Celgene Continues Immunology and Inflammation Asset Development



Immunology and inflammation space

To further strengthen its I&I (immunology and inflammation) franchise, Celgene (CELG) has been actively involved in developing a lifecycle plan for its drug Otezla. This involves exploring additional geographic opportunities for Otezla and developing more convenient-to-use dosage regimens for the drug.

Additionally, Celgene is working on other late-stage assets such as Ozanimod and GED-0301 in the I&I space.

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Otezla research programs

In 1Q16, Celgene witnessed favorable results from its Phase IIIb PSA-0006 clinical trial, which is evaluating the efficacy of Otezla in patients with early stage psoriatic arthritis. In 2016, the company expects to obtain data from a bridging study evaluating a once-daily regimen for Otezla.

Additionally, Otezla is being explored in multiple early to midstage trials for other indications such as ankylosing spondylitis, atopic dermatitis, ulcerative colitis, and Behçets disease. To know more about the Otezla research program, please refer to Will Access and Label Expansion Drive Celgene’s Otezla Growth?

Other research programs

In 1Q16, Celgene completed the enrollment of patients into its endoscopy trial CD-001, exploring the use of its investigational drug GED-0301 for the treatment of Crohn’s disease. Data from this trial is expected in 2017.

Additionally, patients are being enrolled in a Phase III Crohn’s disease study of GED-0301 in 1Q16. Results from this trial are expected in late 2017 or early 2018. GED-0301 was also being explored for the treatment of ulcerative colitis in a Phase II proof-of-concept study in 1Q16.

If the trials result in positive data, after its approval, GED-0301 may pose strong competition to other drugs that currently treat Crohn’s disease such as Biogen’s (BIIB) Tysabri , AbbVie’s (ABBV) Humira, and Johnson & Johnson’s (JNJ) Remicade (through Janssen Pharmaceutica). To know more about Celgene’s I&I research programs, please refer to Celgene Has a Strong Inflammation and Immunology Pipeline.

In 1Q16, Celgene also completed the enrollment of patients in its Phase III clinical trials testing the efficacy of Ozanimod for treating multiple sclerosis. The data from these trials is expected in the first half of 2017.

Additionally, enrollment of patients for Phase III clinical trials testing the use of Ozanimod for the treatment of ulcerative colitis and Crohn’s disease is currently in progress. The data from these trials is expected to be released in 2018.

If these I&I research programs prove successful, Celgene’s share price could rise. The iShares Core S&P 500 ETF (IVV) could also see a rise. Celgene makes up about 0.44% of IVV’s total portfolio holdings.

In the next article, we’ll study Celgene’s guidances for 2016 and 2017, respectively.


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