Hemifacial Spasm

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 .

PARIS, FRANCE, 3 October 2023 – Ipsen (Euronext: IPN; ADR: IPSEY) announced today that its partner Galderma has confirmed receipt from the FDA of a Complete Response Letter related to its Biologics License Application for liquid botulinum toxin type A (QM-1114), noting certain deficiencies related to chemical, manufacturing and controls (CMC) processes. Furthermore, on 28 September 2023, the Arbitral Tribunal of the International Chamber of Commerce (ICC) issued a final decision on arbitration proceedings that Galderma initiated against Ipsen. This dispute was initiated in July 2021 following a difference of opinion on the regulatory submission strategy for QM-1114 related to the potency-assay testing method used in the release of commercial batches of QM-1114 in the United States, Canada and Australia. The result of this arbitration is that any regulatory applications for QM-1114 in the partnership territories submitted by Galderma shall be assigned to Ipsen as the owner of the intellectual property and marketing authorization of QM-1114. Galderma remains responsible for development, regulatory filing strategy, manufacturing and commercialization. As such, the Tribunal declared that Galderma has the right to decide on QM-1114’s regulatory strategy. On 27 July 2023, Ipsen confirmed that it had notified Galderma of its decision to terminate the Parties’ joint R&D collaboration entered into in July 2014 related to the parties’ respective neurotoxin programs, including the development of IPN10200 (longer-acting neurotoxin). ENDS About Ipsen Ipsen is a global, mid-sized biopharmaceutical company focused on transformative medicines in Oncology, Rare Disease and Neuroscience. With total sales of €3.0bn in FY 2022, Ipsen sells medicines in over 100 countries. Alongside its external-innovation strategy, the Company’s research and development efforts are focused on its innovative and differentiated technological platforms located in the heart of leading biotechnological and life-science hubs: Paris-Saclay, France; Oxford, U.K.; Cambridge, U.S.; Shanghai, China. Ipsen has around 5,300 colleagues worldwide and is listed in Paris (Euronext: IPN) and in the U.S. through a Sponsored Level I American Depositary Receipt program (ADR: IPSEY). For more information, visit ipsen.com About Dysport Dysport®, Ipsen’s botulinum toxin type A, is a neuromuscular blocking toxin which acts to block acetylcholine release at motor nerve ends and reduces muscular spasm. It was initially developed for the treatment of movement disorders such as cervical dystonia, blepharospasm, hemifacial spasms and spasticity affecting the upper and/or lower limbs in adults and children aged 2 years or older. Dysport® has marketing authorizations in more than 90 countries worldwide. The product is currently referred to as Dysport® for medical and aesthetic markets, and as Azzalure® in aesthetic indications in the E.U. Alluzience®, Ipsen’s botulinum toxin type A is a neuromuscular blocking toxin in liquid formulation, indicated for the temporary improvement in the appearance of moderate to severe glabellar lines (vertical lines between the eyebrows) seen at maximum frown in adult patients under 65 years, when the severity of these lines has an important psychological impact on the patient. About QM-1114 (relabotulinumtoxinA) QM-1114, is an investigational liquid formulation botulinum toxin A (supported by READY-1 / READY-2 / READY-3 / READY-4 Phase III trials sponsored by Galderma), seeking registration for the improvement of both glabellar and lateral canthal lines in adult patients. For further information: Contacts Investors Craig Marks Vice President, Investor Relations +44 (0)7584 349 193 Nicolas Bogler Senior Manager, Investor Relations +33 6 52 19 98 92 Media Amy Wolf VP, Head of Corporate Brand Strategy & Communications +41 79 576 07 23 Ioana Piscociu Senior Manager Global Media Relations +33 6 69 09 12 96 Ipsen’s forward-looking statements The forward-looking statements, objectives and targets contained herein are based on Ipsen’s management strategy, current views and assumptions. Such statements involve known and unknown risks and uncertainties that may cause actual results, performance or events to differ materially from those anticipated herein. All of the above risks could affect Ipsen’s future ability to achieve its financial targets, which were set assuming reasonable macroeconomic conditions based on the information available today. 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Other risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and healthcare legislation; global trends toward healthcare cost containment; technological advances, new medicine and patents attained by competitors; challenges inherent in new-medicine development, including obtaining regulatory approval; Ipsen's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of Ipsen’s patents and other protections for innovative medicines; and the exposure to litigation, including patent litigation, and/or regulatory actions. Ipsen also depends on third parties to develop and market some of its medicines which could potentially generate substantial royalties; these partners could behave in such ways which could cause damage to Ipsen’s activities and financial results. Ipsen cannot be certain that its partners will fulfil their obligations. It might be unable to obtain any benefit from those agreements. A default by any of Ipsen’s partners could generate lower revenues than expected. Such situations could have a negative impact on Ipsen’s business, financial position or performance. Ipsen expressly disclaims any obligation or undertaking to update or revise any forward-looking statements, targets or estimates contained in this press release to reflect any change in events, conditions, assumptions or circumstances on which any such statements are based, unless so required by applicable law. Ipsen’s business is subject to the risk factors outlined in its registration documents filed with the French Autorité des Marchés Financiers. The risks and uncertainties set out are not exhaustive and the reader is advised to refer to Ipsen’s latest Universal Registration Document, available on ipsen.com. Attachment Ipsen PR_QM-1114_03102023