On January 5, 2022 Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) ("Eagle" or the "Company") reported a business update for 2022 (Press release, Eagle Pharmaceuticals, JAN 5, 2022, View Source [SID1234598213]):
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Near-Term Business Highlights:
Vasopressin: The Company will begin shipping its recently approved vasopressin product on Monday, January 17, 2022, with 180 days of marketing exclusivity. This is an important product for Eagle, as Vasostrict U.S. sales totaled $890 million for the LTM ended September 30, 2021.
PEMFEXY: On February 1, 2022, the Company will launch PEMFEXY, a ready-to-use liquid with a unique J-code. Eagle has been building inventory and believes this is a significant opportunity, as the Alimta U.S. market totaled $1.2 billion for the LTM ended September 30, 2021.
TREAKISYM: Eagle’s bendamustine franchise continues to grow, including the launch of the TREAKISYM ready-to-dilute ("RTD") formulation in Japan in the first quarter of 2021. Together with a potential approval of the rapid infusion ("RI") (50ml) liquid formulation, this could generate approximately $20 million of combined royalty and milestone revenue in 2022.
Fulvestrant: Based on discussions with the U.S. Food and Drug Administration ("FDA"), the Company will commence human pilot studies of its fulvestrant product candidate for the treatment of HR+/HER- advanced breast cancer shortly.
Landiolol: The Company is on track to submit a new drug application ("NDA") in the first half of 2022, seeking approval of Landiolol, a novel therapeutic, for the short-term reduction of ventricular rate in patients with supraventricular tachycardia, including atrial fibrillation and atrial flutter.
CAL02: The Company is preparing to begin clinical trials for CAL02, a novel approach to the treatment of severe bacterial pneumonia, later this year.
"Our business is off to a very strong start this year. With our launch of vasopressin now and PEMFEXY on February 1, we believe that our products will do very well. We are advancing our other pipeline products as we expect to submit an NDA for Landiolol in the first half of this year and to begin our clinical studies for CAL02 later this year. We are also pleased to be moving forward with our fulvestrant product and expect to begin our next clinical studies soon," stated Scott Tarriff, President and Chief Executive Officer of Eagle.
"Importantly, our already-strong balance sheet and cash position will benefit from the two launches and position us well to deploy our cash strategically through additional in-licensing opportunities, as well as potential acquisitions of companies or products," concluded Tarriff.