Hi-Tech Pharmacal’s ECR Subsidiary Signs Exclusive Agreement to Commercialize Sleep Aid in Oral Spray Form

AMITYVILLE, N.Y.--(BUSINESS WIRE)--Hi-Tech Pharmacal Co., Inc. (NASDAQ: HITK) announced today 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.

“The addition of Zolpimist™ enhances our portfolio of differentiated branded prescription products,“ said David Seltzer, President and CEO of Hi-Tech Pharmacal. “We believe that Zolpimist™ fits very well with ECR’s current line of products which are promoted to primary care physicians.”

Hi-Tech is a specialty pharmaceutical company developing, manufacturing and marketing generic and branded prescription and OTC products. The Company specializes in difficult to manufacture liquid and semi-solid dosage forms and produces a range of sterile ophthalmic, otic and inhalation products. The Company’s Health Care Products Division is a leading developer and marketer of branded prescription and OTC products for the diabetes marketplace. Hi-Tech’s ECR Pharmaceuticals subsidiary markets branded prescription products.

Forward-looking statements (statements which are not historical facts) in this Press Release are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not promises or guarantees and investors are cautioned that all forward-looking statements involve risks and uncertainties, including but not limited to the impact of competitive products and pricing, product demand and market acceptance, new product development, the regulatory environment, including without limitation, reliance on key strategic alliances, availability of raw materials, fluctuations in operating results and other results and other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission. These statements are based on management's current expectations and are naturally subject to uncertainty and changes in circumstances. We caution you not to place undue reliance upon any such forward looking statements which speak only as of the date made. Hi-Tech is under no obligation to, and expressly disclaims any such obligation to, update or alter its forward-looking statements, whether as a result of new information, future events or otherwise.