FLEMINGTON, N.J. — NovaDel Pharma Inc. (AMEX: NVD), a specialty pharmaceutical company developing oral spray formulations for a broad range of marketed treatments, reported financial results for its second quarter ended June 30, 2007. For the quarter ended June 30, 2007, NovaDel reported a net loss of $5.3 million, or $0.09 cents per share, compared to a net loss of $5.4 million, or $0.09 cents per share, for the previous quarter ended March 31, 2007.
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The net loss was primarily attributable to continuing research and development expenses, and general and administrative expenses during the second quarter ended June 30, 2007. To date, the Company’s total operating expenses have been primarily focused on the clinical and developmental activities associated with the advancement of NovaDel’s zolpidem and sumatriptan oral spray products. These expenses have remained relatively consistent for the year, totaling $5.6 million for the second quarter and $5.3 million for the first quarter of 2007. As of June 30, 2007, the Company’s cash, cash equivalents and short-term investments were $13.9 million and working capital was $10.0 million.
The Company estimates that it will have sufficient cash on hand to fund development of its current product candidates through December 31, 2007. If the Company elects to raise additional capital before December 31, 2007 to fund future development activities or other strategic opportunities, such funding could be secured through new strategic partnerships, the sale of its common stock and/or other forms of securities.
RECENT NEWS
* In August 2007, NovaDel announced that Par Pharmaceuticals had been granted sublicense rights for the development and commercialization of Zensana[TM] (ondansetron HCl, oral spray) in the U.S. and Canada. In parallel with this sublicense, NovaDel and Hana Biosciences amended their existing license agreement for Zensana[TM] with the key financial provisions of the license agreement unchanged. NovaDel expects to receive a milestone payment upon FDA approval of a future New Drug Application (NDA) for Zensana[TM] and royalties on total net sales ranging from 25% - 15% annually.
* In July 2007, NovaDel’s Board of Directors appointed Steven B. Ratoff, Chairman, to serve as Interim President and Chief Executive Officer coincident with the resignation of Dr. Jan H. Egberts.
* In July 2007, NovaDel announced continuing expansion of its worldwide portfolio of patents covering its novel oral spray technology. NovaDel now holds 79 patents with an additional 90 patents pending world-wide.
* In June 2007, NovaDel announced its clinical development and financial resource strategy for advancing its near-term drug candidates, zolpidem oral spray and sumatriptan oral spray.
* In June 2007, NovaDel announced positive results from two definitive studies comparing its zolpidem oral spray to Sanofi-Aventis’ Ambien[R] tablets. The two studies successfully met their primary endpoints and will be used to support the Company’s NDA submission in the second half of 2007.
ABOUT NOVADEL PHARMA
NovaDel Pharma Inc. is a specialty pharmaceutical company developing oral spray formulations for a broad range of marketed drugs. The Company’s proprietary technology offers, in comparison to conventional oral dosage forms, the potential for faster absorption of drugs into the bloodstream leading to quicker onset of therapeutic effects and possibly reduced first pass liver metabolism, which may result in lower doses. Oral sprays eliminate the requirement for water or the need to swallow, potentially improving patient convenience and adherence.
NovaDel’s oral spray technology is focused on addressing unmet medical needs for a broad array of existing and future pharmaceutical products. The Company’s most advanced oral spray candidates target angina, nausea, insomnia, migraine headaches and disorders of the central nervous system. NovaDel plans to develop these and other products independently and through collaborative arrangements with pharmaceutical and biotechnology companies. To find out more about NovaDel Pharma Inc. (AMX: NVD), visit our website at www. wellbutrin. novadel.com.
FORWARD-LOOKING STATEMENTS:
Except for historical information contained herein, this document may contain 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 oral spray products. The filing of an NDA with the FDA is an important step in the approval process in the United States. Acceptance for filing by the FDA does not mean that the NDA has been or will be approved, nor does it represent an evaluation of the adequacy of the data submitted. 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.