NovaDel Initiates Pilot Study in Humans of a Faster Acting Version of the Leading Migraine Remedy Announcement Covers Second of Five Products Scheduled for Testing in Humans This Year LONDON, May 12 /PRNewswire-FirstCall/ -- NovaDel Pharma Inc. announced that it has commenced a pilot pharmacokinetic feasibility study in humans using its lingual spray technology, to achieve a faster acting version of sumatriptan. Sales of sumatriptan, a migraine remedy marketed as Imitrex(R) in the US by GlaxoSmithKline, are currently $1 billion +. The drug's new formulation utilizes NovaDel's patented lingual spray drug delivery technology to achieve more rapid onset of therapeutic activity. This is considered a desired benefit for patients suffering from a variety of medically treatable conditions, of which migraine headaches are a prime example. "The study we have just commenced involves the administration of the test drug in a range of doses to human subjects to document the profile of blood levels achieved using our proprietary formulation of sumatriptan (Imitrex), an already approved and very successful product in its current pill form" said Gary A. Shangold, MD, NovaDel's chief executive officer. If the study is successful in achieving the expected results, NovaDel would file an Investigational New Drug application to commence an abbreviated clinical development program designed to support a 505(b)(2) submission, a form of New Drug Application (NDA) that relies on data in previously approved NDAs and published literature. The 505(b)(2) would be filed under the agency's PDUFA guidelines and generally involves a 10-month review. Dr. Shangold made the announcement of the study's start here this morning at the Rodman & Renshaw TechVest Global Healthcare Conference at Claridge's Hotel. A webcast of the presentation will be archived for 90 days. Go to http://www.wallstreetwebcasting.com/webcast/rrshq2/nvdl.ob/. Dr. Shangold also confirmed NovaDel's plans to file a 505(b)(2) NDA for lingual spray nitroglycerin by the end of the current quarter. This will be NovaDel's first product submitted for US FDA approval. He said NovaDel is finalizing plans to start human pilot pharmacokinetic feasibility studies of faster acting versions of three more currently marketed products representing total current market sales of approximately $4 billion: Zofran(R) (ondansetron), marketed in the US by GlaxoSmithKline, Ambien(R) (zolpidem) marketed in the US by Sanofi, and Xanax(R) (alprazolam) which is sold by Pfizer and several generic producers. A fourth candidate is propofol, a widely used sedative marketed in the US by AstraZeneca as Diprivan(R) and by Baxter in the generic version. Reformulated as a proprietary lingual spray, it would be indicated for patients undergoing office-based or outpatient diagnostic or therapeutic procedures. A pilot pharmacokinetic feasibility study in humans, using NovaDel's lingual spray technology, has already commenced. NovaDel's patented technology is seen as especially beneficial to innovators seeking to reduce generic brand erosion of hard earned franchises. NovaDel's lingual spray technology is designed to provide rapid therapeutic blood levels by allowing drugs to enter the blood stream directly through the mucosa lining the mouth. This route of delivery avoids the GI tract and first-pass liver effects. Patients self-administer the products just as they would a breath freshener. Dr. Shangold, a former executive at Johnson & Johnson, said "NovaDel's fast acting technology can create new product benefits, while protecting an innovator's existing market. NovaDel is in the business of product life cycle management for the benefit of our customers - whether they be franchise protectors or franchise builders," he said. "Our lingual spray technology offers a distinctive set of product enhancements that will translate into premium benefits for patients. NovaDel's cash position will enable it to implement current programs well into 2005," he said. Yesterday, May 11, the common shares of NovaDel began trading on the American Stock Exchange under the symbol NVD. The company's previous trading symbol was OTCBB: NVDL. 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. 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.. 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. Contact: Barry C. Cohen VP New Business & New Product Development 908.782-3431 x 2160 NovaDel Pharma Inc. Thomas Redington 203-222-7399 212 926-1733 DATASOURCE: NovaDel Pharma Inc. CONTACT: Barry C. Cohen, VP New Business & New Product Development, NovaDel Pharma Inc., +1-908-782-3431, ext. 2160; or Thomas Redington, +1-203-222-7399, +1-212 926-1733, , for NovaDel Pharma Inc.

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