October 3, 2016
By Mark Terry, BioSpace.com Breaking News Staff
On September 21, Gilead Sciences , halted its Phase II/III clinical trial of GS-5745, an anti-MMP9 antibody to treat ulcerative colitis. Essentially no treatment benefit was observed. It had only studied 150 patients, had planned to evaluate 1,600, but there just wasn’t any point, apparently.
Although the drug won’t continue with ulcerative colitis, Gilead plans to continue a Phase III study of GS-5745 in gastric cancer, and has several ongoing Phase II trials in Crohn’s disease, rheumatoid arthritis and cystic fibrosis.
So why is this good news for Celgene ?
Typically, the two companies don’t compete with each other much. And it’s possible they won’t still. Celgene is currently evaluating ozanimod for late-stage ulcerative colitis. It had positive results in a Phase II trial.
Keith Speights, writing for The Motley Fools, says, “Does Gilead’s failure really help Celgene? Yes. Ulcerative colitis treatment is something of a crowded field, with drugs already on the market and in development. The less competition ozanimod has, the better off Celgene is.”
Celgene is projecting that ozanimod’s sales could peak at $4 to $6 billion, assuming it makes it to market. And a big bonus is another possible indication for the drug is multiple sclerosis (MS).
And in ulcerative colitis, another big plus is that ozanimod is taken orally, instead of by injection or infusion. Market leaders Humira, marketed by AbbVie , and Remicade, marketed by Johnson & Johnson , are taken that way.
So now that Gilead appears to be out of the ulcerative colitis market, the two companies won’t go head-to-head in that market. On the other hand, they may compete directly for Crohn’s disease.
Gilead has two drugs, filgotinib and GS-5745, in Phase II trials for Crohn’s. Celgene’s ozanimod is also in Phase II for Crohn’s.
Celgene also has Vidaza to treat acute myeloid leukemia (AML), and another AML candidate in the pipeline. Gilead has entospletinib in Phase II trials for AML.
Speights writes, “These two companies, which are both biotech rock stars that have created big returns for shareholders in recent years, will likely go head to head—eventually. In the meantime, Gilead should continue its domination in HIV treatment and remain a major player in hepatitis C. I expect the company will also emerge as a leader in nonalcoholic steatohepatitis (NASH) treatment. Celgene, meanwhile, should retain its strong position in treating blood cancers and should be a pacesetter in the inflammation and immunology market.”
The NASH market is going to be an interesting place to watch. Sometimes called the “silent” liver disease, NASH resembles alcoholic liver disease, but appears in people who drink little or no alcohol. It can, however, lead to cirrhosis. It affects about 2 to 5 percent of Americans, and there are no specific treatments for it aside from weight loss, increased exercise, avoiding alcohol and unnecessary medications.
In September, Allergan acquired the Bay Area’s Tobira and San Diego’s Akarna Therapeutics, both of which bring Allergan into the liver disease and NASH market.
Gilead is investigating simtuzumab for NASH, and recently acquired Nimbus Apollos for its Acetyl-CoA Carboxylase (ACC) inhibitor program, growing its NASH program.
Two other companies, Intercept Pharmaceuticals and Novartis are also working to take a piece of the NASH market, as well.
Gilead may or may not duke it out with Celgene, but it looks like it has its work cut out for it with Allergan, Intercept and Novartis.
