Recently Alkermes Inc. (ALKS), Amylin Pharmaceuticals Inc. (AMLN) and Eli Lilly & Co. (LLY), the co-developers of type II diabetes candidate Bydureon (exenatide once weekly), announced mixed results from one of several studies conducted to evaluate the superiority of the candidate over other type II diabetes therapies.
The 26-week study (n=820), known as DURATION-4, compared the efficacy of Bydureon, a glucagon-like peptide-1 (GLP-1) molecule, as a monotherapy treatment against Merck’s (MRK) Januvia (sitagliptin), Takeda’s Actos (pioglitazone hydrochloride) and metformin.
The double-blind study revealed that patients treated with Bydureon (n=248) underwent a 1.5% reduction in blood sugar levels as against a 1.2% reduction experienced by patients (n=163) treated with Januvia. However, patients taking metformin (n=246) and Actos (n=163) saw a decline of 1.5% and 1.6%, respectively, in their blood sugar levels.
Furthermore, patients treated with Bydureon underwent an average weight loss of 4.5 pounds, as against the average 1.7 pounds lost by patients treated with Januvia and the average 4.4 pounds lost with metformin treatment. Patients treated with Actos gained 3.3 pounds on an average.
Bydureon is currently under review by the US Food and Drug Administration (FDA). A response from the agency should be out in October this year (target date: October 22). Bydureon has enormous potential in the $13 billion type II diabetes market. However, we believe that the final label is likely to contain warnings regarding the risk of pancreatitis and thyroid cancer.
Furthermore, the candidate will face tough competition on approval. The drug will compete with Novo Nordisk’s (NVO) Victoza, a once-daily injection. Other GLP-1 molecules under development include GlaxoSmithKline’s (GSK) Syncria (albiglutide) and Roche (RHHBY) /Ipsen’s taspoglutide. We note that Glaxo’s Syncria, currently in late-stage development, is also a once-weekly injection.
Our Recommendation
Currently, we are Neutral on both Alkermes and Amylin. However, we have an Underperform rating on Eli Lilly since we remain concerned about the lack of a significant enough pipeline to offset key patent expirations at Lilly. We do not believe the short-term catalysts will translate into sustainable long-term growth until the pipeline significantly improves.
Read the full analyst report on “ALKS”
Read the full analyst report on “AMLN”
Read the full analyst report on “LLY”
Read the full analyst report on “NVO”
Read the full analyst report on “MRK”
Read the full analyst report on “RHHBY”
Read the full analyst report on “GSK”
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