NovaDel, Flemington, NJ, reported a first quarter loss of $2.5 million for the quarter ended October 31, 2006, compared to a net loss of $2.6 million a year ago.
Increased research and development expenses in the quarter ended October 31, 2006 were driven by expenditures related to the development of the company's product pipeline. General and administrative expenses for the quarter decreased primarily as a result of lower personnel related costs. Cash, cash equivalents and short-term investments as of October 31, 2006 were $8.6 million.
Recent company highlights include:
- Approval of NitroMist (Nitroglycerin Lingual Aerosol), the first product approval for a drug created with NovaDel's oral spray formulation technology and the receipt of a milestone payment from Par Pharmaceuticals for this approval
- Filing of the Zensana (Ondansetron HC1) Oral Spray New Drug Application (NDA) by NovaDel's partner, Hana Bioscience, the FDA's subsequent acceptance of the NDA and NovaDel's receipt of a milestone payment for this achievement
- Announcement of positive study results for Zolpidem Oral Spray resulting in the decision to initiate pivotal trials in 2007
- Announcement of positive study results for Sumatriptan Oral Spray resulting in the decision to initiate pivotal trials in 2007
- Announced two new central nervous system compounds, tizanidine and ropinirole, to NovaDel's rapidly expanding pipeline of oral spray drug candidates
- Appointment of David Bergstrom to the position of Chief Operating Officer on December 4, 2006.
"We believe our recent achievements validate the benefits of NovaDel's robust oral spray formulation technology and the productivity it confers upon NovaDel's operations," commented Dr. Jan Egberts, NovaDel's President and CEO. "NovaDel announced positive data from pilot pharmacokinetic studies for our oral formulations of sumatriptan and zolpidem. Both of these trials were completed rapidly and produced statistically significant data demonstrating improved pharmacokinetics compared to tablet formulations of the drugs. These data allowed us to make immediate decisions to advance both candidates into pivotal trials in 2007."
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