Gilead's Bold Combo
Gilead is making a play to dominate the market for HIV treatments. It approached competing companies BMS and Merck about creating a triple-therapy well before the FDA suggested these three work together. Such an alliance directly threatens GSK. Gilead isn't just talking--it's running a head-to-head trial of a combination therapy featuring two of its drugs against another combo that includes Glaxo's. Positive data for Gilead would definitely power its bid to dominate the market.
You may also be interested in...
Gilead's acquisition of Triangle is a clear example of a strong company buying a weak company's assets. Triangle lost the market's confidence, and its partner Abbott, through prolonged clinical difficulties that sapped its cash. Gilead bought the company primarily to get an AIDS drug, Coviricil, that will likely soon win US marketing approval. Gilead aims to co-formulate that compound with its own AIDS drug Viread, to create the first one-pill, once-daily combination therapy for AIDS. Gilead has earned a reputation for finding under-valued assets and turning them into value drivers for itself. Looks like it's at it again.
Gilead plans to maximize the value of its newly-approved anti-HIV drug Viread by launching the product in all major world markets within a year-and by promoting it with the same look, messages and image everywhere. Gilead's campaign will make the point that its product helps patients' drug combinations work better, even if they're failing. By positioning the product this way, Gilead may avoid head-to-head competition with far bigger players. The company got into position to globally market Viread by acquiring NeXstar in 1999, then quickly re-organizing and filling out the very skinny marketing groups it inherited in major European markets. The relatively small company is betting that the cost efficiencies of global branding will bring it a better return on investment, and so help it grow a business that is already highly valued.
New data seems to indicate an uptick in the percentage of premarket applications that receive a major deficiency letter. See what US FDA spokesperson Alison Hunt said about strategies to avoid them.