Proveris SprayVIEW® Measurement System used in Development of First Generic Unit Dose Nasal Spray Approved by FDA

Marlborough, MA, April 19, 2016 – Proveris Scientific Corporation announced today that the Company’s SprayVIEW® measurement system was used by Summit Biosciences during development of the first generic unit dose nasal spray product approved by the FDA.

Approval of the abbreviated new drug application (ANDA) for Sumatriptan nasal spray USP, 5 mg and 20 mg was received by Lannett Company, Inc. from the U.S. Food and Drug Administration (FDA). Summit Biosciences developed the product and will manufacture commercial supplies for distribution by Lannett.
SprayVIEW® measurement systems are the gold standard for measuring spray pattern and plume geometry performance of orally inhaled and nasal drug products (OINDPs). The systems have been validated and are in use in development and production environments at generic and branded pharmaceutical companies, CDO/CMO/CROs, device manufacturers, and regulatory agencies around the world.

“Use of the Proveris SprayVIEW® measurement system was essential in helping us gain FDA approval,” said Greg Plucinski, COO of Summit Biosciences Inc. Dino Farina, CEO of Proveris Scientific said, “We are proud to work with Summit Biosciences as an essential component in their development of the world’s first generic unit-dose nasal spray drug product. We are committed to helping our customers rapidly bring successful drugs to market through sound science and innovative technologies.”

About Summit Biosciences

Summit Biosciences Inc. is a specialty pharmaceutical company focused on developing, manufacturing and commercializing generic and innovative nasal spray drug products. Summit’s headquarters and manufacturing facility is located on the University of Kentucky’s (UK) Coldstream Research Campus in Lexington, KY. In addition to developing an internal pipeline of products, the company provides a broad spectrum of services and expertise in nasal spray product development, manufacturing and analytical testing to pharmaceutical organizations with the goal of commercializing products for both the generic and branded Markets. Along with several generic products, the internal pipeline includes a delta-9 tetrahydrocannabinol (THC or medical marijuana) and products to treat pain. Since inception in late 2009, the company has created over 30 high-tech jobs in the Commonwealth of KY. With this approval and the anticipated commercialization of other Client sponsored and partnered products, Summit anticipates creating many additional high-tech jobs in the next few years.

About Proveris Scientific Corporation

Proveris Scientific Corporation advances the science of nasal and inhaled drug delivery by providing leading technology in spray performance measurement, unrivaled accuracy in automated actuation, and expertise in drug-device optimization. Since its founding in 1995, the company has accelerated the development of 5 of the top 7 spray drug products and has deployed its systems at more than 100 pharmaceutical development and manufacturing sites around the globe. Proveris’s systems are the industry standard and are used by the FDA, CFDA, and the pharmaceutical industry to generate submission-ready data. Proveris is certified to ISO 9001:2008 by TUV Rheinland of North America and has more than 20 patents on its technology issued in United States, Europe, and Asia. For more information, please visit www.proveris.com.