Ulcerative Colitis and Crohn’s Disease

Abstract

As new drugs emerge from the pipeline for the nearly 2 billion patients globally diagnosed with ulcerative colitis and Crohn’s disease, sales of therapies for these conditions are expected to increase from $7.35 billion today to $11.05 billion in 2022.

Ulcerative colitis (UC) and Crohn’s disease (CD) are severe ailments affecting the digestive system.¹

UC is a gastrointestinal (GI) disease that is localized to the large intestine, or colon, where inflammation can affect either the entire organ or a portion of it.² Approximately 1.86 billion patients have been diagnosed with UC globally, with 1.54 billion patients currently receiving treatment. Traditional therapies have yielded $4.18 billion in annual sales around the world, a figure expected to increase to $6.85 billion by 2022 with the approval of various pipeline drugs.³

CD can affect any part of the GI tract, but most commonly involves both the large and small intestines.² Although CD is more severe than UC, the global prevalence is much lower, with only 1.3 million patients diagnosed and 0.8 million who currently receive treatment. Still, traditional therapies have resulted in an impressive $3.17 billion in global market sales, which is predicted to increase to $4.20 billion by 2022.⁴

Traditional therapies are highly effective in these hard-to-treat diseases. Tumor necrosis factor (TNF) inhibitors are firmly established as treatments but sometimes present problems, such as immunogenicity or an eventual loss of response.⁴

Vedolizumab (Entyvio, Takeda) is the newest medication for UC and CD, having received FDA approval on May 20, 2014. This novel biologic treatment is not an anti-TNF agent; it is the first gutspecific medication developed solely for UC and CD.⁵ Future therapies are being developed with the goal of providing patients with highly efficacious options for these complex diseases.^3,4

Future Therapies

Drug Manufacturer	Status	Regimen Information	Pivotal Studies	Expected Approval	Anticipated Peak Year Sales / Pricing
Ulcerative Colitis
Xeljanz (tofacitinib) Pfizer	Phase 3	Oral (5 mg), twice daily Additional studies are ongoing to support a dose of 10 mg	OCTAVE	2017	$101M in 2022; wholesale price is $2,349 for a 30-day supply, which is about 20%–25% lower than current pricing for Humira
Kappaproct (DIMS 0150) InDeX Pharmaceuticals	Phase 3	Rectal (30 mg) via colonoscopy with microinjections Up to 3 doses may be given	COLLECT	2014 (EU)	$47M in 2022 (5EU); expected to be priced similar to Alicaforsen (Atlantic Healthcare), which is $9,500 per unit
Crohn’s Disease
Stelara (ustekinumab) Janssen	Phase 3	One IV injection (approximately 6 mg/kg) at week 0 followed by one SC injection (90 mg) every 8 or 12 weeks thereafter	UNITI CERTIFI	2015	$399.5M in 2022; expected to be priced for CD according to its price per 90-mg dose for its primary indication, psoriasis, which costs $14,747 per dose
Vercimon ChemoCentryx	Phase 3	Oral (500 mg), once or twice daily	SHIELD	2019	$93.6M in 2022; expected to be priced 35% lower than Humira, which costs $1,350 per 40-mg injection

EU = European Union; 5EU = France, Germany, Italy, Spain, and United Kingdom; IV = intravenous; M = million; SC = subcutaneous

Sources: GlobalData; Redbook; FDA

Current Therapies

Drug Manufacturer	Approval Date	Indications	Regimen Information	Cost of Course of Therapy
Ulcerative Colitis and Crohn’s Disease
Entyvio (vedolizumab) Takeda	May 20, 2014	Adult UC; adult CD	UC/CD: IV infusion at weeks 0, 2, and 6, then every 8 weeks thereafter	UC/CD: First-year regimen, $43,371 Subsequent 1-year regimens, $33,733
Humira (adalimumab) AbbVie	UC: September 28, 2012 CD: February 27, 2007	Adult UC; adult CD; adult RA; pediatric JIA; adult PsA; adult AS; adult Ps	UC/CD: 4 SC injections at week 0, 2 injections at week 2, and 1 injection every 2 weeks thereafter	UC/CD: First-year regimen, $38,790 Subsequent 1-year regimens, $32,534
Remicade (infliximab) Janssen Biotech	UC: September 16, 2005 CD: August 24, 1998	Adult and pediatric UC; adult and pediatric CD; adult RA; adult AS; adult PsA; adult Ps	UC/CD: IV infusion at weeks 0, 2, and 6, then every 8 weeks thereafter	UC/CD: First-year regimen, $31,856 Subsequent 1-year regimens, $24,777
Ulcerative Colitis Only
Simponi (golimumab) Janssen Biotech	May 15, 2013	Adult UC; adult RA; adult PsA; adult AS	UC: 2 SC injections at week 0, followed by 1 injection at week 2, then 1 injection every 4 weeks thereafter	UC: First-year regimen, $49,874 Subsequent 1-year regimens, $40,523
Crohn’s Disease Only
Cimzia (certolizumab pegol) UCB	April 22, 2008	Adult CD; adult RA; adult PsA; adult AS	CD: 2 SC injections at weeks 0, 2, and 4, then every 4 weeks thereafter	CD: First-year regimen, $83,075 Subsequent 1-year regimens, $71,998
Tysabri (natalizumab) Biogen Idec	January 14, 2008	Adult CD; adult MS	CD: IV infusion every 4 weeks	CD: 1-year regimen, $60,827

AS = ankylosing spondylitis; CD = Crohn’s disease; IV = intravenous; JIA = juvenile idiopathic arthritis; MS = multiple sclerosis; PsA = psoriatic arthritis; Ps = plaque psoriasis; RA = rheumatoid arthritis; SC = subcutaneous; UC = ulcerative colitis

Sources: GlobalData; Redbook; FDA; prescribing information for Entyvio, Humira, Remicade, Simponi, Cimzia, and Tysabri