Shares of Amylin Pharmaceuticals, Inc. (AMLN) lost more than 25% when the company released disappointing data on Bydureon (exenatide once-weekly) from a head-to-head study. Bydureon failed to achieve its primary endpoint of non-inferiority in the DURATION-6 study, which compared Bydureon with Novo Nordisk’s (NVO) Victoza.
Results showed that patients in the Bydureon arm achieved a reduction of 1.3 percentage points in A1C levels compared to a reduction of 1.5 percentage points in the Victoza arm. Although gastrointestinal adverse events were less frequent in the Bydureon arm, the candidate’s failure to achieve the primary endpoint is a major setback.
The disappointing DURATION-6 data is the latest setback faced by Amylin and its partners, Eli Lilly and Company (LLY) and Alkermes, Inc. (ALKS), in the development of Bydureon.
Earlier in October 2010, Bydureon’s approval was delayed with the US Food and Drug Administration (FDA) issuing a second complete response letter (CRL) for the type II diabetes candidate.
In its second CRL, the FDA asked the companies to conduct a thorough QT (tQT) study. The FDA may have asked for this study based on the recent concerns raised regarding the cardiovascular safety profile of diabetes drugs.
The agency also asked Amylin and its partners to submit data from the DURATION-5 study which was conducted to compare the safety and efficacy of Bydureon versus Byetta (exenatide).
Amylin and its partners intend to submit a response to the second CRL in the second half of 2011. Assuming a six-month review period, Bydureon could gain FDA approval in mid 2012.
DURATION-6 Data Should Benefit Victoza
Novo Nordisk sales reps should be able to use the DURATION-6 results to promote Victoza. Victoza is a glucagon-like peptide-1 (GLP-1) receptor agonist like Bydureon. Victoza, which was launched in early 2010, already has a significant head start over Bydureon. Victoza sales came in at DKK 2,317 million (approximately $432 million) in 2010.
Given Bydureon’s failure to demonstrate non-inferiority to Victoza, Bydureon will find it challenging to take share from Victoza, once launched.
Neutral on Amylin
We currently have a Neutral recommendation on Amylin, which is supported by a Zacks #3 Rank (short-term “Hold” recommendation). We expect investor focus to remain on Byetta’s performance and updates on the approval process for Bydureon. Longer-term, we are optimistic on the mid-stage obesity pipeline. Amylin’s deal with Takeda for the obesity pipeline is a major positive.
ALKERMES INC (ALKS): Free Stock Analysis Report
AMYLIN PHARMA (AMLN): Free Stock Analysis Report
LILLY ELI & CO (LLY): Free Stock Analysis Report
NOVO-NORDISK AS (NVO): Free Stock Analysis Report
Zacks Investment Research
