Exhibit
99.1
NovaDel
Initiates Pilot Clinical Study of Lingual Spray Version of World's Leading
Anti-Emetic
Wednesday
February 9, 8:30 am ET
FLEMINGTON,
N.J.--(BUSINESS WIRE)--Feb. 9, 2005--NovaDel Pharma Inc., (AMEX: NVD -
News)
| · |
Proprietary
formulation may provide more rapid relief of nausea and vomiting induced
by chemotherapy |
| · |
Spray
formulation designed to offer increased convenience for cancer patients
receiving chemotherapy and radiotherapy |
NovaDel
Pharma Inc., (AMEX: NVD -
News), a drug
delivery company headquartered in Flemington NJ, announced today that it has
initiated a pilot pharmacokinetic study in humans of its lingual spray
formulation of ondansetron, the largest selling anti-emetic agent, currently
marketed in the US as Zofran ® by GlaxoSmithKline. Annual U.S. sales for Zofran
® were approximately $1 billion in 2003 and the product's patent expires in
June, 2006.
The pilot
study will compare the pharmacokinetic profile of the lingual spray formulation
of ondansetron to the approved oral dosage of Zofran ® in healthy volunteers.
With positive results of this pilot pharmacokinetic trial, NovaDel's partner for
the ondansetron lingual spray, Hana Biosciences (OTCBB: HNAB - News),
would file an Investigational New Drug (IND) 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.
Ondansetron
belongs to a class of drugs known as 5HT3 antagonists that are widely used to
prevent chemotherapy-induced nausea and vomiting. According to the National
Cancer Institute over 500,000 Americans received chemotherapy in 2004, and the
majority of these patients received an anti-emetic such as ondansetron to
prevent nausea and vomiting.
NovaDel
licensed its patented lingual spray drug delivery technology to Hana for the
purpose of developing and marketing a novel lingual spray formulation of
ondansetron in the United States and Canada. NovaDel was awarded a patent
covering a lingual spray version of ondansetron in 2004.
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 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. More information
about NovaDel can be found on its website at http://www.NovaDel.com.
About
Hana Biosciences
Hana
Biosciences acquires, develops, and commercializes innovative products for the
treatment of important unmet medical needs in cancer and immunological diseases.
The company is committed to creating value by building a world-class team,
accelerating the development of lead product candidates, expanding its pipeline
by being the alliance partner of choice, and nurturing a unique company culture.
Additional information on Hana Biosciences can be found at
www.hanabiosciences.com.
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:
NovaDel
Pharma Inc.
Investor
Contact:
Michael
Spicer, 908-782-3431 ext. 2550
or
The
Investor Relations Group
Erik
Lux/John Nesbett, 212-825-3210
