Pharma majors Ranbaxy Laboratories Ltd and GlaxoSmithKline
(GSK) are jointly developing a drug for the treatment
of respiratory inflammation under their multi-year R&D
A committee consisting of senior members from GSKs center
of excellence for external drug discovery (CEEDD) and
Ranbaxy''s new drug discovery research (NDDR) team has
chosen the compound for preclinical investigation.
As per the multi-year agreement signed recently, Ranbaxy
would be able to further profile this drug candidate through
pre-clinical studies needed to support an investigational
new drug (IND) application.
Ranbaxy would also be responsible for conducting Phase
I and Phase II clinical studies. GSK would then have the
option to conduct further development through to final
commercialisation, it added.
The two companies are collaborating on two research programmes
- one in chronic obstructive pulmonary disease (COPD)
and the other in anti-infectives.
Chronic obstructive pulmonary disease (COPD), which encompasses
both chronic bronchitis and emphysema, is one of the commonest
respiratory disorders of adults in the developed world.
GSK, at a recent pipeline update, announced two key compounds
had progressed into Phase II development; 681313 and 856553
are both p38 kinase inhibitors to treat COPD, although
the first is also being tested for rheumatoid arthritis,
atherosclerosis and pain. These two drug candidates represented
a significant proportion of all GSK drugs moving into
Under the expanded tie-up, Ranbaxy could receive over
$100 million in potential milestone payments for a product
developed by it. The amount may increase after the drug
is subsequently launched by GSK in multiple indications
and could net its double-digit royalties on worldwide
net sales, a Ranbaxy statement said.
GSK has been forced to outsource research and refocus
its business due to increasing costs, pipeline shortages
and patent expiries.
"This is a great moment for our scientists. The agreement
presents a unique opportunity to demonstrate the India
centric advantages of high quality research and development
to deliver value at the cutting
edge," said Ranbaxy''s CEO Brian W Tempest: "I
believe the arrangement with GSK is path-breaking and
acknowledges the higher level of R&D maturity prevalent
today in our state-of-the art labs in India ," he