Yardley, PA, May 9, 2017 – (Business Wire) – OptiNose, a commercial-stage ENT / Allergy specialty pharmaceutical company, today announced that it has closed a $37 million Series D financing led by Fidelity Management and Research Company with participation from Avista Capital Partners, Entrepreneurs Fund and other current investors. OptiNose will use the additional capital to fund commercial readiness for the launch of its lead product candidate, OPN-375, in the United States.
“We are building a company dedicated to meeting the needs of patients treated by ENT / Allergy specialists and using our patented technology and other approaches to create innovative products that improve clinical outcomes and make lives better,” said Peter Miller, CEO of OptiNose. “Chronic Rhinosinusitis (CRS) with or without nasal polyps, our current focus, is a large market worldwide. Data suggest there is tremendous dissatisfaction with the current medical treatment options.”
OptiNose’s first technology is based on a patented closed-palate Breath Powered® platform that is used to develop unique new Exhalation Delivery Systems (EDS) capable of high and deep intranasal deposition of medication. When combined with carefully selected molecules, the EDS approach enables creation of novel pharmaceutical products with potential for meaningful new clinical benefits. OptiNose’s lead product candidate, OPN-375, is an EDS with fluticasone propionate and is being developed for 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.
“This is a serious disease, and it causes a high degree of suffering for millions of people in the U.S. alone. OPN-375 could fill an important role in the care pathway for the many patients who do not get satisfactory relief with current treatments,” stated Ramy Mahmoud, President and COO of OptiNose. “We have an excellent team that is eager to make this product available to patients, and this latest round of funding will put us in a position to make the investments needed to ensure that, if approved, we are ready for launch in the first half of 2018.”
OptiNose is a commercial stage ENT / Allergy specialty pharmaceutical company on a mission to improve lives. The Company’s first technology involves a patented closed-palate Breath Powered® platform used to develop proprietary Exhalation Delivery Systems (EDS) capable of high and deep intranasal deposition of medication. These exhalation delivery systems enable creation of products with the potential for meaningful new clinical benefits. OptiNose successfully developed and out-licensed its first product at the end of Phase 3 development (Onzetra® Xsail® (sumatriptan nasal powder), to Avanir Pharmaceuticals (since acquired by Otsuka Pharmaceutical Co., Ltd.). Onzetra Xsail received FDA approval and was launched in the U.S. in 2016. The Company’s second product and current lead product candidate, OPN-375, is an EDS with fluticasone propionate and is being developed for treatment of nasal diseases characterized by chronic inflammation such as nasal polyposis and chronic sinusitis. An NDA seeking marketing approval for the treatment of nasal polyposis was submitted to the FDA in November 2016, and the Prescription Drug User Fee Act (PDUFA) goal date is in September 2017. Subsequent OptiNose pipeline products will aim to serve the needs of patients treated by ENT and allergy specialists and are expected to include those using EDS and other technologies. The Company is also currently 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). OptiNose has corporate offices in the U.S., U.K. and Norway.
Forward Looking Statements
This press release contains forward looking statements. Forward looking statements include statements about our future plans and other potential future events and may be indicated by words such as, “anticipate,” “plan,” “expect”, “aim” or other similar words. While these forward-looking statements represent our current judgment on what the future holds, they are subject to risks and uncertainties that could cause actual results to differ materially. You are cautioned not to place undue reliance on these forward-looking statements, which reflect our opinions only as of the date of this press release (May 2, 2017). We are not obligating ourselves to revise or publicly release the results of any revision to these forward looking statements in light of new information or future events.