Eagle Pharmaceuticals Receives FDA Approval for Additional Indication for PEMFEXY in Combination with Pembrolizumab and Platinum Chemotherapy

• Additional indication is for the initial treatment of patients with metastatic, non-squamous, non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations
• Represents the fifth indication for PEMFEXY, a ready-to-use liquid with a unique J-code approved to treat non-squamous non-small cell lung cancer and mesothelioma

Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the “Company”) announced today that the U.S. Food and Drug Administration (“FDA”) has approved an additional indication for PEMFEXY® (pemetrexed injection) in combination with pembrolizumab and platinum chemotherapy for the initial treatment of patients with metastatic, non-squamous, non-small cell lung cancer (“NSCLC”) with no EGFR or ALK genomic tumor aberrations. Eagle’s approved PEMFEXY (pemetrexed injection) is a ready-to-dilute (“RTD”) novel liquid intravenous formulation developed to eliminate the reconstitution step of the Listed Drug (“LD”), ALIMTA®.

“With this fifth indication, PEMFEXY is now approved for all of the same indications as ALIMTA, and we believe it allows for key advantages such as eliminating the need for reconstitution. Since its initial launch in February 2022, PEMFEXY has been an important addition to Eagle’s hospital and acute care product portfolio, and we are pleased to bring this treatment option to patients undergoing chemotherapy. At the same time, we also believe that Eagle is well positioned to capture the commercial opportunity that PEMFEXY represents,” stated Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals.

Effective October 1, 2022, the Company amended its agreement to reduce future royalties related to PEMFEXY profits from 25% to a range of 0% to 12.5% based on aggregate profits achieved in exchange for a one-time payment of $15 million.

In February 2020, Eagle received approval from the FDA of its New Drug Application for PEMFEXY, following the settlement agreement of patent litigation with Eli Lilly and Company (NYSE: LLY) in December 2019. The agreement provided for a release of all claims by the parties and allowed for an initial entry of PEMFEXY into the market (equivalent to approximately a three-week supply of current ALIMTA utilization) on February 1, 2022, and a subsequent uncapped entry on April 1, 2022.

About Eagle Pharmaceuticals, Inc.

Eagle is a fully integrated pharmaceutical company with research and development, clinical, manufacturing and commercial expertise. Eagle is committed to developing innovative medicines that result in meaningful improvements in patients’ lives. Eagle’s commercialized products include vasopressin, PEMFEXY®, RYANODEX®, BENDEKA®, BELRAPZO®, TREAKISYM® (Japan), and BYFAVO® and BARHEMSYS® through its wholly owned subsidiary Acacia Pharma Inc. Eagle’s oncology and CNS/metabolic critical care pipeline includes product candidates with the potential to address underserved therapeutic areas across multiple disease states.