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Amneal Launches PEMRYDI RTU®, the First Ready-to-Use Version of Important Oncology Injectable Medicine
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Amneal Pharmaceuticals, Inc. launches PEMRYDI RTU®, the first ready-to-use version of pemetrexed for injection, catering to non-squamous non-small cell lung cancer and malignant pleural mesothelioma patients. The product eliminates the need for reconstitution, dilution, or refrigeration, enhancing pharmacy efficiency. Amneal plans to introduce two to three branded oncology 505(b)(2) products annually, with PEMRYDI RTU® being the first in 2024.
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The introduction of PEMRYDI RTU® represents a significant advancement in the administration of pemetrexed, an established chemotherapy drug for certain types of lung cancer and mesothelioma. Unlike conventional pemetrexed formulations, this ready-to-use version simplifies the preparation process, potentially reducing the risk of medication errors during reconstitution and saving time in busy clinical settings. It's essential to review the efficacy and safety profile of such a product in comparison to existing treatments. While adverse effects appear to be consistent with pemetrexed's known profile, close monitoring for myelosuppression and renal failure among others remains important for patient safety.
Amneal's strategy to target the oncology market with a focus on 505(b)(2) injectables could cater to a niche but critically important segment. The unique J-Code granted by CMS for PEMRYDI RTU® could streamline the reimbursement process, making it more accessible to healthcare providers and patients. The U.S. sales figures demonstrate a robust market for pemetrexed and a simplified administration could enhance market share. However, competition from biosimilars and generics, pricing and adoption hurdles should be carefully monitored to gauge the long-term commercial success of the product.
Amneal Pharmaceuticals' introduction of a novel injectable like PEMRYDI RTU® may be indicative of future revenue streams arising from their oncology portfolio. The commitment to launching additional branded products annually could signal sustained growth potential. Such product launches may improve earnings forecasts, but it is pivotal to assess the cost of investment in development and marketing against the sales revenue. One must also consider the implications of the product's shelf life and storage advantages for the company's operational efficiencies and potential market expansion.
Novel 505(b)(2) presentation of a key injectable for treating non-squamous non-small cell lung cancer and malignant pleural mesothelioma, does not require reconstitution, dilution, or refrigeration
Amneal plans to launch two to three branded oncology 505(b)(2) products per year going forward – this is the first of 2024
BRIDGEWATER, N.J.--(BUSINESS WIRE)--
Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced the launch of PEMRYDI RTU®, the first and only ready-to-use presentation of pemetrexed for injection. This product does not require reconstitution, dilution, or refrigeration, which is different than other versions of pemetrexed for injection.
“The launch of PEMRYDI RTU highlights Amneal’s deep commitment to oncology as we invest to develop injectable products that are important to healthcare providers and patients,” said Sean McGowan, Vice President, Biosimilars and Branded Oncology. “In this first ready-to-use version, we offer hospitals and oncology clinics a new, value-added presentation that should improve pharmacy efficiency by eliminating preparation steps and freeing up refrigerator space with shelf stability for up to 24 months. We expect to launch two to three 505(b)(2) injectables per year going forward.”
PEMRYDI RTU® has a unique J-Code from the Centers for Medicare & Medicaid Services (CMS) to facilitate reimbursement: J9324: Injection, pemetrexed (pemrydi rtu). PEMRYDI RTU® injectable is available in two vial sizes: 100mg/10mL and 500 mg/50mL.
PEMRYDI RTU® is indicated, in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous non-small cell lung cancer with no EGFR or ALK genomic tumor aberration and for initial treatment, in combination with cisplatin, of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery.
Adverse effects include myelosuppression, renal failure, skin toxicity, interstitial pneumonitis and radiation recall. For full prescribing information, see package insert located here.
According to IQVIA®, U.S. annual sales for pemetrexed for the 12 months ended February 2024 were $287 million.
About Amneal
Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in Bridgewater, NJ, is a global pharmaceutical company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of over 270 pharmaceutical products, primarily within the United States. In its Generics segment, the Company is expanding across a broad range of complex product categories and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceuticals focused primarily on central nervous system and endocrine disorders, with a pipeline focused on unmet needs. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. For more information, please visit www.amneal.com.
Cautionary Statement on Forward-Looking Statements
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’s intentions, plans, beliefs, expectations, financial results, or forecasts for the future, including among other things: discussions of future operations; expected or estimated operating results and financial performance; and statements regarding our positioning, including our ability to drive sustainable long-term growth, and other non-historical statements. Words such as “plans,” “expects,” “will,” “anticipates,” “estimates,” and similar words, or the negatives thereof, are intended to identify estimates and forward-looking statements.
The reader is cautioned not to rely on these forward-looking statements. These forward-looking statements are based on current expectations of future events, including with respect to future market conditions, company performance and financial results, operational investments, business prospects, new strategies and growth initiatives, the competitive environment, and other 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.
Such risks and uncertainties include, but are not limited to: our ability to successfully develop, license, acquire and commercialize new products on a timely basis; 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 obtain exclusive marketing rights for our products; our revenues are derived from the sales of a limited number of products, a substantial portion of which are through a limited number of customers; the impact of a prolonged business interruption within our supply chain; the continuing trend of consolidation of certain customer groups; our dependence on third-party suppliers and distributors for raw materials for our products and certain finished goods; legal, regulatory and legislative efforts by our brand competitors to deter competition from our generic alternatives; our dependence on information technology systems and infrastructure and the potential for cybersecurity incidents; our ability to attract, hire and retain highly skilled personnel; risks related to federal regulation of arrangements between manufacturers of branded and generic products; our reliance on certain licenses to proprietary technologies from time to time; the significant amount of resources we expend on research and development; the risk of claims brought against us by 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 Food and Drug Administration product approval requirements; the impact of healthcare reform and changes in coverage and reimbursement levels by governmental authorities and other third-party payers; our dependence on third-party agreements for a portion of our product offerings; 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; our potential expansion into additional international markets subjecting us to increased regulatory, economic, social and political uncertainties, including recent events affecting the financial services industry; our ability to identify, make and integrate acquisitions or investments in complementary businesses and products on advantageous terms; the impact of global economic, political or other catastrophic events; our obligations under a tax receivable agreement may be significant; 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’s filings with the Securities and Exchange Commission, including under Item 1A, “Risk Factors” in the Company’s 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.
What is the name of the new product launched by Amneal Pharmaceuticals, Inc.?
The new product launched by Amneal Pharmaceuticals, Inc. is called PEMRYDI RTU®.
What is unique about PEMRYDI RTU® compared to other versions of pemetrexed for injection?
PEMRYDI RTU® does not require reconstitution, dilution, or refrigeration, making it the first ready-to-use presentation of pemetrexed for injection.
What is the unique J-Code assigned to PEMRYDI RTU® by the Centers for Medicare & Medicaid Services (CMS)?
The unique J-Code assigned to PEMRYDI RTU® by CMS is J9324: Injection, pemetrexed (pemrydi rtu).
What are the available vial sizes for PEMRYDI RTU®?
PEMRYDI RTU® is available in two vial sizes: 100mg/10mL and 500 mg/50mL.
What are the indications for using PEMRYDI RTU®?
PEMRYDI RTU® is indicated for the initial treatment of patients with metastatic non-squamous non-small cell lung cancer and for initial treatment of patients with malignant pleural mesothelioma.
What are some of the adverse effects associated with PEMRYDI RTU®?
Adverse effects of PEMRYDI RTU® include myelosuppression, renal failure, skin toxicity, interstitial pneumonitis, and radiation recall.
What were the U.S. annual sales for pemetrexed for the 12 months ended February 2024?
According to IQVIA®, U.S. annual sales for pemetrexed for the 12 months ended February 2024 were $287 million.
