Apricus Biosciences, Inc.
Apricus Biosciences, Inc.
- ISIN: US9901429525
- Land: .
Nachricht vom 08.08.2012 | 15:07
Apricus Biosciences Announces Second Quarter 2012 Financial Results Conference Call and Provides Corporate Update
Apricus Biosciences, Inc.
08.08.2012 15:07
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Conference Call/Webcast to be Held Friday, August 10, 2012 at 10:30 a.m. ET
SAN DIEGO, 2012-08-08 15:07 CEST (GLOBE NEWSWIRE) --
Apricus Biosciences, Inc. ('Apricus Bio' or the 'Company') (Nasdaq:APRI)
announced today that it will hold a conference call to discuss its second
quarter 2012 financial results and ongoing corporate activities on Friday,
August 10, 2012 at 10:30 a.m. ET. The Company expects to file its Form 10-Q for
the quarter ended June 30, 2012 by the close of business on Thursday, August 9,
2012.
'The second quarter of 2012 was marked by significant progress with our mid-
and long-term commercial and corporate growth strategies,' said Dr. Bassam
Damaj, President and Chief Executive Officer. 'In addition to progress on the
regulatory and intellectual property fronts with a number of our products, we
signed the Finesco-Scomedica transaction, a transformative agreement that
launches Apricus' commercial operations in Europe. We expect the transaction,
which closed in late July, to build a strong revenue base in several key
markets, beginning in France, and create significant value for our shareholders
over the long-term. In addition, we completed two guidance meetings for
Femprox(r) and MycoVa(tm) in Canada. We look forward to announcing additional
partnerships later in the year and to moving forward in 2013 with marketing
authorization filings for some of our product candidates that have completed
late-stage clinical trials.'
Second Quarter 2012 and Recent Highlights
- Announced submission of regulatory response to Swissmedic for Vitaros(r). In
June 2012, Apricus Bio filed its response to regulatory questions received from
Swissmedic, the Agency for Therapeutic Products in Switzerland, relating to its
marketing application previously filed for Vitaros(r), the Company's lead product
candidate for the treatment of erectile dysfunction. Switzerland is not part of
the European Union and is therefore not regulated by the European Medicines
Agency ('EMA'). Marketing drugs in Switzerland requires an independent
application and approval from Swissmedic. In addition, Swissmedic is considered
one of the most well-respected health agencies in the world, and its decisions
often influence the regulatory decisions of other countries.
- Announced acquisition of Scomedica, a leading French drug sales and marketing
company. In July 2012, Apricus Bio announced it acquired Finesco SAS, the
parent and holding company of Scomedica SAS, a revenue-generating healthcare
contract sales and marketing organization. This transaction will give the
Company the ability to in-license and co-promote additional products in the
French market and build a product pipeline in that country. It may also enable
Apricus Bio to directly launch Vitaros(r) in France, Europe's second largest drug
market, when and if approved by the EMA. In addition, the Company intends to
use its French sales force as a base for commercial operations in Europe. As a
reminder Scomedica is comprised of a large pharmaceutical sales force that can
deliver over 100,000 details a year and currently successfully details multiple
products on the French market for companies such as Novartis and had annual
revenues of approximately [Eur]8 million ($10.1 million) in 2011.
- Strengthened patent estate with issuance of 3 new patents. In the second
quarter of 2012, Apricus Bio strengthened its patent portfolio with the grant
and allowance of 3 new patents. The first was a new U.S. patent claiming
certain compositions and methods for inhibiting tumor growth related to
PrevOnco(tm), its Phase III-ready investigational drug for patients with advanced,
unresectable liver cancer. This is the first PrevOnco(tm) patent granted in the
U.S. The Company was also granted a patent in New Zealand for certain
pharmaceutical compositions of Vitaros(r), including a room temperature
formulation and a Canadian patent on certain methods of manufacture for the
Company's platform NexACT(r) drug delivery technology.
Key Upcoming Milestones
- Commercialization of Vitaros(r) in Canada. The Company's Canadian partner,
Abbott Laboratories Limited ('Abbott') has indicated their intention to launch
Vitaros(r) for the treatment of erectile dysfunction in the second half of 2012.
Apricus Bio has completed the transfer of the Canadian New Drug Submission to
Abbott in preparation for the launch later this year.
- Partnerships for multiple pipeline products in Europe. Apricus Bio continues
to engage in partnership discussions for Vitaros(r), as well as its other
pipeline products, throughout the remaining territories in Europe and looks
forward to announcing signed partnerships with upfront cash, milestones, and
royalties. The Company is in commercial contract negotiations for several
territories in Europe, some of which it currently expects to finalize in the
third or fourth quarters of this year.
- Additional Vitaros(r) filings in Europe and Latin America. Apricus Bio
currently intends to file its answers to its DCP in Europe and expects to file
a response in September 2012. On the Latin American front, the Company expects
Mexico to be the first Latin American country in which it will file for
Vitaros(r) and it expects that filing to take place in the near future.
- Regulatory guidance for Femprox(r) development program. The Company met with
Health Canada regarding Femprox(r) in July 2012 and is planning to meet with
regulatory agencies in the U.S. and Europe in the third and fourth quarters of
2012. It hopes to obtain guidance regarding the suitability of the existing
clinical, preclinical, and chemistry data to support approval filings in each
territory.
- Regulatory guidance for MycoVa(tm) development program. The Company met with
Health Canada regarding MycoVa(tm) in July 2012 and is planning to meet with
regulatory agencies in the U.S. and Europe in the third and fourth quarters of
2012. It hopes to obtain guidance regarding the suitability of their existing
clinical, preclinical and chemistry data to support approval filings in each
territory.
Conference Call Information
The call can be accessed in the U.S. by dialing 877-407-8031 and outside of the
U.S. by dialing 201-689-8031 and asking the conference operator for the Apricus
Bio Conference Call. The teleconference replay will be available for one week
by dialing in the U.S. 877-660-6853 and outside of the U.S. by dialing
201-612-7415. Replay passcodes 286 and 398232 are both required for playback.
The conference call will also be webcast live at
http://www.investorcalendar.com/IC/CEPage.asp?ID=168504. The webcast replay
will be available for three months.
About Apricus Biosciences, Inc.
Apricus Bio (Nasdaq:APRI) is a pharmaceutical company that develops and markets
innovative treatments that help large patient populations across numerous,
high-demand therapeutic classes. The Company has four approved products and has
developed a strong pipeline of multiple late-stage product candidates. With
commercial operations in both the U.S. and Europe (France), Apricus Bio
generates revenues and growth from sales of its commercial products and by
out-licensing, in certain territories, its pipeline products and NexACT(r)
technology.
Apricus Bio's growth strategy is to acquire, develop, and commercialize new
products through strategic partnerships. The Company currently has commercial
partnerships with multiple large pharmaceutical companies including Novartis,
Abbott Laboratories, Sandoz, Warner Chilcott, Wockhardt, and Bracco, and
co-promotes multiple products in France.
Apricus Bio is headquartered in San Diego, CA and is publicly traded on the
NASDAQ Capital Market under the ticker symbol APRI.
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.
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 and
product candidates, to have its products and product candidates such as
Vitaros(r), Femprox(r) and MycoVa(tm) receive patent protection and be approved by
relevant regulatory authorities, to successfully commercialize such products as
Totect(r), Granisol(r) , Aquoral(tm) and NitroMist(tm) and NexACT(r) product
candidates and
drug delivery technology and to achieve its development, commercialization and
financial goals, including any and all of the goals set forth above under the
caption Key Upcoming Milestones. Readers are cautioned that there can be no
assurance that the Company will successfully achieve any of these milestones in
a timely fashion, or at all. Readers are further 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.
CONTACT: Apricus Bio Investor Relations:
David Pitts
Argot Partners
212-600-1902
david@argotpartners.com
News Source: NASDAQ OMX
08.08.2012 Dissemination of a Corporate News, transmitted by DGAP -
a company of EquityStory AG.
The issuer is solely responsible for the content of this announcement.
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Language: English
Company: Apricus Biosciences, Inc.
United States
Phone:
Fax:
E-mail:
Internet:
ISIN: US9901429525
WKN:
End of Announcement DGAP News-Service
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