Eiger Appoints Industry Veteran and Regulatory Affairs Expert Mark Mannebach, PhD, RPh as Vice President of Global Regulatory Affairs
"Eiger's pipeline is now late-stage with planned global regulatory activities including an NDA and MAA for Progeria and Progeroid Laminopathies, enrollment of a global Phase 3 study for Lonafarnib in HDV, and End of Phase 2 meetings for Peginterferon Lambda in HDV and Avexitide in Post-Bariatric Hypoglycemia," said
"I am excited to join Eiger's leadership team at this pivotal point in the Company's evolution and look forward to working together to advance multiple, first-in-class, rare and ultra-rare disease programs to bring therapies to patients with unmet medical needs," said Dr. Mannebach.
Dr. Mannebach was most recently Vice President of Global Regulatory Affairs and Quality Assurance at
Dr. Mannebach received a PhD in
Eiger is a late-stage biopharmaceutical company focused on the development and commercialization of a pipeline of first-in-class, well-characterized drugs for serious rare and ultra-rare diseases for patients with high unmet medical needs and for which no approved therapies exist.
The Company's lead program is in Phase 3, developing lonafarnib, a first-in-class prenylation inhibitor for the treatment of Hepatitis Delta Virus (HDV) infection. The company is also advancing peginterferon lambda, a first-in-class interferon, toward a Phase 3 study for the treatment of HDV. Eiger is preparing an NDA and MAA for lonafarnib to treat Hutchinson-Gilford Progeria Syndrome (HGPS or Progeria) and Progeroid Laminopathies with plans to file in 2019. For additional information about Eiger and its clinical programs, please visit www.eigerbio.com.
Note Regarding Forward-Looking Statements
This press release contains "forward-looking" statements that involve substantial risks and uncertainties. All statements other than statements of historical facts, including statements regarding our future financial condition, timing for and outcomes of clinical results, business strategy and plans and objectives for future operations, are forward looking statements. These forward-looking statements include terminology such as "believe," "will," "may," "estimate," "continue," "anticipate," "contemplate," "intend," "target," "project," "should," "plan," "expect," "predict," "could," "potentially" or the negative of these terms. Forward looking statements are our current statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, our ongoing and planned clinical development, including plans to complete enrollment of our D-LIVR study by the end of 2019, and submit an NDA and MAA for Progeria and progeroid laminopathies in 2019, complete end of Phase 2 meetings for peginterferon lambda in HDV and avexitide in post bariatric hypoglycemia. These statements concern product candidates that have not yet been approved for marketing by the
Various important factors could cause actual results or events to differ materially from the forward-looking statements that Eiger makes, including the risks described in the "Risk Factors" sections in the Quarterly Report on Form 10-Q for the quarter ended
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