Pfizer uncouples from GlycoMimetics and its failed sickle cell disease drug
Once largely overlooked, sickle cell disease (SCD) has recently seen a flurry of approvals. For Pfizer — an SCD drug that has faltered in the pivotal stage of development — certainly doesn’t pass muster, not in this market. On Monday, the 170-year-old company severed ties with Maryland-based GlycoMimetics, walking away from the alliance the two entered into nearly a decade ago.
Pfizer tied up with the Rockville biotech to work on an experimental drug — rivipansel — for vaso-occlusive crises that occur as a result of SCD in a deal worth up to $340 million ($22.5 million upfront, with $115 million — which was later adjusted to $80 million — in development milestones) in 2011. At the time, the therapy had been granted orphan drug and fast track status and was in a Phase II trial.
Last year, the drug failed the main and secondary goals in a pivotal late-stage study. On Monday, GlycoMimetics — which has now rebranded into an oncology-focused biotech with pivotal acute myeloid leukemia trials ongoing — disclosed that Pfizer had elected to terminate the agreement.
Sickle cell disease, which encompasses a group of inherited red blood cell disorders that typically afflict those of African ancestry, impacts hemoglobin — and is characterized by episodes of searing pain as well as organ damage.
In recent years — three therapies have won FDA approval. The first — approved in 2017 to reduce the severe complications that come with SCD — is Emmaus’ Endari, which is a purified (pharmaceutical grade) version of the amino acid L-glutamine. Late last year two other therapies received FDA approvals in quick succession. Novartis’ crizanlizumab, branded Adakveo, was given the FDA nod for its ability to prevent vaso-occlusive crises (VOCs) —periodic episodes of debilitating pain that occur when sickle-shaped red blood cells get stuck inside blood vessels and deprive the body of oxygen-rich blood. Soon after, Global Blood Therapeutics’ voxelotor, christened Oxbryta, was approved on the basis of data that showed it increased hemoglobin levels, although its use was not associated with fewer pain crises.