ANAHEIM, Calif., June 23, 2014 /PRNewswire/ -- Questcor
Pharmaceuticals, Inc. (NASDAQ: QCOR) today announced that the
transaction acquiring rights to Synacthen® and
Synacthen® Depot from Novartis Pharma AG and Novartis AG
in certain countries outside the U.S. has now closed.
Available in more than forty countries for multiple indications,
Synacthen (tetracosactide) is a synthetic 24 amino acid
melanocortin peptide. Synacthen Depot is a depot formulation
of Synacthen. The products are approved outside the U.S. for
multiple indications, including certain autoimmune and inflammatory
conditions as well as for diagnostic use, but have never been
developed or approved for patients in the U.S. Questcor is
presently engaged in pre-clinical development for Synacthen in the
U.S.
"As a leader in melanocortin peptide therapeutics, we now have
the opportunity with Synacthen to expand our commercial
presence to more than forty international markets, and
develop a new potential platform for international growth in this
important emerging field of medicine," said Steve Cartt, Chief Operating Officer of
Questcor.
"With the international team that we now have in place, the
closing of this transaction positions us to begin the process of
reinvigorating this important therapeutic in international
markets," continued Mr. Cartt. "Importantly, we are also currently
conducting a pre-clinical evaluation of Synacthen for the U.S.
market, with the goal of working with the FDA to eventually make it
available to U.S. patients."
Under the terms of the transaction agreements, Questcor will
have the right to develop, market, manufacture, distribute, sell
and commercialize Synacthen in all countries worldwide except for
13 European countries in which Novartis has previously granted
rights to another third party. This process will involve the
transfer to Questcor of individual marketing authorizations in more
than forty countries outside the U.S. With the first transfer
expected to take place mid-2014, Questcor anticipates that the
marketing authorizations for Synacthen currently held by Novartis
will be transferred to Questcor on or before the end of
2016.
About Synacthen
Synacthen and Synacthen Depot are available in more than forty
countries to treat a number of conditions including some rheumatoid
diseases, ulcerative colitis, chronic skin conditions not
responsive to corticosteroids, Bell's palsy, acute exacerbations in
patients suffering from multiple sclerosis and periarteritis
nodosa. Synacthen and Synacthen Depot are also used as a
diagnostic test for adrenal insufficiency. Synacthen and Synacthen
Depot are not approved in the U.S.
About Questcor
Questcor Pharmaceuticals, Inc. is a biopharmaceutical
company focused on the treatment of patients with serious,
difficult-to-treat autoimmune and inflammatory disorders.
Questcor also provides specialty contract manufacturing services to
the global pharmaceutical industry through its wholly-owned
subsidiary BioVectra Inc. For more information about
Questcor, please visit www.questcor.com.
Cautionary Statements Related to Forward-Looking
Statements
Note: Except for the historical information
contained herein, this press release contains forward-looking
statements that have been made pursuant to the Private Securities
Litigation Reform Act of 1995. These statements relate to future
events or our future financial performance. In some cases, you can
identify forward-looking statements by terminology such as
"believes," "continue," "could," "ensuring," "estimates,"
"expects," "growth," "may," "momentum," "plans," "potential,"
"remain," "should," "start," "substantial," "sustainable" or "will"
or the negative of such terms and other comparable terminology.
These statements are only predictions. Actual events or results may
differ materially. Factors that could cause or contribute to such
differences include, but are not limited to, the following:
- Research and development risks, including risks associated with
our efforts to develop and obtain FDA approval of Synacthen, our
reliance on third-parties to conduct research and development, our
ability to conduct our own clinical trial research and development
projects, and the ability of research and development to generate
successful results;
- The results of any pending or future litigation, investigations
or claims, including government investigations and private
securities litigation;
- Our ability to comply with federal and state regulations,
including regulations relating to pharmaceutical sales and
marketing practices;
- Our ability to effectively manage our growth, including the
expansion of our sales forces, planned international expansion, and
our reliance on key personnel;
- Our ability to comply with foreign regulations related to the
international sales of Synacthen;
- The impact to our business caused by economic conditions;
- Our ability to protect our trade secrets and other proprietary
rights;
- Our ability to successfully enter into, and operate in,
international markets;
- The risk of unfavorable changes in currency exchange rates;
and
- Other risks discussed in Questcor's annual report on Form 10-K
for the year ended December 31, 2013
as filed with the Securities and Exchange Commission, or SEC, on
February 26, 2014, and other
documents filed with the SEC.
The risk factors and other information contained in these
documents should be considered in evaluating Questcor's prospects
and future financial performance.
Questcor undertakes no obligation to publicly release the result
of any revisions to these forward-looking statements, which may be
made to reflect events or circumstances after the date of this
release.
For more information, please visit www.questcor.com or
www.acthar.com.
SOURCE Questcor Pharmaceuticals, Inc.