In a major development today, the US Food and Drug Administration (FDA) approved Roche’s (RHHBY) Valcyte (valgancyclovir) for the prevention of cytomegalovirus (CMV) disease in pediatric kidney and heart transplant patients. The drug targets patients aged 4 months to 16 years, who are at higher risk of developing the infection due to reduced immunity following organ transplants. The FDA also approved a pediatric oral solution of the drug.

Although the virus lies dormant in the body throughout life, it has the potential to cause severe damage when the immunity system is weakened. For transplant patients, the virus can lead to loss of the transplanted organ and in severe cases may even be fatal.

The recent approval represents a label expansion for the drug, which is already approved for CMV disease in HIV patients. In July 2008, it received pediatric exclusivity from the FDA. Combined sales of Valcyte and Cymevene (ganciclovir) rose 10% to CHF 553 million in 2008, from the year-ago period primarily driven by demand in Europe, with strong gains recorded in Germany and Spain.

Separately, Roche’s subsidiary Genentech agreed to buy Singapore-based Lonza’s cell culture biologic manufacturing facility for $290 million upfront and potential of another $70 million in milestone payments. Roche will use this facility, with 80,000 liters of fermentation capacity, to produce the bulk drug substance of Avastin. The drug that targets lung, colon and breast cancers had annual global sales of $4.92 billion in 2008.

Although these were positive developments for Roche, it was in the news for wrong reasons in the last week. The FDA decided to review the safety features of its diet drug, Xenical, for possible links with liver failure. The agency has asked patients to continue taking the drug and report possible side effects. We would await the results of the study.

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