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News Release - May 7, 2018
Amneal Initiates Phase 3 Study for IPX203, an Investigational Extended-Release Formulation of Carbidopa-Levodopa (CD-LD) in Advanced Parkinson's Disease PatientsBRIDGEWATER, N.J., May 7, 2018 -- (Healthcare Sales & Marketing Network) -- Amneal (NYSE: AMRX), a specialty pharmaceutical company, today announced it has initiated a Phase 3 trial for IPX203. The IPX203 Phase 3 protocol has been agreed upon with the Food and Drug Administration (FDA) in a Special Protocol Assessment. The study is a randomized, multicenter, double-blind, active-controlled, parallel group study of IPX203 versus immediate-release (IR) carbidopa-levodopa (CD-LD) in patients with advanced Parkinson's disease conducted to assess the safety and efficacy of IPX203. Approximately 500 patients are planned to be enrolled.
"The results from the Phase 2b study provide supporting data on the safety and efficacy profile of the investigational drug, IPX203, and underscore the importance of continuing its evaluation in patients with Parkinson's disease," said Robert Stewart, President and Chief Executive Officer of Amneal. "We are committed to investing in our Specialty business and bringing important products to market for the benefit of patients."
Results from a multiple-dose Phase 2b study in 28 patients with advanced Parkinson's disease, confirmed earlier results from a Phase 2a single dose study that were previously presented at the 2017 American Academy of Neurology meeting as part of the Emerging Science program. Treatment-emergent adverse events (TEAEs) reported in two or more subjects in the multiple-dose study included nausea, dizziness, and dyskinesia.
Dr. Robert Hauser, Professor of Neurology at the University of South Florida and Director of the Parkinson's Disease and Movement Disorders Center said, "As Parkinson's disease progresses, patients develop motor fluctuations such that the improvement from a dose of standard levodopa formulations, called "On", lasts a shorter time and then symptoms return. IPX203 demonstrated a significant increase in the duration of "On" time in both single and multiple dose studies."
The company has also discussed the Chemistry and Manufacturing Controls and clinical development plans for IPX203 with the FDA in end of Phase 2 meetings. The Phase 3 clinical development plan includes a single pivotal double-blind, 13-week efficacy and safety study followed by a nine-month safety extension study.
IPX203 is an investigational extended-release oral capsule formulation of carbidopa and levodopa, being studied as a potential treatment for the symptoms of advanced Parkinson's disease. It is designed to have an onset of effect similar to IR CD-LD while providing a longer duration of effect compared to other oral levodopa products available.
Amneal Pharmaceuticals, Inc. (NYSE: AMRX), headquartered in Bridgewater, NJ, is an integrated specialty pharmaceutical company focused on developing, manufacturing and distributing generic, brand and biosimilar products. The Company has more than 6,500 employees in its operations in North America, Asia, and Europe, working together to bring high-quality medicines to patients primarily within the United States.
Amneal is one of the largest and fastest growing generic pharmaceutical manufacturers in the United States, with an expanding portfolio of generic products to include complex dosage forms in a broad range of therapeutic areas. The Company markets a portfolio of branded pharmaceutical products through its Impax Specialty Pharma division focused principally on central nervous system disorders and parasitic infections. For more information, visit www.amneal.com.
"Safe Harbor" statement under the Private Securities Litigation Reform Act of 1995: Certain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in Section 27A of the United States Securities Act of 1933, as amended, and Section 21E of the United States Securities Exchange Act of 1934, as amended). We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995 and include this statement for purposes of complying with the safe harbor provisions. Such forward-looking statements include statements regarding management's intentions, plans, beliefs, expectations or forecasts for the future. The words such as "may," "might," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "seek," "believe," "estimate," "predict," "potential," "continue," "contemplate," "possible," and similar words are intended to identify estimates and forward-looking statements.
Such forward-looking statements are based on the expectations of Amneal Pharmaceuticals, Inc. (the "Company") and involve risks and uncertainties; consequently, actual results may differ materially from those expressed or implied in the statements. Such risks and uncertainties include, but are not limited to, (i) the impact of global economic conditions, (ii) our ability to integrate the operations of Amneal Pharmaceuticals LLC and Impax Laboratories, Inc. and ability to realize the anticipated synergies and other benefits of the combination, (iii) our ability to successfully develop or commercialize new products, (iv) our ability to obtain exclusive marketing rights for our products or to introduce products on a timely basis, (v) the intense competition we face in the pharmaceutical industry from brand and generic drug product companies, (vi) our ability to manage our growth, (vii) the impact of competition, (viii) the illegal distribution and sale by third parties of counterfeit versions of our products or stolen products, (ix) market perceptions of us and the safety and quality of our products, (x) the substantial portion of our total revenues derived from sales of a limited number of products, (xi) our ability to develop, license or acquire and introduce new products on a timely basis, (xii) the ability of our approved products to achieve expected levels of market acceptance, (xiii) the risk that we may discontinue the manufacture and distribution of certain existing products, (xiv) the impact of manufacturing or quality control problems, (xv) product liability risks, (xvi) the regulatory environment, including United States federal and state laws related to healthcare fraud abuse and health information privacy and security; (xvii) changes to FDA product approval requirements; (xviii) federal regulation of arrangements between manufacturers of branded and generic products; (xix) the impact of healthcare reform; (xx) business interruptions at one of our few locations that produce the majority of our products; (xxi) relationships with our major customers; (xxii) the continuing trend of consolidation of certain customer groups, (xxiii) our reliance on certain licenses to proprietary technologies, (xxiv) our dependence on third party suppliers and distributors for raw materials for our products, (xxv) the time necessary to develop generic and branded drug products, (xxvi) our dependence on third parties for testing required for regulatory approval of our products, (xxvii) our dependence on third party agreements for a portion of our product offerings, (xxviii) our ability to make acquisitions of or investments in complementary businesses and products, (xxix) regulatory oversight in international markets, (xxx) our increased exposure to tax liabilities and the impact of recent United State tax legislation, (xxxi) third parties' infringement of our intellectual property rights, (xxxii) our involvement in various legal proceedings, (xxxiii) increased government scrutiny related to our agreements to settle patent litigation, (xxxiv) the impact of legal, regulatory and legislative strategies by our brand competitors, (xxxv) the significant amount of resources we expend on research and development, (xxxvi) our substantial amount of indebtedness, (xxxvii) risks inherent in conducting clinical trials, (xxxviii) our reporting and payment obligations under the Medicaid and other government rebate programs, (xxxix) fluctuations in our operating results, (xl) adjustments to our reserves based on price adjustments and sales allowances, (xli) impact of impairment on our goodwill and other intangible assets, (xlii) investigations and litigation concerning the calculation of average wholesale prices, (xliii) cybersecurity and data leakage risks, (xliv) our ability to attract and retain talented employees and consultants, (xlv) uncertainties involved in the preparation of our financial statements, (xlvi) impact of terrorist attacks and other acts of violence, (xlvii) expansion of social media platforms, (xlviii) our need to raise additional funds in the future, (xlix) the restrictions imposed by the terms of our credit agreement, and (l) our ability to generate sufficient cash to service our indebtedness in the future.
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 events or circumstances after the date hereof or to reflect the occurrence of unanticipated events or circumstances.
Source: Amneal Pharmaceuticals
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