Dive Brief:
- Teva Pharmaceutical Industries got approval Jan. 30 from the Food and Drug Administration’s for two inhalers to treat adolescents and adults with asthma, one a copy of GlaxoSmithKline's blockbuster Advair.
- The Israeli company said both respiratory products — one containing the same active ingredients (fluticasone propionate and salmeterol) as Advair, and the other containing the same active ingredient as GSK's Flovent — will be launched later in 2017. Pricing wasn’t available.
- But the generics giant’s shares fell based on the bigger news of the day: that a U.S. District Court didn’t uphold patents for Teva’s top-selling multiple sclerosis treatment Copaxone. Teva said it plans an immediate appeal.
Dive Insight:
Teva, which ended 2016 with restructuring and a focus on a "culture of compliance" in the wake of a foreign bribery probe that ended up costing the company $519 million in fines, aimed to get 2017 off to a better start.
But Teva’s shares sank to their lowest point in more than a decade after the federal court ruling on Copaxone patents, Bloomberg reported. The judicial decision could allow generic competition for a drug that comprises 20% of Teva’s $20 billion in annual sales and the introduction of two Copaxone copycats in the U.S. could erase as much as $1.2 billion of revenue this year even as the company tries to pay down debt.
The question is whether new FDA approval for Teva’s maintenance inhalers — and expansion of its portfolio of respiratory medicines —will provide a significant upward push.
Rob Koremans, president and CEO of Global Specialty Medicines at Teva, said the company’s expanding RespiClick portfolio of breath-activated inhalers — both of the newly approved medicines use it — will give more treatment options to physicians and their patients "in an inhaler device that does not require hand-breath coordination during inhalation."
However, Teva’s AirDuo RespiClick isn’t directly substitutable for Advair and only secured an FDA approval for asthma. Advair, on the other hand, is also widely used for chronic obstructive pulmonary disease.
GSK told Reuters that because Teva's product isn’t substitutable for or equivalent to Advair, it doesn’t "pose the same competitive dynamics as market entry of generic products in the U.S. would." These are a bigger threat because they are fully substitutable generic copies of Advair, although their potential pricing discounts remain a big unknown.
GSK’s Advair has sold more than $1 billion annually since 2001, reaching global sales of $5.6 billion in 2015, with half of total sales coming from the U.S.
Although generic copies of Advair await U.S. approval, the timeline is fairly short. Mylan expects an FDA decision on its product by March 28, and Hikma and Vectura expect the agency’s decision on their product by May 10.