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NovaDel Raises $14 Million in Private Offering
New Funding Will Accelerate Human Feasibility Studies of Four Top-Selling Drugs;
First NDA Filing Scheduled for Q2-3
FLEMINGTON, N.J., Jan. 12 /PRNewswire-FirstCall/ -- NovaDel Pharma Inc.
(BULLETIN BOARD: NVDL) , a developer of lingual spray drugs, announced that it
completed the sale of securities in a private placement to accredited investors
for gross proceeds of approximately $14 million.
NovaDel said portions of the proceeds will be devoted to human pilot
pharmacokinetic ("PK") studies of lingual spray versions of its Tier One product
candidates, four leading currently marketed drugs with combined annual sales of
more than $4 billion.
The drugs to be tested include lingual spray versions of GlaxoSmithKline's
Zofran(R), the leading anti-emetic, Pfizer's Xanax(R), a leading anti-anxiety
drug, Glaxo's Imitrex(R), the leading migraine remedy, and Sanofi's Ambien(R),
the largest-selling sleep-inducing agent.
The PK 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.
These are the intrinsic features of the company's technology, which allows drugs
to enter the blood stream directly through the mucosal lining of the mouth.
Having completed a pre-NDA (New Drug Application) meeting with the United States
Food and Drug Administration, NovaDel is completing the necessary stability
studies on its lingual spray nitroglycerin to support the filing of an NDA --
its first -- in the second or third quarter of this year.
Investors in the private placement will receive approximately 13.3 million
shares of common stock and warrants to acquire approximately 4.0 million shares
of common stock. Paramount Capital, Inc., acted as placement agent for the
offering.
The securities were offered to accredited investors in reliance on an exemption
from the registration requirements of the Securities Act of 1933 (the
"Securities Act"). The offering has not been registered under the Securities
Act or any state securities or "blue sky" laws and the shares may not be offered
or sold absent registration or an applicable exemption from the registration
requirements of the Securities Act and applicable state securities laws.
NovaDel agreed, subject to certain terms and conditions, to file a registration
statement under the Securities Act covering the resale of the shares purchased
and share issuable upon exercise of the warrants.
This press release does not and shall not constitute an offer to sell or the
solicitation of an offer to buy shares or warrants and is being issued under
Rule 135c under the Securities Act.
About NovaDel Pharma Inc.
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 ability to develop products (independently and through
collaborative arrangements), and the ability to commercialize and obtain
approval for products under development. 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 Thomas Redington
VP Business & New Product Development 203 222-7399
908 782-3431 x 2160 212 926-1733
NovaDel Pharma Inc.
DATASOURCE: NovaDel Pharma Inc.
CONTACT: Barry C. Cohen, VP Business & New Product Development of
NovaDel Pharma Inc., +1-908-782-3431 ext. 2160; or Thomas Redington,
+1-203-222-7399, +1-212-926-1733, , for NovaDel
Pharma Inc.