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LIDBREE™ receives marketing authorization in the United Kingdom

SANTA BARBARA, CALIF., U.S.A. / BUDAPEST / STOCKHOLM, 5-Aug-2020 — /EPR HEALTHCARE NEWS/ — Palette Life Sciences AB (‘Palette’) with Gedeon Richter Plc. (‘Richter’), today announced that as a part of a decentralised regulatory procedure including thirty European Union Economic Area member states, Palette and Richter 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 gynecological 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 gynecological interventions.¹

“Our research group has detected pain nerves superficially throughout the uterus, which enable the use of local pain relief in many gynecological 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.

SOURCE: EuropaWire

Palette Life Sciences expands distribution network across Europe

STOCKHOLM, SWEDEN / SANTA BARBARA, CALIF., USA, 15-Jun-2020 — /EPR HEALTHCARE NEWS/ — Palette Life Sciences, a fully integrated global life sciences company dedicated to improving patient outcomes, today announced global distribution expansion for two of Palette’s products, Deflux and Solesta. The expansion provides commercial access to more than 20 countries through five distributors around the globe, while adding direct sales in four additional countries: Cyprus, Greece, Hungary and Portugal.

KEBOMED, a leading European distributor of medical devices and equipment, will distribute the products in France, Sweden, Norway, Finland, Denmark and Iceland. Stratarium Sarl, will commercialize the products in Germany, Austria, Belgium, Luxembourg, Netherlands and Switzerland leveraging their urology focused subsidiary, RA DistributionCJ Medical, a UK-based distributor of innovative technologies specializing in surgical and medical devices, will distribute the products in Ireland and the United Kingdom. Grifols, one of the leading companies in the production and sale of plasma-derived medicines and a top distributor of a broad range of products within their country will cover Spain, and GP Dermal, a specialist with deep ties across urology and pediatric call points will serve as the distributor in Italy and Malta.

“This enhanced distribution network allows Palette to ensure our customer and patient needs are adequately met across Europe,” said James Leech, Head of Corporate Development at Palette Life Sciences. “We have selected strong partners with deep experience and relationships in the urology and pediatric setting who will help us serve the product and education needs of physicians and hospitals. Palette and its network of partners are making significant investments within local markets to improve physician access to Palette resources, best management and treatment practices, and renewed product training.”

For more information or to place an order, please contact a Palette Life Sciences representative at eusales@palettelifesciences.com. Contact information for product orders or inquires by distributor are as follows:

KEBOMED: ordre@kebomed.dk
Stratarium Sarl: deflux-solesta@stratarium.com
CJ Medical: office@cjmedical.com
Grifols: jose.sagales@grifols.com
GP Dermal: luigi.galandini@gpdermal.com

SOURCE: EuropaWire