On January 6, 2020 Eiger BioPharmaceuticals, Inc. (Nasdaq: EIGR), a late-stage biopharmaceutical company focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases, reported on progress across its product pipeline, including clinical and regulatory program planned milestones, and commercial preparation (Press release, Eiger Biopharmaceuticals, JAN 6, 2020, View Source [SID1234552763]).
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Lonafarnib in Progeria and Progeroid Laminopathies
Rolling New Drug Application (NDA) with FDA initiated in December 2019
Rolling NDA submission planned to complete in 1Q 2020
Marketing Authorization Application (MAA) planned to EMA in 1Q 2020
Commercial launch preparation underway
Lonafarnib in Hepatitis Delta Virus (HDV) Phase 3 D-LIVR Study
Lonafarnib is the only oral agent in development for HDV
Over 80 global sites activated in 2019
Strategic geographic and high enrolling sites activating early in 2020
Enrollment planned to complete in 2020
Topline data planned in 2021
Peginterferon Lambda (Lambda) in HDV
Positive Phase 2 LIFT (Lambda combo) interim end-of-treatment results reported
53% of patients with HDV RNA BLOQ at Week 24
36% of patients with HDV RNA undetectable at Week 24
End of Phase 2 meeting for Lambda monotherapy planned with FDA in 1Q 2020
Additional Phase 2 LIFT data expected at EASL and AASLD 2020
Avexitide in Post-Bariatric Hypoglycemia (PBH) and Congenital Hyperinsulinism (CHI)
Positive End of Phase 2 meeting with FDA for Avexitide in PBH in 2019
Avexitide PBH Phase 3 study design guidance finalized with FDA
Assessing strategic options to advance Avexitide in PBH and CHI
"Eiger begins 2020 with four late-stage, FDA Breakthrough Therapy Designation Programs, with first-in-class therapies, targeting rare and ultra-rare diseases with high unmet medical needs with no approved treatments," said David Cory, President and CEO of Eiger. "We are focused on commercial preparation for an anticipated approval of Lonafarnib in Progeria and Progeroid Laminopathies in 2020 and HDV market development as we prepare for Phase 3 data from our D-LIVR trial in 2021."
Financial Guidance
At December 31, 2019, the Company had approximately $95M in cash, cash equivalents and investments. The company expects 2020 cash burn for planned operations to be generally in-line with 2019 burn.