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.
Ozanimod is currently being studied in inflammatory bowel disease (IBD). The overall safety and tolerability profile of ozanimod was consistent with the results of the RADIANCE Phase 2 trial in RMS, and continues to support the potential for orally administered ozanimod to significantly improve the treatment paradigm for UC patients. A Phase 3 program in UC and a Phase 2 program in Crohn’s disease in 2015 are planned.
Ozanimod phase II data were presented by Receptos at the Gastroenterology ConferenceDigestive Disease Week (DDW) in May 2015 in Washington, D.C. The TOUCHSTONE Phase 2 trial of Ozanimod in UC met its primary endpoint and all secondary endpoints with statistical significance in patients on the 1.0 mg dose of ozanimod in both the 8-week induction and the 32-week maintenance periods. The overall safety and tolerability profile of Ozanimod was consistent with the results of the phase II trial in RMS. A phase III program, TRUE NORTH, in UC has initiated enrollment and a phase II program in CD is expected to initiate by year-end.
Based on clinical studies, Ozanimod demonstrated several areas of potential advantage over existing oral therapies for the treatment of ulcerative colitis (UC) and relapsing multiple sclerosis (RMS), including its cardiac, hepatotoxicity and lymphocyte recovery profile. The phase III TRUE NORTH trial in UC is currently underway with data expected in 2018. The phase III RADIANCE and SUNBEAM RMS trials are ongoing and data are expected in the first half of 2017 to support a RMS approval in 2018. Additionally, Ozanimod is positioned to potentially become the first S1P receptor modulator to be approved for IBD.
“The Receptos acquisition provides a transformational opportunity for Celgene to impact multiple therapeutic areas,” says Bob Hugin, Chairman and Chief Executive Officer of Celgene. “This acquisition enhances our I&I portfolio and allows us to leverage the investments made in our global organization to accelerate our growth in the medium and long-term.”
Celgene’s strong scientific foundation in inflammation and immunology covers a broad spectrum of diseases. Anchored by the successful global launch of OTEZLA (apremilast) — selective inhibitor of phosphodiesterase 4 (PDE4) and the first oral therapy approved by the U.S. Food and Drug Administration for treatment of adult patients with active psoriatic arthritis. A chronic disorder, psoriatic arthritis is characterized by pain, stiffness, swelling and tenderness of the joints, inflammation of specific ligaments and tendons, and a decrease in physical functioning A chronic disorder, psoriatic arthritis is characterized by pain, stiffness, swelling and tenderness of the joints, inflammation of specific ligaments and tendons, and a decrease in physical functioning.
“The approval of oral OTEZLA is significant for patients living with psoriatic arthritis, which is a debilitating, painful disease that has a significant effect on a patient’s day-to-day activities,” says Dr. Alvin Wells, M.D., Ph.D., Director of the Rheumatology and Immunotherapy Center at Franklin, Wisconsin. “OTEZLA offers physicians and patients a meaningful new treatment option, with the potential to benefit psoriatic arthritis patients irrespective of prior treatment.”
With the expansion that will result from the addition of the Receptos programs, Celgene’s I&I pipeline will, upon completion of the transaction, consist of three high-potential commercialized or late-stage assets; OTEZLA, GED-0301 and Ozanimod. All three candidates are in phase III development and encompass four indications: Behet’s disease, Crohn’s disease (CD), UC and RMS. The pipeline also includes seven molecules in phase II development in a variety of indications, including RPC4046 for eosinophilic esophagitis (EoE), and a growing number of phase I and preclinical assets.
“In Celgene, we have found the ideal partner to maximize the potential of Ozanimod and our promising pipeline in order to improve the lives of patients worldwide,” notes Faheem Hasnain, President and Chief Executive Officer of Receptos.
“Ozanimod is a potentially transformational oral therapy that has demonstrated robust clinical activity with impressive immune-inflammatory modulating properties in phase II trials,” says Scott Smith, President, I&I for Celgene. “Ozanimod is a highly differentiated next-generation S1P receptor modulator with important efficacy and safety features that create the opportunity for development across a spectrum of immune-inflammatory diseases.”
Rheumatology and Immunotherapy Center
Rheumatology and Immunotherapy Center