Ticagrelor is an oral, reversible P2Y12 platelet aggregation inhibitor that was approved by the U.S. Food and Drug Administration (FDA) in 2011 for the treatment of acute coronary syndromes. Developed by AstraZeneca, it works by blocking the P2Y12 receptor on platelets to prevent blood clots from forming or growing larger.
Mechanism of action
Plaque build-up in the arteries leads to conditions like heart attack and unstable angina. When a plaque ruptures, it triggers platelet activation and aggregation to form blood clots. The P2Y12 receptor plays a key role in this platelet activation and aggregation process. It selectively and reversibly binds to the P2Y12 receptor to inhibit ADP-induced platelet activation and aggregation. This prevents thrombosis and further reduces the risk of heart attack or stroke in patients with acute coronary syndromes.
Clinical efficacy
Ticagrelor demonstrated superior efficacy over the older antiplatelet drug clopidogrel in the Phase III PLATO trial involving over 18,000 patients with acute coronary syndromes. Patients receiving it experienced lower rates of the combined endpoint of death from vascular causes, myocardial infarction or stroke compared to clopidogrel. It also reduced the risk of a heart attack alone compared to clopidogrel. Based on these positive results, it became the preferred P2Y12 inhibitor over clopidogrel for acute coronary syndrome treatment.
Commercial success
Since its launch, it has become one of the top-selling drugs for AstraZeneca, raking in billions of dollars in annual sales. In 2020 alone, its sales surpassed $2 billion globally despite price cuts and rising generic competition for clopidogrel. The U.S. market accounts for over 30% of ticagrelor sales worldwide. Its adoption rate for acute coronary syndrome treatment has risen steadily over the years to reach 50-60% of eligible patients in major markets like the U.S. and Europe.
Biosimilar competition
As it loses patent exclusivity in later half of this decade, several drugmakers are developing ticagrelor biosimilars. The first biosimilar referencing it, named Tiogiva, was approved by the FDA in 2021. Other companies like Dr. Reddy's, Apollogen, and Asclepion also have ticagrelor biosimilars in late-stage development. Analysts forecast the entry of low-cost biosimilars could reduce sales in the U.S. and Europe by $500-700 million annually by 2028. However, AstraZeneca is confident of maintaining a strong market share through initiatives like branding, education and payor access.
New drug development
While ensuring its commercial leadership, AstraZeneca is also exploring next-gen P2Y12 inhibitors with improved profiles. AZD1283 is a potential oral,selective, reversible P2Y12 inhibitor in Phase II trials for acute coronary syndrome. It aims for a faster onset and offset of action compared to ticagrelor. AZD1283 may also have a better safety profile with lower risks of bleeding. Its once-daily dosing could boost compliance over it twice-daily regimen. If successful, AZD1283 may become the new blockbuster to replace it going forward past 2028.
Investment rationale
Despite rising biosimilar competition expected this decade, it is still expected to remain a top drug for AstraZeneca generating billions in annual revenues through 2028. Its adoption rate has significant room for growth still in developing markets. Meanwhile, AstraZeneca's R&D efforts on next-gen compounds like AZD1283 indicate the company's commitment to leadership in the P2Y12 inhibitor space long-term. At current price levels, AstraZeneca stock provides an attractive opportunity for investors given the revenue visibility provided by ticagrelor and prospects of new launches replacing it successfully.
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