Endo Health Solutions
) recently announced that the transition of the company's Opana ER
franchise to the new version, which is designed to be crush
resistant, is complete. The new version of the painkiller aims to
bring relief to patients suffering from moderate-to-severe pain and
in need of continuous opioid treatment for an extended period of
Following the completion of the transition, the US Food and Drug
Administration (FDA) moved all the dosages of the old formulation
of the painkiller to the discontinued list of its Orange Book.
We remind investors that the FDA approved the new formulation of
Opana ER in December 2011. The path for US approval of the new
formulation of Opana ER was anything but smooth. In January 2011,
the FDA had issued a complete response letter (CRL) for the
painkiller. Even though the US regulatory body declined to approve
the new formulation of Opana ER at that time, the agency did not
ask for additional studies to be conducted.
We believe that the completion of the transition of Endo Health
Solutions' Opana ER franchise to the new version is a positive for
the company's pain franchise as a generic threat looms over the
pain portfolio at Endo. Endo's lead pain drug Lidoderm is slated to
go off patent in 2015. Other key players in the pain market include
Teva Pharmaceutical Industries Ltd.
We note that Endo has made several key acquisitions since 2010
to bolster its product portfolio and pipeline to combat the generic
threat. In June 2011, the company purchased American Medical
Systems, a leading pelvic-health devices provider. In December
2010, Endo acquired generic company Qualitest Pharmaceuticals.
During the same year, Endo also bought Penwest Pharmaceuticals Co.
and HealthTronics Inc. The acquisitions significantly diversified
the company's operations.
The company changed its name to Endo Health Solutions from Endo
Pharmaceuticals Holdings in May 2012 to accurately reflect its
We have a Neutral stance on Endo Health Solutions. The stock
carries a Zacks #3 Rank (Hold rating) in the short run.
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