The Top Stocks From Biotech Confab ASCO

The big buzz in cancer immunotherapy is the anti-CTLA4 drugs -- one from Pfizer and another being co-developed by Medarex(MEDX) and Bristol-Myers Squibb(BMY). Dendreon(DNDN)? Sorry, but I heard nary a peep about Provenge.

Before the conference, I called YM BioSciences(YMI) a potential sleeper for its EGFR inhibitor nimotuzumab. Well, the data presented Sunday in pediatric brain cancer patients was OK. The drug looks like it has some activity, which is pretty good for a stock trading near cash.

Mixed news, too, for ImClone Systems(IMCL). The combination of Erbitux plus chemotherapy boosts survival in head and neck cancer patients compared to chemo alone.

That's a positive, of course, but the drug is already approved for the treatment of head and neck cancer in combination with radiation. Generally speaking, analysts already had this news factored into their Erbitux revenue models, so while Erbitux sales may grow, my sense here is that this head-and-neck cancer data isn't a big driver for the stock.

The bigger focus for Erbitux at this ASCO meeting is the so-called CRYSTAL study, using the drug in front-line colon cancer. A full story on the data can be found here, but to summarize, there's little to convince doctors to choose Erbitux over Avastin in the lucrative first-line colon cancer treatment market.

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Here's some frightening and sad news from ASCO: Dr. Maha Hussain and Dr. Howard Scher, the two oncologists who made rather public stances against the approval of Dendreon's prostate cancer vaccine Provenge, are being provided with private security at ASCO because of physical threats made against them.

I first heard about this from another oncologist on Saturday, and it was confirmed to me by an ASCO spokeswoman. I haven't been able to find Hussain or Scher to get their comments.

It's not known who is threatening to hurt these two doctors for simply voicing an opinion, but there are some real crazies out there; my email inbox can attest to that.

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I strolled through the vast exhibitor's hall on Saturday afternoon to check out Amgen's(AMGN). booth. What I found -- or more accurately, what I didn't find -- was very illuminating.

There was practically no Aranesp marketing presence, whatsoever.

The big, carpeted Amgen compound was dominated by slick displays and signage touting Amgen's oncology drug pipeline. If you walked past quickly and weren't familiar with Amgen, you'd never know they even sold an anemia drug like Aranesp.

Aranesp is an ASCO orphan this year. Its presence is tucked away on one side of the Amgen compound, marked only by a small desk and sign. It was easy to miss, which is probably what Amgen wants these days, given all the problems the company is having with its beleaguered anemia drug.

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The folks at Regeneron Pharmaceuticals(REGN) thought I was a bit harsh Saturday when I threw the label "disappointing" on its phase II study of VEGF-Trap in advanced ovarian cancer patients. I met up with Regeneron Senior Vice President Bob Terifay Sunday to go over the data and to discuss future plans for the drug, which is partnered with Sanofi-Aventis.

The 8% response rate reported in the ovarian cancer study is quite good, argues Terifay, given the advanced level of disease in the enrolled patients. He believes the response rate seen and the relatively low level of side effects -- most notably relatively few bowel perforations -- is encouraging for VEGF-Trap and compares very well to Genentech's Avastin.

The rub, however, is that an 8% response rate, even in a heavily pre-treated patient population, just doesn't give off that "wow" feeling.

Regeneron and Sanofi have announced their intention to "potentially" seek FDA approval of VEGF-Trap in 2008. This is puzzling institutional investors I've spoken with, including some who actually own Regeneron.

The current FDA appears to be conservative, such that approving a drug based on phase II response rate data -- even a cancer drug meant for desperately ill patients -- seems like a Hail Mary.

I expressed this skepticism to Terifay, and while insisting that a filing was a possibility, his argument didn't exactly fill me with confidence.

But there are other data being collected that might give Regeneron and Sanofi something meatier to use for a VEGF-Trap filing. A randomized phase II study of VEGF-Trap is underway in advanced ovarian patients with buildup of fluid in their abdominal cavity, known medically as ascites.

Typically, patients with ascites need painful and potentially dangerous biopsies to drain off the fluid. Terifay says the hope is that VEGF-Trap could be used to reduce the buildup of fluid and increase the time before patients require biopsies.

The trial is still enrolling patients. It's a novel trial with a unique endpoint, so handicapping success is hard. There are data reported already that show VEGF-Trap reduces the incidence of ascites in ovarian cancer patients, but whether that holds true in a randomized clinical trial remains to be seen.

So, one scenario sketched out by Terifay has the companies seeking FDA approval based on a package of two phase II trials with data on response rate and ascites reduction. Such a filing could happen in 2008, as the companies have stated.

It's always better to under-promise and over-deliver -- advice that Regeneron and Sanofi are not necessarily following with VEGF-Trap. Expect a high level of skepticism until the companies deliver.

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I've been a bit surprised by the negative reaction to satraplatin, the oral prostate cancer chemo drug being developed by GPC Biotech(GPCB), at this ASCO meeting. A few doctors I've spoken with feel like satraplatin will be approved by the FDA later this year, but that its use will be minimal. I haven't spoken with enough doctors to say that I've found a consensus opinion, but I haven't found any doctors, especially at academic centers, who seem particularly interested in treating patients with satraplatin.

GPC Biotech has a positive phase III trial for satraplatin under its belt. The drug will be reviewed at an FDA advisory panel meeting on July 24. The FDA is expected to render its approval decision in August.

Pharmion(PHRM) has European rights to satraplatin, while Spectrum Pharmaceuticals(SPPI) gets a royalty on global satraplatin sales.

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