Mitsui & Co. Global Investment (MGI) - Venture Capital, Start-Up

NEWS 2005

[01/06/2005]

BIOLEX SUBMITS IND AND CTA FOR BLX-883, A FORM OF ALFA INTERFERON MANUFACTURED WITH THE BIOLEX LEX SYSTEMS

BLX-883 is First Biolex Protein to Enter the Clinic

PITTSBORO, NC JANUARY 6, 2005: Biolex, Inc., a privately held protein therapeutics company, today announced the submission of an IND to the US FDA and a CTA to the UK MHRA for Phase I clinical trials of BLX-883, a form of alfa interferon.

BLX-883 will be the first product manufactured using Biolex’ proprietary LEX System? to enter the clinic. The LEX System? offers substantial cost-advantages in the production of alfa interferon and other hard-to-make proteins.

Alfa interferon is a recombinant human protein used to treat infectious diseases such as Hepatitis C and certain cancers. In preclinical studies, BLX-883 (interferon alfa-2b) produced with the LEX System? had the same specific activity in in-vitro anti-viral and anti-cancer assays and was shown in-vivo in monkey studies to be comparable in both potency and pharmacokinetics to commercially available INTRONR A*. Alfa interferon has an estimated worldwide annual market value of over $3 billion. Utilizing its patented LEX System?, Biolex has cGMP manufacturing capability to cost-effectively produce a significant portion of the market need.

"We are excited to begin human studies for the first product to enter the clinic that is produced in a contained and controlled plant transgenic system. This accomplishment represents the next step in bringing us closer to delivering on the promise of the LEX System?,” said Jan Turek, President and CEO of Biolex. “There is tremendous need for improved and more efficient approaches to production of hard-to-make therapeutic proteins such as alfa interferon, and we plan to continue offering solutions to help meet this need.”

The study is designed to evaluate safety, pharmacokinetics and pharmacodynamics of the product. Biolex is seeking a partner for further clinical development and commercialization. A product partnering sheet for BLX-883 is available at www.biolex.com/alfa.html.

About Biolex

Biolex, Inc.is a private, venture capital-backed biopharmaceutical company. Biolex is developing recombinant human therapeutic proteins that, until now,have been impossible or very expensive to develop in existing expression systems. Biolex’ proprietary LEX System has demonstrated speed, regulatory and economic benefits with hard-to-make proteins and monoclonal antibodies. Biolex has a pipeline of proprietary products in development and its lead candidate, BLX-883, is currently in a Phase I clinical trial. Biolex also is partnering with pharmaceutical and biotechnologycompanies seeking the protein development and production benefits the LEX System offers. Biolex has entered into corporate partnerships with Centocor, Inc., Medarex, Inc.,OctoPlus and other pharmaceutical/biotechnology companies. The Company’s headquarters, research laboratories and clinical manufacturing facilities are based in Pittsboro, North Carolina. Visit the Company’s web site at www.biolex.com.

http://www.biolex.com/

Contact:

John Irick,Senior Vice President and Chief Business Officer Biolex, Inc.
Michelle Linn, Linnden Communications, 508-419-1555, linnmich@comcast.net.