Here is the background of the question:
SNY's Docetaxel patent will expire in 2010. OGX-011 wont be approved till 2013. There is a 3 year gap in between.
SNY makes about $2B/year of Taxotere. There is no way SNY would let $2B Taxotere sales dry up after the patent expiration. I believe SNY-OGXI partnership or simple buyout of OGXI makes some sense due to how OGX-011 works.
However, is a 3 year gap too late for an SNY-OGXI deal? What happens after a patent expires? How fast the sales dry up due to generics?
Apologies if this question doesnt make sense or it has been discussed before.
Yes and some trials have a very hard time accring patients because the prospects of the investigational drug are not very positive. Here we sit on the other end of the spectrum where the investigated compound has shown strong survival advantage. This will likely hurt accrual of those hundreds of other trials... Of course there is much we don't know about how this will be executed.
I think you're missing the point somewhat. The Jupiter trial had somewhere around 17,000 patients and used an "biomarker" ldc/hdc as an endpoint.
What they found was that they really didn't need 17,000 patients to prove stat sig but they only needed the earliest 6,000 patients.
That trial started enrolling patients in early 2003 so don't kid yourself in thing it was an "fast trail". It still took 5 years before it was stopped.
Your logic is sound, like I said I'm not a researcher. Thank you for the reply. As an aside, if you haven't listened to the ISIS Goldman CC you should. Dr. Crooke noted that ANS works especially well in CA as the concentration of the drug increases due to "leaky vessels." Thanks again, t
revenue would decrease considerably probably by half in a year or two, but I don't necessary agree with the logic for oncology product. More likely SNY or any other company would look for next generation drug or elswhere in pipeline to fill the gap in sales.
That being said, overall generic encroachment is a major reason to go buy a company with a future mega-blockbuster drug. However that story exists for most the major Pharmas.
After talking to Jet, I finally looked at what the heading of this message said and it was in relationship to the patents.
I think everyone is confusing the product "patent" but what they really mean is the "product exclusivity".
While the patents might expire, Oncogenex will keep "exclusivity" of the drug for many years. Congress (waxman) is now debating the bill and the Bio group wants 14 years after appoval and Waxman wants 12 years (bill s.1695).
>revenue would decrease considerably probably by half in a year or two,
Thanks for the estimate. Thus SNY stands to lose ~$1B/year if they dont do anything. Thus, what SNY would do to prevent this is the billion dollar question.
>in pipeline to fill the gap in sales
I dont see anything superior to Docetaxel + OGX-011 (if the numbers hold up) in the pipeline. Am I mistaken? (Serious question)
I believe SNY's first priority would be to maintain its revenue stream even if the solution is a temporary one (assume that OGX-011 does not become a blockbuster).
Do you know which other company provides a solution to SNY's impass?
Have to respectfully disagree, with fast tract status from the FDA, if data looks good I'd look for considerably faster approval than 2013. Agree with possible associations that you noted. t
Yea...i am inclined to agree with "jet" on this one. Fast track desingation will save some time. Phase III trials in this indication is typically 3 years, unless the trial design is set up to allow cross over of patients from phase II trial. Probably mid 2012...maybe sooner.
OGX-011 should be a nice revenue generator for whoever picks it up. The thing to watch is whether the FDA allows OGX-011 to set up hte Phase III trial for 1st line patients. More revenues in that area, than 2nd line (i.e. patinets who failed chemo the first time arouond). And also watch the final survial data on the NSCLC indication expected 3rd qtr. This is for first line patients and there is considerable revenue potential. A very nice one-two punch (i.e. increasing survival rates for patient in prostate and lung cancer indications)