Biotech Values

[DewDiligence]

SemBioSys Achieves Apo AI Milestone

[CC today at 1:30 pm ET to discuss the Apo A1 program. SemBioSys, which has been discussed on this board on several occasions, produces protein drugs using transgenic plants.]

http://biz.yahoo.com/prnews/070712/to377.html?.v=23

>>Thursday July 12, 7:00 am ET

- Canadian Biotechnology Company is the first company in the world to produce recombinant Apo AI, a next generation cardiovascular therapy, using plants -

CALGARY, July 12 /PRNewswire-FirstCall/ - SemBioSys Genetics Inc. (TSX:SBS), a biotechnology company, today announced it has successfully developed commercial levels of apolipoprotein AI and its variant apolipoprotein AI (Milano) (collectively referred to as Apo AI) in safflower seed lines. Apo AI is believed by many clinicians to be the basis for the next generation of cardiovascular drugs, which represented a $35 billion market in 2006. Apo AI is a major component of "good cholesterol" or HDL (high density lipoprotein) which naturally removes atherosclerotic plaque from arteries. This achievement is a key milestone for SemBioSys' cardiovascular drug development program. SemBioSys' plant-produced Apo AI offers the potential to overcome the manufacturing challenges of traditional fermentation-based technologies that have impeded the commercial development of Apo AI.

"Apo AI is a promising new therapy for the treatment of cardiovascular disease which is the largest drug market in the world. Unlike statins, the lead drug class in this market, which halt plaque build-up, clinical results from Apo AI have actually demonstrated significant plaque reduction. We believe manufacturing capacity and cost are major commercialization issues for pharmaceutical companies developing Apo AI. Today's announcement demonstrates that safflower seed is an enabling production vehicle for Apo AI with the scale and economics necessary to allow for the commercialization of this potentially transformative therapy," said Andrew Baum, President and CEO of SemBioSys Genetics Inc. "This is great news for the area of cardiovascular disease therapy. With the recent setbacks reported with other HDL modulators like torcetrapib and AGI-1067, Apo AI is clearly positioned at the forefront of cardiovascular disease therapy (see Nature 2006 Dec 14; pages 794-5). As an enabling manufacturing solution, we believe our Apo AI development program represents an attractive partnership opportunity for companies developing such cardiovascular therapies and with these results we will initiate formal partnering activities."

These results further validate the broad utility of SemBioSys' seed-based production system for critical, large volume biopharmaceuticals in short supply. SemBioSys' technology addresses protein extraction and purification as well as bulk protein production. SemBioSys estimates it can reduce capital costs for protein production by up to 70% and cost of goods by 40% or more with its rapidly scalable system. The Company has also produced authentic human insulin in safflower, which is expected to enter clinical trials in early 2008.

As a next step, SemBioSys expects to confirm the in vivo efficacy of Arabidopsis-produced Apo AI in the third quarter of 2007. SemBioSys intends to scale-up production of safflower-produced Apo AI and perform the necessary preclinical work in 2008 in order to initiate clinical trials in 2009.

About Apo AI

Apo AI is a developmental-stage cardiovascular therapy, designed to rapidly stabilize and diminish atherosclerotic plaque for the prevention and treatment of cardiovascular disease. Apo AI is the major apolipoprotein associated with HDL, commonly referred to as "good cholesterol", which naturally removes plaque from arteries.

In a six week clinical trial, Esperion Therapeutics (acquired by Pfizer in 2003) demonstrated that its Apo AI (Milano)/phospholipid formulation could reduce plaque volume at a level and speed of atherosclerotic regression unattainable with any current drug therapy. Similarly, both CSL Limited and Borean Pharma A/S have more recently confirmed the strong therapeutic potential of their respective Apo AI-based drug candidates (CSL-111 and Trimeric Apo A-I) in clinical and preclinical trials.

High dosing (up to 20 grams per course of patient treatment) coupled with a large patient population is expected to drive volume demand of several tonnes of Apo AI per year, underscoring the value of a highly scalable plant manufacturing solution.

About Cardiovascular Disease

Atherosclerotic cardiovascular diseases are the leading cause of mortality in developed nations and by 2010 are projected to become the leading cause of mortality worldwide. In the United States coronary heart disease and stroke account for 70% of cardiovascular-related deaths, which claims more lives each year than the next four leading causes of death combined (cancer, respiratory disease, accidents and diabetes). Drugs positioned in the cholesterol and triglyceride management market are the single largest class of prescription pharmaceuticals, with global sales exceeding US$35 billion in 2006.

Conference Call

SemBioSys will hold a conference call to discuss its Apo AI production results today, July 12, 2007 at 1:30 p.m. Eastern Time. The call will be hosted by Mr. Andrew Baum, President and CEO of SemBioSys, and will be followed by a question and answer session. The dial in number for the conference call is 1 [phone] or 1 [phone].

A live audio webcast of the conference call will be available through www.sembiosys.com. Please connect to this website at least 15 minutes prior to the conference call to ensure adequate time for any software download that may be needed to hear the webcast. A replay of the webcast will be available for 90 days at www.sembiosys.com. A replay of the conference call will also be available by telephone on July 12, 2007 through July 19, 2007. To access the replay, dial 1 [phone] or 1 [phone] and enter reservation number 21240420 followed by the number sign.

About SemBioSys Genetics Inc. (www.sembiosys.com)

Calgary, Alberta-based SemBioSys Genetics Inc. is a biotechnology company developing protein-based pharmaceuticals for metabolic and cardiovascular diseases. The Company's lead candidate is recombinant human insulin produced in the plant host safflower, to serve the rapidly expanding global diabetes market and to supply insulin for inhalation and other alternative insulin delivery technologies. The Company is also developing Apo AI, a next generation cardiovascular drug. In addition to its pharmaceutical products SemBioSys is developing a series of non-pharmaceutical products addressing animal and aquaculture health, nutritional oils and human topical markets.
<<