Amneal Launches FOCINVEZ™, the First Ready-to-Use Version of Fosaprepitant

Rhea-AI Summary

Amneal Pharmaceuticals (NASDAQ: AMRX) has launched FOCINVEZ™, the first ready-to-use version of fosaprepitant, an anti-nausea agent used in chemotherapy. Unlike other versions, FOCINVEZ does not require reconstitution or dilution, enhancing pharmacy efficiency. It's approved for adults and children over 6 months for preventing nausea and vomiting in highly and moderately emetogenic chemotherapy. The product has a unique CMS reimbursement code J1434 and reported U.S. sales of $36 million over the past year. Adverse effects include fatigue, diarrhea, and neutropenia. This is Amneal’s second ready-to-use injectable in 2024, marking growth in their injectables portfolio.

Positive

• Amneal launched FOCINVEZ, the first ready-to-use version of fosaprepitant, enhancing pharmacy efficiency.
• FOCINVEZ has a unique CMS reimbursement code J1434, facilitating reimbursement.
• The product targets a market with U.S. annual sales of $36 million.

Negative

• Adverse effects of FOCINVEZ include fatigue, diarrhea, neutropenia, asthenia, anemia, peripheral neuropathy, leukopenia, dyspepsia, urinary tract infection, and pain in extremity.

Insights

Medical Research Analyst

Amneal's launch of FOCINVEZ™ represents a noteworthy advancement in the field of oncology supportive care. The introduction of a ready-to-use (RTU) version of fosaprepitant simplifies the preparation process for healthcare providers, which can be a significant improvement considering the time-sensitive and high-stress environment of cancer treatment centers. The elimination of the need for reconstitution or dilution reduces the risk of preparation errors and increases efficiency.

This product is particularly relevant for preventing chemotherapy-induced nausea and vomiting (CINV), a common and debilitating side effect of cancer treatment. By ensuring that the drug is free of Polysorbate 80, a common excipient that can cause adverse reactions, Amneal potentially lowers the risk of hypersensitivity reactions, enhancing patient safety.

From an investor's perspective, this product's features could ensure higher adoption rates among oncologists, thus driving sales. The unique J-Code (J1434) assigned by CMS also facilitates easier reimbursement, which can be a significant factor in the product's market penetration.

Market Research Analyst

Amneal's introduction of FOCINVEZ™ aligns with the company's strategy to diversify its portfolio with complex and differentiated products. The market for fosaprepitant in the U.S. was valued at $36 million over the past year, indicating a stable demand for this class of antiemetic agents.

Given that this is Amneal’s second RTU injectable launched in 2024, it highlights a deliberate push towards innovations that can streamline hospital and clinic operations. The competitive advantage gained from the RTU format should not be underestimated; it positions Amneal favorably against competitors who offer traditional formulations requiring reconstitution.

In the short term, the launch could drive incremental revenues by tapping into existing demand. Over the long term, Amneal could potentially expand its market share by leveraging the enhanced convenience and safety profile of FOCINVEZ™, thereby attracting more healthcare providers to switch from competing products.

• FOCINVEZ (fosaprepitant) 150 mg/50 mL single dose vial is an anti-nausea agent for highly emetogenic and moderately emetogenic chemotherapy (HEC and MEC)
• Second injectable RTU product launched by Amneal in 2024

BRIDGEWATER, N.J.--(BUSINESS WIRE)-- Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) (“Amneal” or the “Company”) today announced the launch of FOCINVEZ™, a ready-to-use injectable. Unlike other versions of fosaprepitant, this single-dose vial product is free of Polysorbate 80 and does not require reconstitution or dilution and can be administered directly from the vial using the included vial hanger.

FOCINVEZ for injection is indicated in adults and pediatric patients 6 months of age and older, in combination with other antiemetic agents, for the prevention of: acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC), including high-dose cisplatin, and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC).

“We continue to launch differentiated complex products that are clinically impactful,” said Sean McGowan, Vice President, Biosimilars and Branded Oncology. “This is the second ready-to-use injectable we have launched this year that offers hospitals and oncology clinics a new presentation format that can improve pharmacy efficiency. These new 505(b)(2) injectables represent a new vector of growth for our expanding injectables portfolio.”

FOCINVEZ has a unique J-Code from the Centers for Medicare & Medicaid Services (CMS) to facilitate reimbursement: J1434, Injection, fosaprepitant (focinvez), 1 mg, and is available in one vial size 150mg/50mL (3mg/mL).

Adverse effects reported with FOCINVEZ include fatigue, diarrhea, neutropenia, asthenia, anemia, peripheral neuropathy, leukopenia, dyspepsia, urinary tract infection, and pain in extremity. For full prescribing information, see package insert located here.

According to IQVIA^®, U.S. annual sales for fosaprepitant for the 12 months ended April 2024 were approximately $36 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 280 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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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.

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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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240709436382/en/

Investor Contact

Anthony DiMeo

VP, Investor Relations & Media

anthony.dimeo@amneal.com

Source: Amneal Pharmaceuticals, Inc.

FAQ

What is FOCINVEZ by Amneal Pharmaceuticals?

FOCINVEZ is a ready-to-use injectable version of fosaprepitant, an anti-nausea agent used in chemotherapy, launched by Amneal Pharmaceuticals.

What are the unique features of FOCINVEZ?

FOCINVEZ is the first ready-to-use version of fosaprepitant that does not require reconstitution or dilution, making it more efficient for pharmacies.

What is the CMS reimbursement code for FOCINVEZ?

FOCINVEZ has a unique CMS reimbursement code J1434.

What are the potential side effects of FOCINVEZ?

Reported side effects include fatigue, diarrhea, neutropenia, asthenia, anemia, peripheral neuropathy, leukopenia, dyspepsia, urinary tract infection, and pain in extremity.

What is the market size for fosaprepitant in the U.S.?

The U.S. market for fosaprepitant had annual sales of approximately $36 million for the 12 months ended April 2024.

Who can use FOCINVEZ?

FOCINVEZ is indicated for adults and pediatric patients 6 months of age and older, in combination with other antiemetic agents, for preventing nausea and vomiting in highly and moderately emetogenic chemotherapy.