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New Drugs for Atrial Fibrillation Represent Choices for Clinicians, Opportunities for Generics

Amherst, NH (PRWEB) December 04, 2013

The availability of a new class of anticoagulants is providing cardiologists with a new set of tools for treating a refractory indication. Atrial fibrillation (AF) represents a growing clinical challenge for healthcare practitioners, due primarily to a set of diverse causative factors and to the secondary nature of AF. Often classified as either valvular or nonvalvular, AF increases the risk of stroke. The degree of increase can be substantial, depending on the presence of additional risk factors (such as high blood pressure). Atrial fibrillation may be treated with medications to either slow the heart rate to a normal range (rate control) or revert the heart rhythm to normal (rhythm control). The prevalence of AF in a population increases with age, with 8% of people over 80 having AF.

Drugs known as novel oral anticoagulants (NOACs) are providing clinicians with a new set of tools to treat patients with AF. NOACs are more convenient, and are considered to be at least equally effective and safer (regarding bleeding complications) for stroke prevention compared with vitamin K antagonists. Drugs in this group include Eliquis (apixaban, BMS), Pradaxa (dabigaran etexilate, Boehringer Ingelheim), and Xarelto (rivaroxiban, Janssen). Together, these three drugs had revenue of $2.3 billion in 2012 (ex-manufacturer basis).

While Pradaxa established the early lead in this market segment, Xarelto and Eliquis have been expected to make gains and win market share over the next three years. Clinical trial results indicated that Eliquis would have an advantage over Xarelto, but since the latter’s FDA approval it has been Xarelto that has made a significant impact, with total expected revenue for 2013 easily exceeding one billion dollars. Meanwhile, Eliquis has struggled, with sales for 2013 well below company and analyst forecasts.

All three drugs have been granted exclusivity by the FDA, with expiration dates that fall in 2015-2017. We expect all three to come under pressure from generics companies during that time frame, with ANDAs likely being disclosed over the next eighteen months. Eliquis has an advantage here, with exclusivity expiring at the tail end of 2017. But BMS will have to find a way to accelerate sales growth in order to maximize its investment in the drug prior to generic market entry. We expect the likely appearance of a first-to-file generic version of Eliquis in 2018 to result in a 37% drop in revenue for the year, relative to our baseline (no early generic entry) forecast for Eliquis.

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About Symporia Bioscience

Symporia Bioscience analyzes generic drug markets, publishing generic drug First-to-File Opportunity Assessments, which are designed to allow industry managers to understand and evaluate the market potential for selected branded drugs from the viewpoint of creating and refining FDA ANDA regulatory filings in pursuit of first-filer generic drug applications. By applying predictive analytics to known drug market data, generic drug first-to-file opportunity assessments provide a unique view into the evolving generics drug sector. The publications represent detailed assessments of selected branded drugs in several important areas. The resulting conclusions are contained in written reports that are structured to provide timely insight to market participants.

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