Pfizer’s (NYSE:PFE) vaccine to prevent pneumococcal diseases (pneumonia, meningitis), Prevenar 13 (known as Prevnar 13 in the U.S.), has received much needed European Medicines Agency (EMA) nod for expanding its use to children and adolescents aged 6 to 17 years.  The new year has been an auspicious one for the drug maker so far as this is the second coveted regulatory approval Pfizer has secured. Recently FDA approved blockbuster potential blood thinner Eliquis (Read Pfizer Secures Coveted FDA Approval For Eliquis). European approval will open the bigger market for the vaccine and will drive the expected growth going forward.
Drugs like Prevenar (7 & 13) hold the key for future growth for Pfizer as the drug marker has been grappling with the issue of patent cliff and has seen its sales slumping in the last couple of quarters. Pfizer lost patent protection for blockbuster drugs Enbrel and Detrol in 2012, which collectively contributed over $3 billion in revenues. Not to forget the patent loss of once mighty cardiovascular drug Lipitor in 2o11.
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With no significant competition in the market, the Prevenar franchise has the potential to make up for the revenue losses due to these patent expiries as we expect sales to nearly double from current $4.5 billion by the end of our forecast period. The vaccine was showing consistent double digit growth rates until Q3, where it surprised the market by posting a decline in revenues (Read Pfizer Earnings Decline As Prevnar And Emerging Markets Disappoint).
The reason behind this unexpected decline was that most eligible pediatric patients were already vaccinated and the adult patients market was largely not open to the vaccine. With the European approval, we believe the drug can once again begin its growth streak. And we expect other countries including the U.S. to follow the suit and extend the vaccine to other age groups. The U.S. Centers for Disease Control and Prevention’s (CDC) recommendation for adults aged 19 years or older with impaired immune system will also lend support. Further, the vaccine received World Health Organization (WHO) qualification for use in adults aged 50 years and above, which means WHO member countries can now use the vaccine for older patients.
However, there are couple of factors that can impact our expectations. The vaccine is awaiting the CDC recommendations for all adults aged 50 years and above in the US. While the FDA approved the vaccine for the above age group in December 2011, the CDC is waiting for the efficacy results of an ongoing clinical study (Pfizer expects to complete the trials by 2013) before deciding on broader recommendations.  Health plans in the U.S. usually wait for the CDC recommendations to cover a vaccine’s use. Without these approvals, Prevenar 13 may not achieve its potential peak sales.Notes: