Tag Archives: vesicoureteral reflux

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 unveils an online resource aimed at paediatric urologists, parents and caregivers in the UK dealing with vesicoureteral reflux (VUR)

SANTA BARBARA, CALIF., U.S.A. / STOCKHOLM SWEDEN, 4-Aug-2020 — /EPR HEALTHCARE NEWS/ — Palette Life Sciences, a fully integrated global life sciences company dedicated to improving patient outcomes, today announced the launch of Deflux.com/UK as part of its global expansion. Deflux.com/UK is a best-in-class online resource developed specifically for healthcare practitioners in the United Kingdom, as well as parents and caregivers managing children with vesicoureteral reflux (VUR). VUR, sometimes referred to as urinary or bladder reflux, is a serious paediatric urinary condition in which urine flows from the bladder through one or both ureters toward the kidneys.

Deflux.com/UK features important information about VUR, including symptoms, causes, risk factors and treatment options, such as Deflux®. Comprised of hyaluronic acid (HA) and dextranomer polysaccharides to form a gel, Deflux is a minimally invasive biocomopatible treatment for VUR. Endoscopic treatment with Deflux takes about 15 minutes in a day procedure setting, and generally allows the child to go back to normal activities the next day.

Deflux.com/UK also provides physicians with access to the Deflux Learning Center, a leading global education platform that features information and training for paediatric urologists and their peers who treat VUR as well as other paediatric urology conditions. The Deflux Learning Center includes clinical articles, educational videos and webinars, brochures, downloadable tools and The PedSpace podcast series, created for and presented by paediatric urology healthcare professionals.

“Deflux is an effective, minimally-invasive treatment option that many caregivers simply aren’t aware of,” said Dr. Marie-Klaire Farrugia, Consultant Paediatric Urologist and Clinical Director for Paediatric Surgery at Chelsea and Westminster Hospital. “My personal long-term experience with Deflux has proven its effectiveness and safety in reducing VUR and preventing UTI recurrence, thus avoiding use of long-term antibiotics. It is my hope that the new website initiative, which includes helpful resources for both physicians and caregivers, will help raise awareness and utilisation of this treatment option.”

“The entire Palette commercial team is excited to launch Deflux.com/UK, which we believe will help elevate the standard of care for VUR patients in the UK,” said Rich Low, Head of Marketing, Palette Life Sciences. “Deflux.com/UK will serve as a truly valuable resource for caregivers, providing critical information to paediatric urology healthcare professionals through the Deflux Learning Center, and to caregivers, connecting them to highly-trained specialists who provide high quality care.”

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