AZ nabs 6 more months of Symbicort exclusivity—and the sales that come with it

Symbicort
AstraZeneca won pediatric exclusivity for its respiratory blockbuster Symbicort, extending its protection from generic rivals.

AstraZeneca’s aging respiratory giant Symbicort won a coveted pediatric exclusivity nod from the FDA on Wednesday, giving the brand a longer life—and potentially hundreds of millions in additional sales before generics hit.

By winning pediatric exclusivity, Symbicort will have 6 months of protection in each of its indications added to the end of its patent life, meaning two quarters of extra branded sales in the U.S. The drug brought in $277 million for AZ in the U.S. in the third quarter of 2016, while worldwide sales for the period were $697 million.

The pediatric exclusivity nod is based on Symbicort trials in children with asthma aged 6 to 12, AstraZeneca said on Thursday. Symbicort is FDA-approved to treat asthma in patients 12 and older and chronic obstructive pulmonary disease (COPD) in adults. The inhaler first won an FDA nod in 2006.

Free Daily Newsletter

Like this story? Subscribe to FiercePharma!

Biopharma is a fast-growing world where big ideas come along daily. Our subscribers rely on FiercePharma as their must-read source for the latest news, analysis and data on drugs and the companies that make them. Sign up today to get pharma news and updates delivered to your inbox and read on the go.

AZ conducted the pediatric studies after receiving a written request from the FDA. The regulator can request such studies when “use of the drug in the pediatric population may produce health benefits,” according to its site.

The new FDA decision marks a win for AstraZeneca as it fights in a crowded respiratory field and pushes toward its long-shot goal of $45 billion in 2023 sales, a pledge made by CEO Pascal Soriot during the company’s Pfizer takeover defense. Soriot has since come back from the goal somewhat.

AstraZeneca's respiratory portfolio has been under pressure for years as a pricing war with rival GlaxoSmithKline has taken a toll on prices. Back in 2015, the FDA unveiled draft guidance aimed at assisting Symbicort copycats advance to the market.

Since turning away that massive Pfizer deal, AstraZeneca has kicked off multiple rounds of job cuts, recently eliminating about 700 positions in its U.S. commercial business. Before that, the company cut 1,600 contract reps and company personnel back in May 2016.

Suggested Articles

An injection that's under FDA priority review as a monthly HIV therapy can suppress the virus even if given every two months, a phase 3 has shown.

Pfizer and Astellas are chasing a new nod for prostate cancer drug Xtandi, and thanks to the FDA, they might not have to wait that long.

Sanofi lost an appeal challenging the ban on its dengue vaccine Dengvaxia in the Philippines, despite an ongoing outbreak there.