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8-K - FORM 8-K - Impax Laboratories, LLC | c10091e8vk.htm |
Exhibit 99.1
GlaxoSmithKline and Impax Pharmaceuticals Enter Global
Agreement to Develop and Commercialize a late stage
compound for Parkinsons Disease
Agreement to Develop and Commercialize a late stage
compound for Parkinsons Disease
London & Hayward, Calif., December 16, 2010 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, Impaxs novel extended release carbidopa-levodopa
product, outside the United States and Taiwan. IPX066, an investigational product under development
for the treatment of Parkinsons 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 Parkinsons
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 Parkinsons 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 Parkinsons 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 Parkinsons 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 Parkinsons 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.
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 Parkinsons 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 Parkinsons Disease
Parkinsons Disease is a chronic neurodegenerative movement disorder affecting over three million people in the U.S., Europe and Japan.
Parkinsons 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 Companys Web site at: www.impaxlabs.com.
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 Companys Web site at: www.impaxlabs.com.
Impax Laboratories, Inc: Company Contact:
Mark Donohue
Sr. Director
Investor Relations and Corporate Communications
(215) 933-3526
www.impaxlabs.com
Mark Donohue
Sr. Director
Investor Relations and Corporate Communications
(215) 933-3526
www.impaxlabs.com
GlaxoSmithKline one of the worlds 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
GlaxoSmithKline Enquiries: |
||||
UK Media enquiries:
|
David Mawdsley | (020) 8047 5502 | ||
Claire Brough | (020) 8047 5502 | |||
Stephen Rea | (020) 8047 5502 | |||
Alexandra Harrison | (020) 8047 5502 | |||
Jo Revill | (020) 8047 5502 | |||
US Media enquiries:
|
Nancy Pekarek | (919) 483 2839 | ||
Mary Anne Rhyne | (919) 483 2839 | |||
Kevin Colgan | (919) 483 2839 | |||
Jennifer Armstrong | (919) 483 2839 | |||
European Analyst/Investor enquiries:
|
Sally Ferguson | (020) 8047 5543 | ||
Gary Davies | (020) 8047 5503 | |||
Ziba Shamsi | (020) 8047 3289 | |||
US Analyst/ Investor enquiries:
|
Tom Curry | (215) 751 5419 | ||
Jen Hill Baxter | (215) 751 7002 |
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 Companys 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 Companys 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 Companys 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 Companys 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.
GSKs 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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