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NOVADEL ISSUES 2004 FISCAL YEAR UPDATE.

In a fiscal year update to shareholders, NovaDel Pharma, Inc. (AMEX:NVD), Flemington, N.J., has reported that all its product development programs are moving forward and that it expects to release pilot study data early this fall on a lingual spray version of GlaxoSmithKline's Imitrex(R), the leading migraine remedy.

-- At July 31, 2004, the end of NovaDel's 2004 fiscal year, the company's cash stood at just under $10 million, which is sufficient to fund operations through 3Q 2005 based on current commitments.

The company submitted the first of its six Tier One product candidates, a lingual spray version of nitroglycerin, for approval to the US FDA in June. The filing was a 505(b)(2) submission, a form of New Drug Application that relies on data in previously approved NDAs and published literature. Under PDUFA guidelines, a 10-month review is customary.

"We're very pleased with the year's accomplishments and the plans being mapped and executed by our senior managers and the team supporting them," said Gary A. Shangold, MD, president and chief executive of NovaDel. We have a challenging and aggressive business plan and we expect another year of significant, value-creating accomplishments."

The past fiscal year's other major accomplishments include the following:

-- In July, the company reported that Manhattan Pharmaceuticals, Inc., its licensee and co-developer of lingual spray propofol, said it plans to file an Investigational New Drug Application (IND) with the US FDA by the end of 2004 for this popular anesthetic agent. The lingual spray version would be indicated for office-based procedures requiring mild sedation and rapid recovery.

-- Pilot studies are planned for three additional Tier One product candidates: Pfizer's Xanax(R), a leading anti-anxiety drug, Glaxo's Zofran(R), the leading anti-emetic, and Sanofi's Ambien(R), the largest selling sleep-inducing agent. The Xanax study will begin in September. The Zofran and Ambien studies will begin in the Fourth Quarter.

The pilot studies are designed to confirm the ability of NovaDel's patented lingual spray technology to provide rapid therapeutic blood levels of the test compound, while avoiding the GI route of administration and first pass liver effects. With NovaDel's technology, drugs can enter the blood stream directly through the mucosal lining of the mouth.

-- Trading of the company's common shares on the American Stock Exchange commenced May 10 under the symbol NVD. The company's shares previously traded on the OTC Bulletin Board.

-- The company's patent portfolio continued to expand, with the fifth US Patent issued in February for lingual spray ondansentron; its third and fourth foreign patents issued in April and June, respectively. The company has 28 patents pending in the US, Canada and the EU.

NovaDel Pharma Inc. is a specialty pharmaceutical company engaged in the development of novel drug delivery systems for prescription and over-the- counter drugs. The company's proprietary lingual spray technology delivery system offers the patient (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.

For more information, call 908/782-3431 ext. 2160 or visit http://www.novadel.com.
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Title Annotation:NovaDel Pharma, Inc.
Publication:Biotech Financial Reports
Geographic Code:1USA
Date:Oct 1, 2004
Words:535
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