Glaxo faces another cardio R&D failure for a lead candidate
- GlaxoSmithKline's losmapimod, which has been studied for various cardiovascular (CV) applications, including myocardial infarction (MI) and chronic obstructive pulmonary disorder (COPD), did not meet its phase 3 primary endpoint. There were 25,000 patients in the study.
- In November 2013, another GSK CV drug, darapladib, also failed to reach its phase 3 endpoint in a large trial involving 16,000 subjects.
- A major GSK investor, Neil Woodford, has been pushing the firm to break up into four separate divisions in the midst of several difficult years. But the firm did get some good news on Wednesday as its profits beat analyst estimates on the strength of HIV drug sales.
Two years, two phase 3 failures in cardio R&D. That's what GSK is facing, in addition to corruption charges in various countries, as well as imminent patent expiration of Advair, an $8 billion a year drug (and the failure of Advair successor Breo to show a survival benefit in COPD patients). It's been a challenging time for GSK, but there are bright spots—notably, the performance of the Viiv division, with its high-selling, innovative HIV drugs, and the consumer health division.
That's where one of GSK's mega-investors Neil Woodford and his Woodford Investment Fund comes in. Woodford has a huge stake in GSK and a solid reputation in biopharma as someone who makes the right moves. (He helped AstraZeneca ward off a Pfizer takeover last year.) He suggests dividing GSK into four distinct divisions: Viiv Healthcare, consumer health, dermatology, and the core prescription business, including vaccines. And as the company's Q3 earnings demonstrated, Viiv continues to be extremely strong, and the company's HIV drug sales have been soaring.
To this point, Glaxo and CEO Andrew Witty have insisted that the company can stand on its own. But the company could use some much better news from its pipeline hopefuls.