DURECT and Voyager Pharmaceutical Announce the Acceptance of DURIN(TM) Investigational New Drug Application and Clinical Protocol by the FDA for the Treatment of Alzheimer’s Disease

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CUPERTINO, Calif., Dec. 20 /PRNewswire-FirstCall/ — 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 acceptance of the
Investigational New Drug Application (“IND”) and clinical protocol by the FDA
for a DURIN(TM)-based leuprolide acetate treatment of Alzheimer’s disease
under development. This trial will consist of a pharmacokinetic study in
normal, healthy volunteers. The objectives of the clinical study are to
determine the safety and tolerability of the DURIN leuprolide implant, as well
as evaluate the pharmacokinetic profile of the product following
administration. Voyager Pharmaceutical is currently engaged in patient
enrollment for this study, which will be conducted in parallel with two
ongoing Phase II Alzheimer’s studies being conducted by Voyager.

“We are pleased to meet this milestone with the first IND accepted for our
DURIN platform technology,” said James E. Brown, DVM, president and chief
executive officer of DURECT. “This product 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 to this point in clinical development.”

“The launch of this study using our unique dose of DURIN-leuprolide
acetate optimized for the treatment of Alzheimer’s Disease is an exciting
event for Voyager,” added Patrick S. Smith, President and CEO of Voyager
Pharmaceutical. “In 2005, we expect to complete this study, our ongoing Phase
II study in women and an interim analysis of our ongoing Phase II study in
men. Based on the results of these three studies, we plan to move into Phase
III pivotal studies for our DURIN-leuprolide Alzheimer’s product during the
second half of 2005. It is our belief that the dosage form that we are
developing in our partnership with DURECT is ideally suited for producing a
convenient and effective therapy for long-term care for Alzheimer’s patients.
We are very excited to advance this program into clinical trials with DURECT.”

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 pharmaceutical 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

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.

NOTE: SABER(TM), ORADUR(TM), DURIN(TM) and MICRODUR(TM) are trademarks of
DURECT Corporation. Other referenced trademarks belong to their respective

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 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.”

The DURIN leuprolide 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.


Schond L. Greenway, Executive Director, Investor Relations and
Strategic Planning, of DURECT Corporation,
Stephanie C.
Diaz (investors),
415-885-2298, or sdiaz@vidaLLC.com,
Tim Brons (media),

646-319-8981, or tbrons@vidaLLC.com,
both of Vida Communication, for DURECT
Michael Giannini, Vice President, Business Operations, or
Voyager Pharmaceutical Corporation,
919-846-4880, or

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/Web site: http://www.voyagerpharma.com /
/Web site: http://www.www.durect.com /

12/20/2004 07:30 EST http://www.prnewswire.com

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