Advancis Pharmaceutical Corporation (AVNC) may look like a small, insignificant, losing pharma venture, but their research has turned up something very interesting. They have developed the "Pulsys" system, which claims full therapeutic treatment for upper respiratory infections with a one-a-day dose instead of the current three or four dose a day regimen.
Not only will this make it easier on the patient, but the Pulsys system actually uses LESS of the drug than the total of the current daily quantity. In the amoxy product, less than 65% is being used!
It is AVNC's first one-a-day drug, though more blockbusters medications have been selected for further trials. Worldwide Amoxycillin sales are estimated around 80 million dollars (and rising) per year.
AVNC submitted the application to the FDA in December 2006, but it was turned down, though not because Pulsys does not work (that part was not queried by the FDA). The problem was that AVNC had not provided all the manufacturing details for production. AVNC has discussed with the FDA what specific details they needed, and have already submitted the additional data. By the end of May 2007 the FDA will make a ruling, and my bet is, since they have no quarrel with the Pulsys technique, approval is likely.
When the company announced details about the positive clinical trials with their new Pulsys system, the stock rose to above $ 6. Since then it has dimmed to $2.10, but, although Avnc is still flying under the radar of analysts, investors have noted this opportunity and Avnc closed last night at $ 2.37.
The Pulsys addition to the generic product will create a new product that could get a patent on its own. As I said, Amoxycillin Pulsys is the first of the one-dose products Avnc plans to produce. In the current market ambiance, where there is increasing talk about a market crash, AVNC would be a good candidate to resist and continue growing.
Sick patients must be treated in whatever kind of market we will have, and Pulsys Amoxi looks like the treatment of choice to cure a kid's strep throat
Disclosure: Author has a long position in AVNC
AVNC 1-yr chart