Lexicon Pharmaceuticals, Inc.
) 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
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
Apart from LX1032, Lexicon Pharma's pipeline includes LX1033
(irritable bowel syndrome), LX2931 (rheumatoid arthritis), LX4211
(diabetes) and LX7101 (glaucoma).
Currently, we have a Neutral stance on Lexicon Pharma in the
long run. The company carries a Zacks #3 Rank (Hold rating) in the
LEXICON PHARMA (
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