Copenhagen, 2011-12-16 14:00 CET (GLOBE NEWSWIRE) --
Apricus Biosciences, Inc. ("Apricus Bio")
has agreed to purchase 100% of the outstanding common stock
of Topotarget A/S' ("Topotarget") American
subsidiary division, Topotarget USA, Inc. ("Topotarget
USA") in exchange for Apricus Bio common stock worth
approximately USD 2 million in upfront payments, and up to
approximately USD 2 million more in Apricus Bio common
stock if certain milestones are achieved, which in total
amount to approximately USD 4 million. Apricus Bio will own
all rights to Totect® in North America and South America
and the respective territories, and possessions of the
countries in North America and South America. Topotarget
had previously sold the rest-of-world rights to Totect®,
which are marketed under the name Savene®. The sale of
Totect® is subject to customary closing conditions and is
expected to close by December 31, 2011.
"We are very pleased with the sale of Totect® to
Apricus Biosciences, which is in line with our core
strategy and commitment to our shareholders to focus on the
late-stage clinical development and commercialization of
belinostat, as well as maintaining a cost-effective
operational structure for this purpose", said Francois
Martelet, CEO of Topotarget A/S.
Revised expectations for 2011
Upfront payments related to the sale of Totect®
amount to approximately USD 2 million of Apricus Bio common
stock which will be accounted for by Topotarget in the
fourth quarter of 2011.
For the fourth quarter of 2011, Topotarget's income statement will be positively influenced by an extraordinary income of around DKK 5 million relating to the difference between the approximately USD 2 million of Apricus Bio common stock and the carrying amount of the assets related to the sale of Totect®. Further, Topotarget's equity will be positively influenced by the sale of Totect® by approximately DKK 5 million.
As a result of the above, Topotarget now expects an estimated pre-tax loss in the range of DKK 20-40 million for the full year financial result of 2011, compared to the latest announced expectations of DKK 25-45 million.
Topotarget expects to have net cash and cash
equivalents of around DKK 110 million at year-end
2011.
Topotarget A/S
For further information, please contact:
Francois Martelet, CEO: Direct: +45 39 17 83 43; Mobile: +45 51 32 83 41
Anders Vadsholt, CFO: Direct: +45 39 17 83 45; Mobile: +45 28 98 90 55
Background information
About Totect® and the Anthracycline Extravasation
Market
Totect®or Dexrazoxane HCl
is used to treat anthracycline extravasation, which is the
leaking of chemotherapy from the veins of cancer patients
into tissues and other areas of the body. Anthracyclines
are among the most used chemotherapy drugs to treat cancer.
There are over 500,000 anthracycline infusions in the U.S.
every year and if an extravasation that occurs following an
anthracycline infusion is left untreated, patients with
this condition may risk serious infection, tissue necrosis,
or in some cases death. It is estimated that in the U.S.,
there are approximately 3,500 cancer centers that provide
chemotherapy treatments where anthracyclines are
administered.
About Topotarget A/S
Topotarget (NASDAQ-OMX: TOPO.CO) is an international
biopharmaceutical company headquartered in Copenhagen,
Denmark, dedicated to clinical development and registration
of oncology products. Topotarget focuses, in collaboration
with Spectrum Pharmaceuticals, Inc., on the development in
pivotal studies of its lead drug candidate, belinostat,
which has shown positive results as a monotherapy treating
haematological malignancies and positive results in solid
tumours. Belinostat may be used in combination with full
doses of chemotherapy, and is in a pivotal trial within
PTCL (peripheral T-cell lymphoma). For more information,
please refer to www.topotarget.com.
About Apricus Biosciences, Inc.
Apricus Bio, a San Diego-based, revenue-generating,
specialty pharmaceutical company, with commercial products
and a broad pipeline across numerous therapeutic
classes.
Revenues and growth are driven from the sales of the Company's commercial products and out-licensing in certain territories of its product pipeline and NexACT®technology. The company's pipeline includes Vitaros®, approved in Canada for the treatment of erectile dysfunction, Totect®the only drug approved in the US for the treatment of anthracycline extravasation, as well as compounds in development from pre-clinical through pre-registration, currently focused on Sexual Dysfunction, Oncology, Dermatology, Autoimmune, Pain, Anti-Infectives, Diabetes and Consumer Healthcare.
The Company also expects to develop and/or acquire and then bring to market additional pharmaceutical products in areas of care that will benefit patient needs worldwide.
For further information on Apricus Bio, visit
http://www.apricusbio.com, and for information on its
subsidiary please visit http://www.nexmedusa.com. You can
also receive information at http://twitter.com/apricusbio
and http://facebook.com/apricusbio.
Topotarget A/S Safe Harbour Statement
This announcement may contain forward-looking
statements, including statements about our expectations of
the progression of our preclinical and clinical pipeline
including the timing for commencement and completion of
clinical trials and with respect to cash burn guidance.
Such statements are based on management's current
expectations and are subject to a number of risks and
uncertainties that could cause actual results to differ
materially from those described in the forward-looking
statements. Topotarget A/S cautions investors that there
can be no assurance that actual results or business
conditions will not differ materially from those projected
or suggested in such forward-looking statements as a result
of various factors, including, but not limited to, the
following: The risk that any one or more of the drug
development programs of Topotarget A/S will not proceed as
planned for technical, scientific or commercial reasons or
due to patient enrolment issues or based on new information
from non-clinical or clinical studies or from other
sources; the success of competing products and
technologies; technological uncertainty and product
development risks; uncertainty of additional funding;
Topotarget A/S' history of incurring losses and the
uncertainty of achieving profitability; Topotarget A/S'
stage of development as a biopharmaceutical company;
government regulation; patent infringement claims against
Topotarget A/S' products, processes and technologies;
the ability to protect Topotarget A/S' patents and
proprietary rights; uncertainties relating to
commercialization rights; and product liability exposure.
We disclaim any intention or obligation to update or revise
any forward-looking statements, whether as a result of new
information, future events, or otherwise, unless required
by law.
Apricus Bio's Forward-Looking Statement Safe
Harbor
Statements under the Private Securities Litigation
Reform Act, as amended: with the exception of the
historical information contained in this release, the
matters described herein contain forward-looking statements
that involve risks and uncertainties that may individually
or mutually impact the matters herein described for a
variety of reasons that are outside the control of the
Company, including, but not limited to, its ability to
further develop its products such as
Vitaros®for erectile dysfunction,
Totect®for anthracycline
extravasation and other products and product candidates, to
have its products and product candidates approved by
relevant regulatory authorities, to successfully
commercialize such products and product candidates, to
integrate successfully its acquired companies such as
Topotarget USA and other companies, products and
technologies and to achieve its development,
commercialization and financial goals. Readers are
cautioned not to place undue reliance on these
forward-looking statements as actual results could differ
materially from the forward-looking statements contained
herein. Readers are urged to read the risk factors set
forth in the Company's most recent annual report on
Form 10-K, subsequent quarterly reports filed on Form 10-Q
and other filings made with the SEC. Copies of these
reports are available from the SEC's website or without
charge from the Company.
To NASDAQ OMX Copenhagen A/S
Announcement No. 23-11 / Copenhagen, December 16, 2011