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Over 13 million Americans have it. More than 120,000 of them die every year. Chronic obstructive pulmonary disease, or COPD, stands as the third leading cause of death in the U.S. The National Institutes of Health says that COPD costs the nation almost $50 billion every year.
Good news for those suffering from COPD could be on the way, though. A new group of drugs should be coming that are more effective than past treatments. Here are three that could be game changers for this deadly disease.
GlaxoSmithKline (NYSE: GSK ) and Theravance (UNKNOWN: THRX.DL ) gained approval from the Food and Drug Administration in May for COPD drug Breo Ellipta. However, the real excitement is over another drug that the two companies have in the wings -- Anoro.
Anoro combines a long-acting muscarinic antagonist, or LAMA, with a long-acting beta agonist, or LABA. LABAs relax the airway muscles, while LAMAs help minimize airway obstruction. Previously approved drugs have either been LAMAs or LABAs rather than both. The combination of the two makes Anoro highly anticipated.
Clinical studies found Anoro to be more effective than the currently most-prescribed COPD drug, Spiriva, which is marketed by Pfizer (NYSE: PFE ) and Boehringer Ingelheim. Glaxo and Theravance submitted the drug for regulatory approval in the U.S. and in Europe, with an FDA decision expected by Dec. 18. Analysts expect that Anoro could generate sales of $1.4 billion annually.
Should Anoro gain FDA approval, it might not hold the position as the only LABA/LAMA COPD drug on the market for long. Novartis (NYSE: NVS ) isn't too far behind with its QVA149.
Novartis submitted QVA149 for approval in Europe and Japan last October. Regulatory filing in the U.S. is expected in 2014, with delays stemming from dosing issues.
As with Anoro, clinical studies found that QVA149 proved more effective at preventing overall COPD exacerbations than Spiriva. Novartis' drug did show numerical improvement over Spiriva in reducing moderate or severe exacerbations, but this improvement was not statistically significant.
Credit Suisse analysts project that QVA149 has around a 50/50 chance to reach peak annual sales of $750 million outside of the U.S. The analysts say that chances are slightly lower for the drug in hitting that level in the U.S.
3. Olodaterol/Spiriva combo
Boehringer Ingelheim isn't sitting on its laurels with the success that it and Pfizer have had with Spiriva. The German drugmaker received a nod from an FDA advisory committee in January for olodaterol.
Olodaterol is intended to be given alongside Spiriva. It is a LABA, while Spiriva is a LAMA. Boehringer Ingelheim hopes that ultimate approval of olodaterol, which the company plans to market as Striverdi Respimat, would help it square off against Glaxo/Theravance and Novartis.
However, requiring patients to take two drugs instead of just one could put Boehringer at a disadvantage. That's why the company is also working on a once-daily combo of olodaterol and Spiriva.Estimates are for olodaterol by itself to reach peak worldwide annual sales of $350 million.
More to come
These are just three of the most promising COPD drugs on the horizon. The Pharmaceutical Research and Manufacturers of America group reports that there are more than 50 drugs in clinical development or awaiting regulatory approval that target treatment of COPD. These advancements hold the potential to help COPD patients, as well as deliver profits to the investors in those companies that lead the way.
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