GlaxoSmithKline & Impax Pharmaceuticals Enter Global Agreement to Develop & Commercialize a late stage compound for Parkinson...
December 16 2010 - 8:00AM
Business Wire
GlaxoSmithKline (GSK) and Impax Pharmaceuticals, the brand
products division of Impax Laboratories, Inc. (Impax), 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.”
About IPX066
IPX066 is an investigational extended release carbidopa-levodopa
product with an enhanced pharmacokinetic profile. The IPX066
pharmacokinetic profile has the potential to offer reliable control
of Parkinson’s Disease symptoms, such as the reduction in “off
time” throughout the day, which has been observed in preliminary
studies of IPX066. “Off time” is the functional state when
patients’ medication effect has worn off and there is a return of
Parkinson symptoms.
The phase III clinical development program for the registration
of IPX066 in the U.S. includes the recently completed APEX-PD trial
in early PD, the ADVANCE-PD study in advanced PD subjects, an open
label extension study for subjects from the ADVANCE-PD and APEX-PD
studies. Additionally, for the European application, Impax is
conducting the ASCEND-PD comparative study of IPX066 and
carbidopa-levodopa and entacapone, which is currently enrolling
subjects.
About Parkinson’s Disease
Parkinson’s Disease is a chronic neurodegenerative movement
disorder affecting over three million people in the U.S., Europe
and Japan.
About Impax Laboratories, Inc.
Impax Laboratories, Inc. is a technology based specialty
pharmaceutical company applying its formulation expertise and drug
delivery technology to the development of controlled-release and
specialty generics in addition to the development of branded
products. Impax markets its generic products through its Global
Pharmaceuticals division and markets its branded products through
the Impax Pharmaceuticals division. Additionally, where
strategically appropriate, Impax has developed marketing
partnerships to fully leverage its technology platform. Impax
Laboratories is headquartered in Hayward, California, and has a
full range of capabilities in its Hayward, Philadelphia and Taiwan
facilities. For more information, please visit the Company's Web
site at: www.impaxlabs.com.
GlaxoSmithKline – one of the world’s leading
research-based pharmaceutical and healthcare companies – is
committed to improving the quality of human life by enabling people
to do more, feel better and live longer. For further information
please visit www.gsk.com.
Impax Laboratories, Inc."Safe Harbor" statement under the
Private Securities Litigation Reform Act of 1995:
To the extent any statements made in this news release contain
information that is not historical, these statements are
forward-looking in nature and express the beliefs and expectations
of management. Such statements are based on current expectations
and involve a number of known and unknown risks and uncertainties
that could cause the Company’s future results, performance or
achievements to differ significantly from the results, performance
or achievements expressed or implied by such forward-looking
statements. Such risks and uncertainties include the effect of
current economic conditions on the Company’s industry, business,
financial position, results of operations and market value of its
common stock, the ability to maintain an effective system of
internal control over financial reporting, fluctuations in revenues
and operating income, reductions or loss of business with any
significant customer, the impact of competitive pricing and
products and regulatory actions on the Company’s products, the
ability to sustain profitability and positive cash flows, the
ability to maintain sufficient capital to fund operations, the
ability to successfully develop and commercialize pharmaceutical
products, the uncertainty of patent litigation, consumer acceptance
and demand for new pharmaceutical products, the difficulty of
predicting FDA filings and approvals, the inexperience of the
Company in conducting clinical trials and submitting new drug
applications, reliance on key alliance and collaboration
agreements, the availability of raw materials, the ability to
comply with legal and regulatory requirements governing the
healthcare industry, the regulatory environment, exposure to
product liability claims and other risks described in the Company’s
periodic reports filed with the SEC. Forward-looking statements
speak only as to the date on which they are made, and Impax
undertakes no obligation to update publicly or revise any
forward-looking statement, regardless of whether new information
becomes available, future developments occur or otherwise.
GSK’s cautionary statement regarding forward-looking
statements
Under the safe harbor provisions of the U.S. Private Securities
Litigation Reform Act of 1995, GSK cautions investors that any
forward-looking statements or projections made by GSK, including
those made in this announcement, are subject to risks and
uncertainties that may cause actual results to differ materially
from those projected. Factors that may affect GSK's operations are
described under 'Risk Factors' in the 'Business Review' in the
company' s Annual Report on Form 20-F for 2009.
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