Thursday, November 29, 2012

Pharmacyclics: Blockbuster cancer drug?


The abstracts released by Pharmacyclics (PCYC) at the American Society of Clinical Oncology had some very important updates, suggesting that its Ibrutinib appears to be well on its way to becoming a blockbuster cancer drug.

In our 25+ years analyzing drug candidates, we have never seen something so simple and satisfying � a once-a-day highly effective and very safe pill, with never-seen-before results in multi-billion dollar markets.

We believe that the PCYC data for ibrutinib are extremely promising and greatly expand the drug�s commercial potential and Pharmacyclics� value proposition. �

The PCYC-1102 study had two cohorts of CLL patients: those with R/R disease (these results were presented at the 2011 ASH meeting) and treatment-na�ve elderly patients (>65yrs.). Patients were treated with ibrutinib monotherapy.

The results among 26 patients showed that 84.6% (22/26) responded to the drug. The estimated 12 month PFS was 93%, and all patients enrolled remained alive.
These data are unheard for a single agent in refractory population � for the first time exhibiting front-line potential.

In another abstract, ibrutinib was combined with ofatumumab in 24 CLL patients who had taken, on average, three prior therapies.

Every one of the 24 participants in this study had a positive response to the combination therapy. Further, no incidences of neutropenia were reported.

Currently, 23 or the 24 patients remain on therapy after 6.5 months. We expect to see a significant update to this data, as the abstract only reflects data current as of November 2011.

Our conviction in the company and the promise of PCI-32765 is so strong that we are raising our buy limit to $35 and our target price to $45.� PCYC is now a buy under $35 with an 18 month target of $45.

We are usually quite reluctant to chase stocks into strength, but the ASCO abstracts reveal an even wider therapeutic window and, hence, market potential.

PCYC has demonstrated that they have a very sound management team and potentially the best cancer drug � or any drug for that matter - around.

The company is poised to deliver a plethora of positive news flow throughout the year as the drug development candidate is in multiple trials for multiple indications.

We have not even discussed the potential for PCI-32765 in the major markets of Non-Hodgkins Lymphoma (NHL) or Multiple Myeloma (MM), which could send the stock to multiples of the current price if even hints of efficacy are delivered. �

We urge investors to purchase PCYC, as the market pullback is providing an excellent entry point as we expect the stock to accelerate once the market stabilizes. PCYC is a now a buy under $35 with an 18-month target of $45.



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