DGAP-News: Apricus Biosciences Provides Third Quarter 2013 Corporate Update
(firmenpresse) - Apricus Biosciences, Inc.
13.11.2013 12:05
---------------------------------------------------------------------------
Vitaros(r) on Track for European Launch in 2014
Company Provides Femprox(r) Update
Company to Host Conference Call/Webcast Today at 9:00 AM ET
SAN DIEGO, Nov. 13, 2013 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc.
('Apricus' or the 'Company') (Nasdaq:APRI) (www.apricusbio.com), today provided
a third quarter corporate update, including clinical, commercial and regulatory
strategies for its topical on-demand product Vitaros(r) for erectile dysfunction
('ED') and its product candidate Femprox(r) for female sexual interest/arousal
disorder ('FSIAD').
'Since the beginning of 2013, we have focused on the successful execution of
our corporate goals, including gaining European regulatory approval for
Vitaros(r), licensing the un-partnered Vitaros(r) territories in Europe, obtaining
regulatory feedback from the FDA on Femprox(r) and streamlining our business,'
said Richard Pascoe, Chief Executive Officer of Apricus. 'We continue to make
progress on each of these fronts, including obtaining an approval for Vitaros(r)
in Europe through the Decentralized Procedure ('DCP'), advancing our partnering
discussions to include licensing Vitaros(r) to Laboratoires Majorelle in France,
Monaco and Africa, obtaining regulatory advice from the FDA on Femprox(r),
strengthening our balance sheet, and completing the divestiture of all
non-strategic assets. Looking forward, our top priorities are to secure
additional Vitaros(r) partnerships and support our commercialization partners'
launch preparations for Vitaros(r). We expect to announce one or more additional
Vitaros(r) partnerships this quarter and anticipate the rollout of multiple
Vitaros(r) launches across Europe in 2014.'
Mr. Pascoe continued: 'Regarding Femprox(r), we received clear regulatory
guidance from the FDA in August 2013, and together with our Scientific Advisory
Board, have drafted a clinical development plan for Femprox(r) in the U.S. Given
the recent DCP approval of Vitaros(r) in Europe, and the fact that Femprox(r)
contains a unique concentration of the same active ingredient and novel
proprietary permeation enhancer as Vitaros(r), we believe there may be a
streamlined path to approval in Europe for Femprox(r). Therefore, we have
requested a meeting with the European regulatory authorities to confirm whether
a more rapid development path for Femprox(r) is possible in Europe. We expect
this meeting to occur in the first quarter of 2014. Additionally, we are
awaiting the outcome of an approval decision by the FDA for a competitive
female sexual dysfunction product that we believe will help us further refine
the Femprox(r) development strategy. With a well-defined U.S. regulatory path in
hand, and with expected near term visibility on two critical pieces of
regulatory feedback, we believe that shareholder interest will best be served
by advancing Femprox(r) into the clinic with a development partner which we
intend to pursue in early 2014.'
Vitaros(r)
-- Launch Preparations Underway. Vitaros(r) was approved in Europe under the DCP
in June 2013. Since then, Apricus, or its commercialization partners, have
received five national phase approvalsin Europe, including Germany,
Ireland, the Netherlands, Sweden and the United Kingdom ('UK'). Apricus
continues to work independently, as well as with its partners, to obtain
country-by-country national phase approvals in the remaining CMS
territories including France, Spain, Belgium, Italy and Luxembourg. The
Company's regulatory efforts, along with actions taken by its existing
European partners, are on track to obtain the remaining five European
approvals. The Company has received commercial product orders from its
commercialization partners and manufacturing activities have commenced for
both sample and commercial product to support the expected Vitaros(r) launch
in Europe. In addition, our existing partners in Europe continue to prepare
for an expected commercial launch in their respective territories in 2014.
-- Partnering Initiative Remains on Track. In June 2013, Apricus launched a
comprehensive partnering process with the goal of licensing Vitaros(r) in the
remaining un-partnered territories in Europe, and the Emerging Markets,
including, Russia, Turkey, Latin America and Africa. The Company's key
partnering objectives for Vitaros(r) are to maximize the total deal value for
the asset, expand existing Vitaros(r) partnerships wherever possible, and
select partners who have a strong clinical, regulatory and commercial
presence in the respective territory. In addition to today's announcement
that we entered into a partnership with Laboratoires Majorelle in France,
Monaco and Africa, Apricus has received and reviewed multiple bids for the
available territories, has narrowed the number of potential partners to a
select group, and is negotiating with multiple parties. The Company expects
to complete negotiations and announce one or more new Vitaros(r) partnerships
in the fourth quarter of 2013.
-- Room Temperature Device and Other Manufacturing Initiatives Progressing.
Apricus continues to make progress with its next-generation, room
temperature version of Vitaros(r). This new version is expected to have a
targeted shelf life of at least 24 months and will not require
refrigeration. The Company has contracted with an additional manufacturing
partner that will serve as a second source of global supply for Vitaros(r).
The Company expects this second manufacturing site, located in Canada, will
be ready to supply cold chain Vitaros(r) product to its commercialization
partners in the second half of 2014. The site will also serve as the
primary manufacturing site for the ongoing room temperature Vitaros(r)
development program. Apricus believes this next-generation, room
temperature version will be a key driver of Vitaros(r) market growth and
expansion in 2015 and beyond.
Femprox(r)
-- Integrating Guidance from U.S. and European Health Authorities. Apricus
completed an End-of-Phase II meeting with the U.S. Food and Drug
Administration ('FDA') in late August 2013. In written guidance received
from the FDA following the meeting, the Agency concurred that the proposed
indication of FSIAD can be pursued in both pre- and post-menopausal women,
but that efficacy in each group must be demonstrated separately. The FDA
also concurred with the Company's proposed dosage levels, clinical
endpoints of Satisfying Sexual Events (SSE) and the arousal domain of the
female sexual function index ('FSFI'), and certain other study design
details. The Agency guided that a future study of Femprox(r) should
incorporate endpoints that would be used to validate the arousal domain of
FSFI. In addition, the FDA also stated that no additional non-clinical
studies, other than a reproductive and developmental assessment, would be
required to support a New Drug Application ('NDA'). The Company recently
met with its Scientific Advisory Board and has developed a draft clinical
development program for Femprox(r) in the U.S.
The Company believes there may be a more streamlined path to approval in Europe
for Femprox(r). Therefore, Apricus is seeking regulatory guidance for Femprox(r)
from the European regulatory authorities and expects to meet to gain insight
from the authorities in the first quarter of 2014. Moreover, the Company, along
with its Scientific Advisors, believes that it is essential to understand the
outcome of a pending approval decision for a competitive female sexual
dysfunction product by the FDA prior to finalizing the Femprox(r) clinical
development program and initiating any potential partnering activities.
Therefore, the Company plans to provide an update in early 2014 following its
analysis of these two critical items.
Financial Status
Cash and cash equivalents totaled $20.6 million as of September 30, 2013,
compared to $15.1 million as of December 31, 2012. Based upon our current
business plan, the Company believes it has sufficient cash reserves to fund its
ongoing operations through 2014. The Company filed its third quarter 2013
financial results with the U.S. Securities and Exchange Commission on November
12, 2013.
Conference Call Information
The call can be accessed in the U.S. by dialing 877-407-9210 and outside of the
U.S. by dialing 201-689-8049 and asking the conference operator for the Apricus
Conference Call. The conference call will also be webcast live at:
http://www.investorcalendar.com/IC/CEPage.asp?ID=171856. 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 Passcode 13572631 is
required for playback. The webcast replay will be available for three months.
About Vitaros(r)
Vitaros(r) has been approved for the treatment of ED by the European Health
Authorities and by Health Canada. Vitaros(r) is a topically-applied cream
formulation of alprostadil, a vasodilator, combined with our proprietary
permeation enhancer DDAIP.HCl, which directly increases blood flow to the
penis, causing an erection. Alprostadil is a widely accepted alternative to
the PDE-5 inhibitors for difficult to treat patients, and Vitaros(r), which was
determined to be safe and effective by the European Health Authorities and
previously by Health Canada, offers greater market opportunity due to its
patient-friendly form versus other alprostadil dosage forms and also relative
to oral ED products. With nearly 150 million men worldwide who suffer from ED
and an ED market size of approximately $1 billion in revenue in Europe alone,
Vitaros(r) represents a major market opportunity for Apricus and its commercial
partners given its unique product profile and its potential to treat a large
underserved population.
About Femprox(r)
Femprox(r) is a product candidate for the treatment of FSIAD. Seven clinical
studies have been successfully completed to date, including one, 98-subject
Phase II study in the US and a nearly 400-subject proof-of-concept study in
China. To date, no product has been approved in the U.S. to treat FSIAD, a
persistent or recurring inability to attain or maintain adequate sexual
excitement, causing personal distress.
About Apricus Biosciences, Inc.
Apricus Biosciences, Inc. (APRI) is a pharmaceutical company that develops and
markets through its licensing partners, innovative treatments that have the
potential to help large patient populations across numerous, large-market
therapeutic classes including male and female sexual health. The Company has
one approved product, Vitaros(r), for the treatment of erectile dysfunction,
which is now approved in Europe and Canada and will be commercialized by
Apricus' marketing partners, which include Abbott Laboratories Limited, Takeda
Pharmaceuticals International GmbH, Hexal AG (Sandoz), Bracco SpA and
Laboratoires Majorelle. Femprox(r), the Company's product candidate for the
treatment of female sexual interest/arousal disorder, has successfully
completed a nearly 400-subject proof-of-concept study.
For further information on Apricus, visit http://www.apricusbio.com.
Apricus' 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 product
Vitaros(r) for ED, such as the room temperature version of Vitaros(r), and product
candidate Femprox(r) for female sexual interest/arousal disorder among others; to
have its product and product candidates receive additional patent protection
and be approved by relevant regulatory authorities in Europe, the United
States, Canada and in other countries, such as additional national phase
approvals for Vitaros(r) in the remaining CMS territories and guidance on
approval of Femprox(r); to successfully commercialize such product and product
candidates and other NexACT(r) product candidates and drug delivery technology;
and to achieve its other development, commercialization and financial goals,
including the manufacture and launch of Vitaros(r). 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, as amended, subsequent quarterly reports
filed on Form 10-Q, as amended, 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 Investor Relations:
David Pitts or Lourdes Catala
Argot Partners
212-600-1902
david(at)argotpartners.com
lourdes(at)argotpartners.com
News Source: NASDAQ OMX
13.11.2013 Dissemination of a Corporate News, transmitted by DGAP -
a company of EQS Group AG.
The issuer is solely responsible for the content of this announcement.
DGAP's Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Media archive at www.dgap-medientreff.de and www.dgap.de
---------------------------------------------------------------------------
Language: English
Company: Apricus Biosciences, Inc.
United States
Phone:
Fax:
E-mail:
Internet:
ISIN: US9901429525
WKN:
End of Announcement DGAP News-Service
---------------------------------------------------------------------------
Themen in dieser Pressemitteilung:
Unternehmensinformation / Kurzprofil:
Datum: 13.11.2013 - 12:05 Uhr
Sprache: Deutsch
News-ID 315836
Anzahl Zeichen: 7046
contact information:
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 316 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"DGAP-News: Apricus Biosciences Provides Third Quarter 2013 Corporate Update"
steht unter der journalistisch-redaktionellen Verantwortung von
Apricus Biosciences, Inc. (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
