Novartis' Zometa Disappoints - Analyst Blog

Recently, Novartis AG (NVS) presented data from the AZURE trial of its bone drug Zometa at the annual Antonio Breast Cancer Symposium. The phase III study tested the effectiveness of Zometa in improving disease free survival in both premenopausal and postmenopausal women with early breast cancer who had undergone surgery.

The data showed that Zometa when added to standard adjuvant (post surgery) chemotherapy and/or hormonal therapy does not have any advantage in disease free survival compared to standard therapy.  However, an improvement in disease free survival and overall survival was seen in women with well-established menopause in the Zometa arm.

Data from a large phase III trial (ABCSG-12) had earlier demonstrated the anti-cancer benefit of Zometa. The trial revealed that Zometa when added to hormonal therapy following surgery for three years showed an improvement in disease free survival by 32%.

In 2009, the company had submitted a supplemental New Drug Application (sNDA) in both the US and the EU for Zometa in the adjuvant treatment of premenopausal women with early breast cancer in conjunction with hormonal therapy. This was based on data from the ABCSG-12 trial. The company has, however, withdrawn the marketing applications and will evaluate future plans based on the latest data presentation.

Zometa, known chemically as zoledronic acid, is currently approved for reducing or delaying skeletal-related events from bone metastases (cancer that has spread to the bones) arising in prostate, breast and lung cancer and Paget's disease patients.  Zometa is also approved for the treatment of hypercalcemia of malignancy (tumor-induced excessive levels of calcium).

Our Recommendation

Currently, we have a Neutral recommendation on Novartis, which is supported by a Zacks #3 Rank. We are pleased with Novartis' wide range of products and its efforts to diversify further as is evident by the recent acquisition of a majority stake in Alcon (ACL).

The company is looking to acquire the remaining stake in the eye-care company.  However, we prefer to remain on the sidelines due to the upcoming patent cliff for the company as a number of Novartis' drugs will face generic competition between 2011 and 2015.

 
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