CUPERTINO, Calif., Jan. 24 /PRNewswire-FirstCall/ —
DURECT Corporation (Nasdaq: DRRX) announced today that it has amended its
development and commercialization agreement with Voyager Pharmaceutical
Corporation governing Memryte(TM), an investigational drug under development
for the treatment of Alzheimer’s disease based on DURECT’s proprietary
DURIN(TM) Biodegradable Implant technology. Under the amendment, among other
changes to the agreement, the royalty rate that we will receive on net sales
of Memryte, if commercialized, was doubled (to 10-14% of net sales after the
amendment), and in addition, we will now receive 10% of any upfront, milestone
and other fees received by Voyager in the event that the product is
sublicensed to another pharmaceutical company. In return, DURECT will pay
Voyager $1 million in cash and forgive approximately $725,000 which was owed
to DURECT for previously provided services.
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“We believe that our support will assist Voyager to collect and analyze
the data from its Phase III trial, and that the data, once collected and
analyzed, will potentially confirm the positive data that was obtained in an
earlier phase II women’s trial,” stated Dr. Felix Theeuwes, Chairman and Chief
Scientific Officer of DURECT. “With this modest investment, we have
substantially strengthened our potential economic returns from this
opportunity.”
In July 2002, DURECT entered into a feasibility, development and
commercialization agreement with Voyager under which we granted Voyager the
exclusive, worldwide rights to develop and commercialize a product, Memryte,
using DURECT’s DURIN implant system to deliver the peptide leuprolide acetate
to treat Alzheimer’s disease based on Voyager’s patented method of treatment.
Voyager has previously announced the completion of a Phase II clinical trial
in women and a Phase II clinical trial in men, in each case using the active
agent (but not the Memryte dosage form incorporating the DURIN implant
system). In October 2005, Voyager initiated its Phase III program for
Memryte. In October 2006, Voyager informed us that Voyager was ending its
Phase III clinical trials for Memryte in order to get an early look at
potential efficacy. There can be no assurance that Voyager will be able to
complete the data analysis from its current Phase III trials to assess
efficacy and that the data from the study will indicate efficacy.
About DURECT Corporation
DURECT Corporation is an emerging specialty pharmaceutical company focused
on the development of pharmaceutical systems based on its proprietary drug
delivery platform technologies focused on treating chronic and episodic
diseases and conditions. The Company currently has a number of late-stage
pharmaceutical products in development initially focused on significant unmet
medical needs in pain management, with a number of research programs underway
in a variety of other therapeutic areas. For more information, please visit
www.www.durect.com.
NOTE: DURIN(TM) is a trademark of DURECT Corporation, and Memryte(TM) is a
trademark of Voyager Pharmaceutical Corporation. Memryte is a drug candidate
under development and has not been submitted or approved for commercialization
by the US Food and Drug Administration or other health authorities.
DURECT Forward-Looking Statement
The statements in this press release regarding Memryte, the potential data
and results from the Phase III clinical trial and DURECT’s potential economic
returns from future sale and sublicensing of Memryte 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, Voyager
Pharmaceutical’s ability to complete the data analysis from its Phase III
trials to assess efficacy, that the data from the study will be positive,
Voyager Pharmaceutical’s ability to obtain future funding or obtain a
corporate partner to fund further development and commercialization of
Memryte, and Voyager Pharmaceutical’s ability to design, enroll, conduct and
complete clinical trials, complete the design, development, and manufacturing
process development of Memryte, obtain product and manufacturing approvals
from regulatory agencies, and manufacture and commercialize Memryte, as well
as marketplace acceptance of Memryte. Further information regarding these and
other risks is included in DURECT’s Form 10-Q dated November 3, 2006 under the
heading “Risk Factors.”
SOURCE DURECT Corporation
01/24/2007
CONTACT: Schond L. Greenway, Vice President, Investor Relations and
Strategic Planning of DURECT Corporation, +1-408-777-1417; or Media, Jeremiah
Hall, Senior Vice President of Feinstein Kean Healthcare, +1-415-677-2700, or
jeremiah.hall@fkhealth.com, for DURECT Corporation
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Web site: http://www.www.durect.com
(DRRX)