Roche (RHHBY - Free Report) recently announced that Committee for Medicinal Products for Human Use (CHMP) in Europe has given a positive opinion on a subcutaneous formulation of Herceptin for treating patients suffering from HER2+ breast cancer.
The positive opinion from the CHMP was based on encouraging results from a phase III study, HannaH. Results from the study showed that the safety and effectiveness of the subcutaneous formulation of Herceptin was similar to that of the intravenous formulation.
While the subcutaneous formulation can be administered in two to five minutes, the intravenous version takes around half an hour to ninety minutes to infuse. Also, since no medicine preparation time is required, the new subcutaneous formulation may significantly reduce pharmacy time.
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.
We expect EU approval of the subcutaneous formulation of Herceptin soon which in turn should further strengthen the breast cancer franchise at Roche.
We note that Novartis’ (NVS - Free Report) Afinitor is also approved in the US and the EU for the treatment of HER2+ advanced breast cancer in combination with Pfizer’s (PFE - Free Report) Aromasin, in postmenopausal women, whose disease has returned or progressed even after undergoing treatment with a non-steroidal aromatase inhibitor.
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