NovaDel Reports First Quarter Fiscal Year 2005 Results
FLEMINGTON, N.J., Dec. 15 /PRNewswire-FirstCall/ -- NovaDel Pharma, Inc. (AMEX:NVD) reported results for the three months ended October 31, 2004, the
first quarter of its 2005 fiscal year.
The net loss for the period was $2.3 million, or seven cents per share,
compared to a net loss of $1.0 million, or six cents per share, in the year-
ago period. The larger net loss is due to increased spending for research and
development, general administrative expenses including depreciation of recently
purchased equipment to enhance formulation efforts, and consulting fees. Cash,
cash equivalents and investment securities at October 31, 2004 stood at $9.8
million compared to $9.7 million at July 31, 2004.
The quarter's operating activities were highlighted by robust partnering
activity, completion of a pilot pharmacokinetic study of lingual spray
sumatriptan, the start of a human pilot study of alprazolam, and the FDA's
acceptance for review of a NDA for lingual spray nitroglycerin.
The company partnered with Par Pharmaceutical for US and Canadian marketing
rights of its lingual spray nitroglycerin. It licensed exclusive rights for
animal health market applications of its lingual spray drug delivery technology
to Velcera Pharmaceuticals, and partnered with Hana Biosciences (HNAB) for the
development and marketing of a lingual spray formulation of ondansetron
(Zofran(R)GSK), the most widely prescribed anti-emetic for preventing
chemotherapy-induced nausea and vomiting.
"We continue to be on schedule with all key components of our development
plan," noted Gary A Shangold, MD, NovaDel's President and Chief Executive
Officer. "We are very pleased with the clinical progress of our early product
candidates and the commercial enthusiasm for our technology, most recently
evidenced by three new partnerships announced last quarter." Subsequent to the quarter's close, NovaDel commenced a pilot pharmacokinetic
study of a lingual spray formulation of zolpidem (Ambien(R)/Sanofi-Aventis),
its fourth product candidate to enter the clinic in calendar year 2004, and
hired Henry Kwan, PhD as Head of Pharmaceutical Sciences.
About NovaDel 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. To find out more about NovaDel Pharma Inc. (AMEX:NVD),
visit our website at http://www.novadel.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:
Barry C. Cohen Thomas Redington
VP Business & New Product Development 203 222-7399
908 782-3431 x2160 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 x2160; or Thomas Redington, +1-203-222-7399, +1-212-926-1733, , for NovaDel Pharma Inc.
Web site: http://www.novadel.com/
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