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May 17, 2018

Eiger expands lonafarnib licensing deal with Merck

Eiger BioPharmaceuticals has expanded a licensing agreement with Merck to cover the right to develop lonafarnib to treat Hutchinson-Gilford progeria syndrome (HGPS or progeria).

Eiger BioPharmaceuticals has expanded a licensing agreement with Merck to cover the right to develop lonafarnib to treat Hutchinson-Gilford progeria syndrome (HGPS or progeria).

Progeria is a rare genetic disorder characterised by rapid aging in children due to a point mutation in the lamin A gene resulting in a farnesylated aberrant protein called progerin.

Lonafarnib is being developed as an orally active inhibitor of the farnesyltransferase enzyme associated with protein modification.

Under the expanded deal, Eiger gets commercialisation and distribution rights to lonafarnib for the licensed and approved indications in the future.

Eiger has also completed a collaboration agreement with the non-profit Progeria Research Foundation (PRF).

As per this agreement, Eiger will provide lonafarnib for ongoing clinical trials and expanded access in HGPS at its own cost and expense. It will also carry out any new drug applications (NDA) for the progeria indication based on PRF data.

“Eiger will work together with PRF to seek regulatory guidance on a pathway toward regulatory approval of lonafarnib for use in children with progeria.”

The company intends to obtain regulatory guidance from the US Food and Drug Administration (FDA) regarding a potential approval for lonafarnib in HGPS.

Eiger BioPharmaceuticals president and CEO David Cory said: “Continued patient access to lonafarnib was the fundamental motivation for these agreements.

“Eiger will provide lonafarnib for ongoing clinical trials and expanded access in progeria and work together with PRF to seek regulatory guidance on a pathway toward regulatory approval of lonafarnib for use in children with progeria.”

Previously, lonafarnib was supplied by Merck for progeria clinical studies supported by PRF.

In 2015, Merck transferred the manufacturing technology for lonafarnib to Eiger, which continued to provide lonafarnib for investigational purposes.

Eiger is planning to further study lonafarnib in a Phase III clinical trial for hepatitis delta virus (HDV) treatment.

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