) recently announced that a subcutaneous formulation of its
oncology drug, Herceptin, has been approved in Europe for
treating patients suffering from HER2+ breast cancer.
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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
) 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
Roche currently carries a Zacks Rank #3 (Hold). Right now,
) looks attractive with a Zacks Rank #2 (Buy).