Updates on the regulatory front are eagerly awaited by investors
in the pharma/biotech sector as they impact the share price of the
concerned company. Regulatory updates include events like filing of
marketing applications, acceptance of these applications for review
by the regulatory agencies, reviews by advisory panels and finally,
a response from the regulatory agency regarding the approval
Late last week,
) announced that beloranib received orphan drug status in the EU
for the treatment of Prader-Willi syndrome (PWS).
In the EU, orphan drug status is granted to a therapy that treats
or aims to treat a life-threatening or chronically debilitating
condition for which satisfactory treatment is not available and
affects ≤5 patients in 10,000 people. This designation provides a
10-year period of marketing exclusivity in the EU after product
According to the press release issued by Zafgen, PWS is the most
common genetic cause of life-threatening obesity. Patients
suffering from this condition experience constant and unrelenting
hunger that leads to problematic food-related behaviors and gain
excessive weight. Zafgen estimates that PWS is diagnosed in both
males and females in the range of 1 person in 8,000 to 1 person in
50,000, around the world.
We remind investors that in Jan 2013, beloranib received orphan
drug status in the U.S. for the treatment of PWS. Zafgen intends to
initiate a phase III study on beloranib in late 2014 for this
indication. Zafgen exclusively licensed beloranib from South
Korea-based Chong Kun Dang Pharmaceutical Corp.
Investors looking for well-positioned stocks in the health care
sector may consider
Synergy Pharmaceuticals, Inc.
Endo International plc
BioCryst Pharmaceuticals, Inc.
). While Synergy Pharma carries a Zacks Rank #1 (Strong Buy), Endo
and BioCryst hold a Zacks Rank #2 (Buy).
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ENDO INTL PLC (ENDP): Free Stock Analysis
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