Hammer Stock Blog

As far as personalized medicine goes, it doesn’t get any sweeter than Pfizer’s (PFE) Xalkori.  As the industry is moving away from a “one size fits all” model to personalized medicine, this drug sets an enviable example of how to get fast approval for a lucrative niche indication by selecting the right patients. Hailed as the poster child of personalized medicine,  Xalkori is currently approved for lung cancer patients whose tumors have rare mutations in the protein ALK, which occurs in ~4% of non-small cell lung cancer cases. (more…)

More melanoma breakthroughs

This year’s meeting will probably be remembered as a historical event with regards to melanoma. Last year, it was a phase III trial for BMS’ (BMY) Yervoy (ipilimumab), which was the first in history to show a survival benefit in advanced melanoma patients (discussed in my ASCO 2010 write up). This trial led to Yervoy’s historical approval 3 months ago.

This year, investigators will present studies evaluating Yervoy as well as Plexxikon/Roche’s vemurafenib in pretreated melanoma patients. Yervoy was evaluated in combination with chemotherapy while vemurafenib was compared with chemotherapy. According to BMS’ and Roche’s press releases, both studies were successful and each drug led to a survival benefit.  The extent of this benefit is still unknown and will be revealed only at the conference. (more…)

In the pharmaceutical industry, it is very common to see multiple drugs in development that go after the same target. Usually, there is a direct correlation between the recognition a target has and the number of competing agents. This is the case with “hot targets” such as PI3K,RAF and mTOR, which are pursued by many pharma and biotech companies.

In most cases (especially with targeted therapies), the different compounds are being developed in parallel, and there is no way of identifying a clear winner. This can persist even after approval. For instance, both BMS Pfizer and Novartis (NVS) have an mTOR inhibitor on the market for the treatment of renal cancer. It is clear both drugs are active but each compound was approved based on a different trial in a different patient population, so neither can claim superiority.

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After a challenging year, Exelixis (EXEL) is finishing 2010 on a positive note, with the help of promising data for its lead agent, XL184. Last week at the EORTC conference, the company published data from a large phase II study in multiple cancer types. The results came at a crucial time for Exelixis, as many were questioning the value of XL184 following BMS’ (BMY) decision to opt-out of its development. As discussed in a previous post, when a partner like BMS dumps a late stage clinical asset after a licensing payment of over $150M, the alarm bells start ringing.

XL184 inhibits several targets, primarily VEGFR2 and Met. As a multi-targeted kinase inhibitor, the drug has some overlap with other drugs, primarily VEGFR inhibitors. There are two drugs that inhibit VEGFR (in addition to other targets) currently in the market as well as a long list of VEGFR inhibitors in late stage clinical testing from GSK (GSK), AstraZeneca (AZN), BMS and Aveo (AVEO). The main question regarding XL184 is whether the drug has a differentiated clinical profile in comparison to other VEGFR inhibitors. Based on recent data presented at EORTC the answer is a resounding “YES”. (more…)

The ESMO meeting is the most important oncology conference in Europe. This year in particular, it included very interesting data that affected the sentiment towards many biotech companies. Here, I intend to focus on what I view as three clear winners from the conference: Seattle Genetics (SGEN), Arqule (ARQL) and Dendreon (DNDN).     

Seattle Genetics

Seattle Genetics is about to conclude the best year in its history, since it was incorporated 13 years ago.  The company’s lead agent, SGN-35 (aka Brentuximab Vedotin), generated astonishing results in two types of blood cancers earlier this year. Based on the results in Hodkin’s Lymphoma, SGN-35’s approval seems inevitable, even though results are not from large randomized studies. Unlike T-DM1’s case, Seattle Genetics negotiated a special protocol assessment (SPA) with the FDA, implying that the trial design and endpoints are acceptable by the FDA.

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