BRIDGEWATER, N.J. - Amneal Pharmaceuticals, Inc. (NASDAQ:AMRX) and Shilpa Medicare Limited announced the FDA approval of BORUZU, a bortezomib injection designed for the treatment of multiple myeloma and mantle cell lymphoma. BORUZU, which references the branded product Velcade®, is set for a second quarter 2025 launch with a unique J-code, simplifying administration by reducing pharmacy preparation steps.
BORUZU is Amneal's fourth 505(b)(2) injectable approval in 2024, marking a significant expansion of their branded oncology injectable portfolio. The product will be available for subcutaneous or intravenous administration, offering a ready-to-use alternative to the currently available lyophilized powder form of bortezomib which requires reconstitution.
Sean McGowan, Vice President of Biosimilars and Branded Oncology at Amneal, emphasized the importance of such ready-to-use injectables in oncology, noting their potential to streamline the treatment process for healthcare providers and patients. Vishnukant Bhutada, Managing Director of Shilpa Medicare, highlighted the approval as evidence of Shilpa's commitment to introducing efficient pharmaceutical solutions.
Clinical studies reported adverse reactions to BORUZU, including asthenic conditions, gastrointestinal and hematological disturbances, peripheral neuropathy, and psychiatric disorders. Detailed prescribing information is available through the product's package insert.
Amneal Pharmaceuticals, a global company headquartered in Bridgewater, NJ, focuses on the development, manufacturing, and distribution of generic and specialty pharmaceuticals. Shilpa Medicare, based in India, specializes in the development and manufacturing of APIs and formulations for generic medications, particularly in the oncology sector.
U.S. annual sales for bortezomib amounted to approximately $96 million for the 12 months ending December 2023, according to data from IQVIA®.
The announcement of BORUZU's approval is based on a press release statement and includes forward-looking statements that involve risks and uncertainties. These statements are not guarantees of future performance and actual results may differ materially.
In other recent news, Amneal Pharmaceuticals has reported noteworthy developments. The company received FDA approval for its generic propofol, marking a significant step towards addressing the chronic shortage of this crucial anesthetic. The approved formulations are expected to be available in the fourth quarter of 2024.
In addition, Amneal reported a significant increase in its Q2 revenues, reaching $702 million, a 17% rise, leading to an upward revision of its full-year guidance for 2024. Also, the company's specialty revenues are projected to surpass $500 million by 2027, boosted by the approval of a new Parkinson's disease drug, CREXONT, set to launch in September.
The generic segment revenues grew by 14% in the first half of 2024, and the biosimilar business is predicted to generate over $125 million in revenue in 2024. Furthermore, Amneal is expanding internationally, expecting revenues of $50 million to $100 million by 2027. The company also plans to launch five additional biosimilar products between 2025 and 2027, signifying Amneal Pharmaceuticals' commitment to growth and market expansion.
InvestingPro Insights
As Amneal Pharmaceuticals Inc. (NASDAQ:AMRX) gears up for the launch of BORUZU in the second quarter of 2025, the company's financial metrics and analyst insights reflect a dynamic picture. The market cap of Amneal stands at $2.61 billion, indicating a substantial presence in the pharmaceutical industry. With a significant 12.37% growth in revenue over the last twelve months as of Q2 2024, the company demonstrates robust financial health and potential for future expansions such as the BORUZU injection.
InvestingPro data also shows a strong gross profit margin of 37.15% for the same period, underscoring efficient operations and a solid foundation for the upcoming product launch. Additionally, the company's recent performance has been notable, with a 122.25% return over the past year, reflecting investor confidence and market recognition of Amneal's strategic initiatives.
InvestingPro Tips suggest that while analysts have revised their earnings downwards for the upcoming period, which could be a point of consideration for investors, the valuation implies a strong free cash flow yield. This could indicate that Amneal is generating sufficient cash flows relative to its share price, an attractive trait for value investors. Moreover, Amneal is expected to become profitable this year, which could be a pivotal turn for the company's financial narrative.
For readers interested in more detailed analysis and additional insights, there are 11 more InvestingPro Tips available for Amneal Pharmaceuticals, providing a comprehensive outlook on the company's financial and market performance. These tips can be accessed through InvestingPro's dedicated page for Amneal at https://www.investing.com/pro/AMRX.
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