) 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
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
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
) Afinitor is also approved in the US and the EU for the
treatment of HER2+ advanced breast cancer in combination with
) 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 #4 (Sell). Right now,
) looks attractive with a Zacks Rank #2 (Buy).
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