Trial setback makes a hard road even tougher for Bydureon

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Experimental diabetes drug Bydureon failed to manage blood glucose levels as well as daily Victoza, a surprising finding which analysts say steepens the drug's challenges should it get approved.

In the trial, called DURATION-6, patients receiving Bydureon saw a reduction in average blood sugar, or A1C, of 1.3 percentage points from baseline, compared to a reduction of 1.5 percentage points for Victoza, which is marketed by Novo Nordisk. “Bydureon did not meet the pre-specified primary endpoint of non-inferiority to Victoza,” Amylin, Eli Lilly and Alkermes said in a joint statement.

Based on previous studies for both drugs, analysts and the companies themselves had expected a positive result on the A1C endpoint.

It was not the first setback for Bydureon. A once-weekly version of the twice-a-day marketed Byetta, Bydureon was meant to contend with Victoza, which is injected once a day and posted $433 million in sales in 2010. But in October, the FDA issued a complete response letter for Bydureon requesting a study of heart effects. It followed another CRL in April and pushed Bydureon approval out to at least 2012.

By then, the GLP-1 receptor agonist class—to which Bydureon, Byetta and Victoza belong—could become more crowded. Among other GLP-1s in late-stage development are Sanofi-Aventis's once-daily lixisenatide and Human Genome Sciences/GlaxoSmithKline's albiglutide.

The delay in its approval timeline, coupled with today's news of lower efficacy than Victoza, complicates matters for Bydureon. “We foresee greater challenges on the reimbursement and formulary access front should the agent be approved,” Barclays Capital analyst Tony Butler, PhD, wrote today in a note to investors.

Butler reduced his Bydureon forecast from estimated FY16 sales of $650 million (assuming roughly 40% of the total GLP-1 market) to $300 million (based on the agent capturing 20% market share). He also lowered his peak sales estimate to $500 million by 2019, from $1 billion.

According to IMS Health data cited by Butler, as of January, Victoza had captured about 41% of TRx and roughly 45% of NRx in the GLP-1 market. And because this segment has expanded at a slower pace than Wall Street expectations, “We believe that Bydureon, with a likely 30-month delay in market entry, would face a challenging trajectory in terms of market penetration in the GLP-1 space,” he noted.

Indeed, “Why would you put a patient on a less effective drug?” Sanford C. Bernstein analyst Jack Scannell told Bloomberg News.

Robert Hazlett, an analyst with BMO Capital Markets, advised clients that the once-daily oral medications—namely Takeda's Actos, Merck's Januvia and BMS/AstraZeneca's Onglyza—could also make a Bydureon entrance “more challenged than some expect,” Bloomberg reported.

On the other hand, weekly dosing could lead to stronger patient adherence with Bydureon, Butler pointed out. Also, gastrointestinal adverse events occurred more frequently among Victoza patients in the head-to-head trial, according to the statement. Both may provide some benefits vs. competitors, the analyst added.

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