AMITYVILLE, N.Y.--(BUSINESS WIRE)--Nov. 16, 2009-- 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.
Source: Hi-Tech Pharmacal Co., Inc.
Hi-Tech Pharmacal Co., Inc.
Bill Peters, 631-789-8228