In 2015, Celgene (NASDAQ: CELG) acquired Receptos, taking full control of Receptos next-generation immune modulating blockbuster drug; Ozanimod. Since, the acquisition, it has shown promising results in multiple sclerosis and inflammatory bowel disease. Looking at from the financial stance, Celgene purchase price for Receptos was $7.6B and taking into account the interest costs and clinical trial costs, the total investment hits $8B figure.
And on 17th Feb 2017, Celgene released top-line data along with brief commentary on what’s the key study of two Phase 3 studies in MS.
According to the top-line data, both ozanimod 1 mg and 0.5 mg treatments illustrated statistically significant & clinically meaningful improvement compared with Avonex ® for the primary endpoint of ARR and the measured secondary endpoints of the number of gadolinium-enhancing magnetic resonance imaging (MRI) lesions and the number of new or enlarging T2 MRI lesions at month 12. As per agreement in the Special Protocol Assessment with the FDA, a pre-specified analysis on the time to onset of disability progression will be conducted using collective results from both the SUNBEAM and RADIANCE phase 3 trials.
The press release also elaborated why Ozanimod may be improvement from current in-market MS drugs, such as Aubagio from Genzyme, Sanofi (NYSE: SNY) and Gilenya from Novartis (NYSE: NVS), which works by a similar mechanism.
Ozanimod is a novel, investigational oral, selective, sphingosine phosphate receptor 1 (S1P1) and 5 (S1P5) modulator in development for immune-inflammatory indications including relapsing multiple sclerosis (RMS), ulcerative colitis and Crohn’s disease. Selective binding with S1PR1 receptors is believed to inhibit a specific sub set of activated lymphocytes from migrating to sites of inflammation. The result is a reduction of circulating T and B lymphocytes that leads to anti-inflammatory activity. Importantly, immune surveillance is maintained.
SUNBEAM Trial:
What is SUNBEAM:
SUNBEAM is a phase III multicenter, randomized, double-blind, double dummy, active-controlled study assessing the efficacy, safety and tolerability of two orally administrated doses (0.5 mg + 1 mg) against weekly intramuscular interferon beta-1a (Avonex®) over minimum of a 12-month treatment period.
SUNBEAM Trial Outcome (summarized version of Celgene press release):
The phase 3 SUNBEAM trial, which evaluated the efficacy & safety of ozanimod (Celgene), an investigational oral, selective, sphingosine phosphate receptor 1 (S1P1) and S1P5 modulator, in patients with relapsing multiple sclerosis (RMS) met its primary endpoint in reducing the annualized relapse rate (ARR) compared with weekly interferon (IFN) beta-1s (Avonex- Biogen (NASDAQ: BIIB)
The Trial (SUNBEAM) evaluated Ozanimod with two orally administrated treatment doses of 0.5 mg and 1 mg on patients for at least one year. The randomized phase III trial enrolled 1,346 RMS patients in 20 countries.
The Phase 2 RADIANCE study is in a phase III extension study, with results due soon. Hence, with current turn of events and projected approvals, the drug could come to market in the US next year. And CELG has not issued any statement on the note as how Ozanimod will be marketed, could be either a direct drug for MS (following FDA approval) or out-license it.
Celgene noted that ozanimod’s overall safety and tolerability profile was consistent with results from previously reported phase-II RMS (RADIANCE) and phase-II ulcerative colitis (TOUCHSTONE) trials.
People living with multiple sclerosis need additional therapies and we are pleased that oral ozanimod showed meaningful improvements across primary and measured secondary endpoints in this study,” said Scott Smith, President of Celgene Inflammation and Immunology. “We look forward to data from the confirmatory phase-III RADIANCE trial in the second quarter as we advance toward planned regulatory submissions by year-end.
Stock performance following positive trial outcome:
On Friday, 17th Feb 2017, after the announcement, CELG’s shares upped 2.11%, closing the trading session at $121.16. A total vol. of 4.85million shares were executed by end of the day, which marked the highest against the 3-month average volume of 4.28miliion shares. The company also was restated a Buy by several different analyst firms. Price target range from $130 a share at Mizuho Securities to maximum at Cantor Fitzgerald of $159.
Tinge Research 