Can someone (mudshark) help us understand why, if you or I could purchase ferric citrate for pennies at CVS, why would Keryx invest millions in developing Zerenex (ferric citrate) for treatment of phosphatemia. I never heard this before and would like to know what the truth about it is. It doesn't make sense. Certainly they would have taken this into consideration, if true.
Johnny, I have explained my understanding of Zerenex vs OTC FeCitrate multiple times, but I will give it one more college try.
Ferric citrate has been around for eons, so any patent to chemical grade Fe3+ citrate cannot be defended. Within this version of FeCitrate and as probably purchased from CVS, healthfood stores etc., the predominant component within the bottle is indeed Fe3+ citrate. But there are other things as well. First, in the standard method of manufacturing FeCitrate, it is difficult to control the amount of Fe2+ in the mix due to oxidation. Second, it is difficult to control the amount of free iron (Fe2+ and Fe3+). Third it is difficult to control the molar ratio of Fe3+ cation to citrate anion. Fourth, the level of molecule hydration is vastly variable from batch to batch as well as between ferric citrate molecules within the same bottle so this must also be controlled (given the mol. wt. of the water molecule, and free iron and citrate, if hydration and molar ratios are not controlled in the manufacturing process, someone receiving ferric citrate that is heavily hydrated vs a batch that is poorly hydrated [for example] would not be receiving the same amount of active compound. So there would be no way to control dosing).
When one purchases ferric citrate from the local ferric citrate store, it only imples that this chemical is indeed in the bottle, but the specific amounts are not known; I can assure you that pure Fe3+ Citrate (1:1: molar ratio) will not be known and probably not listed. This does not matter as much if taken as a healthfood supplement. Many examples of this exist in products from health food stores where, for example, they sell you a compound but as part of a plant extract. So on the bottle it may say in big letters "PRODUCT XYZ" but on the side lable it will say "contains 10% PRODUCT XYZ" as part of an extract from "plant ABC" because it is not in pure form but part of the entire plant extract. Again, this is not a problem if using it as a vitamin supplement, but if one has to take 8-10 grams a day, impurities in the over-the-counter versions can/will beome fatal to the unsuspecting user.
Anyway, Keryx has developed a manufacturing process that controls all the problem parameters that plague the over-the-counter versions of FeCitrate. By controlling all these issues they then have control of the composition of matter patent. In other words by controlling the patent related to production, by definition they control the composition of matter ...unless some other company comes up wth another method for manufacturing Ferric Citrate that does not infringe on the manufacturing patents owned by Keryx. Does this mean that a new process cannot be identified? Certainly not; however, if the process is demonstrably changed, it will require a complete set of new PI, PII and PIII trials to demonstrate bioequivalency.
Hope that clears things up a bit. You can do your own additional reading and use the points I have mentioned above as a basis upon which to better understand the science.
Spectacularly good recap, Zing. Thanks very much.
While the pros on the Street are not worried about the CVS problem, there was a piece written by the shorts attacking IP. The answer that you give goes a long way to refuting that. I would add that the biggest piece from my perspective is the method of use patent that the Company appears to be filing regarding the latest data. As Dr. Lewis points out, the trial tells nephrologists a lot about iron. These results are, to use the term of art, unexpected. US patent law rewards companies for conducting such clinical trials - even on well known molecules - for new indications.
The bottom line is that there will be a series of ring fences:
Patent on composition of matter - likely to be extended, in my opinion.
Manufacturing patent (hard to reverse engineer but not impossible).
Tableting patent for new format (tough - but we'll see).
Method of use patent - usually hard to defend but the better the data the stronger the patent.
The short strategy is to throw mud ; ) and see what sticks. There is so much institutional interest here that I doubt they will succeed. Good luck to all,
Sentiment: Strong Buy
Isn't this the same issue that AMRN is having with their "pure" fish oil compound? Will KERX have the same issues in obtaining NCE status since Ferric Citrate seems to be a compound that has been around for years?
do you visit yahoo MB to get a degree in bio-chemistry, what do you expect? that someone will write you down a formula explaining the difference between pharma grade product and regular vitamins? do you even have enough education to understand the explanation?...Sanofli makes 800M a year on phosphate binder, people at KERX built 600M dollar company, pay millions of dollars to doctors and hospitals for clinical testing, JPM just gave the company 60M dollars, and all these people didn't know that you can by the same thing in your local CVS pharmacy?
stop listening to some idiot with agenda from SA who is talking out of his @$#%..
level of ignorance by some on this board makes me wonder how they even can afford a computer...
In US, the drug is labeled as a specific agent to treat specific medical condition. Z has been studied under SPA protocol from FDA. That's why there are clinical trial. It will be approved by FDA for the medical conditions studied. This is the law. That's why people are watching the trials.
There are people BS about the product and trial results to manipulate the share price. But to be honest, at this point, the trial is positive, and the drug will be approved, and it will be on the market in due time. based on the trial data, Z is a better drug than anything on the market. The debate is about the value of the business. That's a fair debate. But to cite online purchase of a chemical to replace a drug is frankly stupid. You can buy a butcher knife to do surgery too, but that's not a standard care in this country.
There will be a value for this business soon enough and many smart people are looking into this. No matter what, $500m is not close to reality.
#$%$, numb nuts. I asked a simple question. I own 31,000 shares of Keryx and its hard to tell the truth from fiction sometimes. What's also hard is pinpointing the douchebags from the legitimate investors. Glad i found you.........douchebag.
the fn wouldnt. FUD!!!! Fear Uncertainty and doubt is all that article was meANT TO BE. kerx WOULD NOT INVEST MILLIONS IN A DRUG THAT can be bought in a cvs. its total bs. Do you not think dr lewis would have said #$%$ are you guys doing. KERX needs the good dr to refute all of those charges. This is fn bs
Sentiment: Strong Buy
I have gone on the internet in search of what the seeking alpha guy described as over the counter ferric citrate. In multiple attempts the closest I have come is a product called "ammonium ferric citrate". I am a nephrologist but even someone with little knowledge of medicine might be able to determine that a product with ammonia in it would not necessarily be good for a patient with renal failure. While I was shopping at whole foods yesterday I looked for ferric citrate in their supplement sections. I thought that they have every compound known to man there but I couldn't find it and when I asked the people in the store they said they never heard of it. If it is out there somewhere, it certainly isn't easy to find. Also, if the same compound is out there in the marketplace, how could they have gotten the patent? Finally, the reason that dialysis patients have needed to receive iv iron is because all of the commercially available irons are poorly absorbed, in dialysis patients p[articularly so when someone says they can get iron otc, what they are getting is likely not going to be effective in binding phosphorus or repleting the body"s iron supply.
Sentiment: Strong Buy
Brian, take a look at one or more of my posts on this thread. Ferric citrate and ammonium ferric citrate are simply 2 different products. Do not get overly concerned because some Butthead published what he thinks there is a competing drug, Ferriseltz. Ferriseltz is ammonium ferric citrate, not ferric citrate. ..and ammonium ferric citrate is not ferric citrate. Even if there is evidence that Ferriseltz is functional for hyperphosphatemia, it would not invalidate the Ferric citrate patents unless in the same Ferriseltz patent they demonstrated functionality of ferric citrate for hyperphosphatemia. Put another way, did the people who patented Tylenol get their patents overturned because it was a pain reliever like aspirin??? Don't think so. They targeted the same illness but are different compounds. Also, I have not yet seen any evidence that Ferriseltz was tested in hyperphosphatemia. Even if it was tested, it becomes the aspirin and Zerenex becomes the Tylenol in this paradigm. The key issue that should concern us more is in the original patents for the production of non-pharmaceutical grade FeCitrate (circa 1997), it was suggested (and possibly demonstrated ) the relationship between ferric citrate and treatment of hyperphosphatemia. Still, we have the manufacturing patents; these make up the lion's share of Keryx' patent portfolio w/r/t Zerenex.
I had the same question but talking to a "bio chemist" it's apparently all in the delivery uniqueness of their molecule. Prior to this patients would be prone to iron deficiency; this alieviates that prob. How I don't know but appears to be a biggy for orange flavored table salt. I asked the same question several months back when considering a position. No one responded.