Carbidopa/Levodopa

OSLO, Norway, June 27, 2025 /PRNewswire/ -- Navamedic announces that the Swedish Medical Products Agency, acting as the Reference Member State, together with the Concerned Member States in 9 additional countries have approved OraFID® for use with a medicinal product. "OraFID® is a unique, fully mechanical medical device that dispenses precise quantities of minitablets to patients. It enables personalized, fine-tuned treatment with minitablets, and I am thrilled to see the approval of this important milestone." says Kathrine Gamborg Andreassen, Chief Executive Officer of Navamedic. Treatments with a narrow therapeutic window can benefit from hyper-fractioning of the dose, by dividing it into minitablets, each containing a fraction of the dose. OraFID® works with a couple of twists of the hands and ejects an exact number of minitablets. It is approved as an integral combination product for Flexilev®, Navamedic's medication for the treatment of Parkinson's. The launch in Nordic markets is anticipated in October 2025. For further information, please contact: Kathrine Gamborg Andreassen, CEO, Mobile: +47 951 78 880 E-mail: [email protected] Lars Hjarrand, CFO, Mobile: +47 917 62 842 E-mail: [email protected] About Navamedic Navamedic ASA is a Nordic pharmaceutical company dedicated to enhancing people's quality of life by being a reliable supplier of high-quality prescription, consumer health, and hospital products to hospitals and pharmacies. Our growing product portfolio has been carefully selected to meet current public health concerns, such as obesity, Parkinson's disease, and gastro-related ailments, to empower people to live healthier and more fulfilling lives. What sets us apart is our deep-rooted commitment to understanding the needs and requirements of the countries where we are present. Our local insight and competence enable us to understand the specific needs of each country where we operate and ultimately to gain market access. This makes us a preferred partner for international companies expanding their footprint across the Nordics and Benelux regions, through either in-licensing or out-licensing. Navamedic has been listed on the Oslo Stock Exchange since 2006 (ticker: NAVA) and is headquartered in Oslo, Norway. For more information, please visit Navamedic.com This information was brought to you by Cision Navamedic ASA: First approval of the medical device OraFID® as primary package for a pharmaceutical product Oslo, Norway - 2025.06.27 - Navamedic announces that the Swedish Medical Products Agency, acting as News Powered by Cision WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

JERSEY CITY, N.J., June 20, 2025 /PRNewswire/ -- Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced poster presentations on investigational ND0612 in Parkinson's disease (PD) will be shared at the 11th Congress of the European Academy of Neurology (EAN), taking place June 21-24 in Helsinki, Finland, and the 4th Annual Advanced Therapeutics in Movement & Related Disorders Congress (ATMRD), being held June 27-30 in Washington D.C. ND0612 is being evaluated as a 24-hour, continuous, subcutaneous (SC) infusion of liquid levodopa/carbidopa (LD/CD). "Being part of both EAN and ATMRD gives us the opportunity to engage with the broader neurology community, while spotlighting a range of data on ND0612 across two key scientific forums," said Gustavo A. Suarez Zambrano, M.D., Vice President of Medical Affairs, MTPA. "Our presence at these meetings reflects our dedication to supporting scientific exchange and sharing insights from our latest research focused on evaluating motor fluctuations in Parkinson's disease." EAN 2025 Presentation Details MTPA will be presenting one e-poster describing the effect of treatment with ND0612 on OFF and ON episodes, their duration, and transitions, in people experiencing motor fluctuations, as observed from the pivotal Phase 3 BouNDless study (NCT04006210) and its one-year open-label extension (OLE) phase. Effect of 24-hour Subcutaneous Levodopa/Carbidopa Infusion (Investigational ND0612) on Motor Fluctuations in the Phase 3 BouNDless Study (Joaquim J. Ferreira, M.D., Ph.D.; University of Lisbon) ePoster #EPR-052, Movement Disorders 1 Session: 2:35-2:40 p.m. EEST, June 21 ATMRD 2025 Presentation Details Presentations will detail findings from the Phase 3 BouNDless trial, including data derived from patient-reported outcomes assessing quality of life in people with PD experiencing motor fluctuations who are being treated with ND0612, as well as one-year outcomes from the BouNDless OLE phase. Additionally, a poster describing the characterization of dopaminergic treatment-emergent adverse events (AEs) reported in ND0612-treated patients will be shared. MTPA's posters will be viewable in the Exhibit Hall on June 27, 11:30 a.m.-12:20 p.m. EDT. Dopaminergic Adverse Events With 24-hour Subcutaneous Infusion of Investigational ND0612 (Huyen Phan, Pharm.D.; MTPA) Poster #P42 Quality of Life With 24-hour subcutaneous Levodopa/Carbidopa Infusion (Investigational ND0612): QoL Results from a Phase 3, Randomized, Active-Controlled Study (Amanda Goldberg, MPAS, PA-C; MTPA) Poster #P412 Long-Term Efficacy of 24-hour Subcutaneous Levodopa/Carbidopa Infusion (Investigational ND0612) for Motor Fluctuations in Parkinson's Disease (Rajesh Pahwa, M.D., FAAN; University of Kansas Medical Center) Poster #P32 About ND0612 ND0612 is an investigational drug-device combination therapy – a 24-hour, continuous subcutaneous (SC) infusion of liquid levodopa/carbidopa (LD/CD) for the treatment of motor fluctuations in people with Parkinson's disease (PD). Development of investigational ND0612 is being led by NeuroDerm Ltd., a wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC). About Mitsubishi Tanabe Pharma America, Inc. Based in Jersey City, N.J., Mitsubishi Tanabe Pharma America, Inc. (MTPA) is a wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC). It was established by MTPC to develop and advance our pipeline as well as commercialize approved pharmaceutical products in North America. For more information, please visit or follow us on X (formerly Twitter), Facebook and LinkedIn. About Mitsubishi Tanabe Pharma Corporation Mitsubishi Tanabe Pharma Corporation (MTPC) is one of the oldest pharmaceutical companies in the world, founded in 1678, and focusing on ethical pharmaceuticals. MTPC is headquartered in Doshomachi, Osaka, the birthplace of Japan's pharmaceutical industry. MTPC sets the MISSION of "Creating hope for all facing illness". To that end, MTPC is working on the disease areas of central nervous system, immuno-inflammation, diabetes and kidney, and cancer. MTPC is focusing on "precision medicine" to provide drugs with high treatment satisfaction by identifying patient populations with high potential for efficacy and safety. In addition, MTPC is working to develop "around the pill solutions" to address specific patient concerns based on therapeutic medicine, including prevention of diseases, pre-symptomatic disease care, prevention of aggravation and prognosis. For more information, go to About NeuroDerm Ltd. NeuroDerm Ltd. is a wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC), based in Israel, inspired to reduce disease burden and improve the quality of life of patients and their families through innovative drug-device combination therapies and technologies. NeuroDerm is an integrated pharmaceutical and medical technology company developing central nervous system (CNS) product candidates. For additional information, please visit NeuroDerm's website at or follow the Company on LinkedIn. Media inquiries: [email protected] SOURCE Mitsubishi Tanabe Pharma America WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED