ZUG, Switzerland and CUPERTINO, Calif., Nov. 19 /PRNewswire-FirstCall/ —
BioPartners, a global biopharmaceuticals company and one of the leaders in the
emerging field of competitively priced multi-source biopharmaceuticals, has
signed an exclusive agreement with DURECT Corporation (Nasdaq: DRRX), a U.S.
based pioneering pharmaceutical systems company, for the development of a
sustained release formulation of recombinant interferon alpha for the
treatment of Hepatitis C.
The agreement with DURECT entitles BioPartners to exclusively develop and
commercialize the sustained release product in key territories including the
U.S., Europe, Japan, Australia, New Zealand and the Middle East. The worldwide
recombinant interferon alpha market was worth $1.8 Billion in 2001 and is
forecast to grow to $5.5 Billion by 2010 due to the added convenience offered
by sustained release and pegylation products and the predicted rise in the
prevalence of Hepatitis C.
The product will be developed using DURECT’s patented drug delivery
technology SABER(TM) and BioPartners’ daily recombinant interferon alpha
product. The SABER(TM) technology works by encapsulating proteins in a viscous
carrier from which the drug is slowly released. BioPartners believes that
SABER(TM) offers potential advantages in terms of product performance and ease
of administration over the pegylation technology that is currently used in
marketed sustained release alpha interferons. First, as SABER(TM) does not
alter the molecule being delivered (as pegylation does), it may offer greater
efficacy and safety. Further, SABER’s low solution viscosity upon injection
results in the need for a small gauge needle and may result in easier, less
painful administration. BioPartners intends to conduct a full clinical
development program for the product.
“We are very excited about our agreement with DURECT as it not only shows
our commitment and capability to develop multi-source biopharmaceuticals,
which offer therapeutic advances, improved patient convenience and competitive
pricing, but also because it demonstrates our understanding of the market and
highlights that BioPartners is leading the way in multi-source
biopharmaceuticals. Importantly, the sustained release product complements our
existing portfolio for the treatment of Hepatitis C, which includes a daily
recombinant interferon alpha and ribavirin, making it possible for us to
provide patients and physicians with a choice of gold standard treatment
regimes,” stated Brian O’Callaghan, President and CEO of BioPartners.
Commenting on the agreement, Dr. Felix Theeuwes, Chairman and Chief
Scientific Officer of DURECT said, “Our patented SABER technology is ideal for
products such as recombinant interferon alpha because its hydrophobic nature
helps to stabilize proteins and it is well suited for long-term delivery of
these novel therapeutics. The SABER delivery system offers significant
advantages over existing systems in terms of product performance, ease of
administration, and manufacturability. We are thrilled that BioPartners has
chosen to work with DURECT for the development of a sustained release
recombinant interferon alpha, which fits with our own corporate goal to enable
the delivery of biotechnology products”.
Under the agreement, BioPartners and DURECT will share the funding of
certain preclinical development activities at DURECT. BioPartners is
responsible for additional preclinical activities and all clinical activities.
DURECT will receive milestone payments based on the achievement of certain
preclinical development milestones and a royalty on product sales. Specific
financial terms are undisclosed.
Hepatitis C is a blood-borne infectious disease of the liver and is
transmitted through body fluids, primarily blood or blood products, and by
sharing needles. In many patients, the mode of transmission is unknown.
Unfortunately, most people infected with hepatitis C are unaware of it because
it may take years for symptoms to develop and it is therefore sometimes
referred to as the “hidden epidemic”. Hepatitis C chronically infects an
estimated 170 million people worldwide (three percent of the world’s
population), with as many as 180,000 new cases occurring each year. It is the
leading cause of cirrhosis and liver cancer and one of the most common reasons
for liver transplants in Europe and the U.S. It is estimated that less than
30 percent of all cases are diagnosed. The standard treatment for Hepatitis C
is recombinant interferon alpha as monotherapy or combination treatment with
ribavirin. If left untreated, hepatitis C can be fatal for some patients.
Headquartered in Zug, Switzerland, BioPartners (www.biopartners.com) is a
global biopharmaceuticals company and a leader in the emerging field of multi-
source biopharmaceuticals. BioPartners’ mission is to develop patentable and
innovative formulations of “first generation” biopharmaceuticals as well
source advanced delivery systems that may improve patient compliance to its
product portfolio. BioPartners is developing a comprehensive range of
biopharmaceutical products that may offer life-saving therapeutic benefits
across many therapeutic areas, including oncology, virology, haematology,
endocrinology and neurology.
BioPartners was founded by Global Healthcare Partners and Credit Suisse
First Boston. Global Health Care Partners currently consists of some of the
most respected and recognized figures in the international pharmaceutical
industry. These include Henry Wendt, former Chairman of SmithKline Beecham and
current Non-Executive Director of BioPartners and Ted Roberts, former Head of
Pharmaceuticals of Merck KgaA and current Chairman of BioPartners.
BioPartners has partnered with LG Life Sciences, the leading South Korean
manufacturer of biopharmaceuticals for the manufacture of its daily
recombinant interferon alpha as well as other recombinant products in
development
BioPartners is forming a global distribution network for the
commercialization of its products. Worldwide distribution partners include
Nycomed Pharma, Cambridge Laboratories, Grupo Vita, Novatec Healthcare,
Alphapharm, MediQuest, Key Oncologics and MegaPharm.
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. In November 2001, DURECT completed a pilot
phase III program for the CHRONOGESIC(TM) (sufentanil) Pain Therapy System, 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.
The statements in this press release regarding DURECT’s and BioPartner’s
products in development, product development plans and potential
opportunities, 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 BioPartner’s abilities to research,
develop, manufacture and commercialize these products, obtain product and
manufacturing approvals from regulatory agencies, timely enroll patients and
clinical sites in connection with clinical studies, effectively administer
clinical trials, and protect intellectual property rights, 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.
SOURCE DURECT Corporation
CONTACT: Shairose Ebrahim of Zaebra Consulting, +44 207 702 1452, or
mobile, +44 7930 336720, or fax, +44 207 702 1447, or
shairose@zaebraconsulting.com, for BioPartners; or Schond L. Greenway, Senior
Director, Investor Relations and Strategic Planning of DURECT Corporation,
+1-408-777-1417, or schond.greenway@durect.com/
/Web site: http://www.biopartners.com /