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Dr. Reddy’s subsidiary betapharm and Theranica launch Nerivio® in Germany to offer migraine patients drug-free treatment
Augsburg, April 10, 2024 (News Aktuell).- Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY; together with its subsidiaries, jointly referred to as “Dr. Reddy’s”), a multinational pharmaceutical company, has announced the launch of the Nerivio® portable remote electrical neuromodulation (NER) device through its subsidiary betapharm. Nerivio® is a US Food and Drug Administration (USFDA)-cleared, CE-marked device that uses remote electrical neuromodulation (NER) to prevent and treat migraine. This novel wearable device is a drug-free treatment manufactured by Theranica, a neuromodulation therapy company based in Israel and the United States.
Currently, the best estimates for the global prevalence of migraine are 14-15%, and in terms of burden, migraine accounts for 4.9% of global health problems, quantified as years lived with disability [ 1]. In Germany there are between 8 and 10 million people affected, 14.8% of women and 6.0% of men [2].
Nerivio ® is a non-invasive prescription device intended for the acute and prophylactic (preventive) treatment of migraine with or without aura [3] for adults and adolescents aged 12 years and older. Nerivio® is placed on the upper arm and controlled via a mobile app. Each device has capacity for 18 treatment sessions of 45 minutes each. It should be used within 60 minutes of the onset of headache or aura for the acute treatment of migraine or every other day for migraine prevention. The device uses the remote electrical neuromodulation (NER) mechanism to activate conditioned pain modulation (CPM), specifically by stimulating nociceptive nerve receptors located under the skin of the arm. This triggers a natural pain-relieving process in the brainstem, causing an overall pain-inhibiting effect that affects the source of migraine pain in the brain [4].
“Neuromodulation is a significant advance in the treatment of migraine,” says Dr. Arne May, leading researcher at the Department of Systems Neuroscience at the University of Hamburg and director of the outpatient headache clinic at the University Clinic of Hamburg. «For decades, medication has been the mainstay of migraine treatment. However, with these medications many patients experience side effects or limited effectiveness. Neuromodulation technologies offer a much-needed alternative. This modern neuromodulation technology comes to us from Nerivio®. By stimulating specific neural pathways, Nerivio can activate the brain’s natural pain-relieving mechanisms, which have been shown to be deficient among migraine patients, without introducing chemicals into the system. “This drug-free approach is especially promising for vulnerable populations such as adolescents and women of childbearing age, who may not be able to take conventional migraine medications.”
Patrick Aghanian, CEO of Dr. Reddy’s Europe, commented: “Starting in Germany, we are delighted to introduce Nerivio® in Europe, an innovative drug-free treatment that can improve the quality of life of migraine patients. Remote electrical neuromodulation (NER) has the potential to reduce the number of pills patients must take and decrease their dependence on nonspecific drugs for chronic or difficult-to-treat diseases [5]. It sits on your upper arm and is controlled via a mobile app, making it comfortable, discreet and portable. We believe this allows patients to focus on their daily activities more freely while wearing it, which addresses the clinical need for a more comfortable migraine treatment, which has not existed until now, which significantly impacts well-being and quality of life. life”.
Clinically proven in multiple clinical trials [6], the NER wearable device is a drug-free alternative suitable for a wide range of migraine patients, especially those seeking individualized treatment or drug-free therapy, those who are unable to control their migraine with medications or those who show poor tolerance or contraindication to medications. Additionally, sensitive populations such as adolescents, women of childbearing age, and patients at risk for headaches due to medication overuse could benefit from Nerivio® [7]. Studies show that Nerivio® does not cause intolerance problems or systemic side effects, and there are no concerns regarding excessive use of it. It has been evaluated in precisely designed pivotal studies conducted in the US and Israel in patients seeking effective acute or preventive treatment for migraine. Nerivio® has proven effective in relieving not only pain, but also symptoms associated with migraine, such as nausea or vomiting, phonophobia and photophobia. It has also been shown to reduce the need for drugs used for abortive treatment.
In August 2023, Nerivio® received expanded CE Mark approval under the European MDR regulation as a dual-use treatment (acute and/or preventive) for migraine in adolescents and adults. The launch in Germany is the result of multiple exclusive agreements signed between the European subsidiaries of Dr. Reddy’s and Theranica for the marketing and distribution of Nerivio® in Germany, Austria, Czech Republic, Denmark, Finland, France, Italy, Norway, Poland, Slovakia, Spain, Sweden, Switzerland and the United Kingdom [8]. The launch is expected to expand to these markets, starting with Spain and the United Kingdom between May and June.
The product has already been presented in Germany at the DGN Kongress 2023, organized by the German Neurology Association in Berlin, after a successful launch in India in November 2023.
The prescribed Nerivio® portable NER device is indicated for the acute and/or preventive treatment of migraine with or without aura in patients 12 years of age and older. Patients are advised to consult with their doctor or neurologist regarding device use and migraine treatment. More information (only in German) at www.nerivio.de
About Dr. Reddy’s: Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is a multinational pharmaceutical company headquartered in Hyderabad, India. Founded in 1984, we are guided by the goal of accelerating access to innovative and affordable medicines. Driven by our ideal that “good health cannot wait,” we offer a portfolio of products and services that includes APIs, generics, branded generics, biosimilars and OTC. Our main therapeutic areas are gastrointestinal, cardiovascular, diabetes, oncology, pain treatment and dermatology. Our main markets are the United States, India, Russia and the CIS countries, China, Brazil and Europe. As a company with a long history in deep science and that has brought numerous innovations to the sector, we continue to plan and invest in future businesses. As pioneers in sustainability and ESG actions, we published our first Sustainability Report in 2004. Our current ESG objectives aim to raise the bar in environmental stewardship, patient access and affordability, diversity and governance. For more information go to: www.drreddys.com.
Disclaimer: This press release may include statements of future expectations and other forward-looking statements that are based on management’s current opinions and assumptions and involve known or unknown risks and uncertainties that could cause results, performance or events. actual results differ materially from those expressed or implied in such statements. In addition to statements that are forward-looking by reason of context, the words “may,” “will,” “should,” “expect,” “plan,” “intend,” “anticipate,” “believe,” “estimate,” “predicts”, “potential” or “continue” and similar expressions identify forward-looking statements. Actual results, performance or events may differ materially from those indicated in such statements due to, without limitation, (i) general economic conditions, such as the performance of financial markets, defaults, exchange rates, rates of interest, the levels of persistence and frequency/severity of insured losses, (ii) the levels and trends of mortality and morbidity, (iii) changes in levels of competition and general competitive factors, (iv) changes in laws and regulations and in the policies of central banks and/or governments, (v) the impact of acquisitions or reorganizations, including related integration issues, and (vi) the susceptibility of our sector and markets to those to which our products and services and that of our customers are directed to economic downturns as a result of natural disasters, epidemics, pandemics or other widespread diseases, including the coronavirus (or COVID-19), and (vii) other identified risks and uncertainties in our public documents filed with the Securities and Exchange Commission (SEC), including those listed in the “Risk Factors” and “Forward-Looking Statements” sections of our Report Annually on Form 20-F for the year ended March 31, 2023. The company assumes no obligation to update the information contained herein.
[1] 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
[2] Porst et al. J Health Monitoring 2020 5(S6):2–26
[3] Symptoms or sensations, such as flashing lights or zigzag lines or loud sound, which typically precede migraine headache
[4] Nir R-R, Yarnitsky D. Conditioned pain modulation. Curr Opin Support Palliat Care 2015; 9:131-137 https://doi.org/doi:10.1097/SPC.00000000…; Yarnitsky D et al. Remote Electrical Neuromodulation (REN) Relieves Acute Migraine: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial. Headache 2019; 59:1240-1252 https://doi.org/doi:10.1111/head.13551
[5] Marmura: Incorporating Remote Electrical Neuromodulation (REN) Into Usual Care Reduces Acute Migraine Medication Use: An Open-Label Extension StudyFront. Neurol., 07 April 2020 Sec. Headache and Neurogenic Pain Volume 11 – 2020 | https://doi.org/10.3389/fneur.2020.00226
[6] Migraine Headache Treatment – Nerivio | Clinical Trials
[7] Babaei M, Rapoport AM. Expert Review of Medical Devices. 2023 May 12:1-5.
[8] CE mark: https://www.prnewswire.com/news-releases/nerivio-ce-mark-indication-expanded-to-preventive-and-acute-treatment-of-migraine-for-adolescents-and-adults-301896254.html | Europe agreement: https://www.prnewswire.com/news-releases/theranica-enters-into-agreement-with-dr-reddys-for-commercializing-nerivio-in-europe-301986214.html | India agreement: https://www.prnewswire.com/news-releases/theranica-enters-into-agreement-with-dr-reddys-for-commercializing-nerivio-in-india-301715697.html
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