Summit, New Jersey based Celgene Corporation and Receptos, Inc. of San Diego, California, a biopharmaceutical company developing therapeutic candidates for the treatment of immune and metabolic diseases, have announced their joint signing of a definitive agreement in which Celgene will acquire Receptos. Under terms of the merger agreement, Celgene will pay $232.00 per Receptos share in cash, or a total of approximately $7.2 billion, net of cash acquired.
The Receptos acquisition will significantly enhance Celgene’s portfolio of Inflammation & Immunology (I&I) disease treatments, thereby further diversifying the Company’s revenue sources beginning in 2019 and going forward. The transaction adds Receptos drug Ozanimod (formerly RPC1063), which adds to Celgene’s deep and diverse pipeline of potential disease-altering medicines and investigational compounds, and the company’s growing expertise in treatments for inflammatory bowel disease (IBD).
IBD is comprised a disease classification that includes two chronic, autoimmune, gastrointestinal (GI) inflammatory disorders; Ulcerative colitis (UC) and Crohn’s disease (CD). UC is an inflammatory disorder involving ulcers in the colon and is characterized by a chronic course of remissions and exacerbations. Patients suffer from a multitude of GI symptoms, including diarrhea, rectal bleeding and abdominal pain. Lymphocyte trafficking agents such as Tysabri and Entyvio, both injectable or infused therapies, have recently demonstrated proof-of-concept in IBD indications.
Ozanimod is a novel, potential best-in-class, oral, once-daily, selective sphingosine 1-phosphate 1 and 5 receptor modulator (S1P) in development for immunology indications including relapsing multiple sclerosis (RMS) and ulcerative colitis (UC). In a Phase 2 trial in patients with RMS, ozanimod achieved the primary endpoint of reduction in MRI brain lesion activity as well as secondary endpoints measuring effects on other MRI parameters.
Relapsing multiple sclerosis (RMS) is a chronic autoimmune disorder of the central nervous system (CNS), characterized by recurrent acute exacerbations (relapses) of neurological dysfunction followed by variable degrees of recovery with clinical stability between relapses (remission). The CNS destruction caused by autoreactive lymphocytes can lead to clinical symptoms such as numbness, difficulty walking, visual loss, lack of coordination and muscle weakness, experienced by patients. The disease invariably results in progressive and permanent accumulation of disability and impairment, affecting adults during their most productive years. RMS disproportionately affects women, with its peak onset around age 30.
In the past, the treatments for RMS were generally injectable agents with significant side effects. There is consequently a substantial market opportunity for effective oral RMS therapies with improved safety and tolerability profiles.The availability of an oral lymphocyte trafficking agent such as Ozanimod would, if approved, offer patients a more convenient, treatment strategy for this debilitating and progressive disease.
At the 2015 Annual Meeting of the American Academy of Neurology (AAN) in Washington, D.C., Receptos presented results of an Ozanimod phase II study in RMS. The study demonstrated that Ozanimod achieved the primary endpoint of reduction in MRI brain lesion activity as well as secondary endpoints measuring effects on other MRI parameters.
The overall safety profile of Ozanimod has been found to be consistent with the results of prior trials and continues to demonstrate differentiation against other oral agents for treatment of RMS. Receptos is now conducting a Phase 3 clinical development program comprised of two trials: RADIANCE and SUNBEAM, both of which are randomized, double-blind studies designed to compare 0.5 mg and 1.0 mg of ozanimod against interferon beta-1a (Avonex) in patients with RMS.
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