BioPartners and DURECT Corporation Enter Into Agreement for Development Of Sustained Release Interferon Alpha

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BioPartners and DURECT Corporation Enter Into Agreement for Development Of

Sustained Release Interferon Alpha

DURECT Corporation (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. (PRNewsFoto)[JL]

CUPERTINO, CA USA 07/17/2002

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 and BioPartners' daily recombinant interferon alpha

product. The SABER technology works by encapsulating proteins in a

viscous

carrier from which the drug is slowly released. BioPartners believes that

SABER 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 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 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

(http://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 Kline Beecham

and

current Non-Executive Director of BioPartners and Ted , 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 (http://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 (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

Delivery System (a patented and versatile depot injectable useful for

protein

delivery), the MICRODUR Biodegradable Microparticulates (microspheres

injectable system) and the DURIN Biodegradable Implant (drug-loaded

implant system). NOTE: CHRONOGESIC is a trademark of DURECT Corporation.

SABER, MICRODUR and DURIN 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.