Galderma Steps Into Biologics With Chugai Eczema Antibody
Executive Summary
Galderma has acquired most global rights to a first-in-class antibody from Chugai that will both strengthen the Swiss skin specialist's atopic dermatitis portfolio and provide its first biologic therapy.
Dermatology specialist Galderma SA is making its first foray into the world of biologic therapies through a major deal with Chugai Pharmaceutical Co. Ltd.for a novel antibody against atopic dermatitis.
The Swiss firm has entered into an agreement to acquire worldwide development and marketing rights, except in Japan and Taiwan, to the Japanese company's nemolizumab (CIM331), an anti-interleukin-31 receptor A antibody that has recently completed an international Phase II trial.
Financial terms were undisclosed but the deal includes upfront, milestone and royalty payments from privately held Galderma. As well as retaining rights in the two Asian markets, Roche-owned Chugai will manufacture and supply the product as part of the alliance.
The antibody will be positioned for moderate to severe atopic dermatitis (eczema) and will add to a stable of marketed conventional Galderma products for this indication, including the corticosteroid Clobex (clobetasol).
Developed using Chugai's proprietary ACT-Ig antibody engineering technology that extends plasma half-life, Galderma's prescription business vice president, Dr. Thibaud Portal, predicted that nemolizumab "will be truly transformational for our prescription business."
For its part, Chugai gains a global partner with specialist expertise and marketing capabilities in an area which is non-core for the firm. "This partnership with Galderma will ensure that the full potential of nemolizumab will be realized," Chugai Pharma USA chief medical officer Dr. Athos Gianella-Borradori said in a statement.
Promising Results
Moderate to severe cases of atopic dermatitis are usually treated with a topical steroid, but these can cause effects such as skin thinning over chronic use. There are also side-effect/safety balance concerns with some other therapies such as ciclosporin or methotrexate.
Nemolizumab acts to competitively block the binding of IL-31 with its receptor. IL-31, a pruritogenic cytokine, is preferentially produced by type 2 helper T-cells and signals via a receptor complex comprising IL31RA and oncostatin M receptor subunits.
Chugai released positive results from its 264-patient, five-country Phase II program in moderate to severe atopic dermatitis at the American Academy of Dermatology meeting earlier this year. The percent change in pruritus visual analogue scale at week 12 was significantly higher than placebo at all doses (p<0.01), ranging up to -61.2% at 0.5mg/kg subcutaneously every four weeks.
A Phase II study in Japan for the separate indication of pruritus (severe itching) in hemodialysis patients is still ongoing.
The Competition
There appear to be very few other anti-IL-31 therapies in development for atopic dermatitis, with Informa's Biomedtracker showing only Bristol-Myers Squibb Co.'s BMS-981164 in Phase I.
However, Sanofi/Regeneron Pharmaceuticals Inc.'s IL-4 receptor-targeting dupilumab is leading the charge of new biologic therapies in the indication, and is expected to have its first approval filings in the third quarter (Also see "'Transformative' Dupilumab Set For Third Quarter Filing In Atopic Dermatitis" - Scrip, 1 Apr, 2016.).
Others are working on different approaches, including Ziarco Pharma Ltd. with the oral histamine H4 antagonist ZPL-389 (Also see "Atopic Dermatitis: Ziarco Hopes Oral Therapy Will Trump Injectable Biologics" - Scrip, 16 May, 2016.).
The new wave of biologics is expected to stimulate the broader growth of the atopic dermatitis sector, with Datamonitor Healthcare forecasting that the value of this market in the US, Japan and five major EU countries (including the UK) will rise to around $2.1bn in 2024, with a compound annual growth rate of about 16%.
Galderma Japan Rejig
Galderma also said recently that it is strengthening its existing Japanese alliance with Maruho Co. Ltd., transferring to the Japanese firm local marketing rights to several prescription products, including the acne product Differin (adapalene), for which an agreement with Shionogi & Co. Ltd. recently expired.
Galderma’s local operation will now focus on aesthetic/corrective and self-medication products.
From the editors of PharmAsia News.