Industry Trend Analysis - Psoriasis Indication Will Reinforce Cimzia's Worth To UCB - FEB 2017


BMI View: In seeking to expand the number of conditions Cimzia is indicated for, UCB is following a well-trodden path in the autoimmune sphere. A successful indication for psoriasis would prove to be highly beneficial. The condition affects nearly 3% of the world's population, or around 125mn. Cimzia is already a cornerstone drug for UCB, but with key patents for Cimzia expiring in 2024, UCB will be keen to extract maximum value from the drug before it is squeezed by increasing competitive pressure.

Top-line results from CIMPASI-1, a Phase III multicentre, placebo-controlled trial evaluating the efficacy and safety of Cimzia (certolizumab pegol) in adult patients with moderate-to-severe chronic plaque psoriasis have been reported by UCB and Dermira . In the trial, Cimzia demonstrated statistically significant improvements for both co-primary endpoints compared to placebo at both treatment doses.

The Phase III development programme is led by Dermira in collaboration with UCB. Under the terms of the agreement announced in July 2014, Dermira obtained exclusive rights to develop Cimzia in psoriasis in the US, Canada and the EU. Subject to regulatory approval of Cimzia in psoriasis, Dermira is granted an exclusive commercial licence to market Cimzia to dermatologists in the US and Canada.

The programme is designed to evaluate the efficacy and safety of Cimzia in the treatment of adult patients with moderate-to-severe chronic plaque psoriasis. It consists of three trials that have enrolled approximately 1,000 patients, including patients with and without prior treatment experience with biologic products. Successful results will underpin regulatory submissions in the US, Canada and the EU.

CIMPASI-1 is the second of the three Phase III trials evaluating Cimzia in this patient population. UCB and Dermira announced top-line results from CIMPASI-2 in October 2016 and anticipate reporting the results of the third trial, CIMPACT, in Q117. This trial is comparing Cimzia to both placebo and Enbrel (etanercept).

CIMPASI-1 had an identical trial design to CIMPASI-2. The co-primary endpoints evaluated in both trials were the percentage of patients who achieved a 75% or greater disease improvement from baseline as measured by the Psoriasis Area and Severity Index (PASI 75) and the percentage of patients achieving at least a two-point improvement on a five-point Physician's Global Assessment (PGA) scale to a final score representing clear or almost clear skin, each compared with placebo, at week 16. In the CIMPASI-1 trial, consistent with the results of the CIMPASI-2 trial, Cimzia demonstrated statistically significant improvements from baseline to week 16 relative to placebo for both co-primary endpoints at both treatment doses.

A total of 234 patients with moderate-to-severe chronic plaque psoriasis were randomised in the CIMPASI-1 trial to three dosing arms: 400mg every two weeks (n=88); 400mg at weeks zero, two and four followed by 200mg every two weeks (n=95); or placebo every two weeks (n=51). At week 16, the response rate for patients who achieved PASI 75 was 75.8% for patients receiving the 400mg dose every two weeks and 66.5% for patients receiving the 200mg dose every two weeks, compared to 6.5% for patients receiving placebo. The response rate for patients achieving at least a two-point improvement to a final score of clear or almost clear skin on the PGA scale at week 16 was 57.9% for the 400mg dose-treated patients and 47.0% for the 200mg dose-treated patients, compared to 4.2% for the patients receiving placebo. The adverse event profile appears consistent with the adverse event profiles observed with Cimzia in currently approved indications.

In the CIMPASI-2 trial, the top-line results for which were announced in October 2016, Cimzia demonstrated statistically significant improvements for both co-primary endpoints compared to placebo at both treatment doses. A total of 227 patients with moderate-to-severe chronic plaque psoriasis were randomised to three dosing arms: 400mg every two weeks (n=87), 400mg at weeks zero, two and four followed by 200mg every two weeks (n=91), or placebo every two weeks (n=49).

In CIMPASI-2, at week 16, the response rate for patients who achieved PASI 75 was 82.6% for patients receiving the 400mg dose every two weeks and 81.4% for patients receiving the 200mg dose every two weeks, compared with 11.6% for patients receiving placebo. The response rate for patients achieving at least a two-point improvement to a final score of clear or almost clear skin on the PGA scale at week 16 was 71.6% for the 400mg dose-treated patients and 66.8% for the 200mg dose-treated patients, compared to 2.0% for the patients receiving placebo. Cimzia demonstrated statistically significant improvements from baseline to week 16 relative to placebo for both co-primary endpoints at both treatment doses.

Cimzia A Cornerstone Drug For UCB

Cimzia is the only Fc-free, PEGylated anti-TNF. In the US, the drug is currently indicated for the treatment of adults with moderate-to-severe active rheumatoid arthritis (RA), adults with active psoriatic arthritis (PsA), and adults with active ankylosing spondylitis (AS). In addition, it is indicated for reducing signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy.

In the EU, Cimzia in combination with methotrexate (MTX) is indicated for the treatment of moderate-to-severe active RA in adult patients inadequately responsive to disease-modifying anti-rheumatic drugs (DMARDs) including MTX. It is also indicated in combination with MTX for the treatment of severe, active and progressive RA in adults not previously treated with MTX or other DMARDs. Cimzia, in combination with MTX, is also indicated for the treatment of active PsA in adults when the response to previous DMARD therapy has been inadequate. Cimzia is also indicated in the EU for the treatment of adult patients with severe active axial spondyloarthritis.

Cimzia has proved to be a cornerstone drug for UCB, which sees it as one of four main products. In its current indications it has been prescribed to over 90,000 patients across 61 countries. Dermira's Phase III programme for Cimzia was initiated in January 2015, and in September 2015, UCB started a new Phase III study in the US in non-radiographic axial spondyloarthritis. Top-line results for this study are expected in 2018.

In FY15, UCB reported global Cimzia sales worth EUR1,083mn (USD1,202.6mn), reaching blockbuster status for the first time and up by 35.9% over the EUR797mn reported a year earlier. With total sales worth EUR3,512mn (USD3,899.7mn) reported in FY15, Cimzia accounted for 30.8% of total sales. Sales of the drug have risen dramatically: in FY10, Cimzia sales were worth EUR198mn; sales have increased by 447.0% over the previous five years. The drug's importance to UCB has also increased dramatically over the same time period. In FY10, Cimzia sales accounted for only 7.1% of UCB's total.

UCB anticipates estimated peak sales of Cimzia of EUR1.5bn (USD1.6bn) by 2020. However, with US and EU patents scheduled to expire in 2024, the firm will need to squeeze maximum value out of the drug by then.

Cimzia Is Vital To UCB's Financials
Cimzia Sales Compared With Total UCB Sales (EURmn)
Source: UCB