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Strong Buy
Investopedia...Does Celgene Have Another Blockbuster on the Way?...Celgene (NASDAQ: CELG) is best known for its cancer medicines, but it could soon be much better known for therapies designed to address autoimmune disorders, including Crohn's disease. The company is developing GED-0301, an oral antisense drug for the treatment of Crohn's disease that just put up solid results in mid-stage studies. Let's take a closer look. First, a bit of background According to the Crohn's and Colitus Foundation of America, approximately 780,000 people suffer from Crohn's disease and another 33,000 are diagnosed with Crohn's disease in the United States every year. In any given year, about 50% of Crohn's disease patients will have moderate to severe disease activity. Crohn's disease is a form of irritable bowel disease, or IBD, and while the cause of Crohn's disease isn't fully understood, evidence suggests that the inflammation of the gastrointestinal tract is caused by a combination of genetics, immune system disturbances, and environmental factors. Currently, there is no cure for Crohn's disease, but patients who suffer a flare-up of systems are treated with a variety of therapies that may include anti-inflammatory drugs, corticosteroids, or biologics. A new approach GED-0301 is an antisense drug that is designed to target messenger RNA that is thought to be involved in signaling the immune system to attack the gastrointestinal tract. Instead of taking the drug via injection, patients take GED-0301 as an oral pill, which could offer GED-0301 a significant competitive advantage. During phase 2 clinical research trials, patients with moderate to severe Crohn's disease were broken up into two groups. One group was given previously approved medicines, except for biologics, along with GED-0301. The other group received those same non-biologic medicines plus a placebo. Overall, 65% of patients taking the 160 mg dose of GED-0301 were in remission at both day 15 and day 28, versus 10% for the placebo group. Additionally, 67% of the GED-0301 group's patients were in remission on day 84, which was much better than the 21% of placebo patients who were in remission at that point. Importantly, the safety profile for GED-0301 appears to be OK given that 49% of patients taking the 160 mg dose reported at least one adverse event, such as a worsening of symptoms, versus 67% for the placebo group. Looking ahead If GED-0301 can deliver similar results in phase 3, it could mark an important expansion for Celgene, which launched its first autoimmune drug Otezla for psoriasis last year, and open the company up to an increasingly larger patient pool outside of cancer treatment. According to the Crohn's and Colitis Foundation, Americans spend up to $14.8 billion or more annually treating Crohn's disease, and for that reason, investors ought to keep a close eye on Celgene's progress with GED-0301. |
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