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Bristol Myers-Squibb/AstraZeneca's Onglyza Officially Cleared For Europe

This article was originally published in The Pink Sheet Daily

Executive Summary

New DPP-4 inhibitor for diabetes passes noninferiority test against Merck's hugely popular Januvia.

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Business And Finance, In Brief

Coming off Cerezyme sales decrease, Genzyme reduces earnings per share guidance: Having announced a 70 percent decline in sales of the Gaucher disease drug Cerezyme (imiglucerase) during its third-quarter 2009 earnings call Oct. 21, Genzyme reduced its earnings-per-share guidance for the year (1"The Pink Sheet" DAILY, Oct. 21, 2009). The big biotech said it expects non-GAAP earnings per share to come in at roughly $2.26 for the year, down from prior guidance for EPS of between $2.35 and $2.90 per share. Genzyme attributed the reduction to the costs from remediation of its Allston Landing, Mass., manufacturing plant, the decision to discard and write off some of the in-process Cerezyme material on hand at the time of the Allston shutdown, and management of customer-level inventories related to its oncology transaction with Bayer. While overall revenue for the quarter was down roughly $100 million, the company reported an earnings increase in its cardiometabolic and renal drugs franchise, as combined sales of dialysis drugs Renvela (sevelamer carbonate) and Renagel (severlamer hydrochloride) rose nearly $11 million, year over year, to $181.7 million

Business And Finance, In Brief

Coming off Cerezyme sales decrease, Genzyme reduces earnings per share guidance: Having announced a 70 percent decline in sales of the Gaucher disease drug Cerezyme (imiglucerase) during its third-quarter 2009 earnings call Oct. 21, Genzyme reduced its earnings-per-share guidance for the year (1"The Pink Sheet" DAILY, Oct. 21, 2009). The big biotech said it expects non-GAAP earnings per share to come in at roughly $2.26 for the year, down from prior guidance for EPS of between $2.35 and $2.90 per share. Genzyme attributed the reduction to the costs from remediation of its Allston Landing, Mass., manufacturing plant, the decision to discard and write off some of the in-process Cerezyme material on hand at the time of the Allston shutdown, and management of customer-level inventories related to its oncology transaction with Bayer. While overall revenue for the quarter was down roughly $100 million, the company reported an earnings increase in its cardiometabolic and renal drugs franchise, as combined sales of dialysis drugs Renvela (sevelamer carbonate) and Renagel (severlamer hydrochloride) rose nearly $11 million, year over year, to $181.7 million

Januvia Jitters: FDA Warns Blockbuster Diabetes Drug May Cause Pancreatitis

Scrutiny of Merck’s Januvia could raise more questions about Onglyza and other DPP-4 inhibitors.

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