NovaDel announced early Friday the company's NitroMist had received marketing approval from the FDA.
NitroMist is an oral spray developed using NovaDel's oral drug delivery technology for relief of acute or prophylactic attacks of angina pectoris. NitroMist is licensed to Par Pharmaceutical Companies (PRX) for commercialization in North America.
There is one main reason why NovaDel might make a great investment: It provides an alternative method of delivery of drugs already on the market. It is a generics pharmaceutical company, but with a twist. Its oral spray delivery technology provides faster absorption and onset drug action than what is currently available on the market in tablet form.
This, in effect, makes it easier for NovaDel to bring a drug candidate to market as it does not have to go through the same expensive and time consuming clinical trials as other biotech firms.
NitroMist is the company's first approved product based on this exciting technology. Chances now look good that the company's other candidates will also receive FDA approval, and there are plenty of promising pipeline candidates, including:
Zensana - Ondansetron Hydrochloride spray indicated for nausea and vomiting in patients receiving chemotherapy. The drug is partnered with Hana Biosciences and the FDA is currently reviewing a New Drug Application [NDA] filed in June of 2006. If approved, Zensana could hit the market during the first half of 2007.
Ambien - Zolpidem Tartrate oral spray for relief of insomnia. A recent pilot pharmacokinetic study was completed and showed a statistically significant difference in drug absorption between patients using Ambien spray versus those using tablets. NDA is expected to be filed during first half of 2007. Ambien is a trademark of Sanofi-Aventis (SNY).
Imitrex - Sumatriptan Succinate spray for migraine relief. The company is very excited about this candidate, and it should be. A recent pharmacokinetic study showed that patients using Imitrex had an upwards of 30 times absorption of the drug as opposed to those taking Sumatriptan tablets. An NDA is expected to be filed during second half of 2007. Imitrex is a trademark of GlaxoSmithKline (GSK).
Zanaflex - Tizanidine spray for plasticity, and is currently in pre-clinical characterization. Zanaflex is a trademark of Acorda Therapeutics (ACOR).
Requip - Ropinirole spray for Parkinson's disease, currently in pre-clinical characterization. Requip is a trademark of GlaxoSmithKline (GSK)
Insiders have been buying NovaDel stock on a regular basis since December of 2004 and as recently as June of 2006.
A new and exciting drug delivery technology, the relatively quicker and cheaper method of bringing a drug to market, a promising pipeline, and consistent insider buying makes NovaDel an attractive little medical company.
The company has over $10 million in cash and less than $150 thousand in debt.
At $1.30 a share and a market cap of less than $70 million NovaDel looks cheap, and we have no problem making it a BHI Stock Pick.
NVD 1-yr chart: