Ik ben geen dokter maar ik ben het totaal NIET eens met deze Michael Yee van RBC:
Celgene Pitted Against Gilead, Biogen In Crohn's Drug Battle
Celgene's Crohn's disease drug had a positive trial result. (Celgene)
Celgene (CELG), the No. 3 biotech by market cap, could rival Johnson & Johnson (JNJ), Galapagos (GLPS), Gilead Sciences (GILD) and Biogen (BIIB) with a Crohn's disease drug that topped efficacy expectations, the company said Sunday — prompting a boost in shares on Monday.
In the stock market today, Celgene stock lifted 1.2% to 99.64, after briefly slipping to a three-month low below 98. Shares are down 18% this year. RBC analyst Michael Yee says politics are tamping down biotech stocks.
But Yee is bullish on GED-0301, Celgene's drug to combat Crohn's. In a recent study of 52 patients, GED-0301 showed improvements in CDAI (Crohn's disease activity index) and in SES-CD (simple endoscopic score for Crohn's disease).
Wall Street's eyes were more tuned to the latter. By week 12 of the trial, 37% of patients showed at least a 25% reduction in SES-CS, which would be a clinically meaningful endoscopic improvement, says Yee. By the CDAI metric, 67% showed a response and 48% were in remission by week 12.
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"This 37% is good and higher than expected, as our doctor expert said before the data that 25% of patients achieving this would be good, particularly as a convenient oral drug," Yee wrote in a research report Monday.
Gilead's and Galapagos' filgotinib is in Phase 3 testing. Phase 2 didn't look at the SES-CD endpoint, so it can't be compared with Celgene's GED-0301, Yee wrote. J&J's Stelara showed the same improvement in 48% of patients at week eight, but that study included a placebo.
Biogen also has MT-1301, a drug to treat inflammatory bowel disorder, going into Phase 3 testing. Crohn's as well as ulcerative colitis are both major categories of inflammatory bowel disorder.
Yee models GED-0301 adding $1 billion to $2 billion in sales over time for Celgene, as the world moves to pills to treat Crohn's. J&J's Stelara is an injection.
"We believe Celgene's promising early endoscopic improvements will get better over time and GED-0301 could be the Otezla of Crohn's disease — meaning even if not the most potent drug, it can still be a $1 billion-plus drug for Celgene if well tolerated, good safety, convenient, and good efficacy," he wrote.