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For Immediate Release:
Valencia California, March 1, 2009 - NEUROSYSTEC
Corporation announces
the initiation of a Phase Ib clinical trial for the treatment of
tinnitus. NeuroSystec Corporation (NeuroSystec), a privately held
company located in Valencia, CA announced today that they have received
approval from AFSSAPS to begin a Phase 1b clinical trial in
France.
CLICK
HERE for more information
about the current Phase 1b clinical
trial on ClinicalTrials.gov.
About NeuroSystec Corporation
NeuroSystec Corporation (www.neurosystec.com) is a
privately held corporation based
in Valencia, California. NeuroSystec was founded by Al Mann to relieve
the suffering of patients with neurological diseases by combining
therapeutics and delivery devices to reach and treat under served
markets. This combination of modern device technologies with
potent neurologically active therapeutics will be utilized to treat
diseases of the head, brain, hearing and nervous system in
general.
Press Release, June 21, 2004
DURECT Corporation and NeuroSystec Corporation
Announce Exclusive
Agreement to Develop Treatments for Certain Inner Ear Disorders
Including Tinnitus CUPERTINO, Calif., and VALENCIA, Calif.
June [21], 2004 - DURECT Corporation
(NASDAQ: DRRX) and NeuroSystec
Corporation (NeuroSystec), a privately held company located in
Valencia, CA, announced today that they have signed an exclusive
agreement to develop, market and sell products for the treatment of
certain inner ear disorders including chronic tinnitus (ringing in the
ears). Under the agreement, DURECT granted to NeuroSystec exclusive
worldwide rights to develop and commercialize products designed for the
treatment of tinnitus and to improve post-operative recovery and
tolerance of surgical implantation of cochlear devices using specified
DURECT proprietary drug treatment methods and drug delivery
technologies to deliver precise doses of appropriate medications
directly to the middle or inner ear.
“DURECT’s portfolio of innovative otologic drug
treatment methods and
drug delivery technologies and the groundbreaking tinnitus research
already conducted by DURECT and its collaborators provide a compelling
reason to believe that we will one day be able to offer an effective
treatment for the millions of patients in the US and abroad who suffer
constantly with this debilitating disease,” stated Alfred E. Mann,
Chairman of NeuroSystec.
Alfred Mann brings to this collaboration his
impressive track record of vision
and success at other companies he has founded such as Advanced Bionics,
MiniMed, Pacesetter, and Mannkind. We are delighted to have the
opportunity to collaborate on such an innovative and meaningful venture
with Mr. Mann, and their team at NeuroSystec,” stated Felix Theeuwes,
Chairman and Chief Scientific Officer of DURECT. “This collaboration
demonstrates the strengths of DURECT’s pharmacological research
capabilities, as well as the breadth of applications for DURECT’s drug
delivery technologies, and we anticipate will create products that will
offer hope to millions of tinnitus sufferers around the world,” added
James E. Brown, DVM, President and CEO of DURECT.
NeuroSystec paid to DURECT an undisclosed upfront fee and will make
additional payments to DURECT based on the achievement of specific
milestones and specific research and development activities.
NeuroSystec will also pay royalties on sales of products developed
under this agreement. In connection with the agreement, DURECT has
received a minority ownership stake in NeuroSystec.
About Tinnitus
Over eight million people in the U.S suffer from chronic ringing,
hissing, buzzing or other noises in one or both ears, a condition known
as tinnitus. Two million Americans are seriously debilitated by their
tinnitus to the point that it severely impacts their quality of life.
For most sufferers the cause of their tinnitus is unknown and there is
currently no accepted therapy available. Physicians tell most tinnitus
sufferers that there is no effective treatment for tinnitus so they
must learn to live with it.
About DURECT Corporation
DURECT Corporation (www.durect.com) is pioneering
the development and
commercialization of pharmaceutical systems for the treatment of
chronic debilitating diseases and enabling biotechnology-based
pharmaceutical products. DURECT's goal is to deliver the right drug to
the right site in the right amount at the right time. DURECT’s lead
product in development is CHRONOGESIC®, a 3-month product for the
treatment of chronic pain. DURECT also owns three proprietary drug
delivery platform technologies, including the SABER™ Delivery System (a
patented and versatile depot injectable useful for protein and small
molecule delivery), the MICRODUR™ Biodegradable Microparticulates
(microspheres injectable system) and the DURIN™ Biodegradable Implant
(drug-loaded implant system) upon which DURECT is developing a pipeline
of other products.
About NeuroSystec Corporation
NeuroSystec Corporation (www.neurosystec.com) is a
privately held
corporation based in Valencia, California. NeuroSystec was founded by
Al Mann to relieve the suffering of patients with neurological diseases
by combining therapeutics and delivery devices to reach and treat under
served markets. This combination of modern device technologies
with potent neurologically active therapeutics will be utilized to
treat diseases of the head, brain, hearing and nervous system in
general.
Since 1993, Alfred E. Mann has served as Chairman and a Co-Chief
Executive Officer of Advanced Bionics Corporation, the technology
leader and the only American manufacturer of cochlear implants. In June
2004, Boston Scientific announced the acquisition of Advanced Bionics
for an initial payment of approximately $740 million in cash, plus earn
out payments tied to future performance milestones. Mr. Mann is also
Chairman and Chief Executive Officer of Mannkind Corporation. In 1983,
Mr. Mann founded MiniMed, the world leader in insulin pump therapy
products for the treatment of diabetes. In August 2001, Medtronic, Inc.
acquired MiniMed and MRG, an affiliate, for over $4 billion in cash.
Mr. Mann also founded and, from 1972 through 1992, served as Chief
Executive Officer of Pacesetter Systems and its successor, Siemens
Pacesetter, a manufacturer of cardiac pacemakers.
NOTE:
CHRONOGESIC®, SABER™, MICRODUR™ and DURIN™ are trademarks of DURECT
Corporation.
The
statements in this press release regarding DURECT and NeuroSystec’s
products in development, product development plans, clinical trials and
projected financial results are forward-looking statements involving
risks and uncertainties that can cause actual results to differ
materially from those in such forward-looking statements. Potential
risks and uncertainties include, but are not limited to, DURECT and
NeuroSystec’s abilities to complete the design, development, and
manufacturing process development of its products, manufacture and
commercialize its products, obtain product and manufacturing approvals
from regulatory agencies, manage its growth and expenses, manage
relationships with third parties, finance its activities and
operations, as well as marketplace acceptance of these products.
Further information regarding these and other risks is included in
DURECT's Annual Report on Form 10-K for the fiscal year ended December
31, 2003 filed with the SEC on March 11, 2004, DURECT's Quarterly
Report on Form 10Q and other periodic reports filed with the SEC under
the heading "Factors that may affect future results." CHRONOGESIC and
other products mentioned above are under development and have not been
submitted or approved for commercialization by the US Food and Drug
Administration or other health authorities.
CONTACT:
DURECT Corporation: Schond L. Greenway, Executive Director, IR and
Strategic Planning,
+1-408-777-1417.
NeuroSystec Corporation: Mr. Thomas J. Lobl, Vice President
of R & D,
+1-661-702-6880.
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