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RA - Immunology
Brief Marketplace Overview

2Q, 2008


Rheumatoid Arthritis is a chronic, autoimmune disease affecting approximately 2 million people in the U.S., resulting in significant quality of life sequelae.  Affected patients are often within the 45 – 55 age group, while 40% are over 65.  Females are more likely to be affected than males, and onset, although usually in middle age, can occur as early as the 20’s or 30’s.  Pain, stiffness, swelling, redness, and fatigue evidence this joint disease, while other systems are also at risk.  Objectives include symptom relief, joint damage delay or prevention, and maintenance of quality of life with earlier intervention offering greater potential for joint preservation.  The ACR guidelines are most widely utilized for diagnosis and symptom response evaluation.  Brand decisions are rendered by physicians (within Managed Care guidelines), while route of administration preference is largely decided upon by the patients.

UCB recently received approval for the Crohn’s indication, following the FDA request for additional trial data last year.  Approval for the RA indication is projected for 4Q, 2008.  RAPID I and II trials have demonstrated significant advantage, while Psoriasis development is progressing.  Post-launch positioning will focus upon pegylation and the absence of the Fc fragment, along with other elements.  Cimzia’s monthly dosing will offer equivalent ease of use, while the overall picture defines a notable competitive threat for Humira.

Golimumab, JNJ/Centocor’s lifecycle extension compound for their Remicade franchise, will be filed with the FDA within the coming months.  Supply issues have resulted in timeline delays.  Aside from RA, their targeting includes Psoriatic Arthritis and Ankylosing Spondylitis, with secondary priorities including anti-TNF failure patients.  The IV formulation filing will follow the SQ formulation.  While Psoriasis is often a follow-on indication in Immunology franchise management, CNTO-1275 has yielded positive results for moderate – severe Psoriasis, a high priority element of their development program.  Golimumab Inflammatory Bowel Disease development, along with severe Asthma and other line extensions is progressing.  The Remicade sales force, leveraging their established physician relationships, will incorporate the newly marketed compounds as high priority elements, with Schering-Plough selling in Canada among other markets. 

Actemra’s unique IL-6 inhibition mechanism will, no doubt, serve as a focal point of physician-directed promotion in a marketplace defined by anti-TNFs.  While first line usage remains a dynamic variable with Humira progressively ascending, second and third line usage may facilitate Actemra usage based upon the alternative MOA.  Side effects are subject to progressive experiential judgment by the clinical community in the absence of the years of familiarity existent with the marketed anti-TNFs.  First year uptake of IV formulations has been historically slow as compared with SQ preparations.

Subcutaneous self administration vs. IV infusion requiring physician support and accompanied by greater compliance remains a differentiating point, while JNJ/Centocor is developing both formulations.  Kineret’s market share has faded due to frequency of administration, efficacy, and reimbursement issues with patent expiration looming, while Enbrel’s footprint has been progressively dislodged predominantly by Humira, as well as the increasing array of existing and emerging competitors.  Denosumab continues to progress in late Phase III.  Response diversity and prevalence of partial response will support some degree of market presence for each of the new entrants. 

Humira and Enbrel DTC advertising spend has predominated in recent years, while the IV formulations have mainly utilized detailing and meetings and events.  Sales force sizes encompass 100 – 200 outside reps generally, with some recent competitive expansion.  Managed Care discounting is a strategy utilized particularly by JNJ and Amgen/Wyeth in retaining formulary and competitive share.

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