AstraZeneca plc AZN announced top-line data from a late stage study, which showed that its Bevespi Aerosphere led to a statistically significant improvement in lung function in patients with moderate to very severe chronic obstructive pulmonary disease (COPD).
The phase III PINNACLE 4 study included more than 1700 patients across Asia, Europe and the United States. The study evaluated Bevespi Aerosphere administered twice daily via pMDI compared to its monotherapy components and placebo. The improvement in lung function was measured by trough forced expiratory volume in one second (FEV1).
AstraZeneca expects to file regulatory application in China and Japan supported by this latest data from the PINNACLE 4 study as well as past PINNACLE studies.
Bevespi Aerosphere is a fixed dose combination of glycopyrrolate -a long-acting muscarinic antagonist (LAMA) and formoterol fumarate- long-acting beta2-adrenergic agonist in a pressurized metered dose inhaler (pMDI), which is approved for the long-term maintenance treatment of airflow obstruction in COPD.
Bevespi was launched in the United States in January this year. The inhaler recorded sales of $4 million in the first half of 2017. Bevespi is under review in the EU with a launch expected next year.
Several LABA/LAMA combination treatments have been approved by the FDA in the past few years including GlaxoSmithKline’s GSK Anoro Ellipta and Sunovion Pharmaceuticals/Novartis’ NVS Utibron Neohaler.
Importantly, the respiratory therapeutic area saw the FDA approval of the first triple combination therapyfor COPD this month. Glaxo and partner Innoviva, Inc.’s INVA once-daily single inhaler triple therapy, Trelegy Ellipta received FDA approval this month for the treatment of appropriate patients with COPD
A combination of an inhaled corticosteroid (“ICS”), a LAMA and a LABA, Trelegy Ellipta will provide patients with a convenient dosing option.
Respiratory is one of AstraZeneca’s main therapy areas with asthma and COPD treatments like Symbicort, Pulmicort Daliresp, Duaklir and others. The respiratory medicines, accounting for 23% of AstraZeneca’s total product revenue, generated sales of $2.28 billion in the first half of 2017, down 4% at constant exchange rates.
AstraZeneca also boasts a strong respiratory pipeline expecting to launch four new respiratory medicines between 2017 and 2020.
Promising late-stage/under review pipeline candidates include benralizumab (severe asthma and COPD), tralokinumab (severe asthma) and PT010 (COPD).
4 Stocks to Watch after the Massive Equifax Hack
Cybersecurity stocks spiked on recent news of a data breach affecting 143 million Americans. But which stocks are the best buy candidates right now? And what does the future hold for the cybersecurity industry?
Equifax is just the most recent victim. Computer hacking and identity theft are more common than ever. Zacks has just released Cybersecurity! An Investor’s Guide to inform Zacks.com readers about this $170 billion/year space. More importantly, it highlights 4 cybersecurity picks with strong profit potential.
Get the new Investing Guide now>>
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
Astrazeneca PLC (AZN) : Free Stock Analysis Report
Novartis AG (NVS) : Free Stock Analysis Report
GlaxoSmithKline PLC (GSK) : Free Stock Analysis Report
Innoviva, Inc. (INVA) : Free Stock Analysis Report
To read this article on Zacks.com click here.