NeuroDerm Ltd.

One-year outcomes from open-label extension to BouNDless study reaffirm previously published data regarding long-term efficacy of ND0612 Additional new data evaluating quality of life, daily motor experiences and motor fluctuations favor ND0612 treatment vs. oral immediate-release levodopa/carbidopa JERSEY CITY, N.J., Sept. 30, 2024 /PRNewswire/ -- Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced the presentation of three posters discussing new data from the pivotal Phase 3 BouNDless trial (NCT04006210) and its ongoing open-label extension (OLE) evaluating investigational ND0612 in people with Parkinson's disease (PD) experiencing motor fluctuations, as part of the 2024 International Congress of Parkinson's Disease and Movement Disorders (MDS). ND0612 is being studied as a 24-hour, continuous, subcutaneous (SC) infusion of liquid levodopa/carbidopa (LD/CD). The data highlight one-year outcomes from the BouNDless-OLE phase that are consistent with previously-reported 12-week data from the study evaluating the long-term efficacy of ND0612. Additional presentations discussed findings from patient-reported outcomes favoring ND0612 vs. oral immediate-release (IR) LD/CD across various measures of quality of life (QoL) and the effect of treatment on motor signs and motor experiences of daily living (m-EDL). "The longer-term data presented at MDS provide insights into the potential of ND0612 to not only improve symptoms, but also maintain its efficacy, which may provide patients with a meaningful reduction in symptom burden," said Gustavo A. Suarez Zambrano, M.D., Vice President of Medical Affairs at MTPA. "These findings reinforce our commitment to studying ND0612, if approved, as a potential new treatment option for people with Parkinson's disease experiencing motor fluctuations, as well as ensuring the latest scientific knowledge is continuously shared with the community." Key highlights presented at the meeting include: Abstract #653: Long-Term Efficacy of 24-hour Subcutaneous Levodopa/Carbidopa Infusion (ND0612) for Motor Fluctuations in Parkinson's Disease Patients who completed the double-blind double-dummy (DBDD) phase of the BouNDless study were eligible to enter the OLE phase. At six months, patients treated with ND0612 experienced an average reduction of 2.2 hours in daily OFF time and an increase of 2.4 hours in daily ON time without troublesome dyskinesia. These results were sustained at 12 months, showing an average reduction of 2.02 hours in OFF time and an increase of 2.11 hours in ON time without troublesome dyskinesia. In addition, patients with one or more hours of ON time with troublesome dyskinesia at ND0612 initiation (n=45) experienced an average reduction of troublesome dyskinesia by 1.5 hours at 12 months, further demonstrating sustained efficacy. Abstract #648: Quality of Life with 24-hour Subcutaneous Levodopa/Carbidopa Infusion (ND0612): PDQ-39 Results from a Phase 3 Randomized, Active-Controlled Study Following two sequential open-label periods to optimize oral IR-LD/CD and ND0612, study participants were randomized to a 12-week DBDD treatment period with either ND0612 or IR-LD/CD regimens. Change in QoL was assessed at the end of the DBDD period across eight domains of daily living using the PD Questionaire-39 (PDQ-39).[1] At the end of 12 weeks, patients in the continuous 24-hour ND0612 treatment group reported improved QoL (-2.1 [-3.7, -0.6]) compared to no change in the IR-LD/CD group (+0.6 [-0.9, 2.1]). The PDQ-39 domain analyses favored ND0612 treatment in most domains; mean changes were mobility, bodily discomfort, cognition, activities of daily living, stigma, social support, communication and emotional well-being. Abstract #685: Efficacy of Continuous Subcutaneous Levodopa/Carbidopa Infusion (ND0612) on Motor Signs of PD and Experiences of Daily Living During the BouNDless trial, at both eight and 12 weeks, treatment with ND0612 showed superior improvements in m-EDL vs. oral IR-LD/CD, as measured by the Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II and Part III scores. Additionally, a post-hoc analysis of treatment differences for a number of motor signs showed treatment with ND0612 was superior to oral IR-LD/CD, with improvements observed in postural instability-gait disorder (–0.26 vs. 0.02, p=0.0012), speech and oral health (–0.11 vs. 0.05, p=0.0140), tremor (–0.15 vs. –0.05, p=0.0992) and self-care (–0.08 vs. 0.09, p=0.0528). No relevant differences were observed for rigidity and bradykinesia. In the BouNDless trial, ND0612 was generally well tolerated. In patients treated with ND0612, the most common systemic treatment emergent adverse events (TEAEs) reported during the open-label run-in period of the study included dyskinesia (9.3% of subjects), ON and OFF phenomenon and fall (each reported in 5.3% of subjects). During the maintenance period of the clinical trial, 2% of patients in both the ND0612 and oral IR-LD/CD-only groups reported dyskinesia. Additionally, only 6% of study participants treated with ND0612 discontinued the trial during the maintenance period due to any reason – including 5% due to AEs – compared to discontinuation rates of 6% and 3%, respectively, of study participants in the oral IR-LD/CD groups.[2] About ND0612 ND0612 is an investigational drug-device combination therapy – a 24-hours/day, 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), the pharma arm of Mitsubishi Chemical Group (MCG), is one of the oldest pharmaceutical companies in the world, founded in 1678. MTPC is headquartered in Doshomachi, Osaka, the birthplace of Japan's pharmaceutical industry. MCG has positioned health care as its strategic focus in its management policy, "Forging the future". 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 and additionally 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] 1 Parkinson's Disease questionnaire. Oxford University Innovation. Published August 31, 2023. 2 Espay A, Stocchi F, Pahwa R, et al (2024). Safety and efficacy of continuous subcutaneous levodopa-carbidopa infusion (ND0612) for Parkinson's disease with motor fluctuations (BouNDless): a phase 3, randomized, double-blind, double-dummy, multicentre trial. Lancet Neurol. (24)00052-8. 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

JERSEY CITY, N.J., Sept. 27, 2024 /PRNewswire/ -- Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced seven presentations on investigational ND0612 in Parkinson's disease (PD) will be shared at the 2024 International Congress of Parkinson's Disease and Movement Disorders (MDS), being held September 27-October 1 in Philadelphia, Pa. ND0612 is being evaluated as a continuous, 24 hours/day subcutaneous infusion of liquid levodopa/carbidopa. "We're looking forward to showcasing an exciting array of Parkinson's disease research from our Phase 2 and 3 studies at MDS, including one-year outcomes from the open-label extension period of our pivotal Phase 3 BouNDless trial, whose 12-week results were published earlier this year," said Gustavo A. Suarez Zambrano, M.D., Vice President of Medical Affairs, MTPA. "These data presentations reinforce our dedication to the ongoing evaluation of investigational ND0612 and commitment to learning more about Parkinson's disease that nearly one-million people are living with in the U.S."1 MTPA's posters will be presented in Exhibit Hall A on September 29, 1:00-3:00 p.m. ET: Presentation Details: Presentations include a range of data from the pivotal Phase 3 BouNDless trial (NCT04006210) evaluating ND0612 in people with PD experiencing motor fluctuations, utilizing data derived from patient-reported outcomes assessing quality of life and motor experiences of daily living, among other findings. Additionally, one-year outcomes from the ongoing open-label extension phase of the BouNDless trial will be presented. Quality of Life with 24-hour Subcutaneous Levodopa/Carbidopa Infusion (ND0612): PDQ-39 Results from a Phase 3 Randomized, Active-Controlled Study Abstract #: 648 Efficacy of Continuous Subcutaneous Levodopa/Carbidopa Infusion (ND0612) on Motor Signs of PD and Experiences of Daily Living Abstract #: 685 Impact of 24-hour Subcutaneous Levodopa/Carbidopa Infusion (ND0612) on Motor State Transitions Throughout the Day Abstract #: 683 Subgroup Analyses of a Phase 3, Randomized Study of Levodopa/Carbidopa Infusion (ND0612) for Parkinson's Patients Abstract #: 666 Long-Term Efficacy of 24-hour Subcutaneous Levodopa/Carbidopa Infusion (ND0612) for Motor Fluctuations in Parkinson's Disease Abstract #: 653 Additional presentations will highlight findings from analyses of Phase 2 and Phase 3 studies evaluating treatment outcomes from a 24-hour regimen of ND0612, including the characterization of infusion site reactions in patients reported as adverse events (AEs) and the characterization of dopaminergic treatment-emergent AEs reported in patients. Characterization of Infusion Site Reactions With 24-hour Subcutaneous Infusion of ND0612 Abstract #: 665 Dopaminergic Adverse Events With 24-hour Subcutaneous Infusion of ND0612 Abstract #: 684 MTPA will also host an educational disease awareness discussion on PD during the Corporate Therapeutic Symposium on September 29, 1:00-2:00 p.m. ET. About ND0612 ND0612 is an investigational drug-device combination therapy – a 24-hours/day, 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), the pharma arm of Mitsubishi Chemical Group (MCG), is one of the oldest pharmaceutical companies in the world, founded in 1678. MTPC is headquartered in Doshomachi, Osaka, the birthplace of Japan's pharmaceutical industry. MCG has positioned health care as its strategic focus in its management policy, "Forging the future". 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 and additionally 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] 1 National Institute of Neurological Disorders and Stroke. Parkinson's Disease: Challenges, Progress and Promise. . Accessed August 2024. 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

Posters will highlight findings from studies evaluating investigational ND0612 in Parkinson's disease and RADICAVA ORS® (edaravone) in ALS JERSEY CITY, N.J., Sept. 12, 2024 /PRNewswire/ -- Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced four presentations will be shared at the American Neurological Association (ANA) 2024 Annual Meeting being held September 14-17 in Orlando, Fla. The presentations will discuss two abstracts in Parkinson's disease (PD) and two in amyotrophic lateral sclerosis (ALS). "We look forward to sharing the latest findings from our studies in Parkinson's disease and ALS at this year's ANA meeting," said Gustavo A. Suarez Zambrano, M.D., Vice President of Medical Affairs, MTPA. "Our presentations underscore our unwavering commitment to understanding the high unmet needs within these patient communities through continuous research and innovation." PD data to be presented at the meeting include: Investigational ND0612 Presentations include findings from subgroup analyses from the pivotal Phase 3 BouNDless trial (NCT04006210) evaluating the efficacy and safety of investigational ND0612 across a range of sociodemographic groups of people with PD experiencing motor fluctuations, as well as findings from an integrated analysis characterizing infusion site reactions reported in patients treated with ND0612. Efficacy of ND0612 a 24-hour Subcutaneous Levodopa/Carbidopa Infusion for People with Parkinson's Disease Experiencing Motor Fluctuations: Subgroup-Analyses from a Randomized, Controlled Phase 3 Study (Antoinette Harrison, PharmD, BCGP, PCPP, FASCP; MTPA) Poster #M2.123: 6:00 p.m. – 7:30 p.m. EST, September 16 Characterization of Infusion Site Reactions With 24-hour Subcutaneous Infusion of ND0612 (Antoinette Harrison, PharmD, BCGP, PCPP, FASCP; MTPA) Poster #M2.124: 6:00 p.m. – 7:30 p.m. EST, September 16 ALS data to be presented at the meeting include: RADICAVA ORS Final data from the global, double-blind Phase 3b study MT-1186-A02 will be showcased, including the post-marketing study of an investigational once-daily dosing regimen of RADICAVA ORS® (edaravone) to evaluate whether investigational daily dosing displayed superior efficacy vs. the approved on/off dosing regimen of oral edaravone in patients with ALS over 48 weeks. In addition, full results from the RADICAVA ORS Phase 3 open-label safety extension study (MT-1186-A03), which spans 96 weeks, will be presented. Phase 3b Study MT-1186-A02 to Investigate the Superiority of Daily Dosing vs the FDA-approved On/Off Regimen of Oral Edaravone in Patients with Amyotrophic Lateral Sclerosis (Alejandro Salah, M.D. Ph.D., MBA, MHA; MTPA) Poster #M2.029: 6:00 p.m. – 7:30 p.m. EST, September 16 Phase 3, Open-Label, Safety Extension Study of Oral Edaravone Administered Over 96 Weeks in Patients with ALS (MT-1186-A03) (Alejandro Salah, M.D. Ph.D., MBA, MHA; MTPA) Poster #M2.046: 6:00 p.m. – 7:30 p.m. EST, September 16 About RADICAVA ® (edaravone) and RADICAVA ORS ® (edaravone) The U.S. Food and Drug Administration (FDA) approved RADICAVA® (edaravone) on May 5, 2017, and the oral formulation RADICAVA ORS® (edaravone) on May 12, 2022, for the treatment of amyotrophic lateral sclerosis (ALS). In 2024, the FDA recognized RADICAVA ORS with Orphan Drug Exclusivity based on the major contribution to patient care of the innovative oral formulation. RADICAVA is administered in 28-day cycles by intravenous (IV) infusion. It takes 60 minutes to receive each 60 mg dose. For the initial cycle, the treatment is infused daily for 14 consecutive days, followed by a two-week drug-free period. All cycles thereafter are infused daily for 10 days within a 14-day period, followed by a two-week drug-free period. RADICAVA ORS is taken daily for 14 consecutive days followed by a 14-day drug-free period for the initial treatment cycle. For subsequent treatment cycles, RADICAVA ORS is taken for 10 days within a 14-day period followed by a 14-day drug-free period. RADICAVA ORS should be taken in the morning after overnight fasting. Patients should not eat or drink (except water) within one hour after taking RADICAVA ORS.1 Edaravone was discovered and developed for ALS by Mitsubishi Tanabe Pharma Corporation (MTPC) and commercialized in the U.S. by Mitsubishi Tanabe Pharma America, Inc. (MTPA). The MTPC group companies began researching ALS in 2001 through an iterative clinical platform over a 13-year period. In 2015, edaravone was approved as RADICUT® for the treatment of ALS in Japan and South Korea. Marketing authorizations were subsequently granted in Canada (October 2018), Switzerland (January 2019), Indonesia (July 2020), Thailand (April 2021), Malaysia (December 2021) and Brazil (February 2024). Marketing authorization for RADICAVA® Oral Suspension was granted in Canada (November 2022) and Switzerland (May 2023), and RADICUT® Oral Suspension 2.1% was granted regulatory approval in Japan in December 2022. To date, in the U.S., RADICAVA and RADICAVA ORS have been used to treat over 16,000 people with ALS, with over 1.9-million days of therapy, and have been prescribed by over 2,400 HCPs.2-4 IMPORTANT SAFETY INFORMATION Hypersensitivity Reactions RADICAVA (edaravone) and RADICAVA ORS (edaravone) are contraindicated in patients with a history of hypersensitivity to edaravone or any of the inactive ingredients of this product. Hypersensitivity reactions (redness, wheals, and erythema multiforme) and cases of anaphylaxis (urticaria, decreased blood pressure, and dyspnea) have occurred with RADICAVA. Patients should be monitored carefully for hypersensitivity reactions. If hypersensitivity reactions occur, discontinue RADICAVA or RADICAVA ORS, treat per standard of care, and monitor until the condition resolves. Sulfite Allergic Reactions RADICAVA and RADICAVA ORS contain sodium bisulfite, a sulfite that may cause allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown but occurs more frequently in asthmatic people. Adverse Reactions The most common adverse reactions (≥10%) reported in RADICAVA-treated patients were contusion (15%), gait disturbance (13%), and headache (10%). In an open label study, fatigue was also observed in 7.6% of patients receiving RADICAVA ORS. Pregnancy Based on animal data, RADICAVA and RADICAVA ORS may cause fetal harm. To report suspected adverse reactions or product complaints, contact Mitsubishi Tanabe Pharma America, Inc., at 1-888-292-0058. You may also report suspected adverse reactions to the FDA at 1-800-FDA-1088 or . INDICATION RADICAVA and RADICAVA ORS are indicated for the treatment of amyotrophic lateral sclerosis (ALS). For more information, including full Prescribing Information , please visit . About ND0612 ND0612 is an investigational drug-device combination therapy – a 24-hours/day, 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), the pharma arm of Mitsubishi Chemical Group (MCG), is one of the oldest pharmaceutical companies in the world, founded in 1678. MTPC is headquartered in Doshomachi, Osaka, the birthplace of Japan's pharmaceutical industry. MCG has positioned health care as its strategic focus in its management policy, "Forging the future". 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 and additionally 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] 1 RADICAVA and RADICAVA ORS Prescribing Information. Jersey City, NJ: Mitsubishi Tanabe Pharma America, Inc.; 2022. 2 Data on file. Mitsubishi Tanabe Pharma America, Inc. 3 Data on file. Mitsubishi Tanabe Pharma America, Inc. 4 Data on file. Mitsubishi Tanabe Pharma America, Inc. 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