Advair, Armonair From Teva Pharmaceutical Industries Ltd (ADR) (NYSE:TEVA) Gets FDA Approval

0
Advair, Armonair From Teva Pharmaceutical Industries Ltd (ADR) (NYSE:TEVA) Gets FDA Approval

Teva Pharmaceutical Industries Ltd (ADR) (NYSE:TEVA) has announced the approval of AirDuo RespiClick and ArmonAir RespiClick by the U.S. Food and Drug Administration. The two products are used to treat asthma in adult and adolescent patients. AirDuo is a fixed-dose ICS/LABA product that is similar to Advair from GlaxoSmithKline plc (ADR) (NYSE:GSK) with regards to ingredients.

However, AirDuo differs from Advair in a variety of ways. For one, AirDuo possesses a lower level of salmeterol. It has also not been approved for treating chronic obstructive pulmonary disease (COPD). AirDuo is therefore expected to compete with Advair on the basis of price.

Heavy discounts in market share battle

Prior to the entry of AirDuo in the market, Advair had recorded a decline in sales particularly in the United States. This has put GSK under pressure with resulting price discounts as a way of trying to retain market share.

The chief executive officer of GSK, Andrew Witty, considers the competition as having had a positive impact on the pharmaceutical company. Because of the entry of generics into the market, GSK has been forced to focus on newer products including ICS/LABA combo Breo which have better sales.

Despite the entry of Teva’s AirDuo, GSK is not worried for now since the drug is slated to be launched later in the year. Analysts expect the uptake of AirDuo to be determined by the pricing to a large extent.

Conservative outlook for the future

Teva is also not bracing for an overwhelmingly positive response from the market and is instead expecting only gradual improvement.

“We’ll expect peak sales of about $200 million. It will have a slower uptake and … you will see really small numbers in this year, and that’s the way we modeled it. It’s still very much uncertain,” Teva’s chief executive officer of specialty meds, Rob Koremans, said.

The two products from Teva will be administered in the same dosage once they become available as patients will be required to get one inhalation two times in a day.

In Wednesday’s trading session, shares of Teva Pharmaceutical Industries Ltd rose by 3.77 percent to close the day at $34.69.