There is an investor on this board who claims that the incidence of C Diff is decreasing and that there is not much market for this drug. He is WRONG. The incidence and cost of treating C Diff is at all time high. Last year there were 3 million cases in the US. The virulent Quebec strain is extremely dangerous and deadly. Elderly pt from nursing homes are at great risk. Vanco is very effective but relapse rate is higher than fido.So first line will still be vanco (note: metronid is not longer recommended for moderate CDiff which is what most pts present with) Fido will be used for pts who relapse. The question to answer is how many pts relapse from vanco and end up back in the hospital and what is the cost of that? The answer, several hundred thousand with the cost in the hundreds of millions. Relapse has a high morbidity and mortality and some pts end up having a colectomy as a last resort and thousands die!! So fido will be used primarily in relapse, elderly, septic pts who have failed mgmt with vanco. This market is in the several hundred thousand range in the US alone. I am going to estimate that out of the 3 million cases of c diff (2008 data) 10% are severe relapse pts. (range is 3-20% depending on several factors, criteria, etc) That is 300K pts. That is the peak sales potential. 300K x $2800 = 840 million peak sales. I will take 50% off to be conservative with pricing discounts, future unknowns, etc. That is 420 million dollars per year peak sales. You can use whatever metric you want. But the stock is grossly undervalued here. I estimate 4 x sales = 1.6 billion market cap. thanks for listening.
Do you think that vanco will remain first line in order to keep down use of Dificid so that C. diff will not develop resistance to it or are you saying that vanco will remain first line because of cost? If the latter, your argument would seem to support the use of Dificid as first line for all patients, which would ultimately result in overall lower cost.
ok mr pro. I think what we disagree on is the number of cases and the rate of recurrence. The 3 million number I used comes from our hospital infectious disease people from US in 2008. It is hard to get accurate number BUT you have to realize that many million of people, well over 10 million if not more are CDIFF carriers. You can be a healthy carrier of cdiff and it becomes an issue if you pass on to others via the fecal oral route. So 10s of millions have it. 3 million get sick from it and present to hospitals each year from it. Out of that you have mild/moderate/severe cdad. Most are moderate. I think the disagreement over the numbers has to do with severity. It is hard to pin down exactly how many are moderate/severe because data is incomplete/lacking. There is a lot of educated guessing here. So of the moderate cases many will NOT get Fido. The severe cases which are recurrence in elderly, sick folks, WILL get fido. The bulk of recurrence cases in each class will get FIDO because it is known that it has a lower recurrence rate. Price will NOT be an issue because 1. Vanco is expensive. 2. Recurrence and ICU is VERY expensive. 3. Fido is cheap! $2800/10 days is not much in elderly septic pt who is sucking up hospital resources.
So how many pts are moderate recurrence or severe/severe recurrence that is the question. You base your numbers on the VPHM vanco market. You fail to realize that Metornidazole is still being used in many places and that the marketplace for the disease is only going to get bigger with more elderly and sicker nursing home pts, etc. Our overall incidence of pathology is growing in this country. In my earlier estimation is basically said that Fido will be prescribed to 150K pts at the peak. That is not some wild dream number but very conservative and real.
Look, all my arguments are based on facts and historical value of the CDI market....and NO I am NOT wrong.
1) the best indicator for CDI market is sales of VPHM's Oral Vanco which has had exclusivity in the market for reasons stated previously. Oral Vanco, in the initial cure (as you state) works perfectly fine (FIDO being non-inferior). The difference being ~15% versus 25% recurrence rate. I agree that first line will be Vanco and FIDO will be second line and will severely hinder FIDO sales (thanks for making the point, LOL) as your estimates for relapses (based on 3 million CDI cases) are compeltely in dream, smoking hash land...these estimates simply do not have any basis on reality hate to say for the bag holders!
2) Yes the virulent Quebec strain WAS (past tense) dangerous and deadly around the early-mid 2000s. You simply do not hear about out breaks as you there have been in the past. This is a direct result of better cleaning and control practices. Oh, you forgot to mention that in OPTR's Phase 3 trials, FIDO and Oral VANC had EQUIVALENT outcomes (for both recurrence and cure) against NAPI (Quebec's virulent strain)....how convenient for a pumper!
Folks, know the facts!
You ignore all of the facts that support significant fido sales:
1.The FDA in their approval decision made two significant statements. They gave the approval cycle a priority status and made it an orphan drug. They do this in only a few selected cases; when the use of the drug is necessary to combat a previously untreatable disease ( the recurrance of cdiff after treatment with vanco).
2. The approval vote was 13 to 0.
Also the number of potential cases is significant, whether you choose to believe it or not. We have several companies and the FDA that support this fact. Cubist has agreed to market the drug and wouldn't be investing a great deal of their resourses to do so if they didn't see the potential. The asian firm that is partnering with Optimer is paying up-front and continuing payments for the privilage of marketing fido. They would not be doing this unless the potential for a significant number of cases wasn't apparent to them. Also, don't forget the personnel that Optimer has hired to get this drug to market and tied their success monetarily to the sales of Dificid.
You are the lone voice of negativity, attempting to downplay the opinions of all the companies and professionals that see a very bright future for Optimer. I think I'll go with the overwhelming positive opinion of the industry professions and ignore your ramblings.