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How AstraZeneca’s Duaklir and Bevespi Performed in 2017

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Duaklir’s revenue trends

In 3Q17, AstraZeneca’s (AZN) Duaklir generated revenues of $21.0 million, which reflected ~50.0% growth on a year-over-year (or YoY) basis and 31.0% growth quarter-over-quarter. Duaklir reported 9M17 revenues of $56.0 million.

In September 2017, AstraZeneca reported top-line results from the Phase 3 AMPLIFY trial. In the phase 3 AMPLIFY trial, Duaklir[1. aclidinium bromide/formoterol 400µg/12µg twice-daily] demonstrated statistically significant improvement in lung function[2. primary endpoint of the study] in individuals with moderate-to-severe stable chronic obstructive pulmonary disease (or COPD) compared to either aclidinium bromide or formoterol alone.

Additionally, Tudorza (aclidinium bromide) achieved the primary endpoint of non-inferiority compared to tiotropium bromide.

In April 2017, AstraZeneca and Circassia Pharmaceuticals entered into a collaboration for the development and commercialization of Tudorza and Duaklir in the United States. According to the agreement, Circassia received the rights of Duaklir in the US market.

Bevespi’s revenue trends

In 3Q17, Bevespi generated revenues of $4.0 million compared to $3.0 million in 2Q17. Bevespi reported 9M17 revenues of $8.0 million.

In September 2017, AstraZeneca reported top-line results from the Phase 3 PINNACLE 4 trial. In the Phase 3 PINNACLE 4 trial, patients receiving Bevespi Aerosphere[3. glycopyrronium and formoterol fumarate 14.4/9.6 µg] showed a statistically significant improvement in lung function as calculated by forced expiratory volume in one second (or FEV1) in individuals with moderate to severe COPD.

This population was compared to patients on glycopyrronium 14.4 µg, formoterol fumarate 9.6 µg, and placebo monotherapies.

Based on the results from the PINNACLE 4 trial, AstraZeneca will file regulatory applications for Bevespi Aerospere in Japan and China in 2018. AstraZeneca has already submitted regulatory applications to the European Medical Agency for Bevespi Aerospere, and the regulatory decision is expected in 2H18.

Among AstraZeneca’s peers in the asthma and COPD drugs market, GlaxoSmithKline (GSK), Novartis (NVS), and Roche (RHHBY) reported 3Q17 revenues of 7.8 billion pounds, $12.4 billion, and 13.1 billion Swiss francs, respectively.

AstraZeneca, GlaxoSmithKline, and Novartis comprise ~5.2%, ~4.2%, and ~4.8% of the VanEck Vectors Pharmaceutical ETF’s (PPH) portfolio holdings.

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