NovaDel Pharma Inc. recently announced its entry into an exclusive license and distribution agreement with ECR Pharmaceuticals Company, Inc., a wholly owned subsidiary of Hi-Tech Pharmacal Co., Inc. to commercialize and manufacture ZolpiMist in the US and Canada. ZolpiMist is an oral spray formulation of zolpidem tartrate approved by the FDA in December 2008.

Under the terms of the agreement, ECR will pay NovaDel $3 million upon the execution of the agreement. ECR will assume responsibility for manufacturing and marketing the product in the US and Canada. In addition, ECR will pay royalties of up to 15% on net sales of ZolpiMist as well as an additional milestone payment if sales reach a specified level.

“This is an important milestone for our company as it recognizes the opportunity of the use of our NovaMist oral spray technology in what we believe to be an important and sizable clinical application,” said Steven B. Ratoff, Chairman and Interim CEO. “We believe that Hi-Tech has the ability to build a solid position for ZolpiMist in the market for prescription sleep aids. This agreement, in addition to the recently announced license of NitroMist, will allow us to initiate further development of our product pipeline utilizing our patented NovaMist oral spray technology.”

NovaDel Pharma Inc. is a specialty pharmaceutical company developing oral spray formulations for a broad range of marketed drugs. The company’s proprietary technology offers, in comparison to conventional oral dosage forms, the potential for faster absorption of drugs into the bloodstream leading to quicker onset of therapeutic effects and possibly reduced first pass liver metabolism, which may result in lower doses. Oral sprays eliminate the requirement for water or the need to swallow, potentially improving patient convenience and adherence. NovaDel’s oral spray technology is focused on addressing unmet medical needs for a broad array of existing and future pharmaceutical products. The company’s most advanced oral spray candidates target angina, nausea, insomnia, migraine headaches, and disorders of the central nervous system. NovaDel plans to develop these and other products independently and through collaborative arrangements with pharmaceutical and biotechnology companies.

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. Hi-Tech’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.

Source: Web of Drug Delivery Technology