NovaDel Initiates Pilot Study in Humans of a Faster Acting Version of the Leading Migraine Remedy

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., [phone], ext. 2160; or Thomas Redington,

[phone], [phone], , for NovaDel

Pharma Inc.

Copyright