October 6, 2016
By Mark Terry, BioSpace.com Breaking News Staff
Johnson & Johnson might be a staid, old conservative drug and consumer health products company, but it still manages to produce exciting new drugs. Between 2009 and mid-2014, the company brought out 14 new drugs, and half of them hit $1 billion in yearly sales. The company is planning to bring out 10 new blockbuster drugs—the magical $1 billion mark— by 2019. But one of those, guselkumab, is catching everyone’s attention. Sean Williams, writing for The Motley Fool, takes a look.
Guselkumab was introduced by J&J last week at the European Academy of Dermatology and Venerology Congress held in Vienna, Austria. The drug was developed to treat plaque psoriasis and potentially other immune disorders of the skin.
Most drugs for this have a mechanism of action that dampens down the activity of the tumor necrosis factor protein. Guselkumab, however, targets interleukin-23.
J&J provided data from its VOYAGE 1 study, indicating the drug met the co-primary endpoints at week 16. Also, all major secondary endpoints achieved statistical significance.
VOYAGE 1 is a Phase III study that evaluated 837 patients with plaque psoriasis. They were evaluated compared to placebo and to patients receiving AbbVie ’s Humira. After 16 weeks, 6.9 percent of the patients who received the placebo had clear or nearly clear skin. In comparison, 85 percent of patients receiving guselkumab had clear or nearly clear skin. About 65.9 percent of patients receiving Humira had the same results.
The trial also evaluated near-complete skin clearance at week 16. In this, guselkumab was effective in 73 percent of patients, compared to 2.9 percent on placebo and 50 percent on Humira. Andrew Blauvelt, of the Oregon Medical Research Center, said in a statement, “These responses were durable and maintained through week 48.”
Williams points out that if guselkumab is approved, it will likely protect J&J from competition from, biosimilar drugs, which are basically generic versions of biologics. J&J’s Remicade is a treatment for plaque psoriasis that is being targeted by biosimilar drug developers.
He writes, “Johnson & Johnson already has a variety of plaque psoriasis drugs on pharmacy shelves, including blockbusters Remicade and Stelara. However, these therapies target the tumor necrosis factor protein, which, as noted above, is a common target in plaque psoriasis and a host of other skin disorders. By introducing a new pathway of treatment, J&J is providing some degree of separation that physicians and patients may latch onto—especially with results superior to those of both the placebo and Humira.”
And there’s plenty of potential revenue involved. In the first half of this year, Remicade and Stelara brought in $5.1 billion in sales, an increase from $4.4 billion in the same period in 2015. Timing may play a role here, but if guselkumab is approved, and J&J can get patients on Remicade and Stelara to switch over, guselkumab will go big fast.
Williams writes, “The X-factors investors should be aware of from here on out are the Food and Drug Administration, which is never a lock to do what Wall Street and investors expect, and J&J itself. Johnson & Johnson will have to be careful how it prices guselkumab to avoid pricing so highly that it gets excluded from insurance company formularies. However, with a long and successful history of drug launches, J&J will probably be just fine.”
