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PRESS RELEASE
NPIL Research &
Development Limited commences Phase I trials on new molecule
for metabolic disorders in Europe.
Mumbai, February 2008:
NPIL Research & Development Limited commences Phase I trials
on new molecule for metabolic disorders in Europe
NPIL Research & Development Limited (NRDL), recently demerged
from Nicholas Piramal Inidia Limited (NPIL), has commenced
Phase I studies of a new experimental drug molecule, P1201-07,
in The Netherlands.
The Company had submitted the Clinical Trial Application (CTA)
for P1201-07 to the Central Committee on Research Involving
Human Subjects (CCMO), the regulatory authority of The
Netherlands, and the Independent Ethics Committee of the
foundation Evaluation Of Ethics in Biomedical Research (BEBO),
Assen, The Netherlands. Both these bodies have approved the
Company’s application to initiate the Phase I study of
P1201-07.
P1201-07 is an in-licensed compound from Eli Lilly & Co. (USA)
and is being developed for metabolic disorders.
“This is our fourth new drug to enter the clinic and the first
from the research collaboration with pharma major Eli Lilly.
The drug development timeline is on schedule. We in-licensed
this molecule from Lilly only in January 2007, and it has gone
to the clinic in just a year”, said Dr Swati Piramal, Director
– Strategic Alliances & Communications, NPIL.
For further information contact::
About NPIL Research & Development Limited:
NPIL Research & Development Limited (NRDL) is an independent
Company that was recently demerged from Nicholas Piramal India
Limited (NPIL). NRDL was formerly the NCE R&D division of
NPIL. The Company has R&D capabilities in Custom Chemical
Synthesis, Process Innovation, NDDS and Basic Research. NRDL
has state-of-the-art R&D laboratories built over 200,000
square-feet of space and over 300 scientists engaged in
world-class drug discovery research and development. NRDL is
focused on four therapeutic areas – Cancer, Diabetes,
Inflammation and Infectious Diseases – with a pipeline of nine
synthetic chemical compounds in pre-clinical development.
NRDL’s lead chemical compound, a Cdk-4 inhibitor, is currently
Phase I/II trials for Multiple Myeloma. NRDL also has three
phyto-pharmaceutical candidates in clinical trials for
Rheumatoid Arthritis, Infectious Disease and Cancer.
About Nicholas Piramal India Limited:
Nicholas Piramal India Limited (NPIL) is one of India's
largest pharmaceutical companies with a growth track record of
above 30% CAGR since 1988. The Company is currently ranked 4th
in the Indian market with a diverse product portfolio spanning
nine therapeutic areas. NPIL had consolidated Revenues of Rs.
24.7 billion in 2006-07. It has world-class USFDA-approved
formulations and API facilities without any 483s. NPIL has a
long track record of successful collaboration with innovator
companies. Since 2003, the Company has made significant
investments to become a global custom manufacturing
organisation (CMO) for large and medium-sized innovator
companies. NPIL is listed in India on the Bombay Stock
Exchange and the National Stock Exchange.
Forward-looking statements:
This news release may contain forward-looking statements that
are based on the Company’s current beliefs and assumptions and
on information currently available to its management.
Forward-looking statements involve known and unknown risks,
uncertainties and other factors that may cause the Company’s
actual results, performance or achievements to be materially
different from any future results, performance or achievements
expressed or implied by the forward-looking statements. As a
result of these risks, uncertainties and other factors,
readers are cautioned not to place undue reliance on any
forward-looking statements included in this press release.
These forward-looking statements represent beliefs and
assumptions only as of the date of this news release, and the
Company assumes no obligation to update these forward-looking
statements publicly, even if new information becomes available
in the future.
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