Talipes

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 .

Note to editors: A media kit, including the press release, biographies, b-roll footage, and still images, will be available upon request. OTTAWA, Ontario, Dec. 06, 2024 (GLOBE NEWSWIRE) -- Shriners Hospitals for Children Canada (SHC Canada), in collaboration with CHEO Research Institute, is pleased to announce the launch of a joint pediatric metabolic and genetic bone disorders fellowship. Fellows will work in each hospital over two years, thereby developing physicians with expertise in both endocrinology and genetics and allowing children living with rare bone disease to see a single expert instead of visiting clinics at multiple hospitals. The first four years of this fellowship program have been funded by Shriners Hospitals for Children Canada via Tunis Shriners of Ottawa. The fellowship will advance pediatric bone health care and research in rare bone diseases. The fellowship program stands out for its unique structure and is the first of its kind in North America. Fellows will split their time between CHEO in Ottawa, ON, and the SHC Canada facility in Montreal, QC, gaining experience in both a specialized pediatric orthopedic setting and a more general pediatric hospital environment. This will allow the fellows to see a wider variety of cases and develop a broad skill set that blends both metabolic bone disease expertise, genetics and research. The first of the two-year fellowship will take place at CHEO where the team will see children and youth with rare bone disease under the leadership of Dr. Leanne Ward and take part in cutting-edge research. “Mentoring and training the next generation of leaders in pediatric bone health clinical care and research is critical to ensure our unique field of expertise continues to grow so that the kids of today and tomorrow receive the best care possible. It’s through the sharing of combined knowledge and experience across multiple disciplines that we can better train future clinician-scientists to lead the way in exemplary patient care and scientific discovery,” said Dr. Leanne Ward, Pediatric Endocrinologist and Scientific Director of The Ottawa Pediatric Bone Health Research Group at the CHEO Research Institute, who holds a Tier 1 Research Chair in Pediatric Bone Disorders at the University of Ottawa. The second year of the fellowship will take place under the leadership of Dr. Frank Rauch at SHC Canada where children with genetic bone diseases are seen from across North America and state-of-the art clinical and research laboratories focus on these conditions. “This groundbreaking collaboration represents our commitment to advancing the field of pediatric bone disorders, with an emphasis on genetic and metabolic conditions. The fellowship will help shape the future of care for bone diseases in children by ensuring that fellows receive the most comprehensive, multidisciplinary training available, and by extension our patients receive the best care anywhere,” said Dr. Frank Rauch, pediatrician and Director of the Clinical Biomedical Laboratory at Shriners Hospitals for Children Canada. “This first-of-its-kind fellowship is the perfect example of transformative collaboration in action. Together, we are building the future of pediatric care in rare bone disorders by training the next generation of clinician-scientists,” said Dr. Jason Berman, CEO and Scientific Director, CHEO Research Institute, Vice-President of Research, CHEO. “In the true spirit of collaboration with the goal of improving pediatric orthopedic care in Canada, this will not only improve the lives of patients and their families, but will also advance research and teaching,” said Jacques Boissonneault, Administrator, Shriners Hospitals for Children Canada. “This agreement is the second one we have signed this year and there will be more to come as we work with institutions across Canada to open doors for more patients to access our world class expertise. We are able do so with the incredible support of the Shriners and we are truly grateful to Tunis Shriners for believing in this exceptional fellowship.” "The Tunis Shriners have proudly been part of the Ottawa community for nearly fifty years, fundraising to improve children’s health from the very beginning. On behalf of our members, we are delighted to support this wonderful initiative that will continue to help children and families of Ottawa and beyond," said Eric Owen, Potentate of Tunis Shriners of Ottawa. Meet Ella Mae Nicholas, age 4, and her parents Ryan and Anu Ella Mae Nicholas was diagnosed with severe-moderate Osteogenesis Imperfect (OI) Type 4 at birth. Her father, Ryan Nicholas, also has OI, a genetic bone disorder, also known as brittle bone disease, in which a child born with OI may have soft bones that break (fracture) easily. Since his last fracture because of OI, Ryan has witnessed first-hand, through the care his daughter receives, the advancements in research and care for children and youth with OI. “My bones stopped breaking around the age of 18. In that 20-year span until we had Ella Mae, there has been so much study and advancements in the treatment of OI, it’s absolutely mind blowing. I never had any of that as a kid. It’s like being alive for the development of the radio and then being able to see the internet happen. Seeing all the evolutions, you’re taken back by it all, and it’s fantastic,” said Ryan Nicholas. Ella Mae, who is now a chatty four-year-old and in her first year of school, is a strong little girl, with a high-pain tolerance and strong personality. She has been followed by Dr. Ward since birth and she, like other kids, will benefit from this unique fellowship that combines the expertise of both Dr. Rauch and Dr. Ward to train the next generation. Fellowship details The fellowship is designed for Medical Doctors who have completed their pediatric, pediatric endocrinology, or medical genetics training and wish to specialize in pediatric bone diseases. Applications will be processed through McGill University’s Postgraduate Medical Education Office for the Shriners Hospitals for Children Canada portion, and through Dr. Leanne Ward at CHEO for the Ottawa-based component. For more information on the fellowship program and how to apply, please visit McGill PGME and contact pgcoordinator.med@mcgill.ca. About Shriners Hospitals for Children Canada Established in Montreal in 1925, Shriners Hospitals for Children Canada is a bilingual, short-term, acute care hospital, providing ultra-specialized orthopaedic care to children from across Canada and around the world. The mission of the hospital is to provide treatment and rehabilitation to infants, children and young adults with orthopaedic and neuromuscular problems such as scoliosis, osteogenesis imperfecta (brittle bone disease), clubfeet, hip dysplasia, leg length discrepancies and cerebral palsy, among others. The hospital is committed to excellence and innovation in clinical practice, research and education. Affiliated with McGill University, the hospital provides clinical experience and teaching for residents and allied professionals within its outstanding new facility on the Glen site. The hospital is present in communities across Canada, thanks to telemedicine, outreach clinics and satellite clinics. About the CHEO Research Institute The CHEO Research Institute is a global centre of excellence in pediatric research that connects talent and technology in pursuit of life-changing research for every child, youth and family in the CHEO community and beyond. The CHEO Research Institute coordinates the research activities of CHEO and is affiliated with the University of Ottawa. At the CHEO Research Institute, discoveries inspire the best life for every child. For media inquiries contact: CHEO Research InstituteJennifer RuffDirector of Communications at the CHEO Research Institutejruff@cheo.on.camedia@cheo.on.ca Shriners Hospitals for Children CanadaTim FisherDirector of Communications at SHC CanadaTimothy.Fisher@shrinenet.org

Data at 68 weeks of treatment with LEQSELVI showed ongoing and clinically meaningful improvement in scalp hair regrowth Study finds that doctors and patients prefer fast time to onset and proven efficacy in JAK inhibitor options, regardless of dosing schedule MUMBAI, India and PRINCETON, N.J., Oct. 25, 2024 /PRNewswire/ -- Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, together with its subsidiaries and/or affiliated companies, "Sun Pharma") today presented new data highlighting the clinical efficacy and safety of LEQSELVI™ (deuruxolitinib) 8 mg tablets at the 44th Annual Fall Clinical Dermatology Conference, being held October 24-27, 2024, in Las Vegas, Nevada. LEQSELVI 8 mg tablets was approved by the U.S. Food and Drug Administration for the treatment of adults with severe alopecia areata (AA) earlier this year. LEQSELVI, a JAK inhibitor, treats alopecia areata at the source and is clinically proven to deliver statistically significant efficacy. LEQSELVI data presented at Fall Clinical includes pooled long-term results from open-label extension (OLE) studies showing ongoing and clinically meaningful improvements in scalp hair regrowth in adults with AA taking LEQSELVI for up to 68 weeks. To determine long-term efficacy, the Severity of Alopecia Tool (SALT) scores were analyzed using two methods: Last Observation Carried Forward (LOCF) and As Observed (AO). At the end of the qualifying trial period at Week 24, 32.6% of patients receiving LEQSELVI 8 mg BID (twice daily) achieved a SALT ≤20 score; the percentage of SALT 20 responders increased to 48.8% (LOCF analysis) and 76.6% (AO analysis) at Week 68 of the OLE studies. Additionally, 99.6% (282 patients) maintained their response to LEQSELVI 8 mg BID (as defined by sustaining a SALT ≤50 after achieving SALT ≤20 during the OLE studies as of the cutoff date). "This research provides insight into the durability of response experienced with LEQSELVI 8 mg twice daily, adding to a growing body of evidence highlighting the benefits of this treatment for those living with severe alopecia areata," said Brett King, MD, PhD. "These data highlight an important role for deuruxolitinib in the care of patients living with this disease." In addition to the OLE study, two posters presented at Fall Clinical capture patient and clinician feedback for the treatment of AA which confirm the preference for treatment options with fast time to onset and proven efficacy, irrespective of dosing schedules. In the blinded treatment scenario displaying profiles of LEQSELVI, baricitinib and ritlecitinib, patients and clinicians chose the profile of LEQSELVI as the preferred therapeutic option. "As we continue to grow the Sun Pharma dermatology portfolio, the data presented at Fall Clinical support a growing body of clinical evidence, which show LEQSELVI is an effective treatment option for those living with severe alopecia areata," said Marek Honczarenko, MD, PhD, Senior Vice President and Head of Global Development at Sun Pharma. "We're excited to share these important data with the dermatology community and look forward to seeing patients living with alopecia areata access this innovative treatment option." LEQSELVI may cause serious side effects including serious infections, malignancies, thrombosis, gastrointestinal perforations, and certain laboratory abnormalities. There also may be an increased risk of mortality and major cardiovascular events. LEQSELVI should not be used in patients who are CYP2C9 poor metabolizers or who are taking moderate or strong CYP2C9 inhibitors. In placebo-controlled trials, the three most common adverse events were headache (12.4% as compared to 9.4% with placebo), acne (10% as compared to 4.3% with placebo), and nasopharyngitis (8.1% as compared to 6.7% with placebo). Please see full Prescribing Information, including BOXED WARNING and Medication Guide, and see below for Important Safety Information. For more information about LEQSELVI, visit LEQSELVI.com. About LEQSELVI™ and alopecia areata LEQSELVI (deuruxolitinib) 8 mg tablets is an oral selective inhibitor of Janus kinases JAK1 and JAK2 approved for the treatment of adult patients with severe alopecia areata. Alopecia areata is an autoimmune disease in which the immune system attacks hair follicles, resulting in partial or complete loss of hair on the scalp and body. Alopecia areata may affect up to 2.5% of the United States and global population during their lifetime.1,2,3 The scalp is the most commonly affected area, but any hair-bearing site can be affected alone or together with the scalp. Onset of the disease can occur throughout life and affects both women and men. Alopecia areata can be associated with serious psychological consequences, including anxiety and depression. There are currently limited approved treatment options available for alopecia areata. LEQSELVI Important Safety Information Please click here for full Prescribing Information Including BOXED WARNING and Medication Guide. Indications and Usage LEQSELVI (deuruxolitinib) is a Janus kinase (JAK) inhibitor indicated for the treatment of adults with severe alopecia areata. Limitations of Use LEQSELVI is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants. Contraindications LEQSELVI is contraindicated in patients who are CYP2C9 poor metabolizers or who are using moderate or strong CYP2C9 inhibitors. Warnings Serious Infections Increased risk of serious bacterial, fungal, viral and opportunistic infections including tuberculosis (TB) that may lead to hospitalization or death. Interrupt treatment with LEQSELVI if a serious infection occurs until the infection is controlled. Test for latent TB before and during therapy; treat latent TB prior to use. Monitor all patients for active TB during treatment, even patients with initial negative, latent TB test. Mortality Higher rate of all-cause mortality, including sudden cardiovascular death with another Janus kinase inhibitor (JAK) vs. TNF blockers in rheumatoid arthritis (RA) patients. LEQSELVI is not approved for use in RA patients. Malignancy Malignancies have occurred in patients treated with LEQSELVI. Higher rate of lymphomas and lung cancers with another JAK inhibitor vs. TNF blockers in RA patients. Major Adverse Cardiovascular Events Higher rate of MACE (defined as cardiovascular death, myocardial infarction, and stroke) with another Janus kinase inhibitor (JAK) vs. TNF blockers in rheumatoid arthritis (RA) patients. Thrombosis Thrombosis, including PE, DVT & CVT, has occurred in patients treated with LEQSELVI. Increased incidence of pulmonary embolism, venous and arterial thrombosis with another JAK inhibitor vs. TNF blockers. Increased risk of serious adverse reactions in CYP2C9 poor metabolizers or with concomitant use of moderate or strong CYP2C9 inhibitors Do not treat patients who are CYP2C9 poor metabolizers or patients taking a moderate or strong CYP2C9 inhibitor with LEQSELVI. Gastrointestinal Perforations GI perforations have occurred in patients treated with LEQSELVI. Monitor patients who may be at increased risk for gastrointestinal perforation. Evaluate promptly patients presenting with new onset abdominal symptoms. Lipid elevations, anemia, neutropenia, and lymphopenia Monitor for changes in lipids, hemoglobin, neutrophils, and lymphocytes. Immunizations Avoid use of live vaccines during or immediately prior to LEQSELVI treatment. Prior to initiating LEQSELVI, it is recommended that patients be brought up to date with all immunizations. Dosage The recommended dosage of LEQSELVI for the treatment of severe alopecia areata is 8 mg orally twice daily, with or without food. Before treatment with LEQSELVI, perform the following evaluations: CYP2C9 genotype & use of moderate or strong CYP2C9 inhibitors; Active and latent tuberculosis evaluation; Viral hepatitis screening; Complete blood count (LEQSELVI treatment is not recommended in patients with an absolute lymphocyte count (ALC) <500 cells/mm3 absolute neutrophil count (ANC) <1,000 cells/mm3, or hemoglobin level <8 g/dl). Adverse Reactions Most common adverse reactions (≥1%) are headache, acne, nasopharyngitis, blood creatine phosphokinase increased, hyperlipidemia, fatigue, weight increased, lymphopenia, thrombocytosis, anemia, skin and soft tissue infections, neutropenia, and herpes. Use in Specific Populations Based on animal studies, LEQSELVI may cause fetal harm during pregnancy. Pregnant women should be advised of a risk to the fetus. Consider pregnancy planning and prevention for women of reproductive potential. LEQSELVI should not be used by women who are breastfeeding until one day after the last dose. LEQSELVI should not be used by patients with severe renal impairment or severe hepatic impairment. References Benigno M. A Large Cross-Sectional Survey Study of the Prevalence of alopecia areata in the United States, Clinical, Cosmetic and Investigational Dermatology 2020. Lee HH et al. Epidemiology of alopecia areata, ophiasis, totalis, and universalis: A systematic review and meta-analysis, J Am Acad Dermatol. 2020 Mar; 82(3): 675-682. Fricke et al. Epidemiology and burden of alopecia areata: a systematic review, Clin Cosmet Investig Dermatol. 2015 Jul 24;8: 397-403. About Sun Pharmaceutical Industries Limited. (CIN – L24230GJ1993PLC019050) Sun Pharma is the world's leading specialty generics company with a presence in Specialty, Generics and Consumer Healthcare products. It is the largest pharmaceutical company in India and is a leading generic company in the US as well as Global Emerging Markets. Sun's high growth Global Specialty portfolio spans innovative products in dermatology, ophthalmology, and onco-dermatology and accounts for over 18% of company sales. The company's vertically integrated operations deliver high-quality medicines, trusted by physicians and consumers in over 100 countries. Its manufacturing facilities are spread across six continents. Sun Pharma is proud of its multi-cultural workforce drawn from over 50 nations. For further information, please visit and follow us on LinkedIn & X (Formerly Twitter). Disclaimer: Statements in this "document" describing the Company's objectives, projections, estimates, expectations, plans or predictions, industry conditions, or events may be "forward-looking statements" within the meaning of applicable securities laws and regulations. Actual results, performance, or achievements could differ materially from those expressed or implied. The Company undertakes any obligation to update or revise forward-looking statements to reflect developments or circumstances that arise or to reflect the occurrence of unanticipated developments/circumstances after the date hereof. Contacts: Sun Pharma SOURCE Sun Pharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED