Conf Call Notes
Marty Marion Presenting
1. 60 million americans suffer from allergies
2. Cost of allergies in US is 17 billion per year
3. 4.5 billion otc spent a year, 15% growth rate per year
4. International marke is 18 billion per year
5. no new products in pipeline to treat allergies
6. Priced at 1/3 of drugs on the market, non drowsy, can be used with any other drugs, no side effects.
7. explain problems with Ige levels being elavated causing histimine to be released. Prehistin keeps Ige levels normal so histimine is not released.
8. Must be delivered in a very high doseage for weeks. Only current way to do this is shots every day.
9. Prehistin 3.3 mg, 2 a day, same as a shot, taste good (i agree)
10. One course of treatment for 1 month may provide relief for months perhaps as long as a year.
11. FDA - Already a fully approved drug. They have given cobalis a written statement saying they have no safty concerns.
12. P-value of sig in first phase 3 trial was .0028, results where virtually equivalent to allegra which is the highest selling drug on the market which is sadating and has other side effects.
13. 1/2 of migraines, 40% of asthma, dermatitis almost always is atopic. Prehistin should work for all of these indications.
14. Patent until 2019, and can be extended to 2024. It is a method of use patent which makes it very broad. All forms of atopic disease, and all delivery methods. Like having patent for vitamin C for colds.
15. 2nd phase 3 trial, summer of 2006. Submit in qtr 3 2006, approval 2007. Quick turnaround from FDA, treated as a new indication for an existing drug 505(b)
16. quarter 3 and 4 in Australia and EU = marketing will begin in 2006.
17. Start phase 2 trials in other indications in 2006.
18. 3% of market would be 150 million in sales. That would give us a $30 per share stock price (my guess).
19. will be approved for all allergies
questions --->
why do you have to have 2nd phase 3 - all drugs need it (biotech virgin)
1100-1200 patients 3-4 weeks longer then first study. Learned from first study that patients should be treated 4 weeks before allergies and follow them 4-6 weeks once allergy season starts. This may give us a better stat. sig.
trial will cost 4 million dollars
package will include 60 lozenges, $30. I believe he said the cost to cobalis would be 2.50.
currently have 6 digits cash,
in dicussion with a number of tier 1 pharma's, several very interested, talking about which indications or all indications, what geographic markets, we are way down the path with several pharmas.
fully diluted 30 million shares
I could not understand several of these questions.
Randy
AI
