PARSIPPANY, N.J. and TOKYO, May 11, 2011 /PRNewswire/ — Daiichi
Sankyo announced that applications have been submitted for market
approval for vemurafenib (PLX4032/RG7204) for the treatment of
metastatic melanoma to the U.S. Food and Drug Administration (FDA)
and the European Medicines Agency (EMA). Additionally, a
pre-marketing application for approval for a companion diagnostic
test has been submitted in the U.S.; the test also will be
registered in Europe. Vemurafenib is an oral, novel drug that
targets the oncogenic BRAF mutation present in about half of
melanoma cancers and about eight percent of all solid tumors.
In April 2011, Daiichi Sankyo, Co., Ltd. acquired Plexxikon,
which discovered and is co-developing vemurafenib with Roche.
Daiichi Sankyo, Inc. will co-promote vemurafenib in the U.S. with
Genentech under Plexxikon’s co-promote agreement with Genentech, a
member of the Roche Group.
“The NDA submission to FDA for vemurafenib only six years after
its discovery reflects Plexxikon’s highly efficient research
platform to identify unique molecules as well as the team’s
strategic approach to early development,” said Glenn Gormley, MD,
PhD, chief science officer and president, Daiichi Sankyo Pharma
Development. “This is the very reason Daiichi Sankyo is proud to
have made Plexxikon part of the Daiichi Sankyo Group, and from now
on, to jointly bring forward novel medicines for the patients who
need them.”
“Daiichi Sankyo has brought on board a highly experienced sales
team to co-promote vemurafenib with Genentech in the U.S., pending
FDA approval, and we look forward to working with our partner to
bring this new personalized approach to this deadly type of cancer
to patients and providers,” said John Gargiulo, president and CEO,
Daiichi Sankyo, Inc. “We are fortunate and excited that vemurafenib
has the potential to be the first entry into the oncology market
for Daiichi Sankyo, Inc., and we expect it will be followe
‘/>”/>
