ImmuPharma In Lupuzor Licensing Talks As FDA Says Trials Can Begin
November 03 2011 - 4:20AM
Dow Jones News
U.K. drug discovery company ImmuPharma PLC (IMM.LN) Thursday
said U.S. regulators have given it the green light to begin a Phase
III trial for its flagship drug Lupuzor, and said it is in talks
with pharmaceutical companies regarding a potential licensing deal
for the Lupus treatment.
ImmuPharma said the U.S. Food and Drug Administration has
granted Lupuzor fast-track status for the late stage clinical
trial.
The company's previous licensing partner Cephalon Inc. (CEPH)
last month handed back rights to the drug, following its
acquisition by generic drugs giant Teva Pharmaceutical Industries
Ltd. (TEVA), which has a competing lupus drug in development.
ImmuPharma then reviewed the information received from Cephalon
and made a new submission to the FDA, which resulted in the
fast-track designation. Japanese and European regulators have also
approved the start of late stage trials for the drug.
Chief Executive Dimitri Dimitriou said: "We are excited about
the prospects of Lupuzor, its progress in development and the
approvals of the authorities in the U.S., Europe and Japan
regarding its progression to the final stage of testing. The
interest we are seeing already from pharma companies as potential
partners gives us great confidence."
-By Tommy Stubbington, Dow Jones Newswires; 44-20-7842-9268;
tommy.stubbington@dowjones.com
Immupharma (LSE:IMM)
Historical Stock Chart
From Mar 2024 to Apr 2024
Immupharma (LSE:IMM)
Historical Stock Chart
From Apr 2023 to Apr 2024