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NovaDel expects to receive significant milestone payments over next 12 months
By Jennifer Lanning Drey
Portland, Ore., Nov. 1 - NovaDel Pharma Inc. anticipates receiving significant milestone payments over the next 12 months following the launches of NitroMist and Zensana (ondansetron HCl) Oral Spray, president and chief executive officer Dr. Jan Egberts said at the Susquehanna Financial Group Emerging Trends Conference in New York on Wednesday.
The company expects to gain Food and Drug Administration approval for NitroMist by Nov. 3, Egberts said. NitroMist is NovaDel's nitroglycerin lingual aerosol drug candidate for acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease.
Zensana, which is an oral chemotherapy spray, has a Prescription Drug User Fee Act date of April 30, 2007.
NovaDel expects to submit two additional New Drug Applications to the FDA in 2007 for its product candidates, zolpidem oral spray for insomnia and sumatriptan oral spray for migraines.
On Tuesday, the company announced positive results from a pilot pharmacokinetic study comparing zolpidem oral spray to Ambien tablets in 5 or 10 mg doses. The study found the difference between the oral spray and the tablet groups to be statistically significant, and the company expects to file a New Drug Application for Zolpidem in June 2007, Egberts said.
Additionally, NovaDel plans to begin clinical development in 2007 of two of its early-stage product candidates, tizanidine oral spray for spasticity associated with multiple sclerosis and ropinirole oral spray for treatment of symptoms associated with Parkinson's disease.
The company reported cash, cash equivalents and short-term investments of $10.1 million at July 31, and Egberts said NovaDel has averaged a cash burn rate of $800,000 per month for the past 12 months.
NovaDel is a specialty pharmaceutical company located in Flemington, N.J.
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