NovaDel Pharma Inc.
HCID Member | Medical Devices & Tech
25 Minneakoning Road
Flemington, NJ 08822 USA
phone: 908-782-3431
fax: 908-782-2445
Symbol NVD
Exchange AMEX
Founded 1982
Employees 25
www.novadel.com
Research Sector Medical Devices & Tech
Summary Description
Oral spray delivery system for currently marketed prescription drugs
Management
Steven B. Ratoff, Interim President & Chief Executive Officer; David H. Bergstrom, Ph.D., Chief Operating Officer & Senior Vice President; Michael E. Spicer, CPA, Chief Financial Officer & Corporate Secretary
Ownership
Financials Mkt Cap :13


* 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
Drug Delivery, injection, lingual spray, oral spray, drugdelivery, nitroglycerin, zofran, zensana, ondansetron, Hana Biosciences, imitrex, sumatriptan, ambien, zolpidem, xanax, nitroglycerin, NitroMist, ropinirole, tizanidine, zanaflex, requip.,

Comment | Printable Version | Nov. 01, 2008
If you work for NovaDel Pharma Inc. and want to update this profile, click here

Description
NovaDel Pharma Inc. is a specialty pharmaceutical company developing oral spray formulations for a broad range of marketed drugs. 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. NovaDel received approval from the FDA for its first product, NitroMist in November 2006. the company has filed a New Drug Application (NDA) for ZolpiMist indicated for the treatment of insomnia, as well as its advancing product candidate, sumatriptan oral spray, indicated for the treatment of migraine headaches.
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
NovaDel'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.
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.


2008-11-22-3217