Impax Pharmaceuticals Provides an Update on Pipeline Candidate IPX159
May 10 2011 - 8:30AM
Business Wire
Impax Pharmaceuticals, the branded products division of Impax
Laboratories, Inc. (NASDAQ: IPXL), announced the successful filing
of an Investigational New Drug Application (IND) for IPX159 in
Restless Legs Syndrome (RLS) and initiated a Phase I study.
The Company will test multiple formulations of IPX159 in this
Phase I study in healthy volunteer subjects. The Company plans to
start a Phase IIb study in RLS patients in the fourth quarter of
2011 after selection of a preferred formulation.
“We are pleased to announce progress in our neurology pipeline,
with the start of the Phase I study of IPX159 and we look forward
to continued development of this compound in RLS,” said Suneel
Gupta, Ph.D., chief scientific officer, Impax Pharmaceuticals.
About IPX159
IPX159 is an oral controlled-release formulation of a small
molecule with a unique mechanism of action in RLS. IPX159 is a new
molecular entity in the US. The compound has an established
pharmacologic and safety profile for non-RLS use outside the US and
Impax has completed a proof of concept study in RLS.
About Restless Legs Syndrome
Restless Legs Syndrome (RLS) is a condition characterized by an
irresistible urge to move ones’ limbs, most commonly the legs, to
stop uncomfortable sensations and is associated with sleeping
abnormalities, somnolence, pain and discomfort. There are about 25
million RLS sufferers in the US and an estimated current market
size of $800 million.
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 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.
"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, but are not
limited to, the effect of current economic conditions on the
Company’s industry, business, financial position and results of
operations, the ability to maintain an effective system of internal
control over financial reporting, fluctuations in revenues and
operating income, the ability to successfully develop and
commercialize pharmaceutical products, reductions or loss of
business with any significant customer or a reduction in sales of
any significant product, the impact of competition, the ability to
sustain profitability and positive cash flows, any delays or
unanticipated expenses in connection with the operation of the
Taiwan facility, the effect of foreign economic, political, legal
and other risks on operations abroad, the uncertainty of patent
litigation, consumer acceptance and demand for new pharmaceutical
products, the difficulty of predicting Food and Drug Administration
filings and approvals, the inexperience of the Company in
conducting clinical trials and submitting new drug applications,
the ability to successfully conduct clinical trials, reliance on
alliance and collaboration agreements, the availability of raw
materials, the ability to comply with legal and regulatory
requirements, the regulatory environment, the ability to protect
the Company’s intellectual property, exposure to product liability
claims and other risks described in the Company’s periodic reports
filed with the Securities and Exchange Commission. 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.
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