Glaxo's Key Drug Gains Time as FDA Denies Novartis Generic

Updated on
  • Sandoz unit will provide agency with details on Advair copy
  • Glaxo earnings may accelerate if there’s no generic rival

GlaxoSmithKline Plc’s asthma drug Advair won some room to run as U.S. regulators denied approval to rival Novartis AG’s generic version of the blockbuster treatment.

Glaxo extended its gains in London trading Thursday, rising as much as 3.6 percent, after Novartis said its Sandoz unit received a notification from the Food and Drug Administration that its application wasn’t approved in its current form. The regulator’s requests include requirements to submit additional data, the Swiss drugmaker said in an emailed statement.

Novartis will work with the FDA to provide what’s needed and is committed to bringing a generic Advair to patients in the U.S. as soon as possible, the company said. Novartis said it will probably provide an update on the product in its first-quarter earnings call.

Glaxo’s earnings per share, excluding some costs, may increase as much as 7 percent this year if no generic competitor to Advair enters the market, the company said Wednesday. Should an Advair generic appear, profit in 2018 will stay flat or drop as much as 3 percent, the company said.

Vectura Group Plc is uncertain whether revenue from its generic version of Advair will come in 2018, 2019 or 2020, after a delay in U.S. approval last year, CEO James Ward-Lilley said in an interview last month. Glaxo’s drug is forecast by analysts to generate about 2.2 billion pounds ($3.1 billion) in sales this year, according to data compiled by Bloomberg.

U.K.-based Vectura and partner Hikma Pharmaceuticals Plc remain confident that their application will be approved “in due course,” a Vectura spokesman said.

Shares of Novartis were down 0.5 percent at 11:32 a.m. after slipping as much as 1 percent in Zurich trading.

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