Endo Health Solutions
) top line has been under pressure over the past few quarters due
to declining sales of its key drugs. Sales have been hurt by
generic competition. Endo recorded sales of $584.9 million in the
fourth quarter of 2013, down 22%. Soft sales of painkillers,
Lidoderm and Opana ER hurt the top line.
To combat the generic threat, Endo has been signing deals/making
acquisitions and also looking to introduce new products. The
recent approval of Endo's Aveed (a long-acting testosterone
undecanoate injection) by the U.S. Food and Drug Administration
(FDA) is a positive for the company. Aveed has been approved for
treating adults suffering from hypogonadism (deficiency/absence
of the male hormone testosterone).
The FDA approval was gained on the basis of encouraging phase III
data on men suffering from hypogonadism in the U.S. The 84-week
study evaluated men with an average age of 54 years and a serum
total testosterone level below 300 ng/dL. Taking into account the
risks associated with the use of Aveed, the drug will be
distributed through a strict Risk Evaluation and Mitigation
Strategy (REMS) program.
The path leading to the approval of Aveed in the U.S. has been
anything but smooth. The FDA issued a complete response letter
(CRL) to Endo on Aveed in the second quarter of 2013 due to
safety concerns. Endo subsequently resubmitted the new drug
application (NDA) addressing the concerns. The FDA accepted the
resubmitted NDA and gave a favorable decision after reviewing the
With the U.S. approval in hand, focus has shifted to Aveed's
commercialization. Aveed will compete with drugs like
) Testim and
) AndroGel in the market.
Endo carries a Zacks Rank #3 (Hold). An example of a
better-ranked stock in the medical sector is
) with a Zacks Rank #1 (Strong Buy).
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