PRINCETON, N.J. - UroGen Pharma Ltd. (NASDAQ: URGN), a biotechnology firm focusing on urothelial and specialty cancer treatments, has initiated legal action against Teva Pharmaceuticals for alleged patent infringement. The lawsuit, filed in the U.S. District Court for the District of Delaware, claims Teva infringed on two UroGen patents associated with the cancer drug JELMYTO.
The patents in question, numbered 9,040,074 and 9,950,069, are registered in the FDA's Orange Book and pertain to JELMYTO (mitomycin) for pyelocalyceal solution, which is used to treat low-grade upper tract urothelial cancer (LG-UTUC). The filing follows Teva's submission of an Abbreviated New Drug Application, seeking FDA authorization to produce and market a generic version of the drug prior to the expiration of UroGen's patents.
UroGen's CEO, Liz Barrett, expressed confidence in the company's intellectual property and its commitment to defending these rights vigorously. The company's proprietary RTGel technology, which is part of JELMYTO's formulation, enables a sustained release of medication, potentially enhancing treatment effectiveness.
JELMYTO is the first product from UroGen designed to treat LG-UTUC by non-surgical means. It is a reverse thermal gel that transitions from liquid to semi-solid at body temperature, allowing for extended exposure of the drug within the urinary tract.
Upper tract urothelial cancer is a relatively rare form of cancer, with an estimated 6,000 to 7,000 new or recurring cases in the U.S. annually. UroGen's approach offers an alternative to traditional surgery, which can be especially beneficial for older patients who may not be suitable for invasive procedures.
This lawsuit underscores the ongoing challenges in the pharmaceutical industry regarding patent protection and generic drug competition. The outcome of the legal proceedings could have significant implications for UroGen's market exclusivity for JELMYTO.
The information for this article is based on a press release statement from UroGen Pharma Ltd.
InvestingPro Insights
As UroGen Pharma Ltd. (NASDAQ: URGN) takes a stand to protect its intellectual property against generic competition, the company's financial health and market performance provide a backdrop for understanding its current position. With a market capitalization of $480.78 million, UroGen Pharma is navigating the competitive landscape of the biotechnology sector. A notable aspect of UroGen's financials is its impressive gross profit margin, which stands at 88.68% for the last twelve months as of Q4 2023. This indicates a strong ability to manage production costs relative to sales, an essential factor for the company as it seeks to maintain its market exclusivity for JELMYTO.
However, not all indicators are positive. The company is facing challenges, as evidenced by its negative P/E ratio of -3.95, indicating that investors are concerned about the company's profitability prospects. Furthermore, three analysts have revised their earnings downwards for the upcoming period, reflecting a cautious outlook on the company's financial performance. This aligns with the fact that analysts do not anticipate the company will be profitable this year.
Nevertheless, UroGen does have certain financial strengths. The company's liquid assets exceed its short-term obligations, which suggests a solid footing for managing short-term liabilities. This is an InvestingPro Tip that highlights UroGen's ability to cover immediate financial needs, a crucial factor as it faces the costs associated with patent litigation.
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