Ranibizumab biosimilar (Midas Pharma GmbH)

Clover Biopharmaceutical made progress with a booster against Omicron BA.5, the European Commission authorized a biosimilar for wet age-related macular degeneration and TikoMed's platform demonstrated potential in Amyotrophic lateral sclerosis (ALS). For that and more global news, see below. Clover posted positive Phase II/III data for its lead COVID-19 vaccine candidate, SCB-2019. The China-based company announced that SCB-2019 prompted a robust immune response to Omicron BA.5 sub-variant, the dominant strain of COVID-19 circulating the globe. Clover reported that the data from the Phase II/III study adds to the growing evidence supporting the potential use of SCB-2019 as a universal COVID-19 booster vaccine. As a booster dose, SCB-2019 (CpG 1018/Alum) in individuals who previously received two doses of SCB-2019 sparked a "robust and rapid neutralizing antibody immune response," the company noted. Data showed that trial participants who had a prior COVID-19 infection and received two doses of the Clover vaccine three weeks apart saw a 61-fold increase in neutralizing antibodies against BA.5. Additionally, the vaccine also generated a 37-fold boost in neutralizing antibodies against the Omicron BA.2 sub-variant and a 20-fold boost in neutralizing antibodies against Omicron BA.1. These results indicate that Omicron BA.5 neutralizing antibody levels were approximately two to four-fold higher than Omicron BA.1 neutralizing antibody levels induced by SCB-2019. Nicholas Jackson, president of global research and development at Clover, said the new data provides evidence that supports the potential for SCB-2019 to be used across the globe to halt the continued spread of COVID. Clover is focused on completing regulatory submissions to the China National Medical Products Administration, the European Medicines Agency, and the World Health Organization for SCB-2019 in the second half of 2022. Elsewhere around the globe: TikoMed: Sweden's TikoMed published research in Frontiers in Pharmacology supporting the mechanism of action of its ILB neuroprotective drug platform. In multiple preclinical and clinical studies across a variety of neuroinflammation-driven diseases, including ALS, the low molecular weight dextran sulfate compound mobilized and modulated naturally occurring tissue repair mechanisms, the company noted. TikoMed added that the compound restored cellular homeostasis and function by releasing heparin-binding growth factors. TikoMed stated its belief that this approach has the potential to transform current cell and gene therapy paradigms. PolPharma Biologics Group BV: PolPharma, along with Formycon AG and Bioeg AG, jointly announced that the European Commission granted marketing authorization to Ranivisio, a biosimilar to Lucentis used to treat renal diseases. Ranivisio is indicated for the treatment of wet age-related macular degeneration, the treatment of visual impairment due to diabetic macular edema or choroidal neovascularization and the treatment of proliferative diabetic retinopathy. It is also indicated for the treatment of visual impairment due to macular edema secondary to retinal vein occlusion. BrainsWay Ltd.: Israel's BrainsWay received 510(k) clearance from the U.S. FDA for the Deep TMS H7 Coil to treat adults suffering from major depressive disorder and depression, including those with comorbid anxiety symptoms commonly known as anxious depression. The FDA's clearance was based on the review of successful results from a multicenter trial designed to better understand the H7 Coil's efficacy in addressing treatment-resistant depression. The study found overall efficacy rates for the H7 Coil comparable to those achieved with BrainsWay's H1 Coil. Aeterna Zentaris Inc.: Toronto-based Aeterna Zentaris announced that Novo Nordisk exercised its right to terminate an agreement for Macrilen (macimorelin), an oral test for diagnosing adult growth hormone deficiency approved in the United States and Europe. Aeterna will regain full U.S. and Canadian rights to the test. In light of Novo's decision, Aeterna said it plans to engage in robust business development efforts to identify and secure a new development and commercialization partner. Immutep Limited: Based in Australia, Immutep secured a new patent from Japan that covers its lead active immunotherapy candidate, eftilagimod alpha, a LAG-3 fusion protein and an anti-PD-(L)1 antibody. Medtronic: Ireland's Medtronic completed its acquisition of Affera, Inc. The company noted that the acquisition expands its cardiac ablation portfolio to include cardiac mapping and navigation. Affera's investigational technology is designed to provide solutions for patients with cardiac arrhythmias such as atrial fibrillation. The acquisition brings the Affera Prism-1 cardiac mapping and navigation platform into the company, which will complement Medtron's therapeutic catheters and technologies. It also brings the Spere-0 cardiac diagnostic ablation catheter that rapidly creates detailed electro-anatomical maps and delivers radio frequency and pulsed field cardiac ablation therapies. Laverock Therapeutics: Based in the United Kingdom, Laverock was launched with the mission of developing a gene silencing platform for the creation of programmable, allogeneic cell therapies. With financing from its seed funding round, Laverock has opened labs in the Stevenage Bioscience Catalyst. It is conducting experiments to demonstrate cell type and condition-specific programmability, generating data to support allogeneic programs in Type 1 diabetes and solid tumor-directed immune therapy. Futura Medical plc: Also based in England, Futura Medical announced results from the Phase III study of MED3000, an investigational therapy for the treatment of erectile dysfunction. The company announced that the study met coprimary endpoints. MED3000 demonstrated a statistically significant improvement in erectile function compared to baseline. Also, the study achieved a clinically meaningful improvement in erectile function at 24 weeks. Exploratory endpoints demonstrated MED3000 achieved clinically important improvements in erectile function at all time points and was clinically effective in mild, moderate and severe ED sufferers. The company remains on track for potential filing with the FDA and other regulatory agencies. Volta Medical: France's Volta Medical, a health tech company developing AI software solutions, announced that the Journal of Cardiovascular Electrophysiology published peer-reviewed results from its successful Ev-AIFib-Proof-of-Concept-Study with VX1, an expertise-based AI software solution. The study was the first large-scale clinical validation of a companion AI-based software solution that reproduces expert-physician electrogram analysis. Results demonstrated that VX1 allowed for the building of standardized "Volta VX1 maps", used as a reference for operators to conduct EGM-guided ablation.

Teva Pharmaceuticals to commercialize the product in Europe Age related macular degeneration (AMD) affects around 67 million people in Europe and is a leading cause of blindness for working age adults with uncontrolled diabetes1 and the most common cause of blindness in developed countries2. Ranivisio (ranibizumab) will be the first ophthalmology biosimilar of Lucentis to be commercialized in Europe and is approved for treatment for all five Lucentis indications in adults. Teva entered into a strategic partnership with Bioeq AG for the exclusive commercialization of ranibizumab and intends to launch the product throughout Europe following its July ’22 launch in the United Kingdom under the tradename ONGAVIA▼®. TEL AVIV, Israel--(BUSINESS WIRE)-- Teva Pharmaceutical Industries Ltd. announces that the European Commission (EC) has granted a Marketing Authorization for Ranivisio (ranibizumab), a biosimilar of the ophthalmology treatment Lucentis across all five indications in adults for which Lucentis is authorized. Richard Daniell, Executive Vice President, European Commercial, Teva Pharmaceuticals commented: “With millions of people in Europe afflicted by this serious age-related eye condition this important milestone allows us, together with Bioeq, to bring ranibizumab to ophthalmologists and patients throughout Europe. The product is a welcome addition to Teva’s growing biosimilars portfolio, and delivers on our mission to improve patient access to critical therapies while delivering vital savings to healthcare systems.” Ranivisio is licensed in adults to treat age-related macular degeneration (AMD) and four other ophthalmology indications: visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO), visual impairment resulting from diabetic macular oedema (DME), proliferative diabetic retinopathy (PDR), and choroidal neovascularisation (CNV). Around 67 million people in Europe are affected by AMD. It is a leading cause of blindness for working age adults with uncontrolled diabetes3, and the most common cause of blindness in developed countries2. It is estimated that up to 77 million Europeans will be affected with AMD by 20504. AMD is caused by excessive growth of blood vessels in the retina that leads to visual impairment and can even cause blindness. Ranibizumab inhibits vascular endothelial growth factor (VEGF), which is responsible for the excessive formation of these blood vessels in the retina5. In the COLUMBUS-AMD study, a randomized, double-masked, parallel group, multi-centre phase III study6, ranibizumab was shown to be highly similar to its reference medicine in terms of clinical efficacy and ocular and systemic safety in the treatment of AMD and its other ophthalmology indications. * Ranivisio is a registered trademark of Bioeq AG, licensed by Teva ** Lucentis® is a registered trademark of Genentech Inc. About Teva: Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has been developing and producing medicines to improve people’s lives for more than a century. We are a global leader in generic, biosimilar and specialty medicines with a portfolio consisting of over 3,500 products in nearly every therapeutic area. Around 200 million people around the world take a Teva medicine every day, and are served by one of the largest and most complex supply chains in the pharmaceutical industry. Along with our established presence in generics, we have significant innovative research and operations supporting our growing portfolio of specialty and biopharmaceutical products. Learn more at About Bioeq: Bioeq is a Swiss biopharmaceutical joint venture between the Polpharma Biologics Group and Formycon AG. Bioeq develops, licenses and commercializes biosimilars. About Formycon: Formycon is a leading, independent developer of high-quality biopharmaceutical medicines, especially biosimilars. The company focuses on treatments in ophthalmology, immunology and on other key chronic diseases, covering the entire value chain from technical development to the clinical phase III as well as the preparation of dossiers for marketing approval. About Polpharma Biologics: Polpharma Biologics is an international biotechnology company with integrated operations in the European Union (EU), developing and manufacturing biosimilar medicines. Polpharma Biologics develops biosimilar products to treat a range of conditions in major therapeutic areas References: ___________________________ 1 Written by Editor. January 15, 2019 · Last reviewed January 7, 2022. Available at: 2 Colin S. Tan, SriniVas R. Sadda. 2017, Pages 89-116, Chapter 7. Neovascular (Wet) Age-Related Macular Degeneration. Academic Press, ISBN 9780128053133. Available at: 3 Written by Editor. January 15, 2019 · Last reviewed January 7, 2022. Available at: 4 Li JQ, Welchowski T, Schmid M, et alPrevalence and incidence of age-related macular degeneration in Europe: a systematic review and meta-analysis British Journal of Ophthalmology 2020;104:1077-1084 available at: 5 John Lowe et al., Experimental Eye Research 85 (2007) 425e430, Ranibizumab inhibits multiple forms of biologically active vascular endothelial growth factor in vitro and in vivo Available at: 6 Frank G Holz , Piotr Oleksy , Federico Ricci , Peter K Kaiser , Joachim Kiefer , Steffen Schmitz-Valckenberg , COLUMBUS-AMD Study Group - Efficacy and Safety of Biosimilar FYB201 Compared with Ranibizumab in Neovascular Age-Related Macular Degeneration, JAMA Ophthalmol. 2021 Jan 1;139(1):68-76. doi: 10.1001/jamaophthalmol.2020.5053 Available at: Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to the development and commercial success of our biosimilar portfolio; our ability to successfully compete in the marketplace, including our ability to develop and commercialize biopharmaceutical products, competition for our specialty products, including AUSTEDO®, AJOVY® and COPAXONE®; our ability to achieve expected results from investments in our product pipeline, our ability to develop and commercialize additional pharmaceutical products, and the effectiveness of our patents and other measures to protect our intellectual property rights; our substantial indebtedness; our business and operations in general, including uncertainty regarding the COVID-19 pandemic and the governmental and societal responses thereto; our ability to successfully execute and maintain the activities and efforts related to the measures we have taken or may take in response to the COVID-19 pandemic and associated costs therewith; costs and delays resulting from the extensive pharmaceutical regulation to which we are subject or delays in governmental processing time due to travel and work restrictions caused by the COVID-19 pandemic; compliance, regulatory and litigation matters, including failure to comply with complex legal and regulatory environments; other financial and economic risks; and other factors discussed in our Quarterly Report on Form 10-Q for the second quarter of 2022 and in our Annual Report on Form 10-K for the year ended December 31, 2021, including in the section captioned “Risk Factors.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements. View source version on businesswire.com: Contacts Fiona Cohen fiona.cohen@tevaeu.com Source: Teva Pharmaceutical Industries Limited View this news release online at: