Positive Data on Novartis' Glivec - Analyst Blog

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Switzerland-based pharmaceutical company, Novartis AG ( NVS ) announced that a positive phase III trial result of Glivec (imatinib) was published in the Journal of the American Medical Association (JAMA) . The phase III trial evaluated Glivec as an adjuvant treatment in post surgery KIT (CD117)-positive gastrointestinal stromal tumors (KIT+ GIST) patients. Results from this trial were first presented at the American Society of Clinical Oncology ( ASCO ) meeting in June 2011.

The trial compared the use of the drug for 3 years versus the standard 1-year treatment currently approved. Data from the trial revealed that after five years, 66% of the patients who had taken Glivec for 3 years after surgery to remove KIT+GIST were free from cancer recurrence (primary endpoint) versus 48% of those who had taken the drug for one year.

Moreover, 92% of patients who had taken Glivec for 3 years showed overall survival (secondary endpoint) versus 82% of those who had taken the medicine for a year. This is the first large-scale study demonstrating the survival benefits of prolonged treatment with Glivec.

GIST is a rare form of tumor in the gastrointestinal tract. According to the American Cancer Society, approximately 4,000 - 5,000 patients are affected each year in US. The tumors usually originate in the stomach. The primary treatment option for GIST that has not spread is surgery.

However, these patients run the risk of recurrence even after successful and complete surgical removal of the tumor. Glivec thus provides a treatment option for such patients by improving recurrence free survival, when the post-surgical duration of Glivec treatment is extended. Other products currently approved for GIST includes Sutent by Pfizer ( PFE ).

Glivec is currently approved for the treatment of all phases of Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML). It is also approved for the treatment of KIT+GIST, which cannot be surgically removed and/or have already spread to other parts of the body, and for the treatment of adult patients following surgical removal of KIT+ GIST.

In February 2012, the Glivec label was updated by European Commission to include three years of treatment after surgery for adults with KIT+ GIST.

Our Recommendation

Though we are pleased with Novartis' wide range of products and its efforts to diversify further, we prefer to remain on the sidelines in the long term due to the imminent patent cliff faced by the company. Thus, we have a Neutral recommendation on Novartis. The company carries a Zacks #4 Rank ("Sell" rating) in the short run.


 
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of The NASDAQ OMX Group, Inc.



This article appears in: Investing , Business , Stocks

Referenced Stocks: ASCO , NVS , PFE

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