Theranica: Dr Reddy Laboratories : Press Release Nerivio (Global) - Dr. Reddy's launches Nerivio in Europe

Press Release CONTACT DR. REDDY'S LABORATORIES LTD. INVESTOR RELATIONS MEDIA RELATIONS 8-2-337, Road No. 3, Banjara Hills, RICHA PERIWAL USHA IYER Hyderabad - 500034. Telangana, India. RICHAPERIWAL@DRREDDYS.COM USHAIYER@DRREDDYS.COM Dr. Reddy's launches drug-free migraine management device Nerivio® in Europe following successful launch in India Dr. Reddy's has launched Nerivio® in Germany through its step-down subsidiary betapharm To be followed by launch in South Africa later this month, and subsequently in Spain and the UK Nerivio® is a USFDA-approved and CE-mark certified drug-free wearable device that uses Remote Electrical Neuromodulation (REN) mechanism for acute and/or prevention migraine (with or without aura) treatment for adults and adolescents (≥ 12 years) The Nerivio® experience has so far benefited over 45,000 patients globally. It is backed by robust clinical evidence from 19,000+ patients as an acute and preventive treatment option in migraine. Dr. Reddy's launched Nerivio® in India in 2023. It is the first USFDA-approved REN device in India. In India, Nerivio® is backed by Dr. Reddy's comprehensive patient support programme called 'M-Free' for complete migraine care At a time when conversations on migraine focus on migraine as a women's health issue, relief through the use of technology and drug-free solutions, challenges associated with managing migraine during the child-bearing age, and distinguishing migraine from headache, Nerivio® and its Remote Electrical Neuromodulation (REN) technology have been recommended by neurologists across India and brought relief to patients living with migraine Hyderabad India; April 10, 2024 - Dr. Reddy's Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY; hereafter referred to as "Dr. Reddy's"), a global pharmaceutical company, announced the launch of the drug-freenon-invasive migraine management wearable device Nerivio® in Germany through its step-down subsidiary betapharm. The launch marks the company's entry into digital therapeutics in Europe. Nerivio® is approved by the United States Food and Drug Administration (USFDA), and is CE-mark certified in Europe. Nerivio® was presented in 2023 by Dr. Reddy's at the DGN Kongress organised by the German Association of Neurology in Berlin, and the 17 th European Headache Congress held in Barcelona, Spain. Dr. Reddy's will present and launch Nerivio® during the Neurological Association of South Africa annual congress on April 17, 2024, in the presence of Dr. Stewart Tepper, Professor of Neurology at the Geisel School of Medicine - Dartmouth, and Vice President, New England Institute for Neurology and Headache. In May 2024, Nerivio® will also be presented at International Headache Society 2024 iHEAD meeting in Berlin, Germany. In subsequent months, Dr. Reddy's will launch Nerivio® in Spain and the UK. Last year, Dr. Reddy's entered into an exclusive agreement with Theranica, a prescribed digital therapeutics company developing advanced neuromodulation devices for migraine and other pain conditions, for the marketing and distribution of Nerivio® in multiple markets. Migraine is a global health challenge, affecting around 30% of adults on 15 or more days per month, impacting 1.7% to 4% of the population 1 . The current best estimate of global migraine prevalence is 14- 15%, and, in terms of burden, migraine accounts for 4.9% of global ill health, quantified as years lived with disability 2 . Migraines are known to have a disproportionate impact on women. Around 8 to 10 million people in Germany are affected, 14.8% of women and 6.0% of men 3 . In India, women constitute approximately 60% of the 213 million migraine sufferers in India 4 . Dr. Reddy's launched Nerivio® in India in 2023. In India, Nerivio® is supported by Dr. Reddy's unique patient support programme called 'M-Free'. The programme is a comprehensive support system that enhances and streamlines the journey of the patients. M-Free includes services such as onboarding and counseling of patients, device demonstrations, doorstep delivery, flexible payment options, informative content, and dedicated customer care to help patients get the most out of the device. With lifestyle modification as a key recommendation for better management of migraine, M-Free awareness program offers a suite of value-add services such as nutritionist consultation, yoga and meditation sessions with certified specialists for holistic medicine free migraine management. M.V. Ramana, Chief Executive Officer, Branded Markets (India and Emerging Markets) , Dr. Reddy's said, "At a time when conversations on migraine focus on migraine 5 as a women's health issue, relief from migraine through the use of technology and drug-free solutions, challenges associated with managing migraine during the child-bearing age, and distinguishing migraine from headache, we are happy to take our clinically-proven first digital therapeutics product, Nerivio®, to patients in our identified markets. Nerivio® has had an encouraging start in India, with recommendation from neurologists in India and bringing relief to patients living with migraine. We believe this product meets a genuine unmet clinical need among migraine patients, and has the potential to reduce pill burden in migraine. We look forward to receiving patient and HCP feedback from these markets." About Nerivio® and its clinically-proven benefits: The Nerivio® experience has so far benefited over 45,000 patients globally. It is backed by robust clinical evidence from 19,000+ patients as an acute and preventive treatment option in migraine 6 . 1 https://www.neurologyindia.com/article.asp?issn=0028-3886;year=2021;volume=69;issue=7;spage=4;epage=9;aulast=Krishnan Steiner, T.J., Stovner, L.J. Global epidemiology of migraine and its implications for public health and health policy. Nat Rev Neurol 19, 109-117 (2023). https://doi.org/10.1038/s41582-022-00763-1 Porst et al. J Health Monitoring 2020 5(S6):2-26 https://en.gaonconnection.com/india-migraine-stroke-2019-lancet-health-air-pollution-blood-pressure-headache-health- neurological-disorders/ https://www.dailypioneer.com/2024/state-editions/why-women-are-thrice-more-at-risk-of-migraines-than-men---.html https://health.economictimes.indiatimes.com/news/industry/looking-at-migraine-from-a-womens-health-perspective/105041761 https://timesofindia.indiatimes.com/life-style/health-fitness/health-news/drug-free-options-for-managing-migraine-in- adolescents/articleshow/108530401.cms?_gl=1*gv971e*_ga*MTgzOTU4ODIxNy4xNzEwMzM3MTg4*_ga_FCN624MN68*MTcxMDU2NTc 0OS4zLjAuMTcxMDU2NTc2Ni4wLjAuMA..#_ga=2.201980625.1993289292.1710565736-1839588217.1710337188 https://www.thehealthsite.com/diseases-conditions/exploring-drug-free-solutions-insights-into-migraine-care-from-a-neurologist- 1069814/amp/ https://www.deccanherald.com/health/healthcare/the-drug-free-way-to-head-off-a-migraine-2897561 https://www.youtube.com/watch?v=4UgD3OdOnFI&t=1s https://timesofindia.indiatimes.com/life-style/health-fitness/health-news/stop-passing-off-migraine-as- headache/articleshow/106375955.cms?from=mdr https://health.economictimes.indiatimes.com/news/industry/the-hidden-costs-of-delayed-migraine-diagnosis/106232548 Data on file; https://nerivio.com/link-directory/ Nerivio® is a prescription-basednon-invasive device intended for acute and prophylactic (preventive) treatment of migraine with or without aura 7 for adults and adolescents aged 12 years and above. Nerivio® can be worn on the upper arm. Each device has in-built 18 x 45-minute treatment sessions. It is to be used within 60 minutes of onset of headache or aura for acute treatment of migraine or every alternate day for prevention of migraine. The device uses the Remote Electrical Neuromodulation (REN) mechanism to specifically activate conditioned pain modulation by stimulating nerve endings. This initiates a natural pain-relieving process in the brainstem, causing a global effect of pain inhibition that affects the original source of migraine pain in the head 8 . The unique device is accompanied by the Nerivio® app, which is user-friendly and freely available on Google Play Store and the Apple app store for download. The app can be used to control the intensity levels of the device, and to track progression through the in- built digital diary. Clinically proven 9 and safe, Nerivio® is suitable for a wide range of patients, including those who prefer drug-free options, individuals with contraindications to medications or poor medication tolerance, sensitive populations such as adolescents, women of child-bearing age, and patients at risk of medication overuse headache 10 . Studies show that Nerivio® is safe and well tolerated with no systemic side effects or concern for medication overuse. It has been evaluated in robustly designed pivotal studies conducted in the U.S., in patients seeking effective acute or preventive treatment of migraine. Nerivio® has proven efficacy in not only effectively relieving pain and reducing monthly migraine days, but also associated symptoms in migraine such as nausea, vomiting etc. It has been shown to reduce the need for drugs used for acute treatment in nearly 9 out of 10 patients 11 . Being an effective non-invasive therapy, the associated adverse events are not a concern. This is extremely useful in patients seeking preventive treatment of migraine since many patients experience tolerability issues with drugs, resulting in significant impact on their quality of life, when used for long time (>3 months) 12 . Nerivio® is a prescription-based product. Patients are advised to consult their neurologists on the use of the device and management of migraine. For more queries, doctors and patients can call the dedicated helpline number 1800-123-2360(toll-free) or email us at neriviodrl@porteamedical.com or WhatsApp on 6366881900. .............................................................................................................