I have never before boxed with an un-armed man.
Mr. Wexler - follow this if you can - it is a multi-part explanation.
Zonagen's first patent indeed does not hold much hope for Phentolamine as an oral medication to treat ED. Zonagen originally planned to be able to come up with a product that could be administered buccally - but the bitter taste & burning sensation it caused in the mouth were felt to be too much of an obstacle. What to do, what to do??
All of the work detailed in that first patent, however, considered Phentolamine WITHOUT sexual stimulation. When Phentolamine is given IN ADEQUATE DOSES and combined with sexual stimulation IT WORKS. Proof? Beyond Vasomax? There is a product on the market for ED, in France, today, that is another alpha blocker (that's what phentolamine is - pay attention, willie I know this is rocket science). ED is VERY OFTEN a multifaceted problem, with psychology playing a large part. In fact, this action only with sexual stimulation is a desired attribute of this whole market of ED treatments - you would most likely want it to work during sex - and only during sex. Some of the other products offer the benefit of a rock hard erection just from the therapy - and sometimes (you'd probably like this side effect - you know, ...is that a gun in your pocket .......) the erection last for HOURS after you're done.
Back to Zonagen. Instead of giving up, they continued to work on the problem & came to what is covered in the second patent - yet to be issued - but expected to do so very soon (mega-patent lawyer's opinion). The problem with phentolamine is that it is eliminated very quickly in the liver - usually in the first pass of the blood through that organ. A standard tablet takes about 30 minutes to dissolve in the stomach, releasing its drug load slowly & never reaching therapeutic levels in the blood - the liver can eliminate it as fast as it is released. Zonagen has developed a fast dissolving tablet (less than one minute) that "overwhelms" the liver & provide therapeutic blood levels.
The end result is a convenient tablet that provides natural erectile function provided sexual stimulation occurs, and allows normal sexual activity (maybe they'll package it with a cigarette for afterwards) with a normal conclusion. All with no injections or serious side effects.
Company information released to date has not "obfuscated" (how would you determine what is obfuscated anyway) anything about the trial results - as YOU so kindly provided proof of in the link you recently provided to the slides reviewing the clinical trial results. This drug will not work for all classes of ED. It will work in about 40 - 50% of the men who have a vascular cause for their ED - that's been estimated at 70-80% of all those with the disease. Oral medications will be the first to be prescribed by any thinking MD. Vasomax, while perhaps not as effective in the absolute as Viagra (but that's not proven either - as their successful endpoint was not as demanding as Zonagen's), will secure significant market share as it has the more gentle side effects profile & is projected to cost less. For an estimate of what 5% market share means to Zonagen, find my recent post to taxikid.
These are the kinds of facts that Schering Plough bought into to the tune of $57 mm in upfront & milestone payments. Science, willie, look it up. Of course, you have more experience & knowledge in pharmaceuticals than Schering - so we should listen to you.
By the way - your latest link didn't work - maybe this is all just too much for you to master??? |
