) recently received positive news when the U.S. Food & Drug
Administration (FDA) approved a third manufacturing facility at
Mass. U.S. for the production of active pharmaceutical ingredient
(API) in type I Gaucher disease drug, Vpriv.
The news should relieve Shire as it had received a complete
response letter (CRL) for the production of Vpriv's API at the
Lexington, Mass. manufacturing facility.
We note that Shire intends to add a manufacturing capacity in
the Lexington facility to support the rapid growth of Vpriv and
Replagal. The facility was initially approved for the
purification of Replagal API.
Subsequently, Shire submitted regulatory filings with both the
European Medicines Agency (EMA) and the FDA for the production of
Vpriv API at the new facility in Nov 2011. The EMA's Committee
for Medicinal Products for Human Use approved the production of
Vpriv in this facility in Feb 2012, which was later adopted by
the European Commission in Mar 2012. Shire has submitted its
response to the matters raised by the FDA in Oct 2012.
Vpriv generated sales of $342.7 million in 2013. Hence, we are
encouraged by the recent approval which should ensure a smooth
supply of Vpriv .
Last week, Shire reported strong fourth quarter results. Shire
is well placed in the attention deficit and hyperactivity
disorder (ADHD) market driven by key drug Vyvanse and is working
on a label expansion of the drug.
ViroPharma's lead drug Cinryze is approved in the U.S. for
routine prophylaxis against angioedema attacks in adolescent and
adults with hereditary hereditary angioedema (HAE). Cinryze
complements Shire's Firazyr which is indicated for the on-demand
treatment of acute HAE attacks.
We are positive on Shire's acquisition of ViroPharma which
will strengthen its HAE franchise as Cinryze and Firazyr are two
complementary therapies for the treatment of HAE. Meanwhile,
Shire's efforts to realign its business structure to drive growth
and innovation are noteworthy.
Shire currently carries a Zacks Rank #2 (Buy). Other pharma
stocks that look attractive at current levels include
Auxilium Pharmaceuticals Ltd
). All the three stocks carry a Zacks Rank #1 (Strong Buy).
AUXILIUM PHARMA (AUXL): Free Stock Analysis
ENDOCYTE INC (ECYT): Free Stock Analysis
FOREST LABS A (FRX): Free Stock Analysis
SHIRE PLC-ADR (SHPG): Free Stock Analysis
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