- Merck & Co. and Eiger BioPharmaceuticals have expanded a licensing agreement for an investigational enzyme inhibitor to include another indication.
- Through the amended agreement, Eiger can develop lonafarnib for the rare and fatal genetic disease Hutchinson-Gilford Progeria Syndrome. To that end, it's teaming up with The Progeria Research Foundation (PRF), and will front the cost associated with ongoing clinical investigations of lonafarnib in that setting. Eiger said it intends to consult U.S. regulators in the second half of this year about filing the drug as a treatment for Progeria.
- The two drugmakers originally linked up in 2010. Merck gave Eiger exclusive rights to develop, manufacture and market lonafarnib for most human viruses, in exchange for $500,000 worth of preferred shares in the small Californian biotech, which at the time was a private company.
Small biotechs are often quite volatile. Their stocks can soar on news of a big manufacturer partnership, or tank on a clinical trial miss. Eiger is no exception.
The Palo Alto-based company saw its stock value chopped almost in half in January, when another drug it in-licensed, ubenimex, failed a Phase 2 study that tested it as a treatment for pulmonary arterial hypertension. While they haven't fully recovered, Eiger shares were up more than 8% late Wednesday morning following announcement of the expanded licensing agreement.
Progeria is incredibly rare. The PRF estimates just one in 20 million people have the disease. So far, the Food and Drug Administration hasn't approved any treatments for it.
Patients groups therefore heralded recent clinical results published in The Journal of the American Medical Association that showed patients treated twice daily with lorafarnib monotherapy had a significantly lower mortality rate than those who didn't receive the drug — 3.7% versus 33.3%, respectively, after a little more than two years of follow-up.
Despite the data, a report from The Boston Globe indicated Merck isn't interested in submitting lorafarnib for approval in Progeria — a claim that an Eiger spokesperson confirmed to BioPharma Dive. The spokesperson also noted that Merck doesn't get any upfront, milestone or royalty payments in relation to lonafarnib for the treatment of Progeria.
Such a development makes sense, given Merck has more success in combating viruses than rare diseases. As one example, its product Zepatier (elbasvir and grazoprevir), which combines drugs that inhibit a protein and enzyme involved with hep C virus replication, raked in $1.66 billion last year. Notably, hep B and hep C monotherapy was off limits in Merck's original licensing deal with Eiger.
Eiger is also investigating lorafarnib in a severe form of hepatitis called hepatitis delta, and expects to initiate a Phase 3 study in that setting during the fourth quarter.