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Takeda's gamble on Ariad pays off with Alunbrig approval

ALK-inhibitor will treat NSCLC patients as second-line therapy

FDA

Takeda took a chance a few weeks ago when it acquired Ariad with lead pipeline prospect Alunbrig still under regulatory review in the US. Now with an FDA approval in the bag the deal is looking good.

After an accelerated review Alunbrig (brigatinib) has been given a green light as a second-line treatment for ALK-positive, non-small cell lung cancer (NSCLC) after first-line therapy with Pfizer's Xalkori (crizotinib), based on the results of the pivotal ALTA trial.

Takeda agreed to buy Ariad earlier this year in a $5.2bn deal, which included already-marketed haematological cancer drug Iclusig (ponatinib) as well as a pipeline of oncology candidates headed by brigatinib.

It was the first major acquisition under Takeda's new chief executive Christophe Weber - and considered a little pricey by some analysts - but Weber highlighted the prospects for brigatinib as the deal was going through, saying the drug could become the best-in-class ALK inhibitor with sales in excess of $1bn a year if it also claims approval as a first-line therapy.

Alunbrig could have a tough time of it entering the second-line NSCLC market in direct competition with Novartis' Zykadia (ceritinib) and Roche's Alecensa (alectinib), which were both approved in the US in 2015 and so have a sizeable lead. Sales of Zykadia and Alecensa were $91m and $182m respectively last year, while Pfizer reported sales of $561m for Xalkori, which is co-promoted by Merck KGaA in the US.

Takeda is planning to take on Xalkori head-to-head in the first-line setting and has a phase III comparative trial (ALTA 1L) ongoing which should complete enrolment in 2018. The trial is expected to serve as a confirmatory trial to support the accelerated approval of brigatinib in the US.

Iclusig - approved for chronic myeloid leukaemia (CML) and acute lymphoblastic leukaemia (ALL) - has been a slow-grower, largely because of safety concerns and while it has started to gain traction it is not expected to reach more than $500m a year at peak. It's also facing some pushback in the US amid the ongoing scrutiny of medicine pricing.

Article by
Phil Taylor

2nd May 2017

From: Regulatory

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