) recently announced that the company has initiated a phase III
study to evaluate the efficacy and safety of Dermagraft for the
treatment of non-healing wounds in patients suffering from
epidermolysis bullosa (EB).
EB refers to a group of rare genetic skin disorders which
currently have no approved therapies as per Shire.
The company intends to enrol approximately 20 patients (aged
three years and above) suffering from generalized EB at around 10
to 15 sites across the US, Europe and Canada.
Dermagraft has been granted an orphan drug designation in the
US and EU for the EB indication.
In addition, Dermagraft enjoys a Fast Track designation from
the US Food and Drug Administration (FDA) for the same
The designation primarily facilitates the development and
expedites the review of drugs and biologics, which cater to
medical needs with no approved medication.
Moreover, Shire also stated that the European Medicines
Agency's Pediatric Committee has agreed on a pediatric
investigation plan for Dermagraft for treating patients suffering
We note that Dermagraft is currently approved in the US for
the treatment of diabetic foot ulcers (DFU).
We remind investors that Dermagraft received approval from
Health Canada as a class IV medical device for the treatment of
DFU in Sep 2012.
Shire plans to make Dermagraft available in Canada
Additionally, Shire is developing an intravenous protein
replacement therapy for the treatment of dystrophic EB, through
its Human Genetic Therapies business, which it recently acquired
from Lotus Tissue Repair, Inc.
Dermagraft product sales were down 33% y/y in the third
quarter of 2012 to $34 million. The successful development and
commercialization of Dermagraft for the EB indication should
boost the sales potential of Dermagraft.
Shire currently carries a Zacks Rank #3 (Hold). Pharma stocks
Eli Lilly and Company
) currently look attractive with a Zacks Rank #2 (Buy).
BAYER A G -ADR (BAYRY): Free Stock Analysis
LILLY ELI & CO (LLY): Free Stock Analysis
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