Analysts raised revenue projections for Amgen’s denosumab on Wednesday following the release of data from a head-to-head trial, which showed that the RANK Ligand inhibitor met the study’s primary endpoint of non-inferiority to Novartis’ Zometa (zoledronic acid) in delaying serious complications of bone metastases in patients with advanced breast cancer. Company shares gained as much as 16 percent.

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Thomas Weisel analyst Ian Somaiya raised his estimate for potential denosumab sales in 2012 to $2.1 billion from a previous forecast of $1.8 billion, saying that “superior efficacy could enable denosumab to establish a new standard of care.” Eun Yang, of Jefferies & Co., predicted that once it is approved, denosumab would “take significant market share from Zometa in the cancer setting,” with Oppenheim’s Carri Duncan saying that, due to the latest findings, “we anticipate rapid acceptance of this drug by clinicians who will switch patients from Zometa.”

Amgen did not provide detailed safety data from the trial, notably with regard to rates of osteonecrosis of the jaw, saying only that rates were consistent with prior results. However, Thomas Weisel’s Somaiya commented that “though a significant difference in osteonecrosis of the jaw [between denosumab and Zometa] would have been a home run, we believe that superior efficacy will be enough to drive additional (denosumab) front-line use.”

Regarding the potential for the drug to be used in other cancer indications, Jefferies & Co. analysts said “our experts indicate that the first Phase III data in breast cancer would be a good indicator of what would be expected in other cancer settings.”

Source: FirstWord

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