Merz Pharmaceuticals LLC

TORONTO and CHICAGO, Feb. 01, 2023 (GLOBE NEWSWIRE) -- Medexus Pharmaceuticals (Medexus) (TSX: MDP) (OTCQX: MEDXF) wishes to inform investors that the company has reached an agreement with the provincial government of Quebec for government-sponsored coverage of Cuvposa (glycopyrrolate oral solution 1mg/5mL). Cuvposa will be listed for public reimbursement on the Public Prescription Drug Insurance Plan of the Régime de l’Assurance Maladie du Québec, or RAMQ, starting February 1, 2023. Cuvposa is indicated in Canada to reduce chronic severe drooling in pediatric patients 3 to 18 years of age with neurologic conditions associated with problem drooling, such as cerebral palsy. Listing Cuvposa fills a health need recognized as being moderate to high in vulnerable and underserved pediatric populations in Canada who are affected by this condition. Dr Pierre Marois, Pediatric Physiatrist at Montreal’s Ste-Justine Hospital, commented: “Chronic severe drooling, or sialorrhea, is an often-underestimated condition in pediatric patients who are also managing significant neurologic conditions. It can result in dysphagia and impact respiratory health – but can also affect the social and emotional development of these children and the wellbeing of their caregivers and families, contributing to the substantial burden of the underlying conditions.” “The limited number of available treatment options means that chronic severe drooling is often poorly managed,” added Jean-Claude Beaudoin, Vice President—Sales & Marketing at Medexus. “We are therefore proud to make Cuvposa available to more patients in Quebec through this new partnership with the Quebec government. We believe greater access to Cuvposa will help more people seeking to manage the ancillary effects of neurologic conditions, which can have a significant impact on their wellbeing.” About Cuvposa Cuvposa (glycopyrrolate oral solution 1mg/5mL) is indicated to reduce chronic severe drooling in patients 3 to18 years of age with neurologic conditions associated with problem drooling, such as cerebral palsy. Chronic severe drooling may also be diagnosed in patients with other neurological disorders, such as severe developmental delay, autism spectrum disorders, sensory impairments, traumatic brain injuries, or neurogenetic and metabolic disorders. The rate of cerebral palsy incidence in Canada is estimated at around 0.3 per 1,000 for children less than 20 years old, with newly diagnosed cases expected to increase to nearly 2,200 in 2031 and the number of people living with cerebral palsy increasing to more than 94,000. Over this period, Canadians with cerebral palsy are expected to continue to experience, among other things, a reduced quality of life and a rising need for supportive services including informal care. (Source: “Original quantitative research – Cerebral palsy in Canada, 2011–2031: results of a microsimulation modelling study of epidemiological and cost impacts”, Health Promotion and Chronic Disease Prevention in Canada, Vol 40, No 2, February 2020.) Glycopyrrolate indirectly reduces the rate of salivation by preventing the stimulation of acetylcholine muscarinic receptors located on peripheral tissues such as salivary glands. Dry mouth, vomiting, constipation, flushing of the face or skin, headache, problems urinating, and rapid heartbeat are the most commonly reported side effects of Cuvposa. For more information about Cuvposa, including important safety information, see the product monograph. Medexus holds exclusive distribution rights to Cuvposa in Canada. Cuvposa is approved by Health Canada for sale and use in Canada only and is not intended for export outside Canada. Medexus makes no representation that Cuvposa is appropriate for, or authorized for sale to or use by, individuals who are not located in Canada. CUVPOSA® is a registered trademark of Merz Pharmaceuticals, LLC. About Medexus Medexus is a leader in innovative and rare disease treatment solutions with a strong North American commercial platform and a portfolio of proven best-in-class products. Our current focus is on the therapeutic areas of hematology, auto-immune diseases, and allergy. We continue to build a highly differentiated company with a growing portfolio of innovative and high-value orphan and rare disease products that will underpin our growth for the next decade. Our current leading products are IXINITY®, an intravenous recombinant factor IX therapeutic for use in patients 12 years of age or older with Hemophilia B (a hereditary bleeding disorder characterized by a deficiency of clotting factor IX in the blood, which is necessary to control bleeding); Rasuvo® and Metoject®, a unique formulation of methotrexate (auto-pen and pre-filled syringe) designed to treat rheumatoid arthritis and other auto-immune diseases; Rupall®, an innovative prescription allergy medication with a unique mode of action; and Gleolan® (aminolevulinic acid hydrochloride or ALA HCl), an FDA-approved, orphan drug designated optical imaging agent currently indicated in patients with glioma (suspected World Health Organization Grades III or IV on preoperative imaging) as an adjunct for the visualization of malignant tissue during surgery. We have also licensed treosulfan, part of a preparative regimen for allogeneic hematopoietic stem cell transplantation to be used in combination with fludarabine, for commercialization in the United States and Canada. Treosulfan was approved by Health Canada in June 2021 and is marketed in Canada as Trecondyv™. Treosulfan is currently the subject of a regulatory review process with the US Food and Drug Administration. Our mission is to provide the best healthcare products to healthcare professionals and patients. We strive to deliver on this mission by acting on our core values: Quality, Innovation, Customer Service, and Collaboration. Contacts For more information, please contact any of the following: Medexus Ken d’Entremont, Chief Executive OfficerMedexus PharmaceuticalsTel: 905-676-0003Email: ken.dentremont@medexus.com Marcel Konrad, Chief Financial OfficerMedexus PharmaceuticalsTel: 312-548-3139Email: marcel.konrad@medexus.com Investor Relations Victoria RutherfordAdelaide CapitalTel: 480-625-5772Email: victoria@adcap.ca Forward-looking statements Certain statements made in this press release contain forward-looking information within the meaning of applicable securities laws (forward-looking statements). The words “anticipates”, “believes”, “expects”, “will”, “plans”, “potential”, and similar words, phrases, or expressions are often intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words, phrases, or expressions. Specific forward-looking statements in this news release include, but are not limited to, statements regarding the present and future status of Cuvposa as listed for public reimbursement on the Public Prescription Drug Insurance Plan (including related expectations regarding financial or operational performance) and regarding conditions associated with the conditions Cuvposa is indicated to treat (including current and future incidence in Canada). These statements are based on factors or assumptions that were applied in drawing a conclusion or making a forecast or projection, including assumptions based on historical trends, current conditions, and expected future developments. Since forward-looking statements relate to future events and conditions, by their very nature they require making assumptions and involve inherent risks and uncertainties. Medexus cautions that although it is believed that the assumptions are reasonable in the circumstances, these risks and uncertainties give rise to the possibility that actual results may differ materially from the expectations set out in the forward-looking statements. Material risk factors include, but are not limited to, those set out in Medexus’s materials filed with the Canadian securities regulatory authorities from time to time, including Medexus’s most recent annual information form and management’s discussion and analysis. Given these risks, undue reliance should not be placed on these forward-looking statements, which are made only as of the date of this news release. Other than as specifically required by law, Medexus undertakes no obligation to update any forward-looking statements to reflect new information, subsequent or otherwise. Additional note The information in this press release is provided for informational purposes to investors in Medexus securities only, and is not intended to constitute promotion of any product nor any other activity that would violate any applicable law.

RALEIGH, N.C.--(BUSINESS WIRE)-- Bryn Pharma LLC, a privately held pharmaceutical company dedicated to finding a better way for patients and caregivers to treat anaphylaxis, today announced the appointments of Sandy Loreaux and William D. Humphries to its Board of Directors. Ms. Loreaux and Mr. Humphries join Anne Whitaker and Lisa Licht to round out the senior directors focused on commercialization of UTULY™. “Sandy and Bill bring decades of experience and strong commercialization skill sets to our Board,” said Steven Hartman, Chairman of the Board of Directors. “With the completion of the UTULY™ clinical program, we look forward to working with Sandy and Bill to plan for the U.S. market launch.” Ms. Loreaux has over 25 years of experience in the pharmaceutical industry. She currently leads Covis Pharma’s U.S. Operations in her role as U.S. President. Sandy joined Covis in November 2021 after previously serving as Senior Vice President and General Manager, U.S. Critical Care for Mallinckrodt Pharmaceuticals. She has led multiple market access initiatives in her roles as SVP, Head of Market Access at Mallinckrodt Pharmaceuticals and SVP, Head of Market Access, and Commercial Operations at Bausch Health. Ms. Loreaux spent the first 19 years of her career at Sanofi and its legacy companies in various roles of increasing responsibility across medical affairs, sales, marketing and market access. Ms. Loreaux is a pharmacist by training and has a degree from Temple University School of Pharmacy in Philadelphia. As a mother of children who were diagnosed with life-threatening food allergies as infants, Ms. Loreaux brings a personal passion and commitment to bringing epinephrine delivery alternatives to market. Mr. Humphries has more than 30 years of experience building and leading commercial-stage pharmaceutical organizations. He is currently the Chief Executive Officer of Isosceles Pharmaceuticals, a position he has held since May 2021. Previously, Mr. Humphries served as President of Ortho Dermatologics, a Bausch Health Company. Before joining Ortho Dermatologics, he served as President and Chief Executive Officer of the North American business of Merz, an affiliate of Merz Pharma Group, where he oversaw strategic direction and collaboration among three North American companies: Merz Pharmaceuticals LLC, Merz Aesthetics Inc., and Merz Pharma Canada Ltd. Before joining Merz, he served in several leadership positions with Stiefel Laboratories, including Chief Commercial Officer and President, where he spearheaded two significant acquisitions and led the global integration of Stiefel into GlaxoSmithKline. Earlier in his career, Mr. Humphries served in executive roles in sales and marketing, business development, and international marketing for Allergan, concluding as Vice President of its U.S. skincare business. “Sandy and Bill’s appointments bring deep commercial expertise to Bryn that will help us navigate the transition from an R&D organization to a fully integrated commercial organization,” said David Dworaczyk, Ph.D., CEO of Bryn Pharma. “They are joining Bryn’s board at a critical time and we are thrilled to welcome them to our team.” About Bryn Pharma Bryn Pharma, established in 2017, is a privately held pharmaceutical company founded by patients for patients. Bryn is focused on positively disrupting the existing market for epinephrine autoinjectors by delivering an accessible, easy-to-use alternative that better meets the needs of patients. Bryn Pharma seeks to provide this growing population at risk for anaphylaxis with A Better Way to be prepared for a life-threatening allergic reaction. For more information visit .

MENLO PARK, Calif., Feb. 5, 2013 /PRNewswire/ -- Neodyne Biosciences, Inc., today announced positive reception and product sales for its first commercially available product, patented embrace Advanced Scar Therapy. Several Plastic Surgeons in Las Vegas purchased product for upcoming patient procedures and the patented embrace product was very well received. Patented embrace is a device for use in the management of closed hyper-proliferative (hypertrophic and keloid) scars and has been shown, in clinical studies, to offer a highly significant difference between patented embrace treated scars compared to the control (standard-of-care treated) incision sites (p = 0.007). Recent results from Neodyne's REFINE Trial (Scar Prevention and the Clinical Effectiveness of a Novel Mechano-modulating Polymer) convinced the Plastic Surgeons in Las Vegas that this product will help them improve their scar results for their patients. The REFINE study was a randomized control clinical trial designed to assess the efficacy and tolerability of the patented embrace device when used to treat closed incisions following a surgical procedure. The interim analysis demonstrated the efficacy of the patented embrace therapy within one of the most challenging scar-prone surgical procedures, an abdominoplasty (tummy tuck). "I was impressed with the embrace clinical data and technology and felt this could benefit my patients by helping to minimize scar formation," said busy plastic surgeon Dr. Stephen Miller (Las Vegas, NV). "Patients frequently express concerns about scarring after a surgical procedure and embrace is the only product that I know of that reduces the mechanical forces and tension on the wound which will address these concerns. I am happy to have the embrace therapy available for all of my patients." "We are excited to commercially launch embrace scar therapy in the United States and believe that our patented scar therapy can become the treatment-of-choice for those patients concerned with the risk of post-surgical scarring," said Bill Beasley, President and COO of Neodyne. "We expect embrace to successfully compete within the scar treatment market alongside Merz Pharmaceuticals LLC, Molnlycke Health Care, Johnson & Johnson ("JNJ"), Smith + Nephew ("SNN"), and multiple others". About embrace Advanced Scar Therapy A new approach to scar management, patented embrace Advanced Scar Therapy delivers mechano-modulation therapy to the injury site and surrounding tissues. The device includes a simple disposable applicator that transfers a predetermined level of strain to a single use adhesive silicone sheet, which is then adhered over the closed scar. This unique mechanism of action provides a uniform compressive strain, or stress-shield around a closed scar, which can minimize collagen proliferation and formation of scar tissue. The patented embrace device has been FDA Cleared, and is in the beginning phase for initial market release. The Neodyne embrace technology is protected by numerous issued and pending patents. About Neodyne Biosciences, Inc. Neodyne Biosciences ( ) is an evidence based company developing and commercializing innovative tissue repair devices to minimize scar formation, restoring both function and aesthetic appearance. The company is developing stress-shielding devices capable of controlling the mechanical wound environment to ameliorate post-surgical scarring. Although the etiology remains unclear, mechanical forces such as surrounding skin tension and body movement have been demonstrated to increase fibrosis and scar formation. It is estimated that approximately 80 million major surgical procedures are performed in the United States each year and 230 million performed worldwide. Patient frustration with post-surgical scarring spans a variety of procedures with many seeking means of prevention and treatment. SOURCE Neodyne Biosciences,