To: Bill Wexler who wrote (1840 ) 1/21/1998 5:51:00 AM From: khrnyc Read Replies (2) | Respond to of 7041
Hello again everyone. For those of you arriving at this post prior to reading post #1880, please take a moment to start there. That post gives some background and the usual disclaimers. For the rest of us, let's keep going. So what does Zona's patent possess that you can't get by simply swallowing generic oral phentolamine? As discussed in Zona's method of use patent, when you swallow phentolamine into the stomach (which was the case in the studies mentioned in post #1880), three things occur: 1) The drug may be affected by gastrointestinal (GI) transit time (how fast substances move through the GI tract). 2) Stomach ph can inactivate the drug. 3) The drug first goes to the liver and is metabolized and much is inactivated (the so-called "first pass" effect) In other words, the drug doesn't get to where you want it to go in a reasonable amount of time when it has to first pass through the GI tract (recall the 1.5 hours to intercourse in the prior studies). The beauty of the Zona method patent is that the drawbacks noted above are minimized. While the patent allows for an orally administered drug, oral administration does not necessarily mean swallowed into the stomach. This is worth repeating as I think it is at the heart of the confusion in distinguishing Zona's patent rights from simply swallowing generic oral phentolamine: oral administration does not necessarily mean swallowed into the stomach. By having the patent, ZONA is the only company with the right to administer phentolamine through the mucous membranes of the oral cavity. The critical point is that when phentolamine is administered in Zona's patented way, the drug rapidly gets into the blood stream through the mucous membranes of the mouth, avoids the GI tract, increases artrerial blood flow to the penis, and gives what is called an "on demand" (actual words of the patent) response. The effect of phentolamine administered in this way is seen within 10 to 20 minutes after a single administration of the drug. This may well be a competative advantage to Pfizer's Viagra. How does phentolamine produce an erection? Usually in the flaccid penis, smooth muscle is constricted such that arterial blood flow to the penis is limited. Basically, phentolamine allows these smooth muscles to relax and allows arterial blood flow into the penis, thus producing an erection. For a more detailed explanation see the book: Impotence--Diagnosis and Management of Male Erectile Dysfunction, by Kirby, Carson, and Webster. If you would like to read the patent itself, it is can be ordered from the U.S. patent office at ustpo.gov In future posts, among other things I hope to address issues regarding the phase III trials for vasomax and their statistically significant outcomes; some of my differences with a number of views held by Mr. Asencio; and how I arrived at my perceived valuation for Zona. That's all for now. Good luck to all!