ECR Pharmaceuticals : Zolpimist Oral Spray

February 2011 - ECR Pharmaceuticals Co., Inc., a subsidiary of Hi-Tech Pharmacal Co., Inc. (NASDAQ: HITK) announced the immediate availability of Zolpimist Oral Spray, a novel delivery system of the most widely prescribed sleep aid in the US, zolpidem tartrate. The Zolpimist Oral Spray unit contains 60 metered sprays and provides the flexibility of administering either a 5 or 10 mg dose of the zolpidem active ingredient. As with most prescription hypnotic agents, Zolpimist Oral Spray is federally classified as a CIV controlled substance. Zolpimist is only available by prescription.

Hi-Tech President and CEO David Seltzer indicated that "Zolpimist is a significant addition to ECR, our branded products subsidiary, and reflects our continuing commitment to build this segment of our business through the marketing of widely used, innovative products."

Steven Ratoff, the CEO of Novadel Pharma Inc., the developer of Zolpimist Oral Spray, said "we are pleased to have Zolpimist available in the U. S. marketplace." Over 79 million prescriptions are written annually in the US for sleep aid products... ECR Pharmaceuticals' Press Release - Novadel Pharma's Press Release -

HiTech Pharmacal and NovaDel : Exclusive Agreement to Commercialize Sleep Aid in Oral Spray Form

Nov. 16, 2009-- Hi-Tech Pharmacal Co., Inc. (NASDAQ: HITK) announced the signing of an exclusive licensing agreement between Hi-Tech’s ECR Pharmaceuticals subsidiary and NovaDel Pharma, Inc., a drug development company, through which ECR obtained the rights to market zolpidem tartrate oral spray, 5mg per spray, in the United States and Canada. Under the terms of the agreement ECR paid NovaDel $3 million upon closing. In addition NovaDel will receive a royalty of up to 15% on net sales, and a milestone payment if net sales reach a specific level in a calendar year.


The product, branded “Zolpimist™“ will be marketed by ECR Pharmaceuticals, Hi-Tech’s branded prescription pharmaceutical company. Zolpimist™ is an FDA approved product that is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation, and will be available only by prescription. Zolpimist™ is the only approved sleep aid which contains zolpidem tartrate in an oral spray form. In October 2009, NovaDel received a Notice of Allowance from the United States Patent and Trademark Office for claims under U.S. Patent Application No. 10/671,715, related to Zolpimist™. Once issued, the patent will expire in 2018. ECR plans to launch the product in the United States in the first half of calendar 2010... Hi-Tech Pharmacal's Press Release - NovaDel's Press Release -