Pfizer's (
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.
See our complete analysis for Pfizer
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.
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.
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