DGAP-News: Apricus Biosciences and FDA Initiate PrevOnco(TM) SPA Phase III Clinical Protocol Discussion
ID: 350749
17.02.2011 15:11
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SAN DIEGO, 2011-02-17 15:11 CET (GLOBE NEWSWIRE) --Apricus Biosciences, Inc. ('Apricus Bio') (Nasdaq:APRI), announced today that
it is currently in discussions with the U.S. Food and Drug Administration
('FDA') relating to the PrevOnco? Special Protocol Assessment ('SPA') Phase III
protocol submitted by the Company in December 2010.
In the first response received by Apricus Bio relating to this SPA, the FDA
accepted some of the questions submitted by the Company and commented on the
rest. The Company's Clinical Advisory Board, formed to focus on the clinical
development of PrevOnco?, Apricus Bio's first oncology compound, will meet in
late February to discuss the FDA response and comments, and the Company will
prepare a response according to feedback from the Clinical Advisory Board. In
addition, the Company may request a meeting with the FDA to accelerate the
FDA's SPA Phase III protocol review process.
Dr. Bassam Damaj, President and Chief Executive Officer of Apricus Bio, noted,
'We will continue to work diligently with the FDA and respond to their comments
as expeditiously as possible.'
PrevOnco? is Apricus Bio's proprietary treatment for hepatocellular carcinoma
(liver cancer). The Company announced in late November 2010 that it intended to
file the protocol for a proposed Phase III clinical trial of PrevOnco? with the
FDA. Pursuant to the FDA's SPA program, the agency provides approval for the
trial's design, clinical endpoints and statistical analysis. A company's SPA is
not considered accepted until the FDA comments and agrees to all of the
questions and protocol design submitted therein. Once the SPA is accepted, the
PrevOnco? Phase III study is expected to take about 12-24 months, depending on
patient recruitment. If the trial shows positive results within the parameters
agreed upon in the SPA, the data would then be expected to provide the basis
for the filing of a New Drug Application for marketing approval of PrevOnco?
for the treatment of liver cancer in the U.S.
The FDA granted PrevOnco? Orphan Drug status in August 2008. The product
incorporates lansoprazole, a commonly marketed anti-ulcer compound which has
shown strong anti-cancer activity in mice bearing human liver tumors. Upon
acceptance of the SPA, the Company expects that the Phase III study will enroll
up to 218 patients who have advanced, unresectable hepatocellular carcinoma who
no longer respond to Nexavar(r) (the currently marketed first-line anti-cancer
treatment for patients with this type of liver cancer). The subjects will
receive Nexavar(r) and doxorubicin (the widely used chemotherapy anti-cancer
drug), plus either PrevOnco? or a placebo. Nexavar(r) is marketed in the U.S. by
Onyx Pharmaceuticals, Inc. and Bayer HealthCare Pharmaceuticals, Inc., with
close to $1 billion in sales, and is approved in more than 90 countries for the
treatment of patients with hepatocellular carcinoma.
About Special Protocol Assessment
The FDA's Special Protocol Assessment process was implemented under the
Prescription Drug User Fee Act (PDUFA) in November 1997. The SPA process
provides for review and a binding agreement that the Phase III trial protocol
design, clinical endpoints, planned conduct and statistical analyses are
acceptable to support regulatory approval. The SPA process is normally a
multi-step negotiation process with the FDA which may take up to a year pending
FDA review.
About Apricus Biosciences, Inc.
Apricus Bio, a San Diego based revenue-generating pharmaceutical company, has
leveraged the flexibility of its clinically-validated NexACT(r) drug delivery
technology to enable multi-route administration of new and improved compounds
across numerous therapeutic classes.
Revenues and growth are driven from out-licensing of this technology for the
development and commercialization of such compounds to pharmaceutical and
biotechnology companies worldwide. In addition, the Company is seeking to
monetize its existing product pipeline, including its first product, Vitaros(r),
approved in Canada for the treatment of erectile dysfunction, which is
currently expected to be available on the Canadian market in 2011, as well as
compounds in development from pre-clinical through Phase III, currently focused
on Sexual Dysfunction, Oncology, Dermatology, Autoimmune, Pain,
Anti-Infectives, Diabetes and Cosmeceuticals among others.
For further information on Apricus Bio, visit http://www.apricusbio.com and for
information on its subsidiaries please visit www.nexmedusa.com or
www.bio-quant.com
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, FDA review of the PrevOnco? SPA Phase III
protocol FDA approval of the marketing of PrevOnco? and commercialization of
PrevOnco?, timing for seeking approvals for Vitaros(r) for erectile dysfunction
and for a chemical formulation similar to Vitaros(r) for premature ejaculation,
timing and success of the commercial launch of Vitaros(r) in Italy, The Gulf
Countries and part of the Middle East and in Israel and the Palestinian
Territories, the potential size of the market, the ability to develop and
commercialize the Company's products on its own and with partners and the
ability to meet its milestones. 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.
Apricus Biosciences, Inc.
Edward Cox, V.P.
Investor Relations&Corporate Development, Apricus Bio, Inc.
(858) 848-4249
ecox@apricusbio.com
Apricus Bio Investor Relations
Paula Schwartz
Rx Communications Group, LLC
(917) 322-2216
pschwartz@rxir.com
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Language: English
Company: Apricus Biosciences, Inc.
United States
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ISIN: US9901429525
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