Despite Forthcoming Wave of Ulcerative Colitis Drugs, Opportunities will Remain for Pharma

Monday, July 9, 2018 Drug News
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Although five oral drugs are being developed in the late stage ulcerative colitis (UC) pipeline, a window of opportunity still remains for pharmaceutical companies in this space, says GlobalData, a leading data and analytics company.

Novel oral therapies in the UC market have been identified as a significant unmet need. Currently, only one oral therapy has been approved for UC in the US which is Pfizer’s first-in-class Janus kinase (JAK) inhibitor, Xeljanz (Tofacitinib).

Key opinion leaders (KOLs) interviewed by GlobalData have been vocal about the need for novel oral therapies in the UC space, as they would help to reduce the risks of the development of antibodies, immunogenicity, and would also help patients to stop and restart therapy without risks.

Patrick Aiyes, MEng, Pharma Analyst at GlobalData, comments: “Xeljanz seems likely to receive approval in Japan and Europe, and we believe that there will be four more oral therapies approved for UC in the next five years. This has raised questions about whether or not the need for novel oral therapies will be fulfilled by these pipeline agents, and whether or not opportunity for new entrants remains in the UC space.”

GlobalData anticipates the JAK inhibitors, including PfIzer’s Xeljanz, Gilead/Galapagos’ filgotinib, and Abbvie’s upadacitinib, to be the third highest grossing drug class within UC in the forecast period from 2016–2026, producing sales of $606.8m combined across the seven major markets (7MM*). Xeljanz has a slightly different mechanism of action (MOA) to both filgotinib and upadacitinib, which have highly selective JAK1 inhibition; Xeljanz’s JAK 2 inhibition could cause some hematalogic side effects. KOLs suggest that although JAK inhibitors have high efficacy, there are slight concerns over their safety profiles. However upadacitinib and filgotinib have slightly better safety profiles, nevertheless KOLs have indicated this will not be enough to differentiate them from Xeljanz.

Celgene’s ozanimod, which is a first-in-class sphingosine-1-phosphate receptor 1 (S1P1) for moderate to severe UC, met both of its primary efficacy endpoints in its Phase II TOUCHSTONE trial and boasted a very strong safety profile. However, KOLs have noted that it has a slow onset of action, which is not ideal for an oral drug. EA Pharma’s carotegrast, an alpha 4 integrin antagonist that is being evaluated for patients who suffer from mild to moderate UC, demonstrated favorable efficacy in its Phase II trials. KOLs suggested that carotegrast will provide effective competition with 5-aminosalicylic acid (5-ASA) therapy; however, the drug is only being developed in Japan.

Aiyes adds: “Oral therapies are preferred over other routes of administration due to ease of administration. However, all the therapies under development have unique weaknesses with safety and speed of action.

“Furthermore, they are all available for moderate-to-severe and mild-to-moderate UC patients, but there are no new oral mechanisms of action for severe-to-fulminant patients, marking another opportunity for pharmaceutical companies.”

* 7MM: US, France, Germany, Italy, Spain, UK, and Japan


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