March 26, 2009 / 12:39 PM / 10 years ago

PREVIEW-Novo, Astra-BMS diabetes drugs face U.S. grilling

* Onglyza reviewed by FDA panel April 1, Victoza April 2

* Focus on cardiovascular safety of both diabetes drugs

* Share prices may be volatile

By Ben Hirschler

LONDON, March 26 (Reuters) - Two new diabetes drugs face tough appraisals from U.S. experts next week, promising a volatile ride for shares in Novo Nordisk (NOVOb.CO), AstraZeneca (AZN.L) and Bristol-Myers Squibb (BMY.N).

Investors are nervous about prospects for Novo’s Victoza, or liraglutide, and AstraZeneca and Bristol’s Onglyza, or saxagliptin, both of which could face safety issues that delay their approval in the key U.S. market.

Worries have been heightened since March 6, when Takeda Pharmaceutical (4502.T) said the U.S. Food and Drug Administration (FDA) needed more data to review its new diabetes drug alogliptin, sending the Japanese group’s stock tumbling.

Onglyza, which will be assessed by the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee on April 1, belongs to the same DPP-4 drug class as alogliptin.

The only successful DPP-4 drug at present is Merck & Co’s (MRK.N) Januvia, which had sales of $1.4 billion in 2007. Novartis NOVN.VX was also an early pioneer of DPP-4s but it has struggled to get rival medicine Galvus to market.

If successful, Onglyza could theoretically generate sales of more than $3 billion a year, some analysts believe. But most are forecasting just $200 million to $400 million, reflecting uncertainties about its chances in front of a cautious FDA.

Underlining that caution, the FDA in December told companies with diabetes drugs in early-stage development it wanted more evidence on cardiovascular risk, following a scare over heart risks with GlaxoSmithKline’s (GSK.L) Avandia.

Doubts have also grown about Novo’s Victoza, which will go in front of the same committee on April 2.

The Danish company is confident its drug has an excellent cardiovascular safety profile and says it has not been asked by the FDA to conduct any more clinical studies before approval.

But many investors still fear a delay is possible.

Confidence in Victoza — the key driver for Novo in the years ahead — has weakened in recent months because of worries about the FDA’s stance and slowing sales of Amylin Pharmaceuticals’ AMLN.O rival product Byetta.

Both Victoza and Byetta belong to the GLP-1 class of injectable drugs that stimulate insulin release only when glucose levels become too high.

Consensus forecasts for Victoza have come down to around $1.3 billion to $1.5 billion, according to analysts at Citigroup, nearer the brokerage’s own cautious prediction of $1.2 billion in 2015. (Editing by Sharon Lindores)

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