EU Nod for Roche's New Formulation of Herceptin - Analyst Blog

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Roche ( RHHBY ) recently announced that a subcutaneous formulation of its oncology drug, Herceptin, has been approved in Europe for treating patients suffering from HER2+ breast cancer.

Roche has received approval for both early and later stages of treatment.  The EU approval was based on positive data from the HannaH study, which showed that the subcutaneous formulation of Herceptin was more effective than the intravenous formulation in patients suffering from HER2+ early breast cancer.

The EU approval of the drug does not surprise us as in Jun 2013, the Committee for Medicinal Products for Human Use gave a positive opinion on the subcutaneous formulation of Herceptin.


The subcutaneous formulation can be administered in two to five minutes, whereas the intravenous version takes around half an hour to ninety minutes to infuse. The new subcutaneous formulation may significantly reduce pharmacy time as no medicine preparation time is required.

Since the formulation is fixed-dose with a three weekly regimen, it simplifies healthcare procedure by removing the need for reconstitution or dose calculation as per a patient's weight.

We note that Roche has a solid position in the breast cancer market. Apart from Herceptin, Roche has drugs like Perjeta and Kadcyla in its kitty for the treatment of patients suffering from HER2+ breast cancer.

The EU approval of the subcutaneous formulation of Herceptin should further strengthen the breast cancer franchise at Roche which generated sales of CHF 3.3 billion in the first half of 2013, up 11% year over year.

We note that Novartis' ( NVS ) Afinitor is also approved in the US and the EU for the treatment of HER2+ advanced breast cancer in combination with Pfizer's ( PFE ) Aromasin in postmenopausal women, whose disease has returned or progressed even after undergoing treatment with a non-steroidal aromatase inhibitor.

Roche currently carries a Zacks Rank #3 (Hold). Right now, Jazz Pharmaceuticals ( JAZZ ) looks attractive with a Zacks Rank #2 (Buy).



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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: JAZZ , NVS , PFE , RHHBY

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