The FDA, as expected, told Amgen that it could not OK the biotech's request to expand the approval for Xgeva into pre-metastases bone cancer, Amgen said. In its complete response letter, the agency reportedly decided that the survival benefit of the drug—an additional 4.2 months vs. placebo—does not outweigh the risks of the proposed application; Xgeva has been associated with a higher rate of jaw degeneration in users. In February an FDA advisory panel voted 12 to 1 that the benefit of early Xgeva treatment was insufficient to conclude a positive risk-benefit ratio, and analysts were skeptical even before the panel's vote. The denosumab injection is already approved to prevent fractures in patients with advanced prostate cancer that has spread to the bone. A lower-dose version, which Amgen sells as osteoporosis treatment Prolia, has not been linked to the same safety issue. In 2011, US sales of Xgeva and Prolia were $343 million and $130 million, respectively. Approval for earlier use was one key to Amgen's blockbuster forecast for the denomsumab franchise.
Merck reported respectable, if somewhat ho-hum, first quarter results, with worldwide sales up 1% to $11.7 billion and healthy growth of newer products. Worldwide sales of pharmaceuticals rose 3% to $10.1 billion, while Animal Health sales were up 8% to $821 million and Consumer Care sales up 7% to $554 million. Merck's Januvia/Janumet diabetes franchise posted 26% growth, taking in $1.3 billion, while Gardasil sales leapt 33% to $284 million, driven by increased vaccination of males ages 9-26 and by the vaccine's launch in Japan. Zostavax, Victrelis and Isentress also demonstrated healthy growth. The results were weighed down by the loss of US and European exclusivity for Cozaar/Hyzaar and by the transfer of marketing rights for Remicade and Simponi for much of the world to J&J. The company is bracing for the August loss of US patent exclusivity on Singulair, which grossed 1.3 billion worldwide in 2011. On the upside, the Whitehouse Station, NJ-based firm got some good news on Friday when a Federal judge ruled against Mylan, which was contesting Merck's patents for Zetia and Vytorin. The ruling means Merck is safe from generic competition in the US until April 2017. Together, Zetia and Vytorin took in around a billion dollars in the first quarter.