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NovaDel Pharma
HCID Member | Medical Devices & Tech
25 Minneakoning Road
Flemington, NJ 08822 United States
phone:(908) 782-3431
fax:908-782-2445
Symbol NVD
Exchange AMEX
Founded 1982
Employees 25
     novadel.com
Research Sector Medical Devices & Tech
Summary Description
Developing oral spray formulations
Management
Steven B. Ratoff, Interim President, Chief Executive Officer & Interim Chief Financial Officer; David H. Bergstrom, Ph.D., Chief Operating Officer & Senior Vice President; Mark J. Baric, Director; Thomas Bonney, CPA, Director; William F. Hamilton, Ph.D., Director
Ownership
Financials


* numbers in thousands
Recent Results
As of March 31, 2007, NovaDel had cash, cash equivalents and short-term investment balances of $18.7 MM. As of May 1, 2007, NovaDel had 59.5 MM shares of common stock outstanding.
 
Keywords
nitromist, zolpimist, metabolism, gingival, motility

Comment | Printable Version | Modify profile Jan. 01, 2010

Description
NovaDel Pharma is a specialty pharmaceutical company developing oral spray formulations of a broad range of marketed therapeutics. The Company’s proprietary NovaMist technology enables rapid delivery of drugs into the bloodstream, which may result in faster onset of action and potential patient benefits in compliance, convenience and safety. NovaDel’s most advanced candidates target angina, insomnia, and nausea. By focusing its proprietary delivery technology on proven pharmaceuticals, NovaDel leverages existing safety and efficacy data to manage risk in the development and registration process. Their business strategy is to develop products and enter into value-generating partnerships for commercialization.
Products / Services
NovaDel is currently focused on developing multiple oral spray products, including NitroMist which was approved by the FDA in November 2006; Zensana, ondansetron oral spray. for the treatment of severe nausea and vomiting; Zolpidem Oral Spray (active ingredient in Ambien); Sumatriptan Oral Spray (active ingredient in Imitrex); Two additional new oral spray products focused on the neurology sector - tizanidine and ropinirole.
Technology / Differentiation
NovaDels core technology utilizes a proprietary system, NovaMist, to deliver a broad range of marketed drugs through the highly absorptive lining of the mouth into the systemic blood circulation.
Market / Customers
The Company's other intended products also operate in large U.S. markets: approximately $3 billion for insomnia products (zolpidem oral spray), $2 billion for migraine medications (sumatriptan), $500 million for spasticity products (tizanidine) and $700 million for Parkinson's Disease (ropinirole).

NovaDel expects its oral spray delivery system to gain wide acceptance among neurologists, oncologists and other specialty physicians whose patients have difficulty swallowing and who can benefit from fast onset.
Competitors / Substitutes / Alternatives
Competitors in oral spray drug delivery include Generex Biotechnology Corp., GW Pharmaceuticals and Sciele. Alternative drug delivery systems, such as nasal spray and buccal patches, represent another source of competition.
Strategy
NovaDel plans to develop its products both through collaborative arrangements with other pharmaceutical and biotech companies, and to develop products which it can market directly or in co-marketing arrangements. The Company is targeting off patent drugs with existing safety records and intends to use the FDA's 505(b)(2) regulatory path for filing New Drug Applications (NDA) using its oral spray technology.
Status
During the fourth quarter 2007, the company significantly reduced clinical development activities on its product candidate pipeline, reflecting the company's belief that there was insufficient cash to sustain such activities. Despite this reduction in clinical expenditures, capital is required in order to sustain the existing organization until such time as clinical activities can be resumed. Given the current level of spending, the Company estimates that it has sufficient cash on hand to fund operations through the middle of the second calendar quarter, 2008.


2010-01-03-5412