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Dr
Reddys Laboratories Ltd and ClinTec International have
entered into an agreement for the joint development of
an anti-cancer compound, DRF 1042, belonging to the topoisomerase
inhibitors class of compounds for use as potential treatment
of various types of cancer.
Under
the terms of the agreement, Dr Reddys will retain the
commercialisation rights for the US and rest of the world
excluding ClinTec International''s territories for most
of Europe that include most major European markets.
The
financial terms of the agreement have not been disclosed.
ClinTec
International is a UK-based, privately owned full service
contract research organisation located in Windsor (UK)
with presence in with presence in over 30 countries worldwide,
including India, South Africa and the Middle East. It
provides clinical research support services to the pharmaceutical,
biotechnology and medical device industry and assists
them in their product development efforts.
ClinTec''s
has substantial experience in oncology, neurology, dermatology
and rheumatology.
Hyderabad-based
Dr Reddys has completed Phase 1 clinical trials for DRF
1042 in India. Under the terms of the agreement, Dr Reddys
and ClinTec International will co-develop DRF 1042 and
jointly undertake Phase II and Phase III clinical trials.
The two companies intend securing the US FDA and EMEA
approvals.
On
commercialisation of the product, Dr Reddys will receive
royalty on sales by ClinTec International in its designated
territories and ClinTec International will receive royalty
on sales by Dr Reddys in the US. In the event of the product
being out-licensed either party, the proceeds would be
shared at a pre-determined ratio. However, if the out
licenses takes place in Dr Reddys territories outside
the US, Dr Redys would not be required to share the proceeds
with the UK company.
Dr
Reddys will also retain the exclusive rights to supply
commercial quantities of the drug product.
Commenting
on the co-development and commercialisation deal, G V
Prasad, chief executive officer, Dr Reddys, said, "We
are excited about the R&D collaboration with ClinTec
International as it will bring a very exciting cancer
drug to the market and is a step forward in our efforts
to transform ourselves into a discovery led global pharmaceutical
company. ClinTec International brings to this partnership
their vast experience and in-depth expertise in the anti-cancer
clinical development space. We look forward to this exciting
collaboration with ClinTec International."
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