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Lupin joins hands with Sandoz to commercialize biosimilar Ranibizumab across multiple regions
Lupin joins hands with Sandoz to commercialize biosimilar Ranibizumab across multiple regions

Business Standard

time7 days ago

  • Business
  • Business Standard

Lupin joins hands with Sandoz to commercialize biosimilar Ranibizumab across multiple regions

Lupin has announced a strategic partnership with Switzerland-based Sandoz Group AG (Sandoz) to market and commercialize its biosimilar ranibizumab across multiple regions. Under the agreement, Sandoz will handle commercialization of the biosimilar across the European Union (excluding Germany), Switzerland, Norway, Australia, Hong Kong, Vietnam, and Malaysia. Lupin will be responsible for manufacturing the product and managing regulatory submissions. In most designated markets, Sandoz will have exclusive marketing rights, while in France, Australia, Vietnam, and Malaysia, the rights will be semi-exclusive. Additionally, through a separate agreement, Sandoz will acquire sole commercialization rights for Lupins biosimilar ranibizumab in Canada, with Lupin continuing to manage manufacturing and regulatory filings. Ranibizumab is a recombinant humanized IgG1 monoclonal antibody fragment that binds to and inhibits vascular endothelial growth factor A (VEGF-A). Its indications encompass the treatment of patients with Neovascular (Wet) Age-Related Macular Degeneration (AMD), Macular Edema Following Retinal Vein Occlusion (RVO), Diabetic Macular Edema (DME), Proliferative Diabetic Retinopathy (PDR), and Choroidal Neovascularization (CNV). Thierry Volle, President EMEA and Emerging Markets, Lupin, said, We are delighted to partner with Sandoz for the launch and commercialization of ranibizumab in multiple markets globally. This partnership underscores our shared vision to expand global access to cutting-edge biologic therapies and improve outcomes for underserved patients. Lupin is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. It specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Lupins consolidated net profit jumped 52.13% to Rs 1,219.03 crore on 11.78% increase in income from operations to Rs 6,163.75 crore in Q1 FY26 over Q1 FY25. The counter rose 0.45% to Rs 1,955 on the BSE.

Lupin ties up with Sandoz to commercialise biosimilar product
Lupin ties up with Sandoz to commercialise biosimilar product

News18

time7 days ago

  • Business
  • News18

Lupin ties up with Sandoz to commercialise biosimilar product

Agency: PTI Last Updated: New Delhi, Aug 12 (PTI) Drug firm Lupin on Tuesday said it has partnered with Switzerland-based Sandoz Group AG to commercialise its biosimilar ranibizumab across multiple regions. Under the terms of the agreement, Sandoz will oversee commercialisation of the product across the European Union (excluding Germany), Switzerland, Norway, Australia, Hong Kong, Vietnam, and Malaysia, the Mumbai-based drug maker said in a statement. Lupin will be responsible for manufacturing the product and for regulatory submissions, it added. As per the deal, Sandoz will hold exclusive marketing rights in most of the designated markets, except for France, Australia, Vietnam, and Malaysia, where it will have semi-exclusive marketing rights, Lupin Ltd said. Pursuant to another agreement executed between the two companies, Sandoz will acquire sole rights for commercialization of Lupin's biosimilar ranibizumab in Canada, while Lupin will manage its manufacture and regulatory filings, it added. Ranibizumab is a recombinant humanized IgG1 monoclonal antibody fragment that binds to and inhibits vascular endothelial growth factor A (VEGF-A). Its indications encompass the treatment of patients with neovascular (Wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME) among others. 'This partnership underscores our shared vision to expand global access to cutting-edge biologic therapies and improve outcomes for underserved patients," Lupin President EMEA and Emerging Markets Thierry Volle said. Shares of the company were trading marginally up at Rs 1,946.30 apiece on BSE. PTI MSS MSS ANU ANU view comments First Published: August 12, 2025, 13:15 IST Disclaimer: Comments reflect users' views, not News18's. Please keep discussions respectful and constructive. Abusive, defamatory, or illegal comments will be removed. News18 may disable any comment at its discretion. By posting, you agree to our Terms of Use and Privacy Policy.

Lupin partners with Sandoz to commercialize Ranibizumab biosimilar in multiple global markets
Lupin partners with Sandoz to commercialize Ranibizumab biosimilar in multiple global markets

Business Upturn

time7 days ago

  • Business
  • Business Upturn

Lupin partners with Sandoz to commercialize Ranibizumab biosimilar in multiple global markets

By Aditya Bhagchandani Published on August 12, 2025, 11:08 IST Lupin Limited announced on August 12 that it has entered into a licensing and commercialization agreement with Switzerland-based Sandoz Group AG for its biosimilar Ranibizumab. The deal covers multiple regions, including the European Union (excluding Germany), Switzerland, Norway, Australia, Hong Kong, Vietnam, and Malaysia. Under the agreement, Lupin will handle manufacturing and regulatory submissions, while Sandoz will oversee commercialization. Sandoz will hold exclusive marketing rights in most designated markets, except for France, Australia, Vietnam, and Malaysia, where rights will be semi-exclusive. In a separate arrangement, Sandoz will acquire sole commercialization rights for Canada. Ranibizumab is a monoclonal antibody fragment that binds to and inhibits VEGF-A, used in treating conditions such as Neovascular (Wet) Age-Related Macular Degeneration, Diabetic Macular Edema, Proliferative Diabetic Retinopathy, and other retinal diseases. Thierry Volle, President EMEA and Emerging Markets at Lupin, said the partnership aligns with both companies' vision to expand global access to advanced biologic therapies and improve outcomes for underserved patients. Lupin, a global pharmaceutical leader headquartered in Mumbai, has a presence in over 100 markets, with 15 manufacturing sites and seven research centers worldwide. Ahmedabad Plane Crash Aditya Bhagchandani serves as the Senior Editor and Writer at Business Upturn, where he leads coverage across the Business, Finance, Corporate, and Stock Market segments. With a keen eye for detail and a commitment to journalistic integrity, he not only contributes insightful articles but also oversees editorial direction for the reporting team.

Lupin and Avas Launch NaMuscla® in Italy
Lupin and Avas Launch NaMuscla® in Italy

Yahoo

time28-01-2025

  • Business
  • Yahoo

Lupin and Avas Launch NaMuscla® in Italy

Lupin and Avas Launch NaMuscla® in Italy Enables expanded access to the only EU-approved treatment for the myotonia symptoms in adults with non-dystrophic myotonic disorders Mumbai, Zug, January 28, 2025: Global pharma major Lupin Limited (Lupin) and Avas Pharmaceuticals SRL (Avas) today announced the launch of Lupin's orphan drug NaMuscla® (mexiletine) in Italy. Avas will commercialize NaMuscla® for the symptomatic treatment of myotonia in adults with non-dystrophic myotonic (NDM) disorders. NaMuscla® is the first and only licensed product for this indication. NDM disorders are a group of rare, inherited neuromuscular disorders which is characterised by the inability to relax muscles following voluntary contraction. NaMuscla® reduces myotonia symptoms in people with NDM, resulting in a significant improvement in quality of life and other functional and clinical outcomes for patients1. NaMuscla®, which has been designated orphan drug status, received EU marketing authorization in December 20182. Under the terms of the agreement, Avas will initially commercialize NaMuscla® as a Class C (Tier 2), while Lupin negotiates with AIFA (Agenzia Italiana del Farmaco) for the reimbursement of the product in Italy. This will ensure consistent access to NaMuscla® for patients in Italy, leveraging the established supply network that already serves patients across Germany, France, Spain, Austria, Norway, Sweden, and the UK. 'Our collaboration with Avas will not only allow us to introduce the first licensed treatment for myotonia in Italy but also ensure continued access to this essential medication. This partnership reflects Lupin's dedication to addressing unmet medical needs in rare diseases across Europe,' stated Thierry Volle, President EMEA, Lupin. 'We are excited to announce our partnership with Lupin for the launch of NaMuscla® in Italy, a key step in addressing the needs of patients with NDM disorders. This collaboration ensures the availability of best therapeutic solutions, improving the quality of life for individuals affected by NDM disorders in Italy," said Marco Rago, President of the Board of Directors at Avas Pharmaceuticals. Notes for Editors About Myotonic Disorders and Non-Dystrophic Myotonias (NDM) Myotonic disorders are a group of heterogeneous, inherited, neuromuscular disorders characterized by a shared symptom called myotonia3. Myotonia can be described as an inability to relax a contraction of skeletal muscle which originates from a voluntary muscular contraction such as shaking someone's hand and blinking, or everyday activities such as walking across a street and climbing stairs4. Non-dystrophic myotonias (NDM) are a sub-set of rare (prevalence of 1:100,0004), inherited, myotonic disorders which are caused by mutations within ion channels in the sarcolemma membrane of skeletal muscles. Non-dystrophic myotonias exhibit both sodium and chloride channelopathies which result in altered membrane excitability5. For patients with NDM, myotonia is the most prominent symptom and demonstrates different phenotypes in subgroups of NDM disorders, and can affect different parts of the body, such as legs, arms, or facial muscles, more severely5. Myotonia in patients with NDM has an onset in childhood and persists across their lifetime. Patients perceive that myotonia increases in severity over time, impacting daily life. Myotonia is described by patients in a variety of ways (stiffness, cramps, pain, difficulty releasing a fist, or difficulty swallowing or eating) which can contribute to substantial delays in diagnosis and treatment, leading to decreased patient quality-of-life and often significant disability3, 6. About NaMuscla® (mexiletine)NaMuscla® is the first and only antimyotonic agent licensed to treat symptomatic myotonia in adults with non-dystrophic myotonic disorders in Europe2. In randomised controlled trials1, 3, 6, NaMuscla® (167 to 500 mg/day) has been shown to significantly reduce myotonia compared to placebo, reducing skeletal muscle hyperexcitability through its use-dependent, voltage-gated, sodium channel blocking actions which are independent of the cause of channel function. This resulted in an improvement in patient quality-of-life and other functional outcomes, with gastro-intestinal discomfort reported as the most common adverse event, demonstrating NaMuscla® to be safe and well tolerated1, 3, 6, 7. About LupinLupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. Lupin specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Trusted by healthcare professionals and consumers globally, the company enjoys a strong position in India and the U.S. across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women's health. Lupin has 15 state-of-the-art manufacturing sites and 7 research centers globally, along with a dedicated workforce of over 22,000 professionals. Lupin is committed to improving patient health outcomes through its subsidiaries - Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions. To know more, visit or follow us on LinkedIn For further information or queries please contact: Rajalakshmi AzariahVice President & Global Head – Corporate Communications, Lupinrajalakshmiazariah@ About AvasAVAS Pharmaceuticals is a leading pharmaceutical company renowned for its expertise in the commercialization of branded medicines that offer transformative therapeutic solutions. With a deep commitment to improving patient outcomes, AVAS Pharmaceuticals is dedicated to providing innovative treatments that have the potential to significantly impact patients' lives across Italy. Founded on principles of innovation, excellence, and accessibility, AVAS Pharmaceuticals operates in a diverse range of therapeutic areas, including oncology, cardiovascular health, infectious diseases, and neurology. The company also specializes in addressing rare and ultra-rare diseases, offering life-changing medicines for patients with limited or no therapeutic options. AVAS Pharmaceuticals' dedication to quality, innovation, and patient care positions it as a key player in the Italian healthcare landscape, and its continued growth is a testament to the transformative impact it has on patients and their families. Contact for media inquiries: administration@ References: Vicart S, et al. Neuromuscular Discord 2021; 31:1124-1135 NaMuscla®. Summary of Product Characteristics. Stunnenberg, et al. Muscle Nerve 2020;62(4):430-444 Emery AEH, Neuromuscular Discord 1991;1:19-29 Matthews E, et al. Brain 2010;133:9–22 Trivedi JR, et al. Brain 2013; 136:2189-200 Matthews E, et al. Pract Neurol 2021;0:1–10Sign in to access your portfolio

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