CUPERTINO, Calif., Nov. 14 /PRNewswire-FirstCall/ —
DURECT Corporation (Nasdaq: DRRX) and Thorn BioScience LLC announced today
that the two companies have expanded their agreement for the development and
commercialization of veterinary products for reproductive indications using
DURECT’s SABER(TM) Delivery System. The SABER technology has the potential to
successfully deliver therapeutic levels of a wide spectrum of drugs from 1 day
to 3 months from a single administration for human pharmaceutical and
veterinary applications.
“DURECT is impressed with the progress Thorn BioScience has made in the
development of reproductive animal health products utilizing our SABER
technology, with their first product well into the late stage of the NADA
approval process,” said Dr. James Brown, CEO of DURECT. “We are excited to
expand our collaboration with Thorn as they further their efforts in applying
our SABER technology to a broader range of drugs and veterinary applications.”
“Thorn BioScience is pleased with its restructured business relationship
with DURECT. The company anticipates excellent opportunities to develop
products for veterinary medicine that will address unmet customer needs
through Thorn’s collaboration with DURECT,” stated Dr. Barry Simon, CVO of
Thorn BioScience.
Under the revised terms of the agreement, DURECT has granted to Thorn
BioScience an exclusive, worldwide license to develop and commercialize
veterinary products using the SABER delivery system to provide a sustained
release therapy for reproductive indications for specified animal species.
Thorn will also have rights to growth promotion indications for certain drug
classes and for specified animal species. Thorn BioScience has committed to
diligently develop multiple products with the technology. Financial
consideration to DURECT is undisclosed.
Thorn BioScience is presently focusing the development of its portfolio in
the area of controlled-release products to enhance reproduction in horses,
cattle and swine. These products will enhance currently accepted production
methods or fulfill unmet needs for producers. Thorn’s first product using the
SABER technology for managing reproduction in horses has already received
approval for the efficacy portion of its New Animal Drug Application (NADA).
The safety portion of the NADA has also been submitted and approval is
pending. Thorn BioScience expects to submit the chemistry manufacturing and
control section to the FDA’s Center for Veterinary Medicine in 2003.
DURECT’s SABER Delivery System is a patented, biodegradable controlled-
release technology that can be formulated for parenteral, oral, dermal or
other route of administration of active agents for human pharmaceutical and
veterinary applications. The SABER Delivery System uses a high-viscosity base
component, sucrose acetate isobutyrate (SAIB), to provide controlled release
of active ingredients. After administration of a SABER formulation, the
solvent diffuses away, leaving a viscous, adhesive matrix of the remaining
components — SAIB and the active drug. SABER can be formulated to
effectively modify delivery rates of the active agent. SABER formulations
have been tested in over 2,000 animals of various species, with actives
ranging from antibiotics to peptides and proteins. DURECT is currently
conducting preclinical studies in a variety of therapeutic areas using its
SABER Delivery System for human pharmaceutical use.
DURECT Corporation (www.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, the
CHRONOGESIC(TM) (sufentanil) Pain Therapy System is a 3-month product for the
treatment of chronic pain. DURECT owns three proprietary drug delivery
platform technologies, including the SABER(TM) Delivery System (a patented and
versatile depot injectable useful for protein delivery), the MICRODUR(TM)
Biodegradable Microparticulates (microspheres injectable system) and the
DURIN(TM) Biodegradable Implant (drug-loaded implant system).
NOTE:
CHRONOGESIC(TM) is a trademark of DURECT Corporation. SABER(TM),
MICRODUR(TM) and DURIN(TM) are trademarks of Southern BioSystems, Inc., a
wholly owned subsidiary of DURECT Corporation. Other trademarks referred to
belong to their respective owners.
Thorn BioScience LLC is a product driven, science based, controlled
release animal pharmaceutical company. Based in Lexington, Kentucky, since
1995, Thorn BioScience LLC continues the mission of developing novel
commercial veterinary products for use in reproductive management,
therapeutics, and vaccines in animals. These products are a continuation of
work initiated by Laura Thorn Ltd, d/b/a Thornbrook Farms of Mt. Kisco, New
York, a strong supporter of equine reproductive research at leading
universities.
The statements in this press release regarding Thorn BioScience’s and
DURECT’s products in development and product development plans 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, Thorn
BioScience’s and DURECT’s ability to research, develop, manufacture and
commercialize these products, obtain product and manufacturing approvals from
regulatory agencies, 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, 2001 filed
with the SEC on March 28, 2002, under the heading “Factors that may affect
future results,” and other periodic reports filed with the SEC. CHRONOGESIC is
under development by DURECT and has not been submitted or approved for
commercialization by the US Food and Drug Administration or other health
authorities.
SOURCE DURECT Corporation
CONTACT: Schond L. Greenway, Senior Director, Investor Relations and
Strategic Planning of DURECT Corporation, +1-408-777-1417, or
schond.greenway@durect.com/
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