Dr Reddy's Labs, Theranica collaborate for commercialisation of wearable migraine treatment Nerivio in India
Nerivio is the FDA-cleared, prescribed, digitally connected, drug-free wearable device for the acute treatment of episodic and chronic migraine in individuals age 12 and older.
Netanya: Theranica, a prescribed digital therapeutics company developing advanced neuromodulation devices for migraine and other pain conditions, has announced a strategic license and supply agreement with Dr. Reddy's Laboratories Ltd., a global pharmaceutical company, for the exclusive marketing and distribution of FDA-approved Nerivio in India, subject to completion of the regulatory approval process in India.
"Chronic pain is one of India's primary hidden health concerns and migraine represents a huge unmet health care need in the country," said Subhanu Saxena, Managing Partner at New Rhein Healthcare Investors and a member of Theranica's Board of Directors. "Through this partnership, the two companies will work toward improving the quality of life of millions of people in India who suffer from this debilitating neurological disorder.
Under the terms of the agreement, Dr. Reddy's will be responsible for the regulatory approval of Nerivio in India, after which it will exclusively market Nerivio in India, manufactured and supplied by Theranica. The agreement includes licensing fees for exclusive rights to market Nerivio in India. While the agreement applies only to India, the companies will continue discussions about expanding to additional territories outside the United States and China.
Nerivio is the FDA-cleared, prescribed, digitally connected, drug-free wearable device for the acute treatment of episodic and chronic migraine in individuals age 12 and older. Worn on the upper arm, Nerivio utilizes remote electrical neuromodulation (REN) to trigger an endogenous descending pain inhibition mechanism known as conditioned pain modulation (CPM), which aborts or alleviates migraine headache and associated migraine symptoms. Clinical studies have shown Nerivio to be as effective as standard of care pharmacological options for acute migraine treatment. The company recently published topline results of a pivotal trial demonstrating the efficacy and safety of Nerivio for the preventive treatment of migraine, an indication currently under FDA review.
"This agreement aligns exactly with the vision of Theranica's founders," said Alon Ironi, CEO and co-founder of Theranica. "The winning combination of Theranica's neuroscience and digital health R&D with Dr. Reddy's industry leadership and large commercial footprint will bring Nerivio to millions of people in need of effective migraine therapy – in India and hopefully later in other parts of the world. We hope to advance Nerivio as a first-line treatment and contribute to a global paradigm shift in how this debilitating disease is treated."
