Orphan Drug Status for Lexicon Drug - Analyst Blog
March 23 2012 - 8:15AM
Zacks
Lexicon Pharmaceuticals,
Inc. (LXRX) recently announced that its candidate
telotristat etiprate (LX1032) has been granted orphan drug status
by the US Food and Drug Administration (FDA). LX1032 is being
developed to treat patients suffering from carcinoid syndrome.
Carcinoid syndrome refers to a
chronic disorder resulting from tumors in the gastrointestinal
tract. The disorder, which results in severe diarrhea in addition
to flushing episodes, has the potential to cause cardiac valve
disease in the long run.
We note that the orphan drug
designation is granted in the US only to drugs that treat a disease
affecting less than 200,000 people in the country. Moreover, the
orphan drug status for LX1032 provides Lexicon Pharma with seven
years of marketing exclusivity (from the day LX1032 is cleared by
the FDA) in the US for carcinoid syndrome. We remind investors that
LX1032 was granted fast track status by the FDA in 2008. The
candidate already enjoys orphan drug status from the European
Medicines Agency, which provides the drug with ten years of
marketing exclusivity in the EU following approval.
We note that LX1032 has fared well
in clinical trials so far for the carcinoid syndrome indication. In
August last year, Lexicon Pharma presented encouraging data from a
phase II study. The company plans to move the candidate to phase
III study for the indication.
Apart from LX1032, Lexicon Pharma’s
pipeline includes LX1033 (irritable bowel syndrome), LX2931
(rheumatoid arthritis), LX4211 (diabetes) and LX7101
(glaucoma).
Our
Recommendation
Currently, we have a Neutral stance
on Lexicon Pharma in the long run. The company carries a Zacks #3
Rank (Hold rating) in the short run.
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