The blockbuster duo of GlaxoSmithKline and Theravance are pushing a new respiratory combo therapy into late-stage study, pooling the active ingredients from its last two approved COPD treatments to create a once-daily inhaler.
Rivals Novartis and Boehringer Ingelheim are touting positive results for their combination COPD treatments, duking it out with GlaxoSmithKline for dominance of a market that could reach $14 billion by 2018.
Novartis' generic of Advair in Europe is already a thorn in GlaxoSmithKline's side when it comes to sales of the declining blockbuster. Now, it says, another of its lung drugs has turned out positive study data that show its non-inferiority to Glaxo's top seller in COPD, and with its more convenient dosing regimen, it could prompt patients on Advair to make the switch.
European regulatory authorities gave Teva a positive opinion for its DuoResp Spiromax inhalation powder, designed to treat asthma and chronic obstructive pulmonary disease. With the recommendation from the Committee for Medicinal Products for Human Use, Teva hopes to have final approval within a few months.
While it's still unclear how long copycats will take to make a serious dent in GlaxoSmithKline's respiratory franchise once generic competition inevitably erodes sales of the $8.8 billion-selling Advair, Glaxo may soon have a new building block with European regulators' new recommendation for combo med Anoro.
3M Drug Delivery Systems has joined forces with the Delaware outfit Invion to develop inhaled drugs for inflammatory airway diseases.
Massachusetts-based dry-powder specialist Pulmatrix welcomed successful early-stage results for its bronchodilator treatment for chronic obstructive pulmonary disorder, which makes use of its novel lung delivery system iSPERSE.
Boehringer Ingelheim has won over European regulators with its latest COPD therapy, following a favorable FDA panel vote that set the stage for U.S. approval and entrance into a huge but crowded market.
Novartis is launching the expected blockbuster into a rapidly expanding but increasingly competitive market as established players and newcomers vie for their piece of the action.
GlaxoSmithKline and Theravance have nailed down a solid majority of FDA panel votes in favor of marketing their new COPD therapy Anoro Ellipta. The outside experts voted 11 to 2 this afternoon to endorse the therapy, opening the door to the first of several new drug that will likely wind up duking it out in a tough fight for market share.