Cipla Ltd, a global pharmaceutical company, today announced that its wholly owned subsidiary in USA — Cipla USA Inc. has signed a worldwide licensing agreement (except for East Asia) with MEDRx Company Limited (MEDRx) to further develop and commercialize MRX-4TZT, a Tizanidine1 patch for the management of Spasticity.
Under the terms of the agreement, MEDRx is eligible to receive up to USD 30 million cumulatively through upfront and developmental, regulatory, and commercial milestones payments. MEDRx will also receive tiered royalties on the net sales of commercialized licensed products.
MRX-4TZT is a medicated patch that uses ILTS® (Ionic Liquid Transdermal System), an exclusive MEDRx technology that incorporates its ionic liquid expertise2, to deliver Tizanidine, a centrally acting muscle relaxant. MEDRx has concluded Phase I trials in U.S. with a promising horizon for further clinical development. Annual sales of muscle relaxants in the United States were estimated at ~$807 million3 in 2016. MRX-4TZT is expected to be the first transdermal muscle relaxant worldwide. Delivering Tizanidine by transdermal administration, rather than by oral administration, is expected to improve patient experience on the drug by providing sustained efficacy while also reducing adverse events and side effects such as aesthenia, troublesome drowsiness and dry mouth amongst others. Cipla plans to initiate Phase 3 clinical trials after completion of additional Phase 1 studies.
After bolstering its US generics business through two acquisitions last year, Cipla is now actively foraying into the US branded specialty space through a blend of in-house innovation and inorganic efforts. Umang Vohra, MD and Global CEO Cipla Ltd., said: “In-line with our legacy and philosophy of keeping the patient at the centre, we believe that the Tizanidine transdermal patch will address significant unmet needs and benefit patients globally suffering from chronic Spasticity.”
