From your paper
By replacing the -CH2OH group on position 4 of the pyridoxine molecule with -CH2NH2 and -CHO respectively, two related compounds, pyridoxamine and pyridoxal can be formed which are also vitamin active.
Interesting ---- from your other paper
Data submitted to us by Dr. E. E. Snell showed that various procedures
involving amination or oxidation of pyridoxine resulted in substances which
had much greater activity than pyridoxine itself toward certain lactic acid
article about pyridoxamine and Biostram
Almost two years after producing encouraging phase II results, Pyridorin, a capsule with a white powder inside, remains fatherless, with no commercial parent willing to take on the risk of funding an expensive phase III trial.
"There have been some questions regarding the (intellectual property)," says Steiner.
In early clinical trials, the drug was found to be effective. In a phase II trial on 224 patients, Pyridorin was shown to "slow the progression of diabetic neuropathy," the company says in a filing with regulators. Pyridorin was also granted "fast track" status by the U.S. Food and Drug Administration.
INGREDIENT ON THE INTERNET
Whether Pyridorin ever gets to market could depend on how regulators rule on BioStratum's request to stop what it calls sales of "adulterated" pyridoxamine, the active ingredient in Pyridorin.
The problem for BioStratum is that many outfits, often operating with nothing more than a Web site, are marketing pyridoxamine as a nutrition supplement.
Pyridoxamine is synthesized from vitamin B6, which humans derive from eggs, chicken, carrots, fish and walnuts.
Intellectual property law does not allow BioStratum to own patents on pyridoxamine, but the company has a pending patent application on its method of obtaining pyridoxamine from vitamin B6.
Steiner says BioStratum officials wrote individually to companies that were selling the supplements, asking that they halt sales. The targeted companies agreed, Steiner says.
Fearful that other competitors would pop up in the future, BioStratum filed a "citizen petition" in July with the FDA seeking to disallow such sales. It claimed:
Pyridoxamine was not sold as a drug supplement prior to the enactment of the Dietary Supplement Health and Education Act of 1994 and hence was not "grandfathered" in as a dietary supplement.
Internet sales began after July 1999 when BioStratum submitted an "investigational new drug" filing for Pyridorin, and once a substance is part of a clinical trial it cannot be sold as a nutritional supplement, the company believes. "In our mind this is very clear," says Steiner. "Before clinical trials, this substance was not sold ... (so) in the U.S. it is illegal."
The dietary supplement industry is fighting back.
On Sept. 14, the Council for Responsible Nutrition, a Washington, D.C.-based trade association, challenged BioStratum's petition with the FDA, saying it has proof that pyridoxamine was sold for years prior to 1994.
"If this went to court, somebody would trot out some (sales) order," says John Hathcock, a vice president of scientific and international affairs at CRN. "We firmly believe such evidence exists."
Any claim that pyridoxamine is not a dietary supplement will be "laughed at," says Hathcock.
"Under U.S. regulations, it's absolutely permissible for an ingredient to be incorporated as a dietary supplement and sold as a drug," says Hathcock.
The FDA is yet to rule on BioStratum's petition.
DRUG HAS BIG MARKET
The regulatory tussle does not mean Pyridorin is stalled.
If the company can find a partner to fund phase III trials, which could cost as much as $85 million and take another five years, BioStratum could obtain approval for its drug specifically to treat diabetic kidney disease, in which case it would enjoy exclusive rights. Steiner says the company is in discussions with a number of potential commercial partners and could sign a deal soon.
By BioStratum's estimate, about 3.65 million people in the U.S. suffer from diabetic kidney disease every year. At a cost of about $1,200 a year per patient, Pyridorin is targeting a $4.4 billion market in the U.S. alone.
found here http://www.wifil.net/forum/messages/41810.htm
This was a paper written in 2005
Makes one wonder what other supplements might be at risk - let's hope they keep their hands off Vitamin-D and Omega-3
Also, $85 million to fund a Phase III trial!!! Geez