diabetic retinopathy. In 2024, sales of Eylea® (low dose and HD combined) in the U.S. were $4.77 billion.1 In January 2024, Alvotech announced positive top-line results from a confirmatory clinical study (AVT06-GL-C01) comparing the efficacy, safety, and immunogenicity of AVT06 with Eylea® in patients with neovascular (wet) AMD. The study met its primary endpoint, with results demonstrating therapeutic equivalence and comparable safety including immunogenicity between AVT06 and Eylea®. AVT06/AVT29 is a recombinant fusion protein and a biosimilar candidate to Eylea® (aflibercept) 2 mg and 8 mg dose, which binds vascular endothelial growth factors (VEGF), inhibiting the binding and activation of VEGF receptors, neovascularization, and vascular permeability.2 AVT06/AVT29 are investigational products and have not received regulatory approval in any country. Biosimilarity has not been established by regulatory authorities and is not claimed. 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. Two biosimilars to Humira® (adalimumab) and Stelara® (ustekinumab) are already approved and marketed in multiple global markets. The current development pipeline includes nine 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), Dr. Reddy’s (EEA, UK and US), Biogaran (FR), 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 https://www.alvotech.com. None of the information on the Alvotech website shall be deemed part of this press release. Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a global pharmaceutical leader, harnessing its generics expertise and stepping up innovation to continue the momentum behind the discovery, delivery, and expanded development of modern medicine. For over 120 years, Teva's commitment to bettering health has never wavered. Today, the company’s global network of capabilities enables its ~37,000 employees across 57 markets to push the boundaries of scientific innovation and deliver quality medicines to help improve health outcomes of millions of patients every day. To learn more about how Teva is all in for better health, visit www.tevapharm.com. 1. Regeneron investor presentation: https://investor.regeneron.com/static-files/f5556fde-092a-4792-ae53-161550abd551. Accessed on February 10, 2025 2. EYLEA® (aflibercept) injection, for intravitreal use [current prescribing information]. Regeneron Pharmaceuticals, Inc. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125387s087lbl.pdf. Accessed on February 10, 2025. The content above comes from the network. if any infringement, please contact us to modify.

Identifying patients at high risk of developing severe preeclampsia can lead to better prediction, earlier interventions and reduced adverse outcomes.1 In the United States, preeclampsia has increased 25% in the last two decades and is a leading cause of maternal and infant illness and death,2 disproportionately affecting Black women.3 With an extensive U.S. installation base of more than 4,000 cobas® analyzers and a high degree of menu consolidation across various indications, clinicians are supported in making faster, more efficient clinical decisions. INDIANAPOLIS, Feb. 13, 2025 /PRNewswire/ -- Roche announced today that the Roche Elecsys® sFlt-1/PlGF ratio for preeclampsia has received 510(k) clearance from the United States Food and Drug Administration (FDA). The ratio is a prognostic test intended to stratify hospitalized pregnant women with hypertensive disorders of pregnancy into low- and high-risk categories for developing severe preeclampsia within two weeks of testing. Identifying patients at high risk for severe preeclampsia can lead to better prediction, earlier interventions and reduced adverse outcomes.1 In the U.S., preeclampsia has increased 25% in the last two decades and is a leading cause of maternal and fetal illness and death.2 Black women in particular experience higher rates of maternal and adverse fetal and neonatal outcomes than other racial and ethnic groups and are at greater risk for developing hypertensive disorders of pregnancy than other pregnant women.3 "There is a great need for highly reliable tools, such as the Elecsys sFlt-1/PlGF ratio, to address severe preeclampsia," said Brad Moore, president and CEO of Roche Diagnostics North America. "We are eager to partner with our customers so this prognostic test can help clinicians plan care and improve patient outcomes." sFlt-1 and PlGF are key biomarkers in the formation of blood vessels during pregnancy. However, an angiogenic imbalance of these key biomarkers has been proven to play an important role in the development of preeclampsia. Their concentrations in maternal serum are altered even before the onset of the disease, making them a valuable tool for predicting preeclampsia progression.4,5 Nearly 70% of women with a sFlt-1/PlGF ratio greater than 38 delivered their babies within two weeks.1 "The current clinical diagnostic criteria are poor in predicting, with accuracy, the development of preeclampsia among patients with hypertensive disorders of pregnancy," said Sarosh Rana, M.D., MPH, FACOG, University of Chicago Medicine. "The clearance of this ratio provides clinicians with an additional tool to predict the risk of severe preeclampsia and support clinical management by increasing surveillance in high-risk patients or prolonging pregnancy in low-risk patients, ultimately preventing adverse maternal, fetal and neonatal outcomes." Preeclampsia is defined as the new onset of hypertension and proteinuria after 20 weeks of gestation, or in the absence of proteinuria, new-onset hypertension and any of the following: thrombocytopenia, renal insufficiency, impaired liver function, pulmonary edema, or new onset of headache unresponsive to medication.6 Preeclampsia can be treated only by removal of the placenta at delivery.6 The clinical presentation of preeclampsia and the subsequent clinical course of the disorder can vary tremendously, making prediction, diagnosis and assessment of progression difficult.6 "The FDA clearance of the sFlt-1/PlGF ratio on Roche platforms is a major milestone in the quest to solve preeclampsia," said Ravi Thadhani, M.D., MPH, executive vice president of Health Affairs at Emory University. "This test will give clinicians an additional tool to stratify women at highest risk for the development of severe preeclampsia. Preeclampsia biomarker testing has the potential to spur innovation in new therapies that are sorely needed for these patients." Preeclampsia and its symptoms, such as headaches, visual changes, epigastric pain, and shortness of breath,6 have warning signs that are often overlooked and have devastating and lasting impact on mothers and babies if not properly managed.7 Impacts can include maternal organ damage and an increased risk of future heart failure, preterm birth6 and avoidable mental trauma.8 Hospitalization is typically recommended to evaluate the potential for progression to severe disease. Standard diagnostic markers for preeclampsia are often nonspecific and may not accurately predict the severity of the condition or associated adverse outcomes in the subsequent days and weeks.7 The preeclampsia ratio aligns with Roche's commitment to lead with science in order to develop transformational solutions that improve patient outcomes and simplify lab operations. Roche provides an unrivaled ability to scale access to testing at speed for those who need it most. With an extensive U.S. installation base of more than 4,000 cobas® analyzers and a high degree of menu consolidation across various indications, clinicians are supported in making faster, more efficient clinical decisions, providing the ability to scale testing at speed for even more women. About Preeclampsia Preeclampsia is a serious multi-system complication of pregnancy, occurring in 3% to 4% of pregnancies in the U.S., and remains one of the leading causes of maternal and perinatal morbidity and mortality worldwide.7 Preeclampsia can also have negative effects on the fetus and newborn, resulting in complications such as intrauterine growth restriction, low birth weight and stillbirth. These complications often necessitate early induction of labor or cesarean delivery, leading to preterm birth.9 Each year in the U.S., there are 4 million pregnancies, of which 120,000 to 160,000 are affected by preeclampsia. From 2017-2019, hypertensive disorders of pregnancy – including gestational hypertension, chronic hypertension, preeclampsia and superimposed preeclampsia – accounted for 6.3% of pregnancy-related deaths in the U.S.10 In 2022, there were approximately 22 maternal deaths for every 100,000 live births in the U.S. – far above that of other high-income countries.11 About Elecsys sFlt-1/PlGF Ratio The Elecsys sFlt-1/PlGF ratio for preeclampsia is an FDA-cleared test to clinically assess the progression of preeclampsia.12 The preeclampsia ratio supports the management of pregnant patients with a singleton pregnancy, and is intended to help clinicians stratify hospitalized patients into low- and high-risk categories for developing severe preeclampsia within two weeks of presentation.12 Identification of high-risk preeclampsia patients can lead to better prediction, earlier interventions and reduced adverse outcomes.1,5,13 The Elecsys sFlt-1 and Elecsys PlGF assays are provided in separate kits. The ratio must be calculated using Elecsys sFlt 1 and Elecsys PlGF results obtained on the same patient sample and the same cobas immunoassay analyzer per the intended use. The assay results should be used only in conjunction with information available from clinical evaluations and other standard-of-care procedures. The test result is not to be used to replace clinical judgment. About Roche Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world's largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalized healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person, we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice. For over 125 years, sustainability has been an integral part of Roche's business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit . All trademarks used or mentioned in this release are protected by law. References 1. Berg A, Bautista M, Guo G, et al. Circulating angiogenic factors for stratifying the risk of preeclampsia with severe features. SMFM Global Meeting 2024. Pregnancy 2025. 2. Cameron, et al. Trends in the incidence of new-onset hypertensive disorders of pregnancy among rural and urban areas in the United States, 2007 to 2019. J Am Heart Assoc. 2022;11:e023791. 3. Davis NL, Smoots AN, Goodman DA. Pregnancy-Related Deaths: Data from 14 U.S. Maternal Mortality Review Committees, 2008-2017. Atlanta, GA: Centers for Disease Control and Prevention, U.S. Department of Health and Human Services;2019. 4. Levine RJ, et al. Circulating angiogenic factors and the risk of preeclampsia. N Engl J Med 2004;350:672–83. 5. Zeisler H, et al. Predictive value of the sFlt-1:PlGF ratio in women with suspected preeclampsia. N Engl J Med 2016;374:13–22. 6. Gestational hypertension and preeclampsia. ACOG Practice Bulletin No. 222. American College of Obstetricians and Gynecologists. Obstet Gynecol 2020;135:e237–60. 7. Burwick RM, Rodriguez MH. Angiogenic Biomarkers in Preeclampsia. Obstet Gynecol. 2024;143(4):515-523. 8. Not Just Physical: The Psychological Burden Of Preeclampsia And HELLP Syndrome. 9. Backes CH, et al. Maternal Preeclampsia and Neonatal Outcomes. J Pregnancy. 2011;214365. 10. Pregnancy Mortality Surveillance System. 11. Hoyert DL. Maternal mortality rates in the United States, 2022. NCHS Health E-Stats. 2024. 12. Method Sheet Elecsys sFlt-1/PlGF ratio for preeclampsia. 2025 v 1.0. English. 13. Thadhani, et al. Circulating angiogenic factor levels in hypertensive disorders of pregnancy. NEJM Evid 2022;1:(12). For Further Information Roche Diagnostics U.S. Media Relations [email protected] Jennifer Hoopingarner 1-317-797-9741 [email protected] Gina Goodenough 1-317-734-7171 [email protected] SOURCE Roche Diagnostics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED