On October 27, 2017 Eagle Pharmaceuticals, Inc. (Nasdaq:EGRX) (“Eagle” or “the Company”) reported that the United States Food and Drug Administration (“FDA”) has granted tentative approval for the Company’s PEMFEXY, a pemetrexed injection ready-to-dilute formulation for locally advanced or metastatic nonsquamous non-small cell lung cancer in combination with cisplatin; locally advanced or metastatic nonsquamous non-small cell lung cancer whose disease has not progressed after four cycles of platinum-based first-line chemotherapy, as maintenance treatment; locally advanced or metastatic nonsquamous non-small cell lung cancer after prior chemotherapy as a single agent; and malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery in combination with cisplatin (Press release, Eagle Pharmaceuticals, OCT 27, 2017, View Source [SID1234521256]).
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“We are pleased to have received this tentative approval for PEMFEXY, which we believe offers a material benefit to healthcare providers. PEMFEXY fits well within our growing portfolio of oncology drugs, including BENDEKA, bendamustine hydrochloride ready-to-dilute and rapid infusion, DOCETAXEL INJECTION, and fulvestrant, which is in development. We will work toward bringing this much needed drug to market as soon as the patent issues are resolved,” stated Scott Tarriff, Chief Executive Officer.
“Tentative approval” means that FDA has concluded that a drug product has met all required quality, safety and efficacy standards, but is not eligible for marketing in the U.S. because of existing patent protections. The tentative approval will be eligible for conversion to a final approval subject to the resolution of the current patent litigation between Eagle and Eli Lilly and Co.
“Our formulation does not require reconstitution, reducing the potential for dosing errors during mixing as well as the hazards of inhaling cytotoxic vapors that can occur when handling the powder form of the drug during preparation. We believe there is a need in the market for our improved formulation,” concluded Tarriff.
Eagle submitted, and the FDA accepted for filing, its NDA under Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act (“FDCA”) for PEMFEXY ready-to-dilute in December 2016.
This NDA references ALIMTA, the branded product manufactured by Eli Lilly and Co., which had annual U.S. sales of approximately $1.0 billion over the last twelve months.