Zogenix Reports Positive Top-Line Results From Extended Relday(TM) Phase 1
Initiates Efforts to Secure Strategic Development and Commercialization
SAN DIEGO, May 2, 2013 (GLOBE NEWSWIRE) -- Zogenix, Inc. (Nasdaq:ZGNX), a
pharmaceutical company commercializing and developing products for the
treatment of central nervous system disorders and pain, today announced
positive top-line results from its extended Phase 1 clinical trial of Relday™,
an investigational candidate of a proprietary, once-monthly subcutaneous
formulation of risperidone for the treatment of schizophrenia. If approved,
Relday has the potential to be the first subcutaneous antipsychotic product
that allows for once-monthly dosing. Efforts are now underway to secure a
strategic development and commercialization partner for Relday.
The extended Phase 1 clinical trial included a 100 mg dose of Relday,
following previously reported positive results with 25 and 50 mg doses. The
results for the 100 mg dose showed that risperidone blood concentrations in
the therapeutic range were achieved on the first day of dosing, and maintained
throughout the one-month period. In addition, dose proportionality has now
been established across the full dose range that would be anticipated to be
used in clinical practice (50 to 100 mg). The 100 mg dose was safe and
well-tolerated, with no unexpected adverse events, including injection site
reactions, as compared to the initial Phase 1 clinical trial with the 25 and
50 mg doses. The adverse events were generally mild to moderate and consistent
with other risperidone products.
"With the positive top-line results from the Relday Phase 1 extension, we
believe that we have now confirmed the product candidate's viability across
the anticipated commercial dosing range," said Stephen Farr, Ph.D., president
of Zogenix. "We are well positioned to begin a multi-dose clinical trial to
provide steady-state pharmacokinetic and safety data, once a partner is
secured, prior to initiating Phase 3 development studies."
Roger L. Hawley, chief executive officer of Zogenix, said, "We now have
sufficient data to formalize our business development discussions, with a goal
of securing a strategic development and commercialization partner. While we
plan to retain U.S. rights to Relday, based on the 505(b)(2) NDA regulatory
pathway and previous discussions, we believe there is strong partnering
interest in Relday."
In connection with these partnering activities, Zogenix has retained Locust
Walk Partners of Cambridge, MA, a transaction advisory firm for life sciences
companies, to provide exclusive transaction advisory and support services. For
information about Relday partnering opportunities, contact Jay Mohr, Managing
Director, at (617) 300-0174, firstname.lastname@example.org.
Risperidone is one of the most widely prescribed medications used to treat the
symptoms of schizophrenia in adults and teenagers 13 years of age and older.
The global long-acting injectable antipsychotic market was approximately $2
billion in 2011. The leading injectable product in the category requires
twice-a-month dosing, intramuscular injection and drug reconstitution prior to
use. The combined market for oral and injectable antipsychotic products was
estimated at more than $17 billion in 2011.
If approved, Relday has the potential to be the first subcutaneous
antipsychotic product that allows for once-monthly dosing. Zogenix believes
that Relday will offer an improved pharmacokinetic (PK) profile, significant
reduction in injection volume and a simplified dosing regimen (e.g., no need
for loading dose) due to DURECT's (Nasdaq:DRRX) SABER^® controlled-release
depot technology.In July 2011, Zogenix licensed from DURECT exclusive global
rights to develop and commercialize this proprietary formulation which
utilizes DURECT's SABER^® depot technology.
The Phase 1 clinical trial for Relday was conducted as a single-center,
open-label, safety and PK trial of 40 patients with chronic, stable
schizophrenia or schizoaffective disorder across a dose range of 25, 50 and
Zogenix, Inc. (Nasdaq:ZGNX), with offices in San Diego and Emeryville,
California, is a pharmaceutical company commercializing and developing
products for the treatment of central nervous system disorders and pain.
Zogenix's first commercial product, SUMAVEL® DosePro® (sumatriptan injection)
Needle-free Delivery System, was launched in January 2010 for the acute
treatment of migraine and cluster headache. Zogenix's lead investigational
product candidate, Zohydro™ ER (hydrocodone bitartrate), is an oral,
extended-release formulation of various strengths of hydrocodone, without
acetaminophen, intended for administration every 12 hours for around the clock
management of moderate to severe chronic pain. In May 2012, Zogenix submitted
to the FDA a New Drug Application for Zohydro ER. Zogenix's second
investigational product candidate, Relday™, is a proprietary, long-acting
injectable formulation of risperidone for the treatment of schizophrenia; an
investigational new drug application was submitted to the FDA in May 2012.
Zogenix cautions you that statements included in this press release that are
not a description of historical facts are forward-looking statements. Words
such as "believes," "anticipates," "plans," "expects," "indicates," "will,"
"intends," "potential," "suggests," "assuming" and similar expressions are
intended to identify forward-looking statements. These statements are based on
the company's current beliefs and expectations. These forward-looking
statements include statements regarding delivery and dosing benefits of Relday
to both the patient and clinician, the viability of Relday, initiation of a
multi-dose clinical trial and Phase 3 development studies for Relday,
discussions with potential partners for rest-of-world development and
commercialization of Relday, the interest in Relday by potential partners, the
introduction of DosePro technology and the timing thereof, the ability of such
product to address the global anti-psychotic market, and the ability to
develop a once-monthly injectable product with improved pharmacokinetics and
significant reduction in injection volume. The inclusion of forward-looking
statements should not be regarded as a representation by Zogenix that any of
its plans will be achieved. Actual results may differ from those set forth in
this release due to the risk and uncertainties inherent in Zogenix's business,
including, without limitation: the uncertainties associated with the clinical
development and regulatory approval of product candidates such as Relday,
including potential delays in enrollment and completion of clinical trials;
Zogenix's dependence on its collaboration with DURECT Corporation to develop
Relday; inadequate therapeutic efficacy or unexpected adverse side effects
relating to Relday that could prevent its development or commercialization;
difficulties in identifying, negotiating, executing and carrying out strategic
transactions relating to Relday; the terms of any development or
commercialization partnership for Relday may not be favorable, and the partner
may not perform as expected; the market potential for anti-psychotics, and
Zogenix's ability to compete within that market; Zogenix's ability to obtain
and the validity and duration of patent protection and other intellectual
property rights for Relday; and other risks described in the company's prior
press releases and filings with the Securities and Exchange Commission.
You are cautioned not to place undue reliance on these forward-looking
statements, which speak only as of the date hereof, and Zogenix undertakes no
obligation to revise or update this release to reflect events or circumstances
after the date hereof. All forward-looking statements are qualified in their
entirety by this cautionary statement. This caution is made under the safe
harbor provisions of Section 21E of the Private Securities Litigation Reform
Act of 1995.
SUMAVEL^®, DosePro^®, Relday^TM and Zohydro^TM ER are trademarks of Zogenix,
SABER^®is a trademark ofDURECT Corporation.
Zack Kubow | The Ruth Group
646.536.7020 | email@example.com
Caitlin Cox | The Ruth Group
646.536.7033 | firstname.lastname@example.org
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