CUPERTINO, Calif., March 27 /PRNewswire/ —
DURECT Corporation (Nasdaq: DRRX) announced today that it has a long-term
supply agreement with Mallinckrodt, a global manufacturer and marketer of
specialty medical products. Mallinckrodt will supply DURECT’s clinical and
commercial requirements for sufentanil, a potent opioid analgesic and critical
component of the company’s lead product DUROS sufentanil, for the treatment of
chronic pain. DURECT previously announced completion of patient enrollment for
the Phase II clinical trial of DUROS sufentanil.
DUROS sufentanil is designed to deliver sufentanil on a continuous basis
for 3 months for the treatment of chronic pain. Sufentanil is a FDA approved
opioid that is currently used in hospitals as an anesthetic. Chronic pain is
a significant problem associated with chronic diseases, including cancer and
various neurological and skeletal disorders. DUROS sufentanil is intended for
patients whose chronic pain is stable, opioid responsive and results from a
variety of malignant and non-malignant causes. Annual sales of opioids for
the treatment of chronic pain exceed $1 billion.
Commenting on the agreement, James E. Brown, President and Chief Executive
Officer of DURECT, stated, “We are very pleased to secure a long-term drug
supply agreement with a partner of Mallinckrodt’s reputation for quality and
expertise. Securing a long-term supplier of our bulk drug requirements for our
DUROS sufentanil product is a major step towards our drive to manufacture our
FDA registration batches and brings us one step closer to initiating our Phase
III clinical trials. With this supply agreement, we now have secured a
qualified long-term clinical and commercial supply partner for a critical
component to manufacture our lead product, DUROS sufentanil.”
About DURECT Corporation
DURECT Corporation is pioneering the development and commercialization of
pharmaceutical systems to deliver the right drug to the right site in the
right amount at the right time. DURECT’s pharmaceutical systems combine
technology innovations from the medical device and drug delivery industries
with proprietary pharmaceutical and biotechnology drug formulations. These
capabilities can enable new drug therapies or optimize existing therapies
based on a broad range of compounds, including small molecule pharmaceuticals
as well as biotechnology molecules such as proteins, peptides and genes.
In addition to DUROS sufentanil, DURECT’s second product in development,
DUROS hydromorphone, continuously delivers hydromorphone to the spine for
three months for the treatment of end-stage cancer pain. DURECT is also
selling FDA cleared catheters for the delivery of fluids to the inner ear.
DURECT also manufactures, sells and distributes the ALZET osmotic pump product
for use in laboratory research.
Founded in 1998, DURECT is headquartered in Cupertino, CA. The company’s
World Wide Web site can be accessed at http://www.www.durect.com. The company’s
World Wide Web site for ALZET osmotic pumps and IntraEAR line of ear delivery
products can be accessed at http://www.alzet.com and http://www.intraear.com,
respectively. To join DURECT’s email alert service, please register by
selecting “Email Alerts” on the main Investor Relations web page at
http://www.www.durect.com.
DUROS is a registered trademark of ALZA Corporation.
About Mallinckrodt
Mallinckrodt, acquired by Tyco International Ltd.
(NYSE: TYC; LSE: TYI; BSX: TYC) on October 17, 2000, is a global manufacturer
and distributor of specialty medical products designed to relieve pain,
sustain breathing and diagnose disease. In pharmaceuticals, Mallinckrodt is
the number one manufacturer of bulk narcotics and other drug chemicals, and is
the world’s largest producer of acetaminophen. Mallinckrodt also provides
laboratory and microelectronic chemicals. Mallinckrodt is the industry leader
in respiratory care products, including Nellcor pulse oximeters used for
oxygen monitoring; Puritan-Bennett critical care ventilators and oxygen
therapy systems; as well as airway management disposables, some of which are
sold under the Shiley brand name; and products for the sleep therapy market.
Its imaging products include contrast media used in x-ray, magnetic resonance
imaging (MRI), computer axial tomography (C-T) and ultrasound diagnostic
procedures. Mallinckrodt’s radiopharmaceuticals are used for diagnostic and
therapeutic nuclear medicine procedures.
The statements in this press release regarding DURECT’s products in
development, product development plans, clinical trials, and expected product
benefits are forward-looking statements involving risks and uncertainties that
could 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 ability to develop, manufacture and commercialize its
products, complete successful clinical trials, obtain product approvals from
regulatory agencies, build a manufacturing facility, manage its growth and
costs, as well as marketplace acceptance of DURECT’s products. Further
information regarding these and other risks is included in the company’s S-1
registration statement, filed with the SEC on September 22, 2000 and its
424(b) prospectus filed with the SEC on September 28, 2000 and its Quarterly
Report on Form 10Q for the quarter ended September 30, 2000 filed with the SEC
on November 14, 2000.
SOURCE DURECT Corporation
CONTACT: Schond L. Greenway, Director, Investor Relations of DURECT
orporation, 408-777-1417, schond.greenway@durect.com/