Roche Holdings Ltd. (RHHBY) recently announced that the US Food and Drug Administration (FDA) approved prolonging the duration of therapy with Valcyte in adult patients who have undergone a kidney transplant and are at a high risk of cytomegalovirus (CMV) disease.
Results from the IMPACT (IMproved Protection Against Cytomegalovirus in Transplant) study supported the approval of Valcyte for extended use. One year results showed that the occurrence of CMV in patients treated with Valcyte over a 200-day period reduced to 16.8% from the 36.8% incidence observed in patients treated with Valcyte for 100 days.
The study involved 326 kidney allograft recipients who were given either Valcyte 900 mg once daily for 100 days followed by 100 days of placebo or Valcyte 900 mg once daily for 200 days. Both these treatment regimens were initiated 10 days after transplantation.
The overall safety profile of the drug remained almost the same in both the treatment regimens, with the most serious adverse events being hypertension, transplant rejection, and tremors. Four deaths also occurred in the 100-day treatment group.
During the first half of 2010, Valcyte sales increased 11% year-over-year to 296 million Swiss francs. The label expansion of the drug will only add to the already increasing sales of Valcyte.
We currently have a short-term Zacks #3 Rank (‘Hold’) rating on Roche. The company took a debt of 48.2 billion Swiss francs in 2009 to finance the acquisition of Genentech. However, given Roche’s strong operating free cash flow, the company expects to become debt-free by 2015, along with maintaining its dividend outlook. Moreover, the company aims to repay a third of the debt incurred for the Genentech acquisition by the end of 2010.
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