Immunomedics: P-Values? Phooey! These Lupus Data Look Great, Trust Us!

Last Updated Sep 1, 2009 12:09 PM EDT

Last week's press release from Immunomedics and partner UCB concerning lupus drug epratuzumab's success in a Phase IIb trial seemed to be missing something.

Despite claims of "positive" results and "clinically meaningful" data, the release didn't actually say the trial achieved statistical significance, either in the overall population or in any of the subgroups. There were no p-values. The companies didn't even say that the trial had met its endpoints.

To be fair, the Phase IIb trial was dose-ranging and not designed to achieve statistical significance, at least not in the overall population. But the release didn't say that. Instead it claimed epratuzumab could provide a "new hope" for lupus patients thanks to its 24.9 percent treatment advantage over placebo (no mention that the treatment advantage was seen in just one of five dose groups, according to analyst reports).

And yes, it's standard practice to save the detailed data until a scientific conference, but a lot of other biotechs have managed to provide much more top-line analysis without ruining their presentation odds.

Immunomedics' shares jumped 60 percent anyway, conveniently paving the way for a stock and warrant offering announced today. Did all that hypey press release language take investors for a ride? Were folks overly-eager to jump on the lupus bandwagon after Human Genome Sciences got positive Phase III data with lupus drug Benlysta (belimumab), driving a 277 percent stock gain and acquisition rumors?

Maybe. But analysts urged caution and noted that epratuzumab is early stage and the trial was too short to tease out safety signals. And The Motley Fool's Brian Orelli reminded investors that "lupus is where drugs go to die, and epratuzumab is a drug that has already died a few times and come back to life."

The lupus graveyard inludes Genelabs Technologies' Prestara (prasterone), Aspreva Pharmaceuticals' CellCept (oral mycophenolate mofetil), Biogen Idec and Roche/Genentech's Rituxan (rituximab), and La Jolla Pharmaceutical Co.'s Riquent (abetimus sodium). Some might argue that epratuzumab has come awfully close to stepping in that open grave itself, since Amgen dumped the drug in cancer and a previous Phase III program in lupus was discontinued.

But maybe investors know all that, and maybe they just don't care. Heck, Benlysta failed its Phase II trial, but Human Genome Sciences identified an active subgroup to focus on in Phase III and pulled off a win. In biotech, sometimes you gotta go big or go home (just don't go all hypey in your press release).


Snakeoil photo by Flickr user TheeErin, CC.
  • Trista Morrison

    Trista Morrison is a staff writer at BioWorld Today, a daily newspaper that