\nWeek 0
\n
Enrollment\n<\/p>\n
\n\u00a0\n<\/p>\n<\/td>\n
\nWeek 7
\n
Baseline
\n
(Randomization)\n<\/p>\n<\/td>\n
\nWeek 20
\n
End of Study
\n
(or Early Termination)\n<\/p>\n<\/td>\n
\np-value\n<\/p>\n<\/td>\n<\/tr>\n
Mean \u201cGood On\u201d time (h)<\/b><\/p>\n<\/td>\n<\/tr>\n \nIPX-203\n<\/p>\n<\/td>\n \n9.46\n<\/p>\n<\/td>\n \n11.67\n<\/p>\n<\/td>\n \n11.35\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n \n0.0194\u2206<\/sup><\/p>\n<\/td>\n<\/tr>\n \nimmediate-release CD\/LD\n<\/p>\n<\/td>\n \n9.61\n<\/p>\n<\/td>\n \n11.72\n<\/p>\n<\/td>\n \n10.77\n<\/p>\n<\/td>\n<\/tr>\n Mean \u201cOff\u201d time (h)<\/b><\/p>\n<\/td>\n<\/tr>\n \nIPX-203\n<\/p>\n<\/td>\n \n6.15\n<\/p>\n<\/td>\n \n3.95\n<\/p>\n<\/td>\n \n4.18\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n \n0.0252\u2206<\/sup><\/p>\n<\/td>\n<\/tr>\n \nimmediate-release CD\/LD\n<\/p>\n<\/td>\n \n6.05\n<\/p>\n<\/td>\n \n4.02\n<\/p>\n<\/td>\n \n4.75\n<\/p>\n<\/td>\n<\/tr>\n Percentage of patients who reported \u201cmuch improved\u201d or \u201cvery much improved\u201d scores on the PGI-C scale<\/b><\/p>\n<\/td>\n<\/tr>\n \nIPX-203\n<\/p>\n<\/td>\n \nN\/A\n<\/p>\n<\/td>\n \nN\/A\n<\/p>\n<\/td>\n \n29.7%\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n \n0.0015\u25a1<\/sup><\/p>\n<\/td>\n<\/tr>\n \nimmediate-release CD\/LD\n<\/p>\n<\/td>\n \nN\/A\n<\/p>\n<\/td>\n \nN\/A\n<\/p>\n<\/td>\n \n18.8%\n<\/p>\n<\/td>\n<\/tr>\n Mean MDS-UPDRS part III score<\/b><\/p>\n<\/td>\n<\/tr>\n \nIPX-203\n<\/p>\n<\/td>\n \n29.6\n<\/p>\n<\/td>\n \n26.9\n<\/p>\n<\/td>\n \n27.8\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n \n0.9587\u2206<\/sup><\/p>\n<\/td>\n<\/tr>\n \nimmediate-release CD\/LD\n<\/p>\n<\/td>\n \n29.7\n<\/p>\n<\/td>\n \n27.0\n<\/p>\n<\/td>\n \n28.0\n<\/p>\n<\/td>\n<\/tr>\n Mean MDS-UPDRS Sum of part II + III score<\/b><\/p>\n<\/td>\n<\/tr>\n \nIPX-203\n<\/p>\n<\/td>\n \n42.9\n<\/p>\n<\/td>\n \n38.9\n<\/p>\n<\/td>\n \n40.6\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n \n0.9668\u2206<\/sup><\/p>\n<\/td>\n<\/tr>\n \nimmediate-release CD\/LD\n<\/p>\n<\/td>\n \n42.9\n<\/p>\n<\/td>\n \n39.3\n<\/p>\n<\/td>\n \n41.1\n<\/p>\n<\/td>\n<\/tr>\n<\/table>\n \n\u2206 = p-value based on change from Week 7 (Baseline) to Week 20 (End of Study or Early Termination [EOS\/ET])\n<\/p>\n \n\u25a1 = p-value based on comparison of treatments at Week 20 (EOS\/ET)\n<\/p>\n \nThe trial was conducted at 108 clinical sites in the U.S. and European countries, including Czechia, France, Germany, Italy, Poland, Spain and the United Kingdom. The study randomized 506 patients with PD age 40 and older. The study design was reviewed by the FDA and conducted pursuant to a Special Protocol Assessment.\n<\/p>\n \nIn the randomized patient population, eight (3.1%) subjects reported serious adverse events (SAEs) in the IPX-203 study arm and four (1.6%) subjects reported SAEs in the immediate-release CD\/LD arm. Treatment-emergent adverse events (TEAEs) were reported for both study arms (108 [42.2%] for IPX-203, 79 [31.6%] for immediate-release CD\/LD). The most common AEs (\u22653%) were nausea, dry mouth, urinary tract infection, and fall.\n<\/p>\n \n\u201cDespite the introduction of several new medications for Parkinson\u2019s disease in recent years, new treatment options are needed that provide longer-lasting duration of benefit with each dose and simplify medication regimens for patients affected by this devastating disease,\u201d Alberto Espay, MD, FAAN, Professor of Neurology at the University of Cincinnati, Director of James J. and Joan A. Gardner Family Center, and Research Chair for Parkinson\u2019s Disease and Movement Disorders.\n<\/p>\n \n\u201cThe topline data from RISE-PD indicates that IPX-203 has the potential to offer patients superior \u2018Good On\u2019 time with reduced dosing frequency, compared to immediate-release CD\/LD,\u201d said Robert A. Hauser, M.D., Professor of Neurology at the University of South Florida and Director of the Parkinson’s Disease and Movement Disorders Center.\n<\/p>\n \n\u201cThese positive data from the Phase 3 trial of IPX-203 represent a substantial step forward in strengthening Amneal\u2019s Specialty Pharma portfolio, which is heavily focused on medicines for central nervous system disorders,\u201d said Chirag and Chintu Patel, Co-Chief Executive Officers, Amneal. \u201cWe look forward to submitting an NDA with the FDA and potentially making this treatment available to the PD community.\u201d\n<\/p>\n Conference Call Details \nPlease visit https:\/\/lifesci.rampard.com\/WebcastingAppv5\/Events\/eventsDispatcher.jsp?Y2lk=MTM2Mg==<\/a> to register and access the live webinar. A replay will be made available on the company\u2019s website for six months. The presentation materials will be posted on the Investor Relations website following the conclusion of the event.\n<\/p>\n About the Pivotal Phase 3 RISE-PD Trial \nThe trial consisted of a 3-week, open-label immediate-release CD\/LD dose adjustment period and a 4-week, open-label period for conversion to IPX-203. This was followed by a 13-week double-blind treatment period in which patients were randomized 1:1 to receive either IPX-203 (with matching immediate-release CD\/LD placebo) or immediate-release CD\/LD (with matching IPX-203 placebo). Baseline for all endpoints was Week 7 (Visit 4), which occurred pre-randomization.\n<\/p>\n \nThe primary endpoint of the trial assessed the change from baseline in \u201cGood On\u201d time in hours per day at the end of the double-blind treatment period (Week 20 or early termination). \u201cGood On\u201d time is defined as the sum of \u201cOn\u201d time without dyskinesia and \u201cOn\u201d time with non-troublesome dyskinesia. Secondary endpoints assessed the change from baseline in \u201cOff\u201d time in hours per day, proportion of patients who were either \u201cmuch improved\u201d or \u201cvery much improved\u201d in Patients’ Global Impression of Change (PGI-C) scores, change from baseline in the Movement Disorder Society – Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part III score, and the change from baseline in sum of MDS-UPDRS Parts II and III scores.\n<\/p>\n \nThe trial was conducted at 108 clinical sites in the U.S. and European countries, including Czechia, France, Germany, Italy, Poland, Spain and the United Kingdom. The study randomized 506 patients with PD age 40 and older. The study design was reviewed by the FDA and conducted pursuant to a Special Protocol Assessment. A nine-month safety extension study is ongoing.\n<\/p>\n About IPX-203 About Amneal \nAmneal has an extensive portfolio of approximately 250 generic product families and is expanding its portfolio to include complex dosage forms, including biosimilars, in a broad range of therapeutic areas. The Company also markets a portfolio of branded pharmaceutical products through its Specialty segment focused principally on central nervous system and endocrine disorders.\n<\/p>\n \nThe Company also owns 65% of AvKARE. AvKARE provides pharmaceuticals, medical and surgical products and services primarily to governmental agencies, primarily focused on serving the Department of Defense and the Department of Veterans Affairs. AvKARE is also a packager and wholesale distributor of pharmaceuticals and vitamins to its retail and institutional customers who are located throughout the United States focused primarily on offering 340b-qualified entities products to provide consistency in care and pricing. For more information, visit www.amneal.com<\/a>.\n<\/p>\n Forward-Looking Statements \nThe reader is cautioned not to rely on these forward-looking statements. These forward-looking statements are based on current expectations of future events. If the underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of the Company.\n<\/p>\n \nSuch risks and uncertainties include, but are not limited to: the impact of the COVID-19 pandemic; the impact of global economic conditions; our ability to successfully develop, license, acquire and commercialize new products on a timely basis; our ability to obtain exclusive marketing rights for our products; the competition we face in the pharmaceutical industry from brand and generic drug product companies, and the impact of that competition on our ability to set prices; our ability to manage our growth through acquisitions and otherwise; our dependence on the sales of a limited number of products for a substantial portion of our total revenues; the risk of product liability and other claims against us by consumers and other third parties; risks related to changes in the regulatory environment, including U.S. federal and state laws related to healthcare fraud abuse and health information privacy and security and changes in such laws; changes to FDA product approval requirements; risks related to federal regulation of arrangements between manufacturers of branded and generic products; the impact of healthcare reform and changes in coverage and reimbursement levels by governmental authorities and other third-party payers; the continuing trend of consolidation of certain customer groups; our reliance on certain licenses to proprietary technologies from time to time; our dependence on third-party suppliers and distributors for raw materials for our products and certain finished goods; our dependence on third-party agreements for a portion of our product offerings; our ability to identify and make acquisitions of or investments in complementary businesses and products on advantageous terms; legal, regulatory and legislative efforts by our brand competitors to deter competition from our generic alternatives; the significant amount of resources we expend on research and development; our substantial amount of indebtedness and our ability to generate sufficient cash to service our indebtedness in the future, and the impact of interest rate fluctuations on such indebtedness; and the high concentration of ownership of our Class A Common Stock and the fact that we are controlled by the Amneal Group. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company\u2019s filings with the Securities and Exchange Commission, including under Item 1A, \u201cRisk Factors\u201d in the Company\u2019s most recent Annual Report on Form 10-K and in its subsequent reports on Forms 10-Q and 8-K. Investors are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date they are made. Forward-looking statements included herein speak only as of the date hereof and we undertake no obligation to revise or update such statements to reflect the occurrence of events or circumstances after the date hereof.\n<\/p>\n View source version on businesswire.com: <\/span>https:\/\/www.businesswire.com\/news\/home\/20210825005679\/en\/<\/a><\/span><\/p>\n Investor Contact Media Contact Amneal Medical Affairs KEYWORDS:<\/b> United States North America New Jersey<\/p>\n INDUSTRY KEYWORDS:<\/b> Health Clinical Trials Research Pharmaceutical Science Biotechnology<\/p>\n\n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n
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<\/b>Amneal will host a conference call today, Wednesday, August 25, 2021, at 4:30 p.m. ET that will feature members of Amneal\u2019s management team as well as Alberto Espay, MD, MSc, FAAN, FANA (University of Cincinnati), and Robert A Hauser, MD, MBA, FAAN (University of South Florida) to discuss topline results from the pivotal Phase 3 RISE-PD clinical trial. The presentation will be followed by a live Q&A session.\n<\/p>\n
\n
<\/b>The multicenter, randomized, double-blind, double-dummy, active-controlled, parallel-group RISE-PD trial evaluated the efficacy and safety of IPX-203 CD\/LD extended-release capsules compared with immediate-release CD\/LD in the treatment of patients with PD who have motor fluctuations.\n<\/p>\n
\n
<\/b>IPX-203 is a novel, oral formulation of CD\/LD extended-release capsules for patients with PD who have motor fluctuations. IPX-203 was developed with an innovative formulation that contains immediate-release and extended-release granules, and mucoadhesive polymers, to provide rapid absorption and maximize levodopa absorption. This formulation is distinct from RYTARY\u00ae<\/sup> (carbidopa\/levodopa) extended-release capsules, Amneal\u2019s extended-release CD\/LD treatment for PD approved by the U.S. FDA in 2015.\n<\/p>\n
\n
<\/b>Amneal Pharmaceuticals, Inc. (NYSE: AMRX), headquartered in Bridgewater, NJ, is a fully-integrated pharmaceutical company focused on the development, manufacturing and distribution of generic and specialty drug products. The Company has operations in North America, Asia, and Europe, working together to bring high-quality medicines to patients primarily within the United States.\n<\/p>\n
\n
<\/b>Certain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management\u2019s intentions, plans, beliefs, expectations or forecasts for the future, including among other things: discussions of future operations; expected operating results and financial performance; impact of planned acquisitions and dispositions; the Company\u2019s strategy for growth; product development; regulatory approvals; market position and expenditures. Words such as \u201cplans,\u201d \u201cexpects,\u201d \u201cwill,\u201d \u201canticipates,\u201d \u201cestimates\u201d and similar words are intended to identify estimates and forward-looking statements.\n<\/p>\n<\/p>\n
\n<\/b>
Anthony DiMeo
\n
Senior Director, Investor Relations
\n
anthony.dimeo@amneal.com<\/a><\/p>\n
\n<\/b>
Julie Normart
\n
Group Director, Media and Engagement, Real Chemistry
\n
jnormart@realchemistry.com<\/a><\/p>\n
\n<\/b>
888-990-AMRX (2679)
\n
askamrx@amneal.com<\/a><\/p>\n
![\"Logo\"](\"https:\/\/mms.businesswire.com\/media\/20210825005679\/en\/803761\/3\/amneallogo.jpg\")
<\/td>\n<\/tr>\n