OptiNose, a Yardley, Pa.-based commercial-stage ENT / Allergy specialty pharmaceutical company, closed a $37m Series D financing.
The round was led by Fidelity Management and Research Company with participation from Avista Capital Partners, Entrepreneurs Fund and other current investors.
The company will use the additional capital to finalize its lead product candidate, OPN-375, in the United States.
Led by Peter Miller, CEO, and Ramy Mahmoud, President and COO, OptiNose has developed technology based on a patented closed-palate Breath Powered® platform to develop new Exhalation Delivery Systems (EDS) capable of deep intranasal deposition of medication.
The company’s lead product candidate, OPN-375, is an EDS with fluticasone propionate and is being developed for the treatment of nasal diseases characterized by chronic inflammation deep in the nose, such as nasal polyposis and chronic sinusitis.
A New Drug Application (NDA) seeking marketing approval for the treatment of nasal polyposis was submitted to the U.S. Food and Drug Administration (FDA) in November 2016, and the Prescription Drug User Fee Act (PDUFA) goal date, the target date for the FDA to complete its review of the NDA, is in September 2017.
OptiNose, which also has corporate offices in the U.K. and Norway, is also engaged in the early development of products for neurologic orphan diseases where the “nose-to-brain” application of an EDS may enable improved treatment. This includes OPN-300 (Prader-Willi Syndrome, Autism, others) and OPN-21 (narcolepsy and others).