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Replies to post #216615 on Biotech Values
PALO ALTO, Calif., May 16, 2018 /PRNewswire/ -- Eiger BioPharmaceuticals, Inc. (NASDAQ: EIGR), focused on the development and commercialization of targeted therapies for rare diseases, announced today that it has expanded its licensing agreement with Merck, known as MSD outside the United States and Canada, to include rights to develop the investigational farnesyltransferase inhibitor lonafarnib for the treatment of Hutchinson-Gilford Progeria Syndrome (HGPS or Progeria), a rare and fatal genetic condition characterized by accelerated aging in children. The expanded agreement provides Eiger with commercial and distribution rights to lonafarnib across the licensed and approved indications in the future. Concurrently, Eiger announced that it has completed a collaboration agreement with The Progeria Research Foundation (PRF). Eiger, at its sole cost and expense, will provide lonafarnib for ongoing clinical trials and expanded access in Progeria and be responsible for any potential filing of an NDA for the Progeria indication based on PRF data. Eiger plans to seek FDA guidance regarding a potential regulatory approval for lonafarnib in Progeria.
Merck will not receive any milestone payments for the development of lonafarnib for the treatment of Progeria, and has waived royalty obligations from Eiger for a specified quantity of lonafarnib, estimated to supply the worldwide population of children with Progeria on an annual basis.
A study published Tuesday in the Journal of the American Medical Association found that children with progeria who received an experimental drug called lonafarnib orally twice a day had a lower mortality rate than those who got no treatment.
One in 27 kids who took the drug died after slightly more than two years of follow-up, compared with nine in 27 who didn’t get the medicine, according to the study. Gordon was lead author of the article, written by a team of researchers from Boston Children’s Hospital and Brown University.
The children who received the medicine were compared with untreated children of roughly the same age, sex, and continent of residency. All were born in 1991 or later.
Lonafarnib isn’t a cure, Gordon stressed. But the difference in mortality rates — 3.7 percent for children who received the medicine at Boston Children’s Hospital, compared with about 33 percent for children who didn’t — was so stark that she wants the government to approve the drug early, even though it was just a mid-stage clinical trial.
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