EIGER BIOPHARMACEUTICALS, INC. (NASDAQ:EIGR) Files An 8-K Entry into a Material Definitive AgreementItem 1.01
On May15, 2018, Eiger also entered into a Collaboration and Supply Agreement (the “PRF Collaboration Agreement”) with The Progeria Research Foundation (“PRF”).
Under the terms of the PRF Collaboration Agreement, the parties agreed to collaborate with respect to the development and pursuit of regulatory approval of lonafarnib for the treatment of Hutchinson-Gilford Progeria Syndrome (“Progeria”) in humans. The PRF Collaboration Agreement granted PRF a non-exclusive, world-wide, royalty-free license under certain know-how and patents limited to use in research activities with lonafarnib for Progeria. PRF (a)agreed to provide existing clinical data in support of regulatory approval and granted Eiger a right of cross-reference to any data PRF may use in an investigational new drug (“IND”) application; and (b)granted Eiger a non-exclusive, world-wide, royalty-free, sub-licensable license under all intellectual property and data controlled by PRF to prepare and file any new drug application (“NDA”) for a product containing lonafarnib for Progeria.
The PRF Collaboration Agreement further provides that Eiger will (i)exclusively supply lonafarnib to PRF for use in clinical trials and non-clinical research in Progeria (subject to certain rights of PRF to undertake independent supply of lonafarnib for Progeria), at Eiger’s expense; (ii)prepare and be the sponsor of any NDA submission for lonafarnib to the FDA; (iii)use commercially reasonable efforts to file an NDA for Progeria by a specified date; (iv)submit a rare pediatric disease designation and a request for expedited approval in connection with an NDA filing; (v)establish a patient support program in Progeria; and (vi)use commercially reasonable efforts to develop a pediatric formulation of lonafarnib for use in Progeria. The PRF Collaboration Agreement specifies that parties will equally share any proceeds from the sale of a priority review voucher that Eiger may receive as the sponsor of a rare pediatric disease product application.
The PRF Collaboration Agreement continues for an initial term of ten years and automatically renews for subsequent renewal terms of two years each unless either party terminates earlier. PRF has the right to terminate the agreement for convenience on thirty days prior written notice or if Eiger has not submitted an NDA by a specified date; and Eiger has the right terminate the agreement for uncured material breach by PRF or immediately upon termination of the Merck License Agreement.
The foregoing descriptions of the PRF Collaboration Agreement and Merck Amendment do not purport to be complete and are qualified in their entirety by reference to such agreements, copies of which the Company expects to file as exhibits to the Company’s Quarterly Report on Form 10-Q for the quarter ending June30, 2018.
About EIGER BIOPHARMACEUTICALS, INC. (NASDAQ:EIGR)
Eiger BioPharmaceuticals, Inc., formerly Celladon Corporation, is a clinical-stage biopharmaceutical company. The Company is focused on the development and commercialization of products for the treatment of orphan diseases. Its pipeline includes Sarasar (lonafarnib) for hepatitis delta virus (HDV), exendin (9-39) for severe hypoglycemia, and Bestatin (ubenimex) for pulmonary arterial hypertension (PAH) and lymphedema. Lonafarnib is an orally active inhibitor of farnesyl transferase that inhibits the prenylation step of HDV replication inside liver cells and blocks the ability of the virus to multiply. It is conducting over three Phase II clinical trials, which include LOnafarnib With and without Ritonavir (LOWR) HDV-2 (Ankara, Turkey), LOWR HDV-3 (NIH) and LOWR HDV-4 (Hannover, Germany). Exendin is in Phase II clinical studies for the treatment of hypoglycemia associated with bariatric surgery. Ubenimex is in Phase II clinical studies for the treatment of PAH and lymphedema.
