It certainly sounds exciting and promising! I am as surprised as you that no one else has discussed this. I am avidly reading all I can about it right now. So ALL knowledgeable forum members....what is the scoop??? I am newly diagnosed so still very uninformed...but trying to learn as much as I can as fast as I can....but aren't we all :)
Vertex was granted Fast Track designation by the FDA for telaprevir in 2005. In mid-2010, as part of the Fast Track designation, Vertex began to submit completed sections of the NDA for review by the FDA on a rolling basis rather than wait until every section of the application was complete.
Telaprevir was fast tracked in 2005 and reached the market in may 2011
This was a brand new concept Vertex and Merck were coming out with .Because they have led the way with this class of drug,.it shouldn't take near as long for Tibotec(TMC435) and Achillion to get their same class drugs (protease) to market . JMO
A brand new concept? The first protease inhibitor was FDA approved in 1995. They've been used on HIV for years and I remember them being tested on HCV since at least 2003. The two we have now have doubled the number of people that have had to discontinue tx altogether and an arguement could be made that they're being over-prescribed by a factor of 4 to 1 More trials have been halted than have moved through phase III for reasons such as cardiotoxicity.
The patent on the HCV virus expires in 3 years. I would be surprised if anything now in trials will get approval before that patent is unlocked and doctors will be able to know which meds are appropriate for which patients. When that happens, watching the stock market to make tx decisions will make even less sense.
Possibly you misunderstood my post or a poor choice of phrasing on my part.
"A brand new concept" Maybe a "Brand new concept clinically available for the tx. of HCV" Having been on the market for 6 months that is "exactly" what it is.
I disagree with the idea the DAA"s are over prescribed ,however I appreciate your opinion,and as far as seeing more protease"s on the market prior to the three years ,, in (my opinion only) as I stated there will be others used before the three years.
As far as watching the stock market to make tx. decisions...on that we are in complete agreement,however in my post above I never mentioned anything about the correlation of the two..
Best to you..
Patents are normally enforced for three years. If they are not able to keep their patent, due to fees, FDA, govt, etc....the drugs could go generic and cause the stock of the company to tank. Patents just ensure they will be the only one to use that drug, combination of drugs, etc. It also makes the company much more lucrative from a dollar point of view.
Oh, desrt stated that the patent for the hcv virus expires in three years- hence my confusion. I think the Victrelis patent is for ten years. I'm surprised Incivek is only for three years- I thought patents were usually for longer.
The virus itself is patented.
International patent law in the late '80s early '90s was such that the first company to clone a disease held a patent on it and no one could do research on that disease, or medication for that disease, or tests to detect that disease without paying the patentholder.
This is the patent that expires in 2015.
Note in the link that Dr. D.W. Bradley, who was a party in the suit disputing patent rights to HCV, had been working on isolating the virus since 1977 and had been employed by the CDC since 1982. This means that it was U.S. tax dollars that produced the HCV tainted blood from which the virus was cloned.
Note also in paragraph 3, that part of the settlement was an agreement to supply the CDC with funds to research a vaccine against HCV. Twenty two years later - still no vaccine. It would be interesting to compare the $$ in patent fees collected from companies working on treatment drugs and viral load testing compared to $$ spent researching preventing infection.
That might also be viewed as a conflict of interest.
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