Pharmacyclics Inc. Crushes Critical Trial

Pharmaceutical company Pharmacyclics (NASDAQ: PCYC  ) shot skyward today, up nearly 20%, because of some unusual news from a critical phase 3 trial. The company's drug Ibrutinib, now called Imbruvica, has already been approved for mantle cell lymphoma, and just had its phase 3 trial for chronic lymphocytic leukemia stopped early. While in most cases, stopping a clinical trial early is a sign of an ineffective drug, in some rare cases the drug is so effective that it is considered cruel to keep the drug from those acting as the control group for the study, which was the case here with Pharmacyclics' Imbruvica. While the drug showed a clear improvement over its head-to-head competitor, GlaxoSmithKline's (NYSE: GSK  ) Arzerra, which proved to be more of a bust than a blockbuster, there are much bigger competitive fish in this sea. In this video, Motley Fool health-care analyst David Williamson discusses why Roche's (NASDAQOTH: RHHBY  ) Rituxan and AbbVie's (NYSE: ABBV  ) may have major competitive advantages against Pharmacyclics' Imbruvica, and why, despite the likelihood that this drug will be a mega-blockbuster both for PCYC and its partner Johnson & Johnson (NYSE: JNJ  ) , those wins are already priced into the stocks, and investors today may be facing more downside than upside.

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  • Report this Comment On January 07, 2014, at 8:06 PM, Biowizard99 wrote:

    I think that you guys really need to do your research on imbruvica because the flame that was made that there is a major competitive advantage could not be more misleading. The fact remains that no drug in cll or mcl has ever shown results anywhere near Imbruvica. Even when you look at the data that roche put out on that combo study it in no way suggests that they have any competitive advantage. In fact there are a lot of questions surrounding that trial in regards to safety that imbruvica doesn't have. On top of that PfS for imbruvica cannot even be calculated because of so few deaths in there trials and these patients have been treated for over 3 years.. This article was very misleading and I expect more from the motley fool. Please go back and do some real due diligence and report the facts not the rumors

  • Report this Comment On January 07, 2014, at 8:08 PM, Biowizard99 wrote:

    I will post the difference in the two drugs within the next 24 hours and I expect the motley fool to correct the misleading information that was given in this article/video.

  • Report this Comment On January 07, 2014, at 8:29 PM, hongchang wrote:

    I guess that's why you call these guys fool which they thought was a funny name.

  • Report this Comment On January 08, 2014, at 8:51 AM, Warriormuffin wrote:

    You people clearly have no background or understanding of the hematological cancer market. To almost embarassing levels. As a previous poster mentioned, your ascertions that other drugs even pose a fraction of competitive challenge to Imbruvica is criminally incorrect. There is no drug. I repeat. No drug that HAS EVER demonstrated any single agent data even CLOSE to Imbruvica in the indications that it is being studied in. Roche's Rituxan not only does not work as a single agent, but is a combination drug. Every drug that comes on the market will likely be eventually combined with Rituxan. It has an entirely different mechanism of action than Imbruvica, and is to be considered a partner drug. Not a competitive threat.

    It's articles like these that clearly demonstrate why you have "Fool" in your name. Imbruvica is going to be one of the largest blockbuster drugs ever released for cancer. It has never before seen efficacy combined with a safety profile that every single top hematological cancer researcher calls, "like water". I am quoting this directly from the talks I have been attending for 5 years. And this isn't even considering the fact that their mechanism is valid for diseases even beyond liquid tumors.

    You should retract this drivel of an article and go learn more about cancer before commenting. Imbruvica will change the landscape of CLL. And likely other tumors as well. get your facts straight and stop misleading the market.

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David Williamson

The Motley Fool's Healthcare Analyst, I specialize in Pharma, Biotech, and how the ACA (Obamacare) is changing the business of healthcare in America. Follow me on Twitter for breaking stock news, policy thoughts, and misc musings...

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