GlaxoSmithKline and Impax Pharmaceuticals, the brand products division of Impax
Laboratories, Inc., today announced an agreement for the development
and commercialization of IPX066, Impax’s novel extended release
carbidopa-levodopa product, outside the United
States and Taiwan. IPX066, an investigational
product under development for the treatment of Parkinson’s Disease (PD), is currently
in Phase III clinical trials.

Under the terms of the agreement, GSK will receive an
exclusive license to sell IPX066 throughout the world except in the U.S. and Taiwan. Impax will receive an $11.5
million upfront payment and is eligible to receive potential payments of up to
$175 million upon the successful achievement of development and
commercialization milestones. Impax will also receive tiered, double-digit
royalty payments on GSK sales of IPX066. Impax will manufacture and supply IPX066
to GSK.

Impax will complete the current Phase III program for
IPX066, which includes the recently completed APEX-PD trial in early PD. The
results from the remaining Phase III study program are expected to be available
in 2011. In the U.S.,
Impax expects to file a New Drug Application for Parkinson’s Disease in late
2011 and will be responsible for commercialization. In other regions, excluding
Taiwan,
GSK will be responsible for further development and registration of IPX066 and
commercialization of the product in those markets. A team structure with
representatives from both companies is being established to enable effective
coordination of planned global regulatory and commercialization activities.

“We are very pleased to announce this development and
collaboration agreement with GSK, which is a significant milestone in the development
of Impax Pharmaceuticals and an important achievement in the planned global
commercialization for IPX066 for the treatment of Parkinson’s Disease,”
stated Michael Nestor, President of Impax Pharmaceuticals. “GSK is an
ideal partner for IPX066, combining global best-in-class development,
regulatory and commercial experience in Parkinson’s Disease, which will be an
asset in the successful commercialization of IPX066.” “We are excited
by the opportunity IPX066 represents to patients,” commented, Atul Pande,
senior vice president, Neurosciences
Medicines Development
Center, GSK. “There
is a significant need for a therapy which can improve on clinical symptom
management and control in Parkinson’s Disease. We look forward to collaborating
with Impax and hope to deliver an improved treatment option to the millions of
people living with this devastating disease.”