Good news flowed in at
) from Europe when the Committee for Medicinal Products for Human
Use (CHMP) of the European Medicines Agency (EMA) recommended the
approval of AstraZeneca's Zinforo (ceftaroline fosamil) in the
The CHMP recommended the approval of Zinforo for treating adults
with complicated skin and soft tissue infections (cSSTI) or
community acquired pneumonia (CAP). A final decision from the
European Commission (EC) is expected in the coming months.
The positive opinion on Zinforo was based on positive data from
four phase III trials - CANVAS 1 and 2 (cSSTI) and FOCUS 1 and 2
(CAP). AstraZeneca has submitted marketing applications in several
countries and is planning further submissions this year for
We note that in 2009,
) out-licensed co-exclusive development and exclusive commercial
rights to Zinforo in all territories except the US, Canada and
Japan. In March 2011, Forest launched its version of ceftaroline
fosamil under the trade name Teflaro in the US. The company
reported Teflaro sales of $22.4 million for the 12 months ending
March 31, 2012.
Neutral on AstraZeneca
We are encouraged by AstraZeneca's focus on high-potential
emerging markets and are pleased with its effort to drive the
bottom line through cost-cutting initiatives and share
However, we remain concerned about the generic competition faced
by the company's key products. In 2011, the company lost revenues
worth almost $2 billion to generic competition. The weak late-stage
pipeline coupled with the slow Brilinta uptake also bothers us. We
currently have a Neutral recommendation on AstraZeneca. The stock
carries a Zacks #3 Rank (Hold rating) in the short run.
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