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Wellstat Therapeutics Corporation has announced in September that the US Food and Drug Administration granted marketing approval for XURIDEN™ (uridine triacetate), a pyrimidine analog for uridine replacement indicated for the treatment of hereditary orotic aciduria (HOA). With the approval of XURIDEN for the treatment of HOA, the FDA also granted Wellstat Therapeutics a Rare Pediatric Disease Priority Review Voucher. HOA is an extremely rare, potentially life-threatening, genetic disorder in which patients cannot synthesize adequate amounts of uridine and consequently can suffer from hematologic abnormalities, failure to thrive, a range of developmental delays, and episodes of crystalluria leading to obstructive uropathy.
Valeant Pharmaceuticals is a very aggressive acquirer of companies and assets. The Canadian company has most recently purchased the rights to an asset from AstraZeneca in the area of psoriasis. The drug, brodalumab, was previously partnered with Amgen but the company exited the agreement from AstraZeneca earlier this year upon concerns of suicidal thoughts in patients enrolled in trials, allowing AZ to find a new partner for the late-stage asset.
The trajectory of biotech M&A has been steep in 2015, so the $7.2bn acquisition of Receptos by oncology powerhouse Celgene, increases the gradient even further. This deal came out of left field, especially as commentators were still raking over the sizable partnering deal Celgene has just cemented with Juno Therapeutics in immuno-oncology.