Onglyza’s revenue trends
In 3Q17, AstraZeneca’s (AZN) Onglyza generated revenues of $127.0 million, which reflected an ~25.0% decline on a year-over-year basis and a 15.0% decline on a quarter-over-quarter basis. Onglyza reported 9M17 revenues of $431.0 million, which is an ~25.0% decline on a YoY basis.
Onglyza is used for the treatment of individuals with type-2 diabetes mellitus. Onglyza competes with Merck’s (MRK) Januvia, Novartis’ (NVS) Galvus, and Eli Lilly’s (LLY) Tradjenta. In 3Q17, Januvia, Galvus, and Trajenta reported revenues of $1.0 billion, $310.0 million, and $142.0 million, respectively.
Bydureon’s revenue trends
In 3Q17, Bydureon (exenatide) generated revenues of $128.0 million, which reflected ~12% growth on a YoY basis and a 12% decline quarter-over-quarter. Bydureon reported 9M17 revenues of $427.0 million which is an ~2.0% decline on a YoY basis.
In October 2017, the FDA approved Bydureon BCise (exenatide extended-release) injectable suspension, a new formulation of Bydureon for adults with type-2 diabetes mellitus whose blood sugar level remained uncontrolled with one or more oral drugs along with diet and exercise.
In the two clinical trials conducted by AstraZeneca, Bydureon monotherapy or in addition to metformin or any other oral anti-diabetic drug, at 28 weeks, demonstrated a decrease in average HbA1c levels of up to 1.4% and a mean weight loss of up to 3.1 pounds.
Phase 3 EXSCEL trial
In September 2017, AstraZeneca announced the results from the Phase 3 EXSCEL trial. AstraZeneca conducted the Phase 3 EXSCEL trial to evaluate cardiovascular outcomes with Bydureon.
In the EXSCEL trial, Exenatide once-weekly dose did not show any increase in major adverse cardiovascular events (or MACE). Patients on exenatide treatment arm demonstrated fewer cardiovascular events compared to placebo. Of this population, 11.4% of patients on the exenatide treatment arm showed cardiovascular events compared to 12.2% of patients on the placebo treatment arm.
The superior data from the clinical trials of exenatide once-weekly dose and regulatory approval are expected to strengthen the commercialization capabilities of the drug. The BLDRS Developed Markets 100 ADR Index ETF (ADRD) invests ~2.0% of its total portfolio in AstraZeneca.