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.
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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.
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