NovaDel Pharma Inc 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 United States and Canada. ZolpiMist is our oral spray formulation of zolpidem tartrate approved by the FDA in December of 2008.
Under the terms of the agreement, ECR will pay NovaDel US$ 3 million upon the execution of the agreement. ECR will assume responsibility for manufacturing and marketing the product in the United States and Canada. In addition, ECR will pay royalties of up to 15 per cent on net sales of ZolpiMist as well as an additional milestone payment if sales reach a specified level.
Steven B Ratoff, chairman and Interim CEO said, "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. We believe that Hi-Tech has the ability to build a solid position for ZolpiMist in the market for prescription sleep aids."
Ratoff continued, "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 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.
Hi-Tech is a specialty pharmaceutical company developing, manufacturing and marketing generic and branded prescription and OTC products.