Action Date for Endo Pharma Drug - Analyst Blog
June 27 2011 - 9:34AM
Zacks
Endo Pharmaceuticals (ENDP) recently announced
that the US Food and Drug Administration (FDA) has issued a new
action date for the new formulation of painkiller Opana ER. The FDA
stated that it will review Endo Pharma’s response to the agency’s
complete response letter (CRL) by December 13, 2011.
The new formulation of Opana ER is designed to resist attempts
of crushing, breaking, pulverizing or making a powder of the
product. The candidate aims to bring relief to patients suffering
from moderate-to-severe pain and in need of continuous opioid
treatment for an extended period of time.
CRL Issued in January 2011
On January 7, 2011, Endo Pharma announced that the FDA had
issued a CRL for the painkiller. Even though the US regulatory body
declined to approve the new formulation of Opana ER at that time,
the agency had not asked for additional studies to be
conducted.
The CRL was issued in response to the new drug application (NDA)
for the new formulation, a semi-synthetic opioid analgesic, filed
in August 2010 by Endo Pharma. The FDA reviewed the NDA on a
priority basis.
We believe that if the new formulation is approved by the FDA
then it would be a boost for Endo Pharma’s pain franchise. The pain
franchise received a setback recently when Endo Pharma voluntarily
recalled two lots of its pain drug, Endocet, as the lots were
feared to contain tablets having a higher dose of the analgesic,
acetaminophen.
Moreover, a generic threat looms over Endo Pharma’s lead pain
drug Lidoderm. Lidoderm is slated to go off patent in 2015. The
pain products at Endo Pharma compete with players such as
Cephalon Inc. (CEPH) and Pfizer
(PFE).
Our Recommendation
We have a Neutral stance on Endo Pharma. The stock carries a
Zacks #3 Rank (Hold rating) in the short run.
CEPHALON INC (CEPH): Free Stock Analysis Report
ENDO PHARMACEUT (ENDP): Free Stock Analysis Report
PFIZER INC (PFE): Free Stock Analysis Report
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