HT55 said:
Sales of hair-loss-treatment agents have been dismal in drug company terms, less than $200 million per year. Thus, drug companies have essentially dropped this as an area of formal drug development. Even the two drugs ( minoxidil and finasteride ) that have gone thru the FDA mill were already approved for other uses. It takes at least $500 million and 10 years to get a new drug thru the FDA.
So, this area has been taken over by physician researchers like me or (e.g.) Dr. Lee who use various exceptions to FDA regs to develop and market topical products. If you are going to get something new, it is going to come from one of us. BTW, this is the way many drugs were developed before about 1960, now termed "The Golden Age of Drug Development". So there is nothing unusual about it.
The one exception is TEMPOL, on which I hold the primary patents and use in our formulations. This agent is in clinical trials for radiation-induced hair loss. See http://www.mitos.com . Works too.
If you need further proof: Other companies have patents on SOD's ( e.g., L'Oreal SA, look up on http://www.uspto.gov ). Similarly, Japanese pharmaceutical and cosmetic giant Shiseido has patents on NANO esters. I hold the primary patents on all of these agents and use them in our formulations.
What pharmacuetical companies are interested in is other uses for our patented compounds. We promote these uses to the drug companies, hair loss treatment being a lost cause as far as they are concerned. E.g., the disulfonyl derivative of our patented agent PBN (NXY-059) was in clinical trials for stroke.
NXY-059 passed the first wing of the phase-3 trial, then flunked the second wing. Likely reason was that the active form was another spin trap (NtBHA/MNP) formed during storage. I also hold the primary patents for this compound. Naturally, we also use these compounds in our formulations.
See our paper in the journal "Stroke" , linked at http://www.centpharm.com.
The title is "SAINT-1 Worked, But the Neuroprotectant is not NXY-059". Lots of disappointment all around when the second trial failed. Danged Swedes would insist on making their product purer. I have some other things in the pipeline that I cannot discuss right now.
BTW, all these agents work at a very basic cellular level of pathogenesis, be it (e.g.) stroke or hair loss. Neuroprotection was what got me into this field decades ago. Tissues only go bad in certain limited ways and these drugs affect those fundamental pathways. Another example is low-energy infrared light, also quite credibly-reported to be neuroprotectant in stroke. Essentially the same helmet is used to treat hair loss.
True. the big guys are much better at marketing, which takes tens of millions of $. Likewise, the various FDA exemptions we operate under limit what we can do. This has nothing to do with whether our formulations work.
Peter H. Proctor, PhD,MD
