|
NovaDel Announces FDA Acceptance of Zensana(TM) NDA For Review |
|
|
|
31 Aug 2006 |
FLEMINGTON, NJ, USA | Aug 30, 2006 | NovaDel Pharma (AMEX: NVD) today announced that the US Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for Zensana(TM) (ondansetron HCl) Oral Spray which was submitted by Hana Biosciences, NovaDel's North American partner for ondansetron oral spray, on June 30, 2006. This acceptance triggers the next payment in a series of milestone payments to NovaDel.
"This NDA acceptance is yet another demonstration of the strength of NovaDel's business model based on leveraging our proprietary oral spray formulation technology," commented Jan Egberts, President and CEO of NovaDel. "The Zensana(TM) development cycle, via the 505(b)(2) regulatory pathway, has been very time and cost-efficient, generating multiple milestone opportunities for NovaDel in a short period while providing a rapid commercialization strategy. In addition, Zensana(TM) represents a near-term royalty opportunity for NovaDel based on potential product approval and launch by Hana in 2007."
The NDA was filed under Section 505(b)(2) of the Food, Drug and Cosmetic Act. If approved by the FDA, Hana targets commercial launch of Zensana(TM) in the United States in the first half of 2007. NovaDel is due an additional milestone payment upon product approval, and royalties on the sales of the product. NovaDel retains worldwide rights to Zensana(TM) outside of North America.
About Zensana(TM) (ondansetron HCl) Oral Spray
Zensana(TM) (ondansetron HCl) Oral Spray is the first oral spray 5-HT3 antagonist that conveniently delivers full metered doses of ondansetron faster than tablets, potentially allowing patients to gain and maintain protection from chemotherapy-, radiation- and post-operatively induced nausea and vomiting. Ondansetron, a selective blocking agent of the hormone serotonin, is a FDA-approved active ingredient that is commonly used in tablet form to prevent chemotherapy- and radiation-induced and post-operative nausea and vomiting. Many patients receiving chemo and radiation therapy experience discomfort or difficulty swallowing. Hana Biosciences completed clinical trials of Zensana(TM) related to bioequivalence and bioavailability in early 2006 and filed its NDA under Section 505(b)(2) of the Food, Drug and Cosmetic Act. A 505(b)(2) form of registration relies on data in previously approved NDAs and published literature.
About NovaDel Pharma Inc.
NovaDel Pharma Inc. is an emerging specialty pharmaceutical company that is developing and commercializing oral spray therapeutics to fulfill unmet medical needs predominantly focused on neurology. The Company's proprietary oral spray technology delivery system offers the patient the potential for (i) fast onset of action; (ii) improved drug safety by reducing the required drug dosage and reducing side effects; (iii) improved patient convenience and compliance; and (iv) enhanced dosage reliability. The Company plans to develop such products independently and through collaborative arrangements with major pharmaceutical and biotech companies. To find out more about NovaDel Pharma Inc. (AMEX: NVD), visit our website at www.novadel.com.
Zensana is a pending trademark of Hana Biosciences.
Except for historical information contained herein, this document contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve known and unknown risks and uncertainties that may cause the Company's actual results or outcomes to be materially different from those anticipated and discussed herein including, but not limited to, the successful completion of its pilot pharmacokinetic feasibility studies, the ability to develop products (independently and through collaborative arrangements), the ability to commercialize and obtain FDA and other regulatory approvals for products under development and the acceptance in the marketplace for lingual spray products. The filing of an NDA with the FDA is an important step in the approval process in the United States. Acceptance for filing by the FDA does not mean that the NDA has been or will be approved, nor does it represent an evaluation of the adequacy of the data submitted. Further, the Company operates in industries where securities may be volatile and may be influenced by regulatory and other factors beyond the Company's control. Important factors that the Company believes might cause such differences are discussed in the risk factors detailed in the Company's most recent Annual Report and Registration Statements, filed with the Securities and Exchange Commission. In assessing forward-looking statements contained herein, if any, the reader is urged to carefully read all cautionary statements contained in such filings.
|
