Theravance, Glaxo Lung Drug Passes Two Pivotal Trials; Two More to Go
GlaxoSmithKline is counting on a new respiratory drug it is developing with South San Francisco-based Theravance, and today the companies got some good news about the treatment.
Glaxo and Theravance (NASDAQ: THRX) said today that its once-daily inhaled corticosteroid combined with a long-acting beta agonist (Relovair) passed a pair of pivotal stage studies looking at safety and effectiveness against chronic obstructive pulmonary disease (COPD). Those results were from six-month studies that randomly assigned 2,200 patients to the drug or a placebo. The companies plan to combine those findings with more data from a pair of 12-month studies when that is available, and submit applications to regulators for approval.
The new drug for respiratory disorders is a big bet for Glaxo and Theravance. Glaxo is hoping that Relovair will replace fluticasone and salmeterol (Advair), its best-selling drug with $8.4 billion in sales in 2010, according to a Reuters report. Besides chronic obstructive pulmonary disease—an umbrella term for emphysema and chronic bronchitis—the new drug is being developed for asthma, another disease that makes it difficult to breathe. The World Health Organization estimated that COPD, often caused by smoking, killed 3 million people worldwide in 2004, and is on pace to become the world’s third-leading cause of death by 2030. Asthma and allergies are estimated to affect 60 million people in the U.S. alone.
Darrell Baker, a senior vice president with Glaxo, said in a statement that passing the two pivotal studies is an “important milestone” for the new drug. More details on how the drug performed will be presented at later scientific meetings.