Hi Bill,
Regarding your "extremely reliable information", let's consider each of the points you've raised:
(By the way this is not just a rehash. There are several new citations in response to your points)
<<Phentolamine is a 45 year old generic drug>>
Correct, but not the point. Zona has reformulated phentolamine into a rapidly dissolving pill that allows phentolamine to enter the circulation rapidly enough (within 15 minutes) to produce an "on demand erection". This is quite different than generic oral phentolamine which has been shown in methologically verified gas chromatography studies to take at least 1.5 hours to enter the circulation in > 5ng levels. The 1975 Imhof study that you and Asensio quote to contradict this claim is in my opinion an illegitimate study (non peer reviewed, no methodology, no controls, etc...). But don't take my word for it. The following is a quote from the 1978 journal "Analytical Chemistry" (March 3, by de Bros and Wolshin),
"A rapid and specific, clinically applicable assay with nanogram sensitivity for phentolamine has not previously been published"
In fact, earlier in 1978, Imhof himself neglected to use the presently considered gold standard of gas chromatography (which by the way Zona used in their assays). To measure phentolamine levels he instead chose platelet aggregation as a means of inferring plasma phentolamine levels (British Journal of Clinical Pharmacology, 1978 vol,5). Don't you think that if he really had this gas chromatography thing down he wouldn't have bothered to come up with a whole new means of measuring plasma phentolamine levels?
<< 2) There is zero evidence that phentolamine produces erections>>
What about the two studies that C.K. recently posted? Or how about the Gwinup study? Or how about this 1997 abstract by Armin J. Becker, et al. from the Journal of Urology (vol 157, #4, supplement, April 14) -- a double blind, placebo controlled trial. Their results "suggest that oral phentolamine may be of benefit in the treatment of erectile dysfunction. The good safety data on that substance and the acceptable side effects further support its use in that indication". And who has the method patent pending for oral phentolamine in the treatment of erectile dysfunction?...Zonagen.
<< 3) Zonagen's patent does not cover the oral administration of phentolamine>>
Well yeh, kinda, sorta...not really. This is exactly the kind of statement that, intentionally or not, confuses those who have not examined the documents themselves. True, Zonagen's presently owned method patent does not cover phentolamine which is swallowed and is subsequently absorbed into the circulation. True, this is the only patent that Zonagen currently owns regarding phentolamine in erectile dysfunction. HOWEVER, Vasomax and the oral use of phentolamine in erectile dysfunction IS described in the 34 page international patent application that Zonagen has filed and that Schering has reviewed in full prior to its investment in Zonagen (including any correspondance that would have taken place with the patent office subsequent to the filing).
<< 4) Zonagen's current patent application does not describe a unique formulation of a phentolamine tablet>>
Sure it does. That it is a simple and clever formulation is beside the point. The rapidly dissolving formulation is different from the standard release tablet in that it enters the bloodstream much faster and therefore exerts its erectile effect much earlier.
<< 5) In fact, any manufacturing pharmacy can produce the exact same tablets easily>>
Yes, but if the method patent is granted to Zonagen, and it seems likely that it will, those pharmacies won't be able to sell it or market it as a treatment for erectile dysfunction. To me it is a situation akin to rebetol, another old medication that Schering found (via ICN) that is now nearing approval for treatment in hepatitis C (in combination with interferon A). Theoretically anyone could make this generic drug, but not for the treatment of hep C once Schering is given approval.
<< 6) Zonagen's paid shills...to artificially inflate the stock price>>
I let the reader decide who is and who is not trying to be objective
<< 7) ...patent fraud...Immumax>>
See the previous post from 1/28 that addresses this
<< 8) Investors have been dumping the stock and the price has collapsed from a high of 45 to as low as 13>>
These fluctuations in stock price are irrelevent. At the end of the day what will matter is whether or not Zona has a product, patent protection, and the ability to market their product in light of the competition.
In my opinion they have all three; and their tiny current market cap is going to allow those well informed investors to profit out of the present confusion. |
