(1) There are not many choices for C.Diff treatment (2)Recurrence rate versus Vancomycin is statistically much lower- avoiding hospital re-admissions (this is where you save the big bucks) (3)Fida is dosed twice daily, vanco and metro is dosed 4 times a day...non compliance is an issue here (4)Length of therapy is only 10 days thus minimizing any serious side effects (maybe a transient liver enzyme elevation-this is seen in many drugs that is already FDA approved) (5)In high risk patients and those that has failed vanco, fida is the only choice left (this is non-negotiable).
Based on the above, it is clear the benefits far outweigh the risks. Expect a FDA panel positive recommendation (Orex= $18-20) exepects an FDA final approval (Orex= $23-$30). Fida data is as clean as it can possibly be....
I think the general concensus is that Vancomicin is "poorly absorbed" -- not that it is not absorbed (hence the argument about bio-equivalence studies vs a clinical end-point etc.). Whereas, I understood that Fidax is not absorbed -- although I have not seen the ADME data which could provide conclusive proof.
Agreed IV Vancomycin is the drug of choice against MRSA infections. Staph Aureus colonizes on the nasopharynx and is often either a respiratory tract or skin pathogen. PO Vancomycin has no effect on the respiratory tract or skin, only superficial layers of the GI system as it is non-absorbable.
If you misunderstand this, you're missing the main reason why both Vancocin (PO Vancomycin - NOT IV) and Fidaxomicin are supposed to have very low #s of systemic adverse reactions, because they are not absorbed systemically.
This is also the crux of the liver enzyme/hyperuricemia controversy. If these drugs are not absorbed systemically, then how did they elevate liver enzymes or cause high urate levels in the blood stream? I'm not sure what the details were - I have not been able to find them, simply read the results and not which patients and which number had what.
Not everyone agrees with your statement that vancomicin does not work agains MRSA:
...the drug of choice for treating CA-MRSA has is now believed to be Vancomycin, according to a Henry Ford Hospital Study. The study was presented on October 23, 2010, at the 48th annual meeting of the Infectious Diseases Society of America in Vancouver. HA-MRSA is resistant even to these antibiotics and often is susceptible only to vancomycin....Vancomycin and teicoplanin are glycopeptide antibiotics used to treat MRSA infections"
Several newly discovered strains of MRSA show antibiotic resistance even to vancomycin and teicoplanin. These new evolutions of the MRSA bacterium have been dubbed Vancomycin intermediate-resistant Staphylococcus aureus (VISA)."
From the hospitals perspective, they need to reduce the aggregate use of vancomycin, oral and injectable, to curb the development of resistance for this valuable, last resort antibiotic.
I guess release is on Friday as per the following Analyst. How to access it?
Canaccord Genuity Assumes Coverage on Optimer Pharmaceuticals (OPTR) at Buy; FDA Panel Expected to Weigh Favorably on Fidaxo NDA11:08 am ET 03/31/2011 - StreetInsiderCanaccord Genuity assumes coverage on Optimer Pharmaceuticals (NASDAQ: OPTR) with a Buy. PT $16.
Canaccord analyst says, "Going into an upcoming FDA advisory committee meeting on Tuesday, we maintain our rating on OPTR given our view of high likelihood of support for the company s lead drug, fidaxomicin, for treatment of C. diff. infection. Briefing documents expected for release on Friday could support this claim, thus setting the stage for marketing approval by the May 30 PDUFA date." (Coverage has been transitioned to George Farmer)
"Initially to be positioned in a high-risk treatment market and in vancomycinfailures, we model for a slow ramp to peak fidaxomicin sales of $250M by2016. More rapid adoption will depend largely on physician experience andaccelerated acceptance by hospital formularies."
Major flaw in your analysis, for most investors with a brain, which excludes most on this board, the stock price is already heavily priced in (and IMO heavily over valued)for a successful outcome. The numbers you randomly through out have absolutetly no valuation basis to support it.
I think his basis for support is as good as anyone's. And, no, approval is not "already heavily priced in." The market cap for OPTR, with FDA approval, is likely rise to about $750M -- that's equivalent to $16.25 per share. And, if they get a buyout bid -- since they have two late-stage products -- I'd look for $24+.