SemBioSys Achieves Critical Apo AI Milestone
Calgary, Canada (ots/PRNewswire)
- Canadian Biotechnology Company is the First Company in the World to Produce Recombinant Apo AI, a Next Generation Cardiovascular Therapy, Using Plants
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 CDN$35 billion market in 2006. Apo AI is a major component of "good cholesterol" or HDL (high density lipoprotein) which naturally removes atheroscleroticplaque from arteries. This achievement is a key milestone for SemBioSys'cardiovascular drug development program. SemBioSys' plant-produced Apo AIoffers the potential to overcome the manufacturing challenges of traditionalfermentation-based technologies that have impeded the commercial developmentof 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(800)731-5774 or +1(416)644-3417.
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(877)289-8525 or +1(416)640-1917 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.
This press release contains certain forward-looking statements, including, without limitation, statements containing the words "believe", "may", "plan", "will", "estimate", "continue", "anticipate", "intend", "expect" and other similar expressions which constitute "forward-looking information" within the meaning of applicable Canadian securities laws. Forward-looking statements reflect the Company's current expectation and assumptions, and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those anticipated. These forward-looking statements involve risks and uncertainties including, but not limited to, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process and other risks detailed from time-to-time in the Company's ongoing filings with the Canadian securities regulatory authorities which filings can be found at www.sedar.com. Given these risks and uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. The Company undertakes no obligation to publicly update or revise any forward-looking statements either as a result of new information, future events or otherwise, except as required by applicable Canadian securities laws.
Backgrounder
SEMBIOSYS ACHIEVES CRITICAL APO AI MILESTONE
- Canadian Biotechnology Company is the first company in the worldto produce recombinant Apo AI, a next generation cardiovasculartherapy, using plants -
Introduction
SemBioSys Genetics Inc. is developing apolipoprotein AI and its variant apolipoprotein AI(Milano), collectively referred to as Apo AI, to reduce and stabilize vascular atherosclerotic plaque associated with acute coronary syndrome (ACS), including heart attack and unstable angina, and stroke indications.
Issues
- Atherosclerotic cardiovascular diseases (CVD) are the leading causeof mortality in developed nations and by 2010, are projected to become the leading cause of mortality worldwide.
- There is significant clinical need for pharmacological therapies that rapidly stabilize and diminish atherosclerotic plaque for the prevention and treatment of CVD.
- Apo AI fulfills a critical role in natural processes of reverse cholesterol transport and offers considerable promise in the treatment of atherosclerotic disease.
- Overwhelming epidemiological evidence demonstrates that people with low Apo AI are more susceptible to adverse cardiovascular events.
- In a six week clinical trial, Esperion Therapeutics demonstrated that its Apo AI(Milano)/phospholipid formulation could reduce plaquevolume at a level and speed of atherosclerotic regression unattainable with any current drug therapy.
- High dosing (up to 20 grams per course of patient treatment)coupled with a large patient population is expected to drive volume demand ofseveral tonnes of Apo AI per year.
- Production of recombinant Apo AI using traditional fermentation- basedtechnologies have suffered from technical, economic and scalemanufacturing barriers that limit its commercial viability
Announcement
- SemBioSys has successfully developed commercial levels of Apo AI insafflower seed lines.
- SemBioSys' plant technology will address key Apo AI manufacturingconstraints and enable the clinical application of this promising new class of therapeutics.
- SemBioSys is the first company in the world to produce recombinant Apo AI using plants.
Benefits
- Targets the leading cause of global mortality through the treatment And prevention of cardiovascular disease.
- Uses the naturally occurring protein and therefore appears to be lessprone to side effects.
- Provides a low-cost, highly-scalable source of recombinant Apo AI to enable the clinical and commercial development of a transformativecardiovascular therapy.
- Positions SemBioSys to participate in the CDN$35 billion cholesterolmanagement drug market.
- Validates the broad potential of SemBioSys' transgenic technology in the production of therapeutic and industrial proteins facing cost andcapacity barriers to commercialization.
About Apo AI
Apo AI is a development-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 high density lipoprotein (HDL), commonly referred to as "good cholesterol", which naturally removes plaque from arteries. Apo AI appears to have specific potential in the acute treatment of patients presenting with acute coronary syndrome or a recent stroke event, who are at high risk of a recurrence due to unstable plaque.
In a six week Phase II clinical trial involving 47 patients, Esperion Therapeutics, Inc. (acquired by Pfizer in 2003 for US$1.3 billion) demonstrated that its proprietary Apo AI(Milano)/phospholipid formulation could reduce absolute atheroma (plaque) volume by 4.2%; a level and speed of atherosclerotic regression unattainable with current drug therapies 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.
Based upon Esperion's Phase II clinical dosing (15 to 45 mg/kg body weight) and a large addressable patient population, SemBioSys estimates that an Apo AI-based therapeutic could drive demand for several tonnes of protein per year. Recombinant Apo AI is currently produced at high-cost using microbial fermentation. This process presents severe capacity limitations and endotoxin contamination issues. SemBioSys' plant-based technology overcomes these manufacturing barriers and is expected to bring significant cost and scale benefits to Apo AI production.
Until recently, torcetrapib, a first-in-class cholesteryl ester transfer protein (CETP) inhibitor developed by Pfizer, was viewed as the forerunner small molecule drug designed to elicit atherosclerotic regression. After promising early and mid-stage clinical trials, Pfizer recently terminated their pivotal Phase III trials of torcetrapib due to increased rates of angina, heart failure and death in the treatment population. Unlike torcetrapib, which increased serum HDL through dysregulation of lipoprotein metabolism, Apo AI uses the natural mechanism of HDL particles to promote the body's innate reverse cholesterol transport and is not expected to be obstructed by the adverse events observed with torceptrapib. The clinical setbacks reported with other HDL modulators like torcetrapib and AGI-1067 clearly position Apo AI at the forefront of the cardiovascular therapeutic candidates (see Nature 2006 Dec 14; pages 794-5).
About Cardiovascular Disease
According to the World Health Organization, 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 (IMS Health, 2007).
Acute coronary syndrome (ACS) is associated with physiological conditions characterized by insufficient blood flow to the heart and describes individuals that present with either acute myocardial infarction (heart attack) or unstable angina. Stroke is a condition or event associated with neurological damage to the brain due to an interruption in blood flow resulting from either the blocking or bursting of brain vasculature. SemBioSys believes there is a significant clinical need for pharmacological therapies that rapidly stabilize and diminish atherosclerotic plaque for the prevention and treatment of ACS and stroke.
Upcoming Milestones
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 SemBioSys Genetics Inc. (www.sembiosys.com)
SemBioSys Genetics Inc. (SBS.TSX) is a Calgary-based biotechnology company engaged in the development and commercialization of protein pharmaceutical and non-pharmaceutical products.
Its proprietary protein production system addresses major commercialization challenges associated with the production of recombinant proteins including overcoming limitations in scale, capital costs and production costs. SemBioSys' proprietary technology harnesses the natural ability of seeds to produce, extract and purify proteins in large quantities and at low cost, while dramatically reducing downstream purification costs.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. It is unique as the only transgenic technology that addresses protein recovery and purification simultaneously with bulk protein production SemBioSys' technology is compatible with simple peptides, polypeptides and complex proteins such as antibodies.
SemBioSys' pharmaceutical pipeline is focused on metabolic and cardiovascular disorders. The Company's two lead pharmaceutical products, insulin and Apo AI target the USCDN$7.3 billion insulin market and the US$35 billion cholesterol/triglyceride therapeutic market. SemBioSys' insulin will provide an economical alternative to commercially available insulin to better serve developing nations and meet the anticipated surge in demand with the advent of alternative insulin delivery technologies. Apo AI is a novel therapy with the ability to reduce and stabilize atherosclerotic plaque, a key risk factor in acute coronary syndrome and stroke.
SemBioSys' non-pharmaceutical pipeline consists of products aimed at human topical (personal care, over-the-counter and prescription products), nutritional oil, animal health and aquaculture markets. SemBioSys launched its first non-pharmaceutical product, the DermaSphere(R) Oleosome Technology in 2004 with first sales being made in mid-2005. Our second non- pharmaceutical product, ImmunoSphere(TM), is a specialty feed additive that enhances viral disease resistance in shrimp, a widespread and often devastating problem for the US$7.5 billion shrimp aquiculture market.The non-pharmaceutical segment of our business will generate short and intermediate term income and enable us to develop the infrastructure required to commercialize our high-value pharmaceutical product candidates.
Contact:
For further information: SemBioSys Genetics Inc., Mr. Andrew Baum,
President and Chief Executive Officer, Phone:+1-403-717-8767, Fax:
+1-403-250-3886, E-mail: bauma@sembiosys.com, Investor Relations,
Ross Marshall, The Equicom Group Inc., Phone: +1-416-815-0700 (Ext.
238), Fax: +1-(416) 815-0080, E-mail: rmarshall@equicomgroup.com
(SBS.)