CUPERTINO, Calif., and RALEIGH, N.C., Jan 28, 2005 /PRNewswire-FirstCall via COMTEX/ — DURECT Corporation (Nasdaq: DRRX), an emerging specialty pharmaceutical
systems company, and Voyager Pharmaceutical Corporation, a privately held
specialty pharmaceutical company focused on diseases of aging, announced today
the completion of enrollment for the recently approved study for the
DURIN(TM)-based leuprolide acetate product candidate for Alzheimer’s disease
under development by the parties (the DURIN(TM)-leuprolide implant). The U.S.
Food and Drug Administration (FDA) accepted Voyager’s Investigational New Drug
Application (IND) and clinical protocol in late December, 2004, and this
unique formulation is being used in the present study in healthy volunteers to
evaluate the product candidate’s bioavailability, as well as determine its
safety and tolerability following administration. Voyager has completed the
enrollment and initial dosing of all screened subjects necessary to complete
the trial.
“We are pleased with the progress of this development program. In the last
two weeks, the program has achieved two important milestones. First, Voyager
has completed enrollment in the 50-patient Phase I pharmacokinetic study for
the DURIN-based product candidate. Second, Voyager has completed dosing in its
Phase II dose ranging study in women utilizing the active agent,” said James
E. Brown, DVM, president and chief executive officer of DURECT. “This product
candidate fits with DURECT’s mission of utilizing our proprietary drug
delivery platforms to develop products that treat chronic debilitating
diseases. It has been a pleasure to work with Voyager to bring this product
through clinical development.”
“The full enrollment of this study brings Voyager closer to introducing an
innovative long-term care therapy for Alzheimer’s patients,” said Patrick S.
Smith, President and CEO, Voyager Pharmaceutical Corp. “We are pleased with
the recruiting and enrollment efficiency of our clinical site, and fully
expect our upcoming meeting with the FDA will result in an approval of our
plans to proceed with our pivotal studies during the second half of 2005.”
According to the Alzheimer’s Association and National Institute of Aging,
Alzheimer’s disease is an incurable, neurodegenerative disorder that affects
more than 4.5 million Americans. The disease typically leads to progressive
memory loss, impairments in behavior and language and physical deterioration.
Current direct and indirect costs for caring of Alzheimer’s patients are
estimated at $100 billion annually.
DURECT’s DURIN biodegradable implant technology is a platform for
short- and long-term parenteral drug delivery lasting in duration from weeks
to six months. The technology is based on the use of biodegradable polymer
excipients, which have a proven record of safety and effectiveness in approved
drug delivery and medical device products. Voyager Pharmaceutical owns a
broad-based patent covering the use of leuprolide acetate and other compounds
for the treatment of Alzheimer’s Disease.
About DURECT Corporation
DURECT Corporation is an emerging specialty pharmaceuticals systems
company focused on the development of pharmaceutical systems based on its
proprietary drug delivery platform technologies that treat chronic
debilitating diseases and enable biotechnology products. These platform
technologies include the SABER(TM) Delivery System (a patented and versatile
depot injectable useful for protein and small molecule delivery), the
ORADUR(TM) sustained release oral gel-cap technology (an oral sustained
release technology with several potential abuse deterrent properties), the
DURIN(TM) Biodegradable Implant (drug-loaded implant system) and the
MICRODUR(TM) Biodegradable Microparticulates (microspheres injectable system).
DURECT also partners with pharmaceutical companies to develop and
commercialize proprietary and enhanced pharmaceutical products based on its
technologies. DURECT has five disclosed on-going development programs of which
three are in collaboration with pharmaceutical partners. Additional
information about DURECT is available at www.www.durect.com.
NOTE: SABER(TM), ORADUR(TM), DURIN(TM) and MICRODUR(TM) are trademarks of
DURECT Corporation. Other referenced trademarks belong to their respective
owners.
About Voyager Pharmaceutical Corporation
Voyager Pharmaceutical is a privately held specialty pharmaceutical
company based in Raleigh, NC focused on disease of aging. The company’s
proprietary approach applies a new understanding of the role of gonadotropins
and other hormones in Alzheimer’s disease and many other diseases. In addition
to its Alzheimer’s Disease program, Voyager is pursuing active research
programs in other areas, including cancer, Parkinson’s Disease and ALS
(Amyotrophic Lateral Sclerosis). Further information about Voyager
Pharmaceutical can be found at www.voyagerpharma.com.
The statements in this press release regarding DURECT’s and Voyager
Pharmaceutical’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,
DURECT’s and Voyager Pharmaceutical’s abilities to complete the design,
development, and manufacturing process development of these products,
manufacture and commercialize these products, obtain product and manufacturing
approvals from regulatory agencies, manage their growth and expenses, manage
relationships with third parties, finance their activities and operations, as
well as marketplace acceptance of these products. Further information
regarding these and other risks is included in DURECT’s Quarterly Report on
Form 10Q for the quarter ended September 30, 2004 filed with the SEC on
November 5, 2004 under the heading “Factors that may affect future results.”
SOURCE DURECT Corporation
CONTACT:
Investors, Schond L. Greenway
Executive Director, IR and Strategic Planning,
1-408-777-1417 or Press,
Melissa M. Ta Associate Director, Corporate
Communications, 1-408-777-1417 both of DURECT Corporation; Or investors, Stephanie
C. Diaz 1-415-885-2298 sdiaz@vidaLLC.com Or press, Tim Brons 1-646-319-8981
tbrons@vidaLLC.com both of Vida Communication; or Investors and Press, Michael
Giannini Vice President, Business Operations of Voyager Pharmaceutical Corporation,
1-919-846-4880