Celgene Corporation (NASDAQ:CELG) reported that the company is submitting an NDA (New Drug Application) to the U.S Food and Drug Administration. The company stated that the reason that they are doing this, is so that they will be able to further strengthen their I&I (inflammation and immunology) product portfolio.
The NDA, which the company is filing has the main intent to gain approval for the treatment of multiple sclerosis via the company’s primed medical drug, Ozanimod.
Market opportunity that Ozinimod can potentially gain for Celgene
The global incidence for the case of individuals who suffer from multiple sclerosis is currently close to the one million mark. This offers a great opportunity for companies, who have working opportunities, due to the potential that this market holds.
However, with the success of Ozanimod, the company will not only benefit from its own portfolio but also from the portfolio of Vanguard Growth ETF (NYSEARCA:VUG), to which Celgene holds a 0.94 percent share in their portfolio.
Progress of Ozanimod in clinical trials
However, prior to any record-breaking sale possibilities from this drug, it first has to successfully pass through the various phases of clinical trials, to ensure that it is safe and ready for public market distribution.
Currently, the drug is effective at delaying the relapse date of the disease by a substantial level. However, the company has stated that they plan to further improve this period of time, prior to the release of the drug.
Celgene also announced that they expect the release date from the Phase 3 trials, to be sometime this coming year. The trials in question, are referred to as the Phase 3 SUNBEAM and RADIANCE trials, which are responsible for evaluating the effectiveness of treatment that the drug is capable of yielding.
Ozanimod is excelling past the company’s expectations, however, with the report results stating that the drug is considered as the best in class, next generation sphingosine-1-phosphate receptor 1 (more commonly known as S1P1), modulators.