REDWOOD CITY, Calif.,
Sept. 21, 2015 /PRNewswire/
-- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty
pharmaceutical company focused on the development and
commercialization of innovative therapies for the treatment of
acute and breakthrough pain, today announced the monetization of
the expected royalty stream from the sales of Zalviso™ (sufentanil
sublingual tablet system) in the European Union by its commercial
partner Grunenthal GmbH. Gross proceeds from the sale are
$65 million from PDL BioPharma
(NASDAQ: PDLI). Specifically, PDL will receive 75% of the European
royalties under the Grunenthal license as well as 80% of the first
four commercial milestones, subject to a capped amount.
AcelRx will receive 25% of the royalties, 20% of the first four
commercial milestones, 100% of the remaining commercial milestones
and all development milestones, including a potential $15 million payment for the approval of the
Zalviso MAA. The proceeds from the transaction will provide
AcelRx with additional operating capital, which will be used for
general corporate purposes, including regulatory activities
associated with ARX-04 and Zalviso.
Timothy E. Morris, chief
financial officer of AcelRx Pharmaceuticals, commented, "This
transaction provides AcelRx with significant capital in a
non-dilutive manner. It will increase our estimated cash at year
end to over $100 million and should
provide sufficient capital to complete regulatory submissions for
ARX-04 in the U.S. and Europe, and
to conduct limited additional work on Zalviso, if needed, in
preparation for re-submitting a New Drug Application to the U.S.
Food and Drug Administration."
The transaction will be treated as a sale for tax
purposes. AcelRx has established a wholly owned subsidiary,
ARPI LLC, to facilitate the transaction. Credit Suisse acted
as sole structuring and financial advisor to AcelRx in connection
with the transaction. AcelRx was represented by Cooley LLP, PDL by
Gibson, Dunn & Crutcher LLP and Credit Suisse by Cadwalader,
Wickersham & Taft LLP.
Separately, concurrently with the closing of the royalty
monetization, AcelRx amended its existing credit facility with
Hercules Technology Growth Capital, Inc. (NYSE: HTGC), which
includes an interest only period from October 1, 2015 through March 31, 2016 (with the potential for further
extension to September 30, 2016 upon
satisfaction of certain conditions). Loans under the credit
facility will mature on October 31,
2017. In connection with the amendment, AcelRx reduced the
exercise price of warrants previously issued to Hercules in
connection with the credit facility.
About AcelRx Pharmaceuticals, Inc.
AcelRx
Pharmaceuticals, Inc. is a specialty pharmaceutical company focused
on the development and commercialization of innovative therapies
for the treatment of acute pain. In the US, the Company's
late-stage pipeline includes ARX-04 (sufentanil sublingual tablet,
30 mcg) for the treatment of moderate-to-severe acute pain in a
medically supervised setting; and Zalviso™ (sufentanil sublingual
tablet system) for the management of moderate-to-severe acute pain
in adult patients in the hospital setting.
ARX-04 delivers 30 mcg sufentanil sublingual, a high therapeutic
index opioid, through a disposable, pre-filled, single-dose
applicator (SDA). AcelRx has reported positive results from the
pivotal Phase 3 SAP301 ambulatory surgery study, and will be
advancing ARX-04 into a study in emergency room patients in 2015.
Zalviso delivers 15 mcg sufentanil sublingual tablets through a
non-invasive delivery route via a pre-programmed,
patient-controlled analgesia device. In response to the New Drug
Application (NDA) AcelRx submitted to the U.S. Food and Drug
Administration (FDA) seeking approval for Zalviso, the Company
received a Complete Response Letter (CRL) on July 25, 2014. The FDA has requested an
additional clinical study prior to the resubmission of the Zalviso
NDA.
The Company has two additional pain treatment product
candidates, ARX-02 and ARX-03, which have completed Phase 2
clinical development. For additional information about AcelRx's
clinical programs, please visit www.acelrx.com.
Forward Looking Statements
This press
release contains forward-looking statements, including, but not
limited to, statements related to potential milestones payments
under the Grunenthal agreement and expected royalty stream from the
sales of Zalviso in the European Union by Grunenthal; future
financial results, including anticipated cash balance at year-end
2015 and use of proceeds from the sale of royalty and milestone
payments to PDL BioPharma; potential extension of the
interest-only period under amended credit facility with Hercules
Technology Growth Capital, Inc.; the process and timing of
anticipated future development of AcelRx's product candidates,
including Zalviso and ARX-04, including the timing and
potential additional clinical work necessary for resubmission of
Zalviso NDA to the FDA; potential approval of Zalviso and the
timing of commercial launch of Zalviso in Europe; and the
anticipated timing of the emergency room study for ARX-04. These
forward-looking statements are based on AcelRx's current
expectations and inherently involve significant risks and
uncertainties. AcelRx's actual results and the timing of
events could differ materially from those anticipated in such
forward-looking statements as a result of these risks and
uncertainties, which include, without limitation, risks related
to: any delays or inability to obtain and maintain regulatory
approval of its product candidates, including Zalviso and ARX-04,
in the United States and Europe; any delay of
the European Commission's decision regarding Zalviso;
inability to successfully manufacture Zalviso to meet the
requirements of Grunenthal and potential delays in the timing of
the European launch; AcelRx's ability to receive milestones and
royalty payments under the Grunenthal agreement; the market
potential for its product candidates, including Zalviso and ARX-04,
in the United States and Europe; its ability to
timely resubmit Zalviso NDA to the FDA and to receive
regulatory approval for Zalviso, that fact that FDA may
dispute or interpret differently positive clinical results obtained
to date from the pivotal Phase 3 SAP301 ambulatory surgery study of
ARX-04; its ability to obtain sufficient financing to receive
regulatory approval for and commercialize Zalviso in the
United States and Europe, and complete Phase 3 clinical
development of ARX-04; the success, cost and timing of all product
development activities and clinical trials, including the planned
Phase 3 ARX-04 emergency room trial; the accuracy of AcelRx's
estimates regarding expenses, capital requirements and use of
proceeds from the sale of royalty and milestone payments
to PDL BioPharma; and other risks detailed in the "Risk
Factors" and elsewhere in AcelRx's U.S. Securities and
Exchange Commission filings and reports, including its
Quarterly Report on Form 10-Q filed with
the SEC on August 4, 2015. AcelRx undertakes
no duty or obligation to update any forward-looking statements
contained in this release as a result of new information, future
events or changes in its expectations.
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SOURCE AcelRx Pharmaceuticals, Inc.