Replies to post #73499 on Biotech Values

[DewDiligence]

Re: Market shares of Copaxone and Tysabri

A few points before we close out this thread:

1. We don’t disagree on the MS market dynamics as much as you might think. We both recognize that Copaxone gained patient share and dollar share during 2008 and Tysabri flatlined in the fourth quarter. The main difference between your assessment and my assessment is that you consider the Tysabri flatlining in 4Q08 to be a temporary phenomenon and hence you want to focus on the full year’s results. I, on the other hand, consider the 4Q08 results to be more indicative of the state of the MS market than the full year’s results, and I’m not so sure the Tysabri flatlining is temporary.

2. Manufacturer’s ASP is not a “straw man”; to the contrary, it’s the only way to convert between dollar sales and number of Rx’s during a given time period.

3. Tysabri is an unusual case because the TOUCH program restricts access, allowing BIIB/ELN to have greater control over retail pricing—and less variation in ASP—than is the case for most drugs.

4. I added your post to the MNTA ReadMeFirst even though I think you’re drawing the wrong inferences about the state of the worldwide MS market.

Regards, Dew

[DewDiligence]

Do Raptiva PML cases change the FDA's mindset?

I would like to start a new thread: Raptiva and PML. Any opinions as to how these latest safety issues might effect future immunosuppressive drugs to come before the FDA, specifically FTY-720 and Cladribine?

It’s hard to imagine how the FDA could become any more cautious about new-drug approvals than it already is, so my initial assessment is that the Raptiva/PML development does not change the FDA’s approval threshold to a material degree.

This is not a new story. If you look at the FDA’s non-approval decisions during the past few years on such cases as Galvus, Bridion, and Sparlon, the pattern is pretty clear. From #msg-31148666:

“It looks like the FDA is in a bunker-down mode,
with Congress all over them. They're taking an
extraordinarily cautious approach.”
—Barbara Ryan, Deutsche Bank

[genisi]

My original post was to counter argue against two points made by genisi and yourself. The first was that Tysabri was priced 2 fold more than Copaxone.

Regarding the 2 times fold price: I was making a point that Tysabri's introduction at such a premium, ignited aggressive price hikes from other MS drugs. I believe we agree on that.

...This was not due to some brilliant new marketing strategy of TEVA or new found wonders of Copaxone, but due to the confirmed cases of PML...

Not a wonder but in fact the clinical trials done by its rivals which proved its non-inferiority to high dose Rebif (REGARD trial) and Betaseron (BEYOND trial) do impact Copaxone utilization.

On competition - agree that there is no direct competition between Tysabri and Copaxone being used in different lines of therapy. Patients will keep failing interferons and Copacxone and there will be need for Tysabri. Question as you noted before is how will the number of patients on Tysabri grow? we also agree it depends much on future incidents of PML. Hopefully, the rate of PML will remain well below the 1 per 1000 patients, which is considered acceptable by the FDA.

Sorry I'm still talking about this, we live in different time zones and I was asleep while you and Dew posted your last arguments.