Pfizer‘s (NYSE:PFE) Eliquis has received a positive opinion from the Committee for Medicinal Products for Human Use (CMPH) panel for expanding the use of the drug to prevent heart attack and stroke in adult patients with nonvalvular atrial fibrillation (a category of atrial fibrillation). 
Eliquis is a drug used in blood thinning and is currently approved in many countries (excluding the U.S.) for preventing blood clots in patients who have knee or hip replacements. Based on these recommendations, the European Medicines Agency (EMA) will now decide whether to extend the drug’s use. The approval will come at an opportune time for the company as the drug has been delayed several times in the U.S. while Johnson & Johnson is pushing hard to get approval for Xarelto, a close rival to Eliquis.
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Atrial fibrillation (abnormal heart beat) is estimated to impact millions of individuals worldwide (6 million in Europe alone) and offers a multi-billion dollar opportunity for drug manufacturers to come up with an antithrombotic drug that can help prevent heart attack in patients with a history of heart problems. Atrial fibrillation increases the risk of stroke almost five times than those without it. An antithrombotic drug helps prevent clotting inside the body that can restrict blood circulation to the organs. Pfizer’s Eliquis and JNJ’ Xarelto belong to the antithrombotic family.
The indication holds the key for Eliquis’s future. The EMA’s approval will open a larger market as the drug is not yet approved for indication anywhere. Without continuous approvals, the drug cannot meet its peak sales expectations of $3-3.5 billion. Eliquis recently suffered a setback as the FDA delayed approval for the drug the second time in a year, citing need for more information on management and verification of data.
However, we are confident that the drug will eventually be approved in the U.S. by early next year as the drug has displayed a better safety profile earlier. Recommendations from the CMPH panel also strengthen our views. The drug is also undergoing phase III clinical trials for the treatment of Venous thromboembolism (VTE), considered the third most common cardiovascular illness after acute coronary syndrome and stroke.
However, any further delay in approvals could have a substantial impact on the company’s value as the cardiovascular division (excluding Lipitor) contributes nearly 10% of the our $26 price estimate for Pfizer. Also, JNJ has filed second application to get approval for Xarelto after its first application was rejected (Read JNJ Knocks On FDA Door A Second Time For Broader Use Of Anticlotting Drug Xarelto). If JNJ manages to get approval before Pfizer’s Eliquis, it will have a first mover advantage.Notes:
- ELIQUIS® (apixaban) Receives CHMP Positive Opinion For The Prevention Of Stroke And Systemic Embolism In Patients With Nonvalvular Atrial Fibrillation, Pfizer Press Release, Sept 21 2012 [↩]