Switzerland based Roche (RHHBY - Analyst Report) 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 plus).
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 elderly people.
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 Herceptin.
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.