Replies to post #119058 on Biotech Values

[DewDiligence]

PFE—Didn't mention anything on how Humira arm was doing.

It would be nice to know how Tofacitinib did compared to Humira, but the comparison to placebo was technically the primary endpoint in ORAL Standard (http://clinicaltrials.gov/ct2/show/NCT00853385 ). I’m not sure we can infer anything about the Humira arm from the top-line data reported in today’s PR.

[DewDiligence]

More on the phase-3 Tofacitinib trial called ‘ORAL Sync’ that tested DMARD ± Tofacitinib in the second-line setting:

http://finance.yahoo.com/news/Pfizer-Announces-Detailed-bw-3663629904.html?x=0&.v=1

PFE reported that this trial hit its primary endpoint in Mar 2011 (#msg-60574470). ORAL Sync is one of five registrational trials for Tofacitinib—see the prologue of #msg-62546621 for details.

Also mentioned in the above PR is a phase-2 trial of Tofacitinib ± Lipitor in patients with RA.

[DewDiligence]

Peculiar statement on Tofacitinib pricing:

http://www.reuters.com/article/2011/05/26/pfizer-arthritis-price-idUSLDE74O27Q20110526

Georg Schett, head of rheumatology and immunology at the University of Erlangen-Nuremberg, believes tofacitinib should be priced between biological anti-TNFs, costing up to $20,000 a year, and the around $1,000 older drug methotrexate.

LOL—he’s not exactly going out on a limb.

[DewDiligence]

PFE details Tofacitinib data to be presented at ACR in Nov 2011:

http://ih.advfn.com/p.php?pid=nmona&article=49101189&symbol=PFE

See the prologue of #msg-62546621 for a scorecard of the five pivotal Tofacitinib trials.

[genisi]

On efficacy - tofacitinib and Humira were numerically similar for all outcomes:

http://acr.confex.com/acr/2011/webprogram/Paper19572.html

[DewDiligence]

Tofacitinib Scorecard

Yesterday, PFE reported positive Tofacitinib-vs-Methotraxate data in the first-line setting in a study called ‘ORAL Start’; this is the sixth (!) positive phase-3 study involving Tofacitinib:

http://finance.yahoo.com/news/pfizer-announces-positive-top-line-141200791.html

ORAL Start, an ongoing two-year study in methotrexate (MTX)-naïve patients with moderate-to-severe active RA, randomized to receive tofacitinib 5 or 10 mg twice-daily (BID) as monotherapy or MTX, met its primary endpoints at both the 5 and 10 mg BID doses. Tofacitinib was found to be superior to MTX with statistically significant changes shown in inhibiting structural damage, as measured by change from baseline in modified Total Sharp Score (mTSS), and in reducing signs and symptoms of RA, as measured by ACR70 response rates. Both primary endpoints assessed tofacitinib versus MTX at six months. The data reported are from a planned analysis at one year.

No new safety signals emerged in the ORAL Start study, and the safety profile of tofacitinib remained consistent with that seen previously in the clinical development program.

Although ‘ORAL Start’ is a phase-3 study, it is not part of the NDA/MAA package currently under review by the FDA and EMA. That package consists of five other positive phase-3 studies as follows:

• ‘ORAL Solo’ – Tofacitinib vs placebo in the second line (#msg-56398000)

• ‘ORAL Scan’ – MTX ± Tofacitinib in the second line (#msg-62106415).

• ‘ORAL Sync’ – DMARD (investigator’s choice) ± Tofacitinib in the second line (#msg-60574470);

• ‘ORAL Step’ – MTX ± Tofacitinib in the third line for patients who failed a TNF-a drug in the second line (#msg-62546621); and

• ‘ORAL Standard’ – Tofacitinib vs Humira in the second line as an addend to MTX for patients who failed MTX in the first line (#msg-62546621).

If there’s a reason to not approve this drug, it hasn’t surfaced yet!