Molecular Partners Receives Orphan Drug Designation for MP0250 for Multiple Myeloma
Zurich-Schlieren, Switzerland, December 27, 2019. Molecular Partners AG (SIX:MOLN), a clinicalstage biotech company pioneering the use of DARPin® therapeutics to treat serious diseases, announces the receipt of Orphan Drug Designation by the US Food and Drug Administration (FDA) for its novel therapeutic, MP0250, for the treatment of Multiple Myeloma.
MP0250 is a first-in-class, tri-specific multi-DARPin® drug candidate neutralizing VEGF-A and HGF and is binding to human serum albumin to increase plasma half-life. The unique mechanism of action of MP0250 represents a new approach to targeting the tumor microenvironment and increase patients’ responses to already approved therapies for multiple myeloma, potentially even after progression.
The mission of the FDA’s Office of Orphan Products Development (OOPD) is to advance the evaluation and development of products that demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions that affect fewer than 200,000 people in the U.S. In fulfilling that task, the OOPD evaluates scientific and clinical data submissions from sponsors to identify and designate products as promising for rare diseases and to further advance scientific development of
such promising medical products. Orphan drug designation provides incentives for sponsors to develop products for rare diseases. These incentives may include a partial tax credit for certain clinical trial expenditures, the waiver of certain FDA user fees, and potential eligibility for seven years of orphan drug marketing exclusivity, if approved.