BRIDGEWATER, N.J. - Amneal Pharmaceuticals, Inc. (NASDAQ:AMRX) has announced the launch of CREXONT® (carbidopa and levodopa) extended-release capsules, a new treatment for Parkinson's disease now available in U.S. pharmacies. The medication offers a novel oral formulation that combines immediate-release granules and extended-release pellets, designed to provide patients with longer periods of symptom control, known as "Good On" time, with less frequent dosing.
Starting today, healthcare providers can schedule appointments with Amneal sales representatives to discuss CREXONT and obtain samples. Amneal is also offering a savings program that may reduce the copay for eligible commercially insured patients to $25. For patients who need additional assistance, the Amneal Patient Assistance Program and CoverMyMeds® service are available to facilitate access to the medication.
In conjunction with the launch, Amneal will host a symposium and present scientific data at the International Congress of Parkinson's Disease and Movement Disorders in Philadelphia, PA, from September 27 to October 1, 2024. Dr. Robert Hauser, the principal investigator for CREXONT, will introduce the drug at a symposium on September 27, and further data will be presented on September 29, including an analysis of patient diary data regarding motor states upon awakening.
CREXONT's formulation and dosage strengths differ from RYTARY® (carbidopa and levodopa) extended-release capsules, which the U.S. FDA approved in 2015. The new drug is indicated for the treatment of Parkinson's disease and related conditions and is available only by prescription. However, patients are advised not to take CREXONT with certain antidepressants known as nonselective monoamine oxidase (MAO) inhibitors and to avoid activities requiring alertness until they know how the drug affects them.
Parkinson's disease is the fastest-growing neurological disorder worldwide, with an estimated 1 million people diagnosed in the U.S. It is a progressive disorder that affects movement and is characterized by symptoms such as slowness of movement, stiffness, and impaired balance.
This launch represents an addition to Amneal's portfolio, which includes over 280 generic and specialty pharmaceuticals. The information regarding CREXONT's availability and the upcoming symposium is based on a press release statement from Amneal Pharmaceuticals, Inc.
In other recent news, Amneal Pharmaceuticals has seen significant growth, underscored by a surge in Q2 revenues to $702 million, a 17% increase. This strong performance led to an upward revision of its full-year guidance for 2024. The company's success has been attributed to its strategic focus on complex generics and biosimilars. JPMorgan recently upgraded Amneal's stock from Underweight to Neutral, highlighting the firm's business transformation and expected compound annual growth rate (CAGR) of 9% from 2024 to 2028.
Amneal has received FDA approval for BORUZU, a new oncology drug designed for the treatment of multiple myeloma and mantle cell lymphoma. This marks a significant expansion of their branded oncology injectable portfolio. Additionally, the company gained FDA approval for its generic propofol, addressing the chronic shortage of this essential anesthetic.
These recent developments are part of Amneal's commitment to growth and market expansion. The company's specialty revenues are projected to surpass $500 million by 2027, bolstered by the approval of a new Parkinson's disease drug, CREXONT. Furthermore, Amneal is expanding internationally, expecting revenues of $50 million to $100 million by 2027, and plans to launch five additional biosimilar products between 2025 and 2027.
InvestingPro Insights
As Amneal Pharmaceuticals, Inc. (NASDAQ:AMRX) launches CREXONT® for Parkinson's disease, the company's financial health and market performance are essential for investors tracking its growth potential. According to recent data from InvestingPro, Amneal has a market capitalization of $2.69 billion, showcasing its significant size within the pharmaceutical industry. The company's revenue has grown by 12.37% over the last twelve months as of Q2 2024, indicating a positive trajectory in its financial performance. Additionally, the gross profit margin stands at a healthy 37.15%, which suggests that Amneal is effectively managing its production costs and maintaining profitability on its products.
InvestingPro Tips highlight that analysts expect Amneal's net income to grow this year, which could be bolstered by the new product launches such as CREXONT. However, it's important to note that three analysts have revised their earnings downwards for the upcoming period. This could signal caution for investors relying on earnings growth as a key metric. For those looking at long-term performance, Amneal has delivered a strong return over the last year, with the price total return reaching 107.64%.
Investors interested in a deeper dive into Amneal's performance and prospects can find additional InvestingPro Tips on the company's profile, which includes insights on valuation, profitability, and stock performance trends. With a total of 11 InvestingPro Tips available, individuals can gain a comprehensive understanding of the factors that may influence Amneal's future in the competitive pharmaceutical market.
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