BUENA, N.J., Sept. 25, 2014 /PRNewswire/ -- IGI
Laboratories, Inc. (NYSE MKT: IG), a New
Jersey based specialty generic pharmaceutical company, today
announced it has acquired the regulatory rights and related
documents and records for 18 drug products from AstraZeneca, 17 of
which were marketed. The acquisition includes the regulatory
rights and documents for 17 injectable products and 1 suppository
product. All of these products had been previously approved by
the US FDA as abbreviated new drug applications (ANDAs) or new drug
applications (NDAs) prior to their discontinuation or withdrawal
from the market. According to IMS Health, the current addressable
market in the United States for
the therapeutic areas that these products were previously indicated
for is estimated at $200 million as
of May 2014.
Jason Grenfell-Gardner, President
and CEO of IGI Laboratories, commented, "This acquisition begins
the next critical phase of our growth strategy, and will enable us
to expand our existing generic topical pharmaceutical platform to
now include injectable products. Expanding our development and
commercial focus to include injectable pharmaceutical products will
leverage our existing expertise and capabilities, and broaden our
platform for sustainable growth. Almost half of the products
we acquired are currently listed on the US FDA shortage list, and
we look forward to working closely with the US FDA to return these
products to the market as soon as possible."
About IGI Laboratories, Inc.
IGI Laboratories is a specialty generic drug development and
manufacturing company. Our mission is to be a leading player in the
specialty generic prescription drug market.
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.
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SOURCE IGI Laboratories, Inc.