Amneal and Shilpa Announce U.S. FDA Approval of BORUZU™, the First Ready-to-Use Version of Bortezomib for subcutaneous administration

Rhea-AI Summary

Amneal Pharmaceuticals (AMRX) and Shilpa Medicare have received FDA approval for BORUZU™, the first ready-to-use version of bortezomib for subcutaneous administration. This oncology treatment is used for multiple myeloma and mantle cell lymphoma. BORUZU reduces compounding preparation steps, offering a more efficient solution for clinicians. It's Amneal's fourth 505(b)(2) injectable approval in 2024. The product is expected to launch with a unique J-code in Q2 2025. BORUZU references the branded product Velcade®, but offers a ready-to-use formulation. According to IQVIA®, U.S. annual sales for bortezomib were approximately $96 million for the 12 months ended December 2023.

Positive

• FDA approval for BORUZU™, a novel ready-to-use oncology treatment
• Fourth 505(b)(2) injectable approval for Amneal in 2024, expanding their oncology portfolio
• Expected launch in Q2 2025 with a unique J-code
• Potential market opportunity of $96 million based on 2023 bortezomib sales
• Reduces compounding preparation steps, potentially improving efficiency for healthcare providers

Negative

• Launch not expected until Q2 2025, delaying potential revenue generation
• Entering a competitive market with existing bortezomib products
• Common adverse reactions reported in clinical studies may impact patient adoption

Insights

Oncology Doctor

The FDA approval of BORUZU™, a ready-to-use version of bortezomib, marks a significant advancement in the treatment of multiple myeloma and mantle cell lymphoma. This innovative formulation eliminates the need for reconstitution, potentially reducing preparation time and minimizing dosing errors. As a proteasome inhibitor, bortezomib has been a cornerstone in hematologic malignancy treatment. The subcutaneous administration option may improve patient comfort and potentially reduce side effects compared to IV administration. However, it's important to note that the adverse reaction profile remains significant, including serious side effects like peripheral neuropathy and thrombocytopenia. While this approval doesn't introduce a new molecule, it does represent a meaningful improvement in drug delivery that could enhance treatment efficiency and patient experience.

Financial Analyst

Amneal's fourth 505(b)(2) injectable approval in 2024 demonstrates the company's strong momentum in expanding its oncology portfolio. With U.S. annual sales for bortezomib at approximately $96 million, BORUZU™ enters a substantial market. The expected launch in Q2 2025 with a unique J-code suggests potential for favorable reimbursement, which could drive adoption. This approval strengthens Amneal's position in the branded oncology space, potentially diversifying revenue streams and improving margins. The partnership with Shilpa Medicare for development showcases a smart strategy to leverage external expertise. However, investors should note the competitive landscape in oncology and the time gap until launch, which may impact initial market penetration. Overall, this approval represents a positive step in Amneal's growth strategy, but its full financial impact remains to be seen.

Market Research Analyst

The approval of BORUZU™ aligns with the growing trend towards patient-centric drug design and healthcare efficiency. Ready-to-use formulations are increasingly valued in oncology settings, where time and precision are critical. This product could potentially capture market share from traditional bortezomib preparations, especially in outpatient settings where ease of use is paramount. The subcutaneous administration option may be particularly appealing, potentially expanding the product's applicability across different healthcare settings. However, market adoption will depend on factors such as pricing strategy, reimbursement policies and the ability to demonstrate tangible benefits in clinical practice. The delayed launch until Q2 2025 gives competitors time to respond, which could impact BORUZU's market entry. Nonetheless, this approval positions Amneal well in the evolving oncology market landscape.

Represents Amneal’s fourth 505(b)(2) injectable approval in 2024

Ready-to-use oncology treatment used for multiple myeloma and mantle cell lymphoma

BRIDGEWATER, N.J.--(BUSINESS WIRE)-- Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) and Shilpa Medicare Limited (“Shilpa”) announced U.S. Food and Drug Administration (FDA) approval of BORUZU^™, a new presentation of bortezomib for ready-to-use subcutaneous administration or intravenous (IV) administration. This new ready-to-use oncology product reduces the compounding preparation steps typically required with administration.

BORUZU (bortezomib injection), a proteasome inhibitor, is used for the treatment of multiple myeloma and mantle cell lymphoma. This product references the branded product Velcade^®, a lyophilized powder requiring reconstitution before use. Shilpa developed the molecule and Amneal will manufacture and commercialize the product. BORUZU is expected to launch with a unique J-code in the second quarter of 2025.

“We are building a distinct branded oncology injectable portfolio. The approval of BORUZU is our fourth 505(b)(2) injectable approval this year. These ready-to-use injectable presentations are important innovations for oncology providers as they reduce the pharmacy preparation steps for clinicians. We look forward to bringing more branded oncology products to the market for providers while expanding access for patients,” said Sean McGowan, Vice President, Biosimilars and Branded Oncology.

“This second NDA approval in the US market from our novel injectable portfolio is a testament of our capabilities and commitment to introduce pharmacy efficient solutions that enhance preparation and have the potential to reduce patient wait times. This development exemplifies Shilpa’s constant endeavor to work towards introducing novel first of its kind pharmaceutical products that help improve the healthcare requirements of a large patient pool,” said Vishnukant Bhutada, Managing Director of Shilpa Medicare.

The most commonly reported adverse reactions for BORUZU in clinical studies include asthenic conditions, diarrhea, nausea, constipation, peripheral neuropathy, vomiting, pyrexia, thrombocytopenia, psychiatric disorders, anorexia and decreased appetite, neutropenia, neuralgia, leukopenia and anemia. For full prescribing information, see package insert located here.

According to IQVIA^®, U.S. annual sales for bortezomib for the 12 months ended December 2023 were approximately $96 million.

About Amneal

Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in Bridgewater, NJ, is a global pharmaceuticals company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of over 280 generic and specialty pharmaceuticals, 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.

About Shilpa

Shilpa Medicare is a specialized API and formulations focused pharmaceuticals company. Founded in 1987, India-based Shilpa develops, manufactures and markets active pharmaceutical ingredients (APIs) and formulations for generic medications across Oncology and other therapeutic areas. Further to consolidation in the field of oncology API and formulations, we are striving to put in our efforts in the field of novel drug delivery systems and biotech products along with widening our focus to other therapy areas. For more information, please visit www.vbshilpa.com.

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 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. 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/20240905166831/en/

Investor Contact

Anthony DiMeo

VP, Investor Relations

anthony.dimeo@amneal.com

Shilpa Contact

Dilip Kankani

AGM

dilipkankani@vbshilpa.com

Source: Amneal Pharmaceuticals, Inc.

FAQ

What is BORUZU and what was its recent FDA approval for AMRX?

BORUZU is a ready-to-use version of bortezomib for subcutaneous administration, recently approved by the FDA for Amneal Pharmaceuticals (AMRX). It's used to treat multiple myeloma and mantle cell lymphoma.

When is BORUZU expected to launch for AMRX?

BORUZU is expected to launch with a unique J-code in the second quarter of 2025 for Amneal Pharmaceuticals (AMRX).

What are the advantages of BORUZU over existing bortezomib products for AMRX?

BORUZU offers a ready-to-use formulation that reduces compounding preparation steps, potentially improving efficiency for healthcare providers compared to existing bortezomib products like Velcade®.

What was the market size for bortezomib in the US as of December 2023 for AMRX?

According to IQVIA®, U.S. annual sales for bortezomib were approximately $96 million for the 12 months ended December 2023, representing the potential market opportunity for Amneal's BORUZU.