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BMS’s plan to dispose of Otezla increases focus on putative TYK2i class

BMS to disclose TYK2 inhibitor data that backed Phase III move for psoriasis 1

BMS’s plan to dispose of Otezla puts focus on putative TYK2i class

Bristol-Myers Squibb has announced plans to divest the anti-inlammatory drug Otezla (apremilast) – which it would ostensibly obtain in its pending merger with Celgene – seemingly to allay anti-trust concerns over new oral treatments for psoriasis. The move is likely to be of interest not only because of the size of the potenital transaction  needed to clear the merger – Otezla’s sales are running at $1.6bn/year and such a disposal could net $10bn or more – but also because of the fact it places an increased focus on the emerging TYK2 inhibitor class.

The assumption is that when faced with the choice, BMS decided to retain its internally developed competitor, known by its code-name BMS-986165, over Otezla, presumably as it has greater sales potential. BMS-986165 is the lead molecule in the TYK2 inihbitor class and its most advanced indication is psoriasis, where two large Phase III studies are underway, one of which has Otezla as the active control. BMS-986165 is also in mid-stage Phase II studies for lupus, ulcerative colitis, Crohn’s disease, and psoriatic arthritis. Otezla is approved for psoriatic arthritis and moderate to severe plaque psoriasis and in Phase III development for ulcerative colitis and Behçet’s disease.

Both drugs are of course orally available and that is presumably a key factor with the US antitrust regulator, the Federal Trade Commission. Although there are multiple injectable (and some topical) drugs approved or in development for psoriasis, there are very few orals (indeed the only one in Phase III trials is CF101/piclidenoson from the Israeli biotech Can-Fite).

Celgene has an option to licence a preclinical TYK2 programme from the private US company Nimbus Therapeutics, although it is assumed that this will be allowed to lapse (both for antitrust and contractual reasons).

In this putative new class of oral anti-inflammatories, BMS is followed by Pfizer, which has a dual TYK2/JAK1 inhibitor, which has Phase II studies underway in lupus, psoriatic arthritis, Crohn’s and ulcerative colitis, and vitiligo. AbbVie and Galapagos have both just enterered TYK2 inhibitors into first in man studies this year, while the UK biotech Sareum (SAR) has a compound with this mechanism in preclinical studies.

The disposal remains subject to further review by the FTC and will require a consent decree. Once the FTC accepts the consent order, however, the Celgene transaction can close, which it now expects at the end of 2019 or early 2020. BMS and Celgene have separately concluded their pre-notification process with the European Commission, and have submitted the formal application for antitrust clearance in Europe.

 

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