BUENA, N.J. and HAYWARD, Calif., June
20, 2014 /PRNewswire/ -- IGI Laboratories, Inc. (NYSE
MKT: IG), a New Jersey based
generic topical pharmaceutical company, today announced it has
submitted its seventh abbreviated new drug application (ANDA) in
2014 to the U.S. Food and Drug Administration (FDA). The
seventh ANDA submission was in connection with an existing
development, supply and marketing agreement with Impax
Laboratories, Inc. (NASDAQ: IPXL). The agreement designates
IGI Laboratories, Inc. (IGI) as the developer, manufacturer, and
owner of a generic topical pharmaceutical drug product, which will
be licensed, marketed and distributed in the United States by Global Pharmaceuticals,
Impax's generics division. In accordance with the agreement, Impax
is required to pay IGI when certain milestones are met related to
the filing and approval of the associated ANDA.
Jason Grenfell-Gardner, President
and CEO of the Company commented, "We have collaborated with Impax
over the past few years, and we are grateful for the continued
support from one of the leaders in the specialty pharmaceutical
industry. We believe the addressable market for this product
to be over $100 million based on
recent data from IMS Health. We look forward to working with Impax
to continue to help us grow our pipeline of generic topical
prescription drugs."
President of Global Pharmaceuticals Dr. Carole Ben-Maimon stated, "We are pleased to be
the partner of choice with IGI on this product opportunity. This is
another example of our commitment to diversifying our product base
and the expansion of our topical portfolio."
About IGI Laboratories, Inc.
IGI Laboratories is a generic topical pharmaceutical
company. We develop and manufacture topical formulations for
the pharmaceutical, OTC, and cosmetic markets. Our mission is to be
a leading player in the generic topical prescription drug
market.
About Impax Laboratories, Inc.
Impax Laboratories, Inc. (Impax) 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 central
nervous system disorder 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 develops
marketing partnerships to fully leverage its technology platform
and pursues partnership opportunities that offer alternative dosage
form technologies, such as injectables, nasal sprays, inhalers,
patches, creams and ointments. For more information, please visit
the Company's Web site at: www.impaxlabs.com.
IGI Laboratories, Inc. Forward-Looking Statements
This press release includes certain "forward-looking statements"
within the meaning of the Private Securities Litigation Reform Act
of 1995. These forward-looking statements include, but are not
limited to, plans, objectives, expectations and intentions, and
other statements contained in this press release that are not
historical facts and statements identified by words such as "plan,"
"believe," "continue", "should" or words of similar meaning.
Factors that could cause actual results to differ materially from
these expectations include, but are not limited to: our inability
to meet current or future regulatory requirements in connection
with existing or future ANDAs; our inability to achieve
profitability; our failure to obtain FDA approvals as anticipated;
our inability to execute and implement our business plan and
strategy; the potential lack of market acceptance of our products;
our inability to protect our intellectual property rights; changes
in global political, economic, business, competitive, market and
regulatory factors; and our inability to complete successfully
future product acquisitions. These statements are based on
our current beliefs or expectations and are inherently subject to
various risks and uncertainties, including those set forth under
the caption "Risk Factors" in IGI Laboratories, Inc.'s most recent
Annual Report on Form 10-K, Quarterly Reports on Form 10-Q
and other periodic reports we file with the Securities and Exchange
Commission. IGI Laboratories, Inc. does not undertake any
obligation to update any forward-looking statements contained in
this document as a result of new information, future events or
otherwise, except as required by law.
Impax Laboratories, Inc. Forward-Looking Statements
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: fluctuations in revenues and operating income; the
Company's ability to promptly correct the issues raised in the
warning letter and Form 483 observations received from the FDA; the
Company's ability to successfully develop and commercialize
pharmaceutical products in a timely manner; reductions or loss of
business with any significant customer; the impact of consolidation
of the Company's customer base; the impact of competition; the
substantial portion of our total revenues derived from sales of a
limited number of products; the Company's ability to sustain
profitability and positive cash flows; any delays or unanticipated
expenses in connection with the operation of the Company's
manufacturing facilities; the effect of foreign economic,
political, legal, and other risks on the Company's operations
abroad; the uncertainty of patent litigation and other legal
proceedings; the increased government scrutiny on the Company's
agreements with brand pharmaceutical companies; product development
risks and the difficulty of predicting FDA filings and approvals;
consumer acceptance and demand for new pharmaceutical products; the
impact of market perceptions of the Company and the safety and
quality of the Company's products; the Company's determinations to
discontinue the manufacture and distribution of certain products;
the Company's ability to achieve returns on its investments in
research and development activities; the Company's inexperience in
conducting clinical trials and submitting new drug applications;
the Company's ability to successfully conduct clinical trials; the
Company's reliance on third parties to conduct clinical trials and
testing; the Company's lack of a license partner for
commercialization of IPX066 outside of the United States; impact of illegal
distribution and sale by third parties of counterfeits or stolen
products; the availability of raw materials and impact of
interruptions in the Company's supply chain; the Company's policies
regarding returns, allowances and chargebacks; the use of
controlled substances in the Company's products; the effect of
current economic conditions on our industry, business, results of
operations and financial condition; disruptions or failures in the
Company's information technology systems and network
infrastructure; the Company's reliance on alliance and
collaboration agreements; the Company's reliance on licenses to
proprietary technologies; the Company's dependence on certain
employees; the Company's ability to comply with legal and
regulatory requirements governing the healthcare industry; the
regulatory environment; the Company's ability to protect its
intellectual property; exposure to product liability claims; risks
relating to goodwill and intangibles; changes in tax regulations;
the Company's ability to manage growth, including through potential
acquisitions; the restrictions imposed by the Company's credit
facility; uncertainties involved in the preparation of the
Company's financial statements; the Company's ability to maintain
an effective system of internal control over financial reporting;
the effect of terrorist attacks on the Company's business; the
location of the Company's manufacturing and research and
development facilities near earthquake fault lines; expansion of
social media platforms 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 the Company 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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SOURCE IGI Laboratories, Inc.; Impax Laboratories, Inc.