AZN in Aralez deal, disappointed with Brilinta trial
Source - SMW
AstraZeneca said it has entered into an agreement with Aralez Pharmaceuticals Trading DAC, and separately that it is disappointed with the top-line results from the Brilinta EUCLID study.
The company's agreement with Aralez Pharmaceuticals Trading DAC, a subsidiary of Aralez Pharmaceuticals Inc, is for the rights to branded and authorised generic Toprol-XL (metoprolol succinate) in the US.
Toprol-XL is a beta-blocker medicine for the control of hypertension (high blood pressure), angina (chest pain) and heart failure. It was first approved in the US in 1992.
Under the terms of the agreement, Aralez will pay AstraZeneca $175 million to acquire the rights to Toprol-XL tablets in the US, and the authorised generic medicine marketed by Par Pharmaceuticals. Aralez will also pay AstraZeneca up to $48 million in milestone and sales-related payments, as well as mid-teen percentage royalties on sales.
AstraZeneca will continue to manufacture and supply Toprol-XL and the authorised generic medicine to Aralez.
AstraZeneca is disappointed with top-line results from the Brilinta EUCLID study which did not meet the primary endpoint of the trial.
Brilinta (ticagrelor) did not demonstrate a benefit over clopidogrel in a symptomatic peripheral artery disease (PAD) patient population.
The EUCLID trial included 13,885 patients in 28 countries and is the largest cardiovascular (CV) outcomes trial to date conducted exclusively in symptomatic patients with PAD. It evaluated the treatment of Brilinta 90mg tablets twice daily versus clopidogrel 75mg once daily for the prevention of atherothrombotic events (a composite of cardiovascular death, heart attack or ischaemic stroke). The primary endpoint of the trial was the time to first occurrence of any such event.
Based on preliminary analyses, safety data is consistent with the known safety profile of Brilinta.
Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: "The proven benefits of Brilinta in acute coronary syndrome and post-myocardial infarction patients are established and remain unchanged. We are disappointed that the EUCLID trial results showed Brilinta did not demonstrate a benefit over clopidogrel in this specific symptomatic PAD population."