- AstraZeneca plc has handed over an exclusive worldwide license to a pre-clinical reversal agent for its blood thinner Brilinta.
- The agent, dubbed PB2452, is heading to Pennsylvania-based PhaseBio Pharmaceuticals Inc. While the biotech didn't disclose financial terms of the licensing deal in a Tuesday statement, it did note that Phase 1 testing of the treatment should commence in the first half of 2018.
- Brilinta works by inhibiting a key protein responsible for platelet aggregation, the P2Y12 receptor. Though there are other blood thinners that operate in a similar fashion, AstraZeneca's drug is the only P2Y12 antagonist that can reversibly bind to the receptor, according to PhaseBio — and that's where PB2452 comes in handy. The agent is an intravenous antigen-binding antibody fragment that attaches to Brilinta and its active metabolite and prevents the drug's anti-platelet effects.
The purpose of reversal agents is to quickly negate the effects of drugs. For blood thinners, they are usually deployed in emergency cases where patients are bleeding uncontrollably. Healthcare providers have long used Vitamin K to counter warfarin, for instance; and in 2015, the Food and Drug Administration approved the first reversal agent for a new oral anticoagulant, Praxbind (idrucizumab), which inhibits Boehringer Ingelheim GmBH's Pradaxa (dabigatran etexilate).
Importantly for makers of anticoagulant and antiplatelet therapies, reversal agents can also bolster the safety profile of their drugs, and in turn increase their prescription rates.
Should that be the case for PB2452, it would likely be a boost to AstraZeneca's Brilinta (ticagrelor) franchise. Sales of the drug totaled $284 million during the third quarter, representing a 36% increase year over year. From January to September, the drug raked in $780 million for the British pharma. The company has been working tirelessly for years to give Brilinta an extra edge through further indications, as well as further clinical study. Yet, the drug fell short in a stroke trial in 2016, failing to beat out over-the-counter aspirin in preventing major strokes. AstraZeneca is hoping the drug will finally break $1 billion in annual sales next year.
As for PhaseBio, the new licensing deal further fleshes out the clinical-stage company's pipeline of orphan cardio-pulmonary treatments. CEO Jonathan Mow told BioPharma Dive in an interview that his company plans to apply for orphan drug designation for PB2452 soon, as well as breakthrough designation once it has the appropriate data set from in-human testing.
"Since MedImmune was shepherding the asset until they outlicensed it, they've had fairly extensive conversations with regulatory authorities," Mow said. "We expect to be able to have a very expeditious path to approval, obviously if clinical data allows that."