Incobotulinum toxinA (Biotecon)

BURLINGTON, Ontario--( BUSINESS WIRE )-- Merz Therapeutics, a business of Merz Group and a leader in the field of neurotoxins, today announced that Health Canada approved XEOMIN ® (incobotulinumtoxinA) for the treatment of post-stroke lower limb spasticity involving the ankle and foot in adults. “This approval means that adult patients who have suffered from a stroke and are experiencing lower limb spasticity in the ankle and foot will now have a safe and effective treatment option,” explains Michael Stone, Country Manager, Canada for Merz Therapeutics. “With this label extension, healthcare providers can now utilize XEOMIN to pursue more comprehensive and individually ambitious treatment goals for their patients.” Addressing multiple patterns of spasticity with XEOMIN Strokes are the primary cause of spasticity resulting from damage to the upper motor neuron, producing an abnormal increase in muscle tone. In Canada, 109,000 people annually suffer a stroke 1 , and 25% to 43% of stroke survivors experience spasticity within a year 2 . XEOMIN with the active ingredient incobotulinumtoxinA is injected intramuscularly to reduce the abnormally increased muscle tone. With the new approval, XEOMIN can be administered in up to 600 units for upper and lower limbs combined, enabling qualified healthcare professionals in Canada to treat both regions together or individually, adjusting the dosage depending on patient requirements and mobility goals. The safety findings were similar to previous adult studies and in line with the known safety profile of XEOMIN. The most common adverse reactions affecting ≥1% of patients were nasopharyngitis, pharyngitis, tinea pedis, muscular weakness, epilepsy, fall, eczema, dehydration, and blurred vision. “Foot and ankle spasticity are the most common posture problems seen in the lower limb in adult patients following a stroke. They typically present with an equinovarus deformity, which refers to the foot turning downwards and inwards in these limbs," said Professor Lalith Satkunam, Glenrose Rehabilitation Hospital, Edmonton, Alberta. "Lower limb spasticity can limit ambulation and impede on patients' daily lives, so this latest approval for XEOMIN provides healthcare professionals, like me, the ability to comprehensively treat multiple areas of spasticity.” “The ability to simultaneously treat both upper and lower limb post-stroke spasticity in adults with botulinum toxin using a combined total dose of 600 units makes it an essential tool in our treatment arsenal,” shared Dr. Jehane Dagher, Institut de réadaptation Gingras-Lindsay-de-Montréal (IRGLM), Montreal, Quebec. A label extension built on solid data Canada is the third country to authorize XEOMIN for lower limb treatment based on data from a Japanese study (J-PLUS), which investigated the effects of XEOMIN on spasticity in Japanese stroke survivors. “Health Canada’s decision to extend XEOMIN’s area of application once again underlines the quality and robustness of our Japanese data and is a testament to our conviction that delivering better outcomes for more patients must be an international effort,” says Stefan Albrecht, Chief Scientific and Medical Officer at Merz Therapeutics. “We were able to extrapolate the clinical data generated in Japan to support the application with Health Canada based on a larger dataset from multiple clinical trials and decisive efficacy data from a Japanese study.” Previously, data from J-PLUS had also been included in application packages for label extensions for lower limb treatment in the United Kingdom and Switzerland. This is the sixth therapeutic indication for XEOMIN in Canada, which was first licensed by Health Canada in 2009 for the treatment hypertonicity disorders of the seventh nerve such as blepharospasm, including benign essential blepharospasm and hemifacial spasm in adults, to reduce the subjective symptoms and objective signs of cervical dystonia (spasmodic torticollis) in adults, and for the treatment of upper limb spasticity in adults. 3 XEOMIN was also licensed for adult patients with chronic sialorrhea in 2020 and for pediatric patients (age 2-17 years weighing 12 kg or more) in 2022. References 1. Holodinsky JK, Lindsay P, Yu AYX, Ganesh A, Joundi RA, Hill MD. Estimating the Number of Hospital or Emergency Department Presentations for Stroke in Canada. Can J Neurol Sci . 2023;50(6):820-825. doi:10.1017/cjn.2022.338 2. Effects of Stroke, Phyiscal Effects, Spasticity . 30 May 2023, www.stroke.org/en/about-stroke/effects-of-stroke/physical-effects/spasticity . Accessed 4 Nov. 2024. 3. XEOMIN ® Product Monograph. Merz Pharma Canada Ltd. December 11, 2024. About XEOMIN ® XEOMIN ® (incobotulinumtoxinA) is a prescription medicine that is injected into muscles or glands and used to treat adults and pediatric patients with chronic drooling (sialorrhea), eyelid spasm (blepharospasm) and spasm in one side of the face (hemifacial spasm), twisted neck (spasmodic torticollis), spasticity of the upper limb in adults and post-stroke lower limb spasticity involving the ankle and foot in adults. Copyright © 2024 Merz Pharma Canada Ltd. All rights reserved. MERZ, the MERZ logo, and XEOMIN are registered trademarks of Merz Pharma GmbH & Co. KGaA. For more information, please see the XEOMIN ® full Product Monograph . About Merz Therapeutics Merz Therapeutics GmbH is dedicated to improving the lives of patients around the world. With its relentless research, development, and culture of innovation, Merz Therapeutics strives to serve unmet patient needs and realize better outcomes. Merz Therapeutics seeks to address the unique needs of people who suffer from movement disorders, neurological conditions, liver disease, and other health conditions that severely impact patients’ quality of life. Merz Therapeutics is headquartered in Frankfurt am Main, Germany and is represented in more than 90 countries, with a Canada affiliate based in Burlington, Ontario, Canada. Merz Therapeutics GmbH is part of the Merz Group, a privately held, family-owned company that has dedicated 116 years to developing innovations that serve unmet patient and customer needs. Please visit www.merztherapeutics.com About Merz Merz Group is a global, diversified company in the healthcare sector based in Frankfurt, Germany. Family-owned for over 116 years, the company is distinguished by its commitment to innovation, long-term perspective, and focus on profitable growth. Merz Group includes the businesses Merz Aesthetics, Merz Therapeutics, Merz Consumer Care, Merz Real Estate, and Merz Financial Investments. The company employs 4,337 people (as of the 22/23 financial year) in 28 countries worldwide. To learn more, please visit www.merz.com .

Backed by IBF, Merz, and Laborie, Vensica to Advance Needle-Free Delivery of Botulinum Toxin A (Xeomin®) for Minimally Invasive Treatment BROOKLYN, N.Y., Oct. 28, 2024 /PRNewswire/ -- Vensica Medical ("Vensica"), a pioneering urology therapeutics company, today announced the successful closing of an $11 million funding round. The investment will fund the company's upcoming Phase 2 clinical trials across the United States and Europe for its revolutionary treatment of overactive bladder (OAB) using botulinum toxin A (Xeomin®) delivered through a proprietary, needle-free device. Continue Reading (from l-r) Avner Geva, Vensica Therapeutics CEO & Co Founder; Avi Eftel, Vensica Therapeutics CTO & Co Founder The investment round was led by Israel Biotech Fund (IBF), alongside key strategic partners, Merz, a global player in neurotoxins, and Laborie, a prominent urology medical device company. This funding will enable Vensica to continue its mission of providing a minimally invasive, simple, and effective solution for people with overactive bladder ("OAB"). Vensica's unique technology leverages a needle-free drug delivery system, that administers Xeomin® directly to the bladder wall. This approach is expected to offer patients a less invasive, more comfortable treatment option compared to traditional injections, potentially transforming the standard of care for OAB. Vensica's needle-free drug delivery system aims to be a urology treatment platform for the treatment of additional bladder indications. "We are thrilled to have the support of leading investors and partners who share our vision of transforming overactive bladder treatment," remarked Avner Geva, CEO of Vensica. "This funding will allow us to push forward with Phase 2 trials and move one step closer to bringing this innovative therapy to the patients who need it." As part of its strategic partnership with Merz, Vensica has secured exclusive rights to Xeomin® in needle-less therapeutic application in several urologic indications and will benefit from Merz's clinical development support. This collaboration marks a significant step forward in the company's goal of delivering next-generation urology treatments. For more information on Vensica and its upcoming clinical trials, visit . About Vensica Medical Vensica Medical is a biotechnology company focused on developing novel therapies for urological conditions. The company's leading product is a needle-free delivery system for Xeomin® (botulinum toxin A) aimed at treating overactive bladder in a minimally invasive manner. Vensica was established in the incubator program of The Trendlines Group (SGX: 42T) (OTCQX: TRNLY), and The Israel Innovation Authority. Contact: Avner Geva, Chief Executive Officer [email protected] Photo: SOURCE Vensica Medical WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED