BiotechBull

Rigel Pharmaceuticals: Biotech Crisis or Opportunity?

Big pharma company is going to fork over large $ to license rights to R788....that efficacy data (ACR scores) are the best we have seen in any pipeline drug....

Rigel's Punishment May Prove Short-Sighted

I completly agree--and have seen enormous overreaction as a huge buying opportunity. A couple of quick thoughts:

- High probability Rigel will partner drug soon
- $442m is conservative--after 4-years on market and tons of safety data generated should be in $600-$800 range
-ACR20/50/70 (efficacy) is as good, if not better, than efficacy of current blockbusters TNF drugs (which also come with safety issues)
-Safety is the wild-card here,
-Actemra situation as analogue--drug has cholesterol safety issues (but awesome efficacy), and the advisory committee voted overwhelming in favor of approval (delayed because-FDA only requested non-clinical data in order to satisfy approval.)
-If the side effects with RIgel's drug are predicatable and reversable, should get FDA approval.

Investing in Biotech: The 3 Phases of Clinical Trials

One major point of conetntion.......if a phase 1 cancer drug shows efficacy (even though the trial is not controlled) you are talking about ~$30-$50mm upfront payment for the developer if it decides to out-license at that point....if they wait that $ increases exponentially.

Let's say this phase 1 drug is in-licensed by a big-pharma company---it could get to the market in as fast as 3-4 years--producing significant revenue streams much faster for the small biotech developer that anyone expects--inherently leading to undervaluation by the street.

Wyeth and Elan Take Hits on Bad Trials

I am not impressed that you "called" the negatively perceived data based on top-line resutls that essetially gave you a good picture of yesterday's data 2 weeks ago.

What is striking is that you lack a fundamental understanding of drug development--all pipeline programs are evaluated by drug companies based on their NPV. That said, bapineuzumab addresses a market with an enormously high unmet need and prevalence--and inherently has an attractive NPV--so would you "gamble" $100-$200mm on a phase 3 with the potential (>67% probability of success based on industry standards) of generating revenue >=$1B?

All this drug has to do is show that it won't kill anybody (deaths in study were not treatment related) and demonstrate some efficacy in ApoE4 non-carriers and it will sail through FDA approval and see rapid uptake in the AD market as either a monotherapy or combination with current drugs (that produce minimal benefits for patients).

The bottom line--is that the data didn't impress the investment community (and yourself)--because so many forecasts out there were >$10B.

Bapineuzumab still has a much better than average chance of becoming a blockbuster drug and Wye/Eln will be laughing in a few years when this thing is launched.................