PALO ALTO, Calif., June 10, 2019 /PRNewswire/ -- Eiger BioPharmaceuticals, Inc. (Nasdaq: EIGR), focused on the development and commercialization of therapies for rare and ultra-rare diseases, today announced the appointment of Mark Mannebach, PhD, RPh as Vice President of Global Regulatory Affairs. Dr. Mannebach has more than 30 years of experience in the pharmaceutical industry in leadership roles including Parke-Davis, Warner Lambert, Pharmacia, Baxter, and Pfizer. Dr. Mannebach brings extensive global regulatory experience in the development of branded and specialty pharmaceuticals and biologics, including orphan designated products, with global regulatory authority interactions across multiple therapeutic areas leading to over 20 product approvals in his career. Dr. Mannebach spent most of the last decade as Vice President of Global Regulatory Affairs and as a member of the Executive Management Team at Covidien and Mallinckrodt Pharmaceuticals.
"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 David Cory, President and CEO of Eiger. "Mark's global regulatory expertise and experience will strengthen our leadership team and execution. We look forward to Mark's strategic insights and contributions as we evolve into a commercial company."
"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 Charleston Laboratories where he was a member of the executive team and responsible for global regulatory strategy as well as developing technical requirements of supply and quality management. In the preceding decade, he was Vice President of Global Regulatory Affairs at Covidien and Mallinckrodt Pharmaceuticals, where he built and managed a worldwide regulatory team of 160 employees and was responsible for the filing of several NDAs, ANDAs, and INDs, and leading the company's first FDA Advisory Committee meeting and multiple product approvals. Previously, Dr. Mannebach was Vice President of U.S. Regulatory Affairs and Quality Assurance at Santen Incorporated. Earlier in his career, Dr. Mannebach was at Pfizer for over a decade where he served in multiple operating positions of increasing responsibility. Dr. Mannebach began his industry career at Sanofi in Product Development.
Dr. Mannebach received a PhD in Pharmacy Administration from University of Michigan, an MS in Chemical Engineering from University of Detroit, and a BS in Pharmacy from Wayne State University.
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 U.S. Food and Drug Administration (FDA). No representation is made as to their safety or effectiveness for the purposes for which they are being investigated.
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 March 31, 2019 and Eiger's subsequent filings with the SEC. Eiger does not assume any obligation to update any forward-looking statements, except as required.
Investors: Ingrid Choong, PhD
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