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2015-09-10

Apricus Biosciences, Inc.: Apricus Biosciences Enters Into License Agreement With Allergan for the U.S. Rights to Vitaros(TM)

Apricus to Lead Clinical and Regulatory Efforts; Allergan Retains Commercialization Option in U.S.SAN DIEGO, Sept. 10, 2015 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc.
(Nasdaq:APRI), a biopharmaceutical company advancing innovative medicines in
urology and rheumatology, today announced that it has licensed the U.S.
development and commercialization rights for Vitaros(TM)from Allergan. Under
the license agreement, Apricus will be responsible for all Vitaros
development efforts in the United States. Upon the Food and Drug
Administration's ("FDA") acceptance of a New Drug Application ("NDA") for
Vitaros, Allergan may elect to exercise its one time opt-in right to assume
all future marketing and selling activities in the United States in exchange
for certain financial considerations.

Vitaros is a novel, on-demand topical cream for the treatment of erectile
dysfunction ("ED") and a new potential entrant into the U.S. ED treatment
market. On February 3, 2009, Warner Chilcott, now a subsidiary of Allergan,
acquired the U.S. rights to Vitaros from Apricus. Since that time, Vitaros
has been approved by the European health authorities and by Health Canada,
and is currently being promoted by Apricus' licensees throughout Europe.

Richard Pascoe, Chief Executive Officer of Apricus, commented, "We are pleased
to announce this transaction for the return of the U.S. Vitaros rights to
Apricus and we look forward to working with Allergan to transition the
regulatory submission back within our organization. This agreement creates a
framework where both parties can leverage their respective strengths with the
goal of bringing this novel topical treatment to the world's largest ED
market, which had sales of over $3 billion in 2014 according to IMS Health.
Moreover, we believe that with Apricus' broad Vitaros expertise and internal
know-how, coupled with our proven success in obtaining regulatory approvals
for Vitaros in other territories, we are well equipped to pursue regulatory
approval for Vitaros in the U.S."

Mr. Pascoe will discuss the transaction during his presentation at the
Rodman&Renshaw 17th Annual Global Investment Conference on Thursday,
September 10, 2015, at 4:40 p.m. Eastern Time. A live audio webcast of the
presentation and the presentation slides can be accessed via the Investor
Relations section of Apricus' website atwww.apricusbio.com.

Terms of the Agreement

Under the terms of the agreement, Allergan granted Apricus exclusive rights to
develop and commercialize Vitaros in the U.S in exchange for a $1 million
upfront payment and a future $1.5 million regulatory milestone payable to
Allergan. Upon FDA acceptance of the NDA for Vitaros, Allergan may elect to
exercise a one-time opt-in right to assume all future marketing and selling
activities in the United States. If Allergan exercises its opt-in right,
Apricus may receive up to a total of $25 million in upfront and potential
launch milestone payments, plus a double-digit royalty on net sales of
Vitaros. If Allergan elects not to exercise its opt-in right, Apricus may
commercialize Vitaros and in return will pay Allergan a double-digit royalty
on net sales of Vitaros. Allergan retains the right to launch a future
authorized generic under a profit share structure with Apricus.

About Apricus Biosciences, Inc.

Apricus Biosciences, Inc. (APRI) is a biopharmaceutical company advancing
innovative medicines in urology and rheumatology. Apricus has initiated a
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 recently
completed enrollment in a Phase 2a trial for RayVa(TM), its product candidate
for the treatment of the circulatory disorder Raynaud's phenomenon. Apricus'
lead commercial product, Vitaros(TM), for the treatment of erectile
dysfunction, is approved in Europe and Canada and is being commercialized in
several countries in Europe. Apricus' marketing partners for Vitaros include
Mylan NV, Takeda Pharmaceuticals International GmbH, Hexal AG (Sandoz),
Recordati Ireland Ltd. (Recordati S.p.A.), Bracco S.p.A. and Laboratoires
Majorelle. Apricus' second-generation room temperature Vitaros is under
development.

For further information on Apricus, visithttp://www.apricusbio.com.

About Allergan

Allergan plc headquartered in Dublin, Ireland, is a unique, global
pharmaceutical company and a leader in a new industry model - Growth Pharma.
Allergan is focused on developing, manufacturing and commercializing
innovative branded pharmaceuticals, high-quality generic and over-the-counter
medicines and biologic products for patients around the world. Allergan
markets a portfolio of best-in-class products that provide valuable
treatments for the central nervous system, eye care, medical aesthetics,
gastroenterology, women's health, urology, cardiovascular and anti-infective
therapeutic categories, and operates the world's third-largest global
generics business, providing patients around the globe with increased access
to affordable, high-quality medicines. With commercial operations in
approximately 100 countries, Allergan is committed to working with
physicians, healthcare providers and patients to deliver innovative and
meaningful treatments that help people around the world live longer,
healthier lives.

For more information, visit Allergan's website atwww.allergan.com.

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: references to
the timing and success of the development plan and the regulatory pathway for
Vitaros in the U.S.; the size of the commercial opportunity and Vitaros'
ability to capture market share in the U.S.; the timing of any acceptance of
the NDA related to Vitaros by the FDA; the timing and costs of Apricus'
option to assume future marketing and selling activities in the United
States; and the potential for Vitaros to achieve commercial success. Actual
results could differ from those projected in any forward-looking statements
due to a variety of reasons that are outside of Apricus' control, including,
but not limited to: Apricus' ability to submit an NDA related to Vitaros to
the FDA and to receive FDA approval of Vitaros; the effect of the
previously-reported 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; its ability
to further develop its product Vitaros for the treatment of ED, such as the
room temperature version of Vitaros, as well as the timing of such events;
Apricus' dependence on its commercial partners to carry out the commercial
launch of Vitaros in various territories and the potential for delays in the
timing of commercial launch; competition in the ED market and other markets
in which Apricus and its partners operate; Apricus' ability to raise
additional funding that it may need to continue to pursue its commercial and
business development plans; Apricus' ability to obtain the requisite
governmental approval for Vitaros in the U.S.; the fluctuation of currency
exchange rates; the potential for adverse reactions to the product; and
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 atwww.sec.govor without charge from Apricus.

CONTACT: Matthew Beck
mbeck@troutgroup.com
The Trout Group LLC
(646) 378-2933

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This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Apricus Biosciences, Inc. via Globenewswire

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