​Budapest, Stockholm- 04 August 2020 - Gedeon Richter Plc. ('Richter') and Palette Life Sciences AB ('Palette'), today announced that as a part of a decentralised regulatory procedure including thirty European Economic Area member states, Richter and Palette received national marketing authorization for LIDBREE™in the United Kingdom (UK). The product is a novel, proprietary thermo gelling intrauterine formulation that can provide significant pain relief during common gynaecological procedures.

LIDBREE™'s marketing authorization is based on compelling data from clinical trials and investigations of sensory innervation in the reproductive area. In a pivotal clinical trial, LIDBREE™ treatment was associated with a significant reduction of pain and discomfort in women undergoing gynaecological interventions.

'Our research group has detected pain nerves superficially throughout the uterus, which enable the use of local pain relief in many gynaecological procedures such as insertion of an intrauterine device and sampling biopsies from the cervix and/or from the uterus - procedures that are currently routinely performed today without pain relief. LIDBREE™ is a novel gel containing the local anesthetic lidocaine which adheres to the mucosal tissue upon application to provide excellent analgesic effect', says Gunvor Ekman-Ordeberg, MD PhD Professor at Karolinska Institute and founder of the LIDBREE™ program. 'The gratification of observing the culmination of over 40 years of research into clinical practice via a new, simple, and effective treatment is a great privilege to share with all of my colleagues.'

In October 2017, Richter and Palette signed an agreement to commercialise LIDBREE™, a novel innovative proprietary pain relief pharmaceutical formulation, in Europe and in certain other markets.

'We are very pleased with the approval of LIDBREE™ in the UK, it is a great accomplishment from everyone involved. This is an important milestone and allows us to address a significant unmet medical need in women's health. We look forward to supporting LIDBREE™'s product launch through our partner Gedeon Richter and pursuing additional markets, such as the U.S., in collaboration with future regional partners.' says Helena Jansson, Managing Director at Palette Life Sciences AB.

'We've been expecting this regulatory development and we are looking forward to successfully introduce LIDBREE™ to all of the territories covered by our agreement in order to further improve the quality of life of women experiencing pain during their gynaecological interventions,' stated Tibor Horváth, Commercial Director of Gedeon Richter Plc.

About LIDBREE™

LIDBREE™ is a product employing a novel lidocaine delivery technology to provide pain relief on mucosal tissue. Unlike other topical formulations, the unique features of LIDBREE™ make gel remain on the mucosal surface of the cervical canal and the uterus for the necessary time for the pain relief to work. LIDBREE™ is indicated for topical anaesthesia for moderate acute pain during cervical and intrauterine procedures, such as such as placement of intrauterine contraception, hysteroscopy, cervical and endometrial biopsies in adults and adolescents from 15 years of age.

About Gedeon Richter Plc

Gedeon Richter Plc. (www.richter.hu), headquartered in Budapest/Hungary, is a major pharmaceutical company in Central Eastern Europe, with an expanding direct presence in Western Europe, in China and in Latin America. Having reached a market capitalization of EUR 3.6 billion (USD 4.1 billion) by the end of 2019, Richter's consolidated sales were approximately EUR 1.6 billion (USD 1.7 billion) during the same year. The product portfolio of Richter covers many important therapeutic areas, including Women's Healthcare, Central Nervous System and Cardiovascular areas. Having the largest R&D unit in Central Eastern Europe, Richter's original research activity focuses on CNS disorders. With its widely acknowledged steroid chemistry expertise, Richter is a significant player in the Women's Healthcare field worldwide. Richter is also active in biosimilar product development.

About Palette Life Sciences

Palette Life Sciences is a fully integrated life sciences company. Palette Life Science's products improve patient outcomes in gynaecology, urology and urogynaecology disorders, colorectal conditions, radiotherapy, and interventional oncology procedures. The company's portfolio of available products includes LIDBREE™, Deflux®, Solesta® and Barrigel®. Palette Life Sciences moves rapidly to leverage novel applications of existing technologies to create breakthrough medical solutions. This focus enables the company to serve those often overlooked by traditional medical companies and improve patient quality of life. Led by experienced healthcare executives, Palette Life Sciences is headquartered in Stockholm, Sweden with offices in Santa Barbara, California and Dallas, Texas. Learn more at http://www.palettelifesciences.com.

For more information:

Richter:

Investors:

Katalin Ördög: +36 1 431 5680

Media:

Zsuzsa Beke: +36 1 431 4888

Palette Life Sciences:

Helena Jansson, Stockholm +46 70 212 07 87

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Gedeon Richter plc published this content on 04 August 2020 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 04 August 2020 06:36:07 UTC