NovaDel's Oral Spray Delivery Technology Looks Promising
Little known biotech company NovaDel Pharma (NVD) is primed for great gains both financially and medically in the coming two years.
NovaDel announced early Friday the company's NitroMist had recieved 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 i 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 of action of drugs currently 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 recieve FDA approval, and there are plenty of promising pipeline candidates;
Zensana - Ondansetron Hydrochloride spray indicated for nausea and vomiting in patients recieving 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 characeterization. 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 brining 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.
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Little known biotech company NovaDel Pharma (NVD) is primed for great gains both financially and medically in the coming two years.
NovaDel announced early Friday the company's NitroMist had recieved 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 i 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 of action of drugs currently 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 recieve FDA approval, and there are plenty of promising pipeline candidates;
Zensana - Ondansetron Hydrochloride spray indicated for nausea and vomiting in patients recieving 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 characeterization. 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 brining 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.
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posted by Nico at
10:30 AM
2 Comments:
How do you feel about tonight's news that Zensana will be delayed due to "scale-up and stability experiments indicating that there is a need to make adjustments to the formulation and/or manufacturing process"? How does this effect your NVD BUY recommendation?
Well,
for me personally I think it is more of a time delay issue.
I think Hana has to take its time now to figure out what is that "precipitate" found in batches that the FDA was concerned about.
How much time it takes them to figure that out will be the key issue as to how long investors will have to wait to see Novadel's expected revenue surge.
Remember, Novadel is not a one trick pony. While a delay in the launch of Zensana is not a good thing, in the meantime, the company's other candidates are moving through testing.
I personally will be holding my shares through this, but will be watching Hana very closely.
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