COPD pipeline grows 
despite patent cliff

One of the main plotlines of the big story called the drug industry over the past several years has been the patent cliff, the steady loss of patent protection on blockbuster primary care drugs and subsequent generic competition that has forced many drug companies to find new revenue streams. Much of this has taken place in the form of a gradual shift to specialty drugs for such conditions as cancers and autoimmune disorders, but recent developments have shown that primary care drugs may still have some steam left in them.


One market that still seems to be doing fairly well is chronic obstructive pulmonary disorder, which comprises emphysema and chronic bronchitis. The disease affects more than 13 million Americans, and an additional 12 million may have it without knowing it, according to the National Institutes of Health. In addition, it’s the third-leading cause of death, claiming the lives of more than 120,000 Americans each year.


In response, drug development has continued at a brisk pace. According to the Pharmaceutical Research and Manufacturers of America, more than 50 drugs are currently in clinical development for treating COPD, ranging from pharmaceutical drugs to stem-cell therapies that attack the biological mechanisms behind the disease. 


Some new drugs for the condition already have hit the market. In October 2011, the FDA approved Boehringer Ingelheim’s Combivent Respimat (ipratropium bromide and albuterol sulfate), which is delivered in a propellant-free inhaler that uses a slow-moving mist to deliver the same active ingredients as the Combivent Inhalation Aerosol. The company expects to launch the drug in the middle of this year. 


In November, generic drug maker Mylan bought rights to a drug delivery platform made by Pfizer that would allow it to manufacture and commercialize generic versions of GlaxoSmithKline’s Advair Diskus and Seretide Diskus (fluticasone propionate and salmeterol).