Eagle Pharmaceuticals Announces Positive Type C Meeting With FDA for an Estrogen Receptor Antagonist Used in the Treatment of Metastatic Breast Cancer in Post-Menopausal Women

Eagle Pharmaceuticals, Inc. recently announced a positive Type C meeting with the US FDA. Eagle and the FDA agreed on a path forward to advance the clinical development of EA-114, an estrogen receptor antagonist used in the treatment of breast cancer in post-menopausal women. EA-114 has the potential to provide healthcare providers with a formulation that meaningfully optimizes the dosing regimen for all fulvestrant patients. Eagle currently anticipates filing a new drug application (NDA) for EA-114 in 2024. If approved for all uses, EA-114 would allow physicians to provide a personalized treatment regimen to all patients, including specific sub-populations.

Over the course of 5 years and multiple studies, Eagle has dosed more than 800 people with the brand formulation of fulvestrant and multiple Eagle internally developed formulations. The Company’s rigorous analysis of the data from these studies yielded significant insights which led Eagle to develop a novel formulation, EA-114, which if approved would optimize the dosing regimen of fulvestrant to allow for a more personalized treatment approach. EA-114 has the potential to improve treatment for all fulvestrant patients, including multiple subpopulations. These subpopulations collectively represent approximately half of the total patient population. EA-114 may additionally result in improved patient outcomes.

Eagle is committed to conducting the necessary clinical program to support approval of this novel formulation of fulvestrant. It is anticipated that EA-114 would be approved as a monotherapy and for use in combination with CDK4/6 inhibitors as described in the approved labeling for Faslodex. According to IQVIA, products anticipated to be co-administered with EA-114 have had sales of $7 billion in the 12 months ending June 30th, 2023, and grew by 27% over the prior 12-month period.

Eagle anticipates filing the NDA in 2024 while pursuing a label expansion for the subpopulations in parallel.

“We are very pleased that the Eagle team’s perseverance, motivated by our desire to help breast cancer patients, has resulted in this novel formulation. We anticipate EA-114 being a very important part of a more personalized treatment regimen for post-menopausal metastatic breast cancer patients,” said Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals. “Eagle is very proud that this development program has been created in-house by the company’s formulation, clinical, and regulatory teams. We believe EA-114 has the potential to become an ever-increasing part of the personalized medicine paradigm in cancer care.”

Eagle continues to advance personalized medicine in the oncology sector by working to bring critically needed novel and complementary therapies to market. If approved, this will be Eagle’s seventh internally developed NDA, highlighting the depth of Eagle’s pipeline and its research and development capabilities in the area of medical oncology.

Eagle has filed a patent application pertaining to EA-114 and anticipates pursuing a robust patent portfolio over time. The company believes EA-114 is eligible for a unique J-code from CMS under the current regulatory framework. In addition, Eagle believes EA-114, if the label expansion for subpopulations is approved, may be eligible for a period of regulatory exclusivity of three years and a separate period of potential patent protection, including potential patents eligible for listing in the Orange Book.

Currently, fulvestrant is indicated as monotherapy first-line endocrine treatment in post-menopausal women with hormone receptor-positive metastatic breast cancer (MBC) and in combination therapy to treat hormone receptor positive, advanced breast cancer in women whose breast cancer has spread or worsened after being treated with anti-estrogen medications. Eagle intends to provide additional updates on the progress of the EA-114 development program for the sub-populations as discussions with the FDA progress.

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 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, and the company is focused on developing medicines with the potential to become part of the personalized medicine paradigm in cancer care. For more information, visit www.eagleus.com.