COPENHAGEN, Denmark, Feb. 25, 2016 /PRNewswire/ -- Ascendis Pharma A/S (Nasdaq: ASND), a clinical stage biotechnology company that applies its innovative TransCon technology to address significant unmet medical needs, today announced that it has appointed Jonathan A. Leff, M.D. as Chief Medical Officer.
"We are pleased to welcome Jonathan to the executive management team," commented Jan Mikkelsen, President and Chief Executive Officer of Ascendis. "His proven leadership and drug development skills will play an important role as Ascendis advances its internal pipeline, including its lead clinical program, TransCon Growth Hormone, which is expected to begin a pivotal Phase 3 study in mid-2016."
Dr. Leff stated, "I am thrilled to join the Ascendis team. I have been extremely impressed by the technology, the focus on patient benefits, the pipeline opportunities, and the overall quality of the team. It is a privilege to join such an accomplished group of dedicated professionals."
Dr. Leff most recently served as InterMune's Executive Vice President, Research and Development from February 2012 to March 2015, where he led the development of Esbriet® for the treatment of idiopathic pulmonary fibrosis through a successful Phase 3 trial, resubmission of a New Drug Application and eventual approval from the Food and Drug Administration. Prior to his role at InterMune, he served as Chief Medical Officer of KaloBios Pharmaceuticals and Halozyme Therapeutics. Dr. Leff began his industry career working in various clinical development and medical affairs roles of increasing responsibility at Merck and Co., Amgen, and Roche.
Dr. Leff earned a B.A. in Chemistry from the University of Pennsylvania, and received his M.D. from the University of Pennsylvania School of Medicine. He completed his medical training in Internal Medicine and Pulmonary and Critical Care Medicine at the University of Colorado, Denver.
Additionally, Ascendis announced today that Dr. Michael Beckert, Ascendis Pharma's former acting Chief Medical Officer, will continue his consulting role with the company with a focus on leading the company's European clinical operations.
"We would like to thank Michael for his valuable contributions to Ascendis' clinical development efforts, including his leadership of the TransCon Growth Hormone program through two successful Phase 2 studies," stated Jan Mikkelsen.
About Ascendis Pharma A/S
Ascendis Pharma is applying its innovative TransCon technology to develop an internal pipeline of therapeutics to address unmet medical needs in rare disease indications carrying billion-dollar potential. The Ascendis Pharma internal pipeline consists of existing parent drugs with known pharmacology, and features TransCon Growth Hormone, a wholly-owned program that has completed Phase 2 studies in adults and children with growth hormone deficiency. TransCon Growth Hormone is expected to begin a pivotal Phase 3 pediatric study in mid-2016.
Additionally, Ascendis Pharma has formed collaborations with Sanofi in diabetes and Genentech in the field of ophthalmology, which are focused on developing leading products in large markets of strategic importance to these partners.
The TransCon technology combines the benefits of prodrug and sustained release technologies, and is the key driver of Ascendis Pharma's mission to develop a pipeline of therapeutics with best-in-class profiles. The TransCon technology can be applied to a broad range of drug therapies, including proteins, peptides and small molecules, to create prodrugs that provide for the predictable and sustained release of an unmodified parent drug.
This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding our future operations, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to our product pipeline, including our plans to initiate a pivotal Phase 3 pediatric study of TransCon Growth Hormone in mid-2016. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that we make, including the following: unforeseen safety or efficacy results in our lead development program TransCon Growth Hormone or other development programs; unforeseen expenses related to the development of TransCon Growth Hormone or other development programs, general and administrative expenses, other research and development expenses and our business generally; delays in the development of TransCon Growth Hormone related to manufacturing, regulatory requirements, speed of patient recruitment or other unforeseen delays; dependence on third party manufacturers to supply study drug for planned clinical studies; and our ability to obtain additional funding, if needed, to support our business activities. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to our business in general, see our current and future reports filed with, or submitted to, the U.S. Securities and Exchange Commission (SEC), including our Annual Report on Form 20-F for the year ended December 31, 2014 and our Report on Form 6-K which we submitted with the SEC on November 16, 2015. Forward-looking statements do not reflect the potential impact of any future in-licensing, collaborations, acquisitions, mergers, dispositions, joint ventures, or investments we may enter into or make. We do not assume any obligation to update any forward-looking statements, except as required by law.
Martin Auster, M.D.
Chief Business Officer