Zydus Lifesciences Ltd's shares gained as much as 1 percent in the opening trade amid a muted market on September 30, after the company received final approval from the United States Food and Drug Administration (USFDA) for its prostate cancer medicine -- Enzalutamide Capsules, 40 mg.
The stock rose to Rs 1088.85 soon after opening, adding to the previous session's 0.74 percent gain. Zydus Life share price has jumped 76 percent over the past year, taking the company’s market capitalisation to over Rs 1.1 lakh crore. The stock has outperformed benchmark NSE Nifty 50, which gained 34 percent in the same period. However, it has languished of late, falling about 17 percent since August mainly due to profit booking and competitive pressure.
The US FDA approval is significant as Enzalutamide capsules are used in treatment of metastatic castration-resistant prostate cancer. The drug will be manufactured at the company's facility in Moraiya, Ahmedabad.
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The Enzalutamide capsules reportedly generated annual sales of $869.4 million in the United States in one year. A research report projected that enzalutamide is one of the two agents that will have a combined total sales of $14.2 billion by 2029.
Earlier this month, Zydus Life shares were in focus due to a ruling from the US Court of Appeals for the Federal Circuit concerning a patent covering Mirabegron. The court stated that the district court, which previously invalidated the patent, erred in its decision-making process. Zydus Life and Lupin are currently the only two players that have launched generic Mirabegron at risk.
Astellas Pharma Inc., the original maker of Mirabegron, had sued to block the generic versions from Zydus and Lupin, claiming patent infringement. However, a federal judge rejected Astellas' request in April 2024. Mirabegron is used to treat overactive bladder (OAB) and its associated symptoms, including urge urinary incontinence, urgency, and urinary frequency.
Both Zydus Life and Lupin are among the first to launch the generic version of Mirabegron in 25 mg dosages in the US market and are preparing to introduce 50 mg dosages imminently.
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