) repositioned its business in 2013 undertaking a realignment
program with strategic focus on rare diseases and greater
Shire holds a strong position in the attention deficit and
hyperactivity disorder (ADHD) market driven by key drugs like
Vyvanse, Intuniv and Adderall XR.
Shire also has drugs for ulcerative colitis and hereditary
angioedema in its portfolio. However, the company recently
suffered a setback when it announced the initiation of a
voluntary recall in one batch of Gaucher disease drug Vpriv in
The recall is due to the presence of visible particulate
matter in certain vials of Vpriv which was identified as
stainless steel and barium sulfate. The company announced that
the recalled lot should not be used.
This particulate matter was found in a small number of vials
in the three packaged lots of Vpriv.
Shire identified the root cause of the particulate matter as
the finishing process at the third party supplier.
However, Shire believes there is very low safety risk in such
vials but there is a slight possibility of rare but serious
adverse events associated with particulate containing barium
We believe additional lots being recalled will be a cause of
concern for Shire. Vpriv generated sales of $342.7 million in
2013. Hence, we expect investor focus to remain on additional
recalls of Vpriv by Shire if any.
We remind investors that
) Genzyme (Sanofi acquired Genzyme in 2011) also faced
manufacturing issues with its Gaucher drug Cerezyme.
The U.S. Food and Drug Administration's (FDA) inspections at
the Allston facility in 2010 resulted in a warning letter to
Genzyme citing manufacturing deficiencies. Thereafter, Genzyme
entered into a consent decree with the FDA relating to the
facility at Allston.
Genzyme is currently working on resuming normal supply of the
products that were affected by manufacturing issues. In Apr 2011,
the company submitted a remediation plan to the FDA. According to
the plan, the remediation of the Allston plant is expected to
continue until 2016.
Shire currently carries a Zacks Rank #1 (Strong Buy). Right
now, stocks like
) look equally attractive. Both carry a Zacks Rank #1.
QUESTCOR PHARMA (QCOR): Free Stock Analysis
SHIRE PLC-ADR (SHPG): Free Stock Analysis
SALIX PHARM-LTD (SLXP): Free Stock Analysis
SANOFI-AVENTIS (SNY): Free Stock Analysis
To read this article on Zacks.com click here.