AstraZeneca PLC (ADR) (NYSE:AZN)’s COPD Drug Meets Main Goals In Phase 3 Trials


AstraZeneca PLC (ADR) (NYSE:AZN) disclosed that its respiratory drug candidate PT003 achieved the expected results in two late-stage trials on COPD sufferers. The development clears the way for the British drugmaker to seek regulatory approval for the potential blockbuster both in the U.S. and Europe. If approved, PT003 could bring in peaks sales of up to $4 billion in annual basis.

AstraZeneca PLC (ADR) (NYSE:AZN) conducted a pair of Phase 3 trials of PT003 on more than 2,000 subjects suffering from respiratory condition known as COPD. The results showed that the drug was able to improve lung function as was expected. However, AstraZeneca said the drug showed some side effects with the most common ones being colds, shortness of breath and infections in the upper respiratory tract.

AstraZeneca PLC (ADR) (NYSE:AZN) secured PT003 through its $1.2 billion buyout of Pearl Therapeutics.

A crowded market

Following the successful Phase 3 trials, the company intends to file for regulatory approval of the treatment in Europe and the U.S. this year. The COPD market is already crowded but AstraZeneca hopes that it will be able to complete effectively.

Some of the rivals that AstraZeneca will have to overcome in COPD therapies market are GlaxoSmithKline PLC (ADR) (NYSE:GSK), which has Anoro Ellipta and Novartis AG (ADR) (NYSE:NVS). The other competitor awaiting approval for its COPD treatment is Boehringer Ingelheim.

In the U.S. alone, COPD affects nearly 27 million people. According to Citigroup Inc (NYSE:C) analysts, the market for COPD treatment could jump to $14 billion by 2018 compared to slightly over $10 billion in 2014.

Betting on respiratory treatments

AstraZeneca PLC (ADR) (NYSE:AZN) is placing a huge bet on respiratory therapies. In addition to PT003, whose way to the market is already cleared for the most part, the company has handful of other respiratory drug candidates thanks to its $2.1 billion deal for Almirall. AstraZeneca is also developing a drug known as benralizumab, which is designed for COPD and severe asthma. The drug candidate is in Phase 3 and could generate $2 billion in peak sales if approved.


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