Apricus Biosciences Announces Year-End 2015 Update and 2016 Growth Strategy
(Thomson Reuters ONE) -
Top-Line Phase 2b Data for Fispemifene Expected in Q1
SAN DIEGO, Jan. 06, 2016 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc.
(Nasdaq:APRI), a biopharmaceutical company advancing innovative medicines in
urology and rheumatology, today reviewed its 2015 corporate progress and
highlights its plans for 2016.
2015 Accomplishments:
* Initiated and completed enrollment in its fispemifene Phase 2b clinical
trial for the treatment of symptomatic male secondary hypogonadism;
* According to IMS Midas, over 633,000 Vitaros units sold in Europe in 2015
through November;
* Vitaros(®) monthly sales in Europe tracked on a 111,000 monthly unit run
rate, which is expected to grow in both existing markets and new markets
with additional launches throughout 2016 by our commercialization partners;
* Completed and reported top-line data on the Phase 2a clinical trial of
RayVa((TM)) for Raynaud's phenomenon secondary to scleroderma;
* Licensed the U.S. development and commercialization rights for Vitaros from
Allergan plc; and
* Expanded Vitaros partnerships to include parts of Asia, Eastern Europe and
Latin America.
"2015 was a very productive year for Apricus as we achieved our primary goals of
advancing our clinical pipeline and enhancing the commercial value of Vitaros,"
said Richard Pascoe, Chief Executive Officer. "Looking forward to the rest of
the year, we expect a number of important clinical and commercial value drivers,
including continued growth of Vitaros in Europe, Phase 2b fispemifene data in
the first quarter, the re-submission of the Vitaros New Drug Application (NDA)
in the second half of this year, and the advancement of our development
pipeline."
Goals and Priorities for 2016
* Apricus will continue to leverage Vitaros as a cash-generating asset through
royalty and milestone payments and by expanding the product's market reach
via additional ex-U.S. launches by our commercialization partners;
* Apricus expects to obtain European approval for one or more variations to
the approved Vitaros product with the goal of enhancing the profile of
Vitaros;
* Apricus expects to re-submit the New Drug Application (NDA) for Vitaros'
approval in the U.S. in the second half of 2016;
* Apricus plans to complete the Phase 2b clinical trial and report top-line
data for fispemifene in symptomatic secondary hypogonadism in the first
quarter 2016. Positive results from this trial, if achieved, would position
Apricus to move fispemifene into additional late-stage clinical trials, when
appropriate. Apricus will also continue development of fispemifene in Lower
Urinary Tract Symptoms (LUTS) throughout 2016;
* Apricus expects to initiate a Phase 2b at-home dosing clinical trial with
RayVa in the second half of 2016.
Mr. Pascoe concluded, "I would like to thank our employees and partners for
their hard work and commitment to execution of key goals for 2015. I especially
want to thank our investors for their patience and support as we look forward to
commercial and clinical success in 2016 and beyond."
In addition, Apricus provided an update to its corporate presentation on the
Company's website, www.apricusbio.com.
About Apricus Biosciences, Inc.
Apricus Biosciences, Inc. (APRI) is a biopharmaceutical company advancing
innovative medicines in urology and rheumatology. Apricus recently completed
enrollment in its Phase 2b trial for fispemifene, a selective estrogen receptor
modulator for the treatment of symptomatic male secondary hypogonadism, and
plans to conduct additional studies in other urological conditions. Apricus has
completed a Phase 2a trial for RayVa((TM)), its product candidate for the
treatment of the circulatory disorder Raynaud's phenomenon, and plans to conduct
additional clinical trials in patients with Raynaud's phenomenon secondary to
scleroderma. Apricus' lead commercial product, Vitaros(®), for the treatment of
erectile dysfunction, is approved in Europe and Canada and is being
commercialized in several countries in Europe. Apricus recently in-licensed the
U.S. development and commercialization rights for Vitaros from Allergan.
Apricus' marketing partners for Vitaros include Laboratoires Majorelle, Bracco
S.p.A., Hexal AG (Sandoz), Takeda Pharmaceuticals International GmbH, Recordati
Ireland Ltd. (Recordati S.p.A.), Ferring International Center S.A. (Ferring
Pharmaceuticals) and Mylan NV. Apricus' second-generation room temperature
Vitaros is currently under development.
For further information on Apricus, visit http://www.apricusbio.com.
*Vitaros(®) is a registered trademark of NexMed International Limited. Such
trademark is registered in certain countries throughout the world and pending
registration in the United States.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act, as amended. Statements in this press
release that are not purely historical are forward-looking statements. Such
forward-looking statements include, among other things: the potential for key
catalysts to drive value in 2016; Apricus' ability to continue to generate cash
from licensing and milestone payments and royalty revenues from the sale of
Vitaros(®) in various countries by Apricus' commercial partners; the development
and potential resubmission of an NDA for U.S. Food and Drug Administration
("FDA") approval of Vitaros in the United States and expected timing thereof;
the planned launch of Vitaros in additional countries and the growth of Vitaros'
sales in existing markets; the potential European approval for one or more
variations of Vitaros; the expected timing of top-line data for and the
completion of the Phase 2b clinical trial for fispemifene in symptomatic
secondary hypogonadism, and the potential of positive results to move
fispemifene into additional late-stage clinical trials; the expected continued
development for the second indication for fispemifene; the timing of the Phase
2b at-home dosing clinical trial of RayVa; and the timing and success of current
and planned clinical trials. Actual results could differ from those projected in
any forward-looking statements due to a variety of reasons that are outside the
control of Apricus, including, but not limited to: the effect of the out-of-
stock situation for Vitaros in Germany and the potential that Apricus' partner
there, Sandoz, does not resume ordering product for Germany or other countries
pending the results of an ongoing out-of-specification investigation by our
contract manufacturer; Apricus' ability to have its product Vitaros approved by
the FDA in the United States and by relevant regulatory authorities in Europe
and in other countries; Apricus' ability to further develop Vitaros into new
variations, such as the room temperature version of Vitaros, and its other
product candidates, RayVa and fispemifene, as well as the timing of such events;
Apricus' ability to successfully carry out and complete clinical studies for
Vitaros, if required, RayVa and fispemifene, as well as the timing and success
of such studies; feedback received from regulatory agencies, such as the FDA on
the development of Apricus' product candidates; Apricus' dependence on its
commercial partners to carry out the commercial launch or grow sales of Vitaros
in various territories and the potential for delays in the timing of commercial
launches in additional countries; competition in the erectile dysfunction market
and other markets in which Apricus and its partners operate; Apricus' ability to
obtain and maintain intellectual property protection for Vitaros, RayVa,
fispemifene or any other product candidates; Apricus' ability to raise
additional funding that it may need to continue to pursue its commercial and
business development plans; Apricus' ability to remain in compliance with the
terms and restrictions under its credit facility; Apricus' ability to access
additional capital under its equity facility; Apricus' ability to obtain the
requisite governmental approval for Vitaros, RayVa and fispemifene; and general
market conditions. These forward-looking statements are made as of the date of
this press release, and Apricus assumes no obligation to update the forward-
looking statements, or to update the reasons why actual results could differ
from those projected in the forward-looking statements. Readers are urged to
read the risk factors set forth in Apricus' 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 at
www.sec.gov or without charge from Apricus.
CONTACT: Institutional / Retail Investors:
Matthew Beck
mbeck(at)troutgroup.com
The Trout Group
(646) 378-2933
This announcement is distributed by GlobeNewswire on behalf of
GlobeNewswire clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Apricus Biosciences, Inc. via GlobeNewswire
[HUG#1976900]
Unternehmensinformation / Kurzprofil:
Datum: 06.01.2016 - 13:00 Uhr
Sprache: Deutsch
News-ID 442715
Anzahl Zeichen: 10611
contact information:
Town:
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Kategorie:
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