) recently announced that the US Food and Drug Administration
(FDA) has approved Tamiflu (oseltamivir phosphate) for the
treatment of acute influenza in infants (two weeks
Tamiflu, developed in collaboration with Gilead (GILD), was
initially approved in 1999 for the treatment of adults infected
with flu symptoms for no longer than two days. Tamiflu was
subsequently approved for the treatment of flu in children aged 1
year and above with flu symptoms for no longer than two days.
Tamiflu is also approved for the prevention of flu in adults and
children aged 1 year and above. We note that the latest label
expansion is not for the prevention indication.
As per the World Health Organization (WHO) and the US Center
for Disease Control and Prevention (CDC), Tamiflu is one of two
approved antivirals, which work against the pandemic strain of
H1N1 influenza virus.
The recent approval will enable doctors to prescribe Tamiflu
to people of all age groups ranging from two weeks of age to
Meanwhile, in another development, the European Union's
Committee for Medicinal Products for Human Use (CHMP) gave a
positive recommendation for Perjeta (pertuzumab) plus Herceptin
(trastuzumab) and docetaxel to treat patients with HER2-positive
metastatic or locally recurrent unresectable breast cancer (mBC).
Still in the nascent stage after having got approval in the
U.S. in 2012, Perjeta complements Herceptin in attacking
HER2-positive tumors. The approval of Perjeta in combination with
Herceptin and docetaxel will open up the market for Roche to
include patients that have already initiated a prescription with
Perjeta generated sales of CHF 26 million in the first nine
months of 2012.
We currently have a Zacks #3 Rank (Hold) on Roche. Roche has
identified Perjeta, T-DM1 and Actemra to positively impact
results in 2013 while Pegasys and Lucentis will continue to pose
challenges for the company.
Roche expects total revenue and revenue from the
Pharmaceuticals Division to grow in the low-to-mid single digits
in 2012. Sales from the other division, Diagnostics, is expected
to exceed market growth rate. Moreover, despite the unfavorable
market environment, Roche expects the bottom line to experience
high single-digit growth in 2012 driven by expected sales growth
and continued efficiency improvements.
Right now, we have a Zacks #2 Rank (Buy) on
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