SemBioSys’ first commercial products, Hydresia™ and Hydresia™G2, was lauched into the personal care market under the trade name, Dermasphere®, in 2004.  Hydresia™ is an oil-in-water emulsion comprised of naturally occurring liposomes from safflower seeds, called oleosomes, in which oil is surrounded by a shell of phospholipids and unique emulsifying proteins called oleosins.

Botaneco, a subsidiary of SemBioSys, manufactures and markets Hydresia™ and Hydresia™G2 to the personal care ingredient market.

Hydresia™ and Hydresia™G2 represents a breakthrough in formulation science, offering an all natural emulsifying system enabling “cold” formulation, which dramatically simplifies the process. These naturally occurring benefits reduce production costs, accelerate formulation and development timelines, and eliminate the need for synthetic surfactants. The emollient spheres are harvested fully intact using an advanced process which involves no solvents or chemicals as with traditional “seed crushing” methods.

Hydresia™ is a renewable base for moisturizers, body lotions, hand and body washes, fragrances, cosmetics and sunscreens. Hydresia™ offers advanced skin barrier protection, natural anti-aging properties, superior hydration, longer lasting effects and better skin absorption delivered in the mildest possible way.

We are developing Apo AI to be used in cardiovascular therapies to reduce plaque associated with stroke and acute coronary syndrome (heart attacks and angina).

According to the World Health Organization, cardiovascular and atherosclerotic diseases represent the leading cause of mortality in developed nations and by 2010 are projected to become the leading cause of mortality worldwide. Drugs aimed at cholesterol and triglyceride management are the single largest class of prescription pharmaceuticals with sales in 2005 exceeding US$32 billion (IMS Health, 2006).

Apo AI is the major apolipoprotein associated with high density lipoprotein (HDL), or “good cholesterol”, whose function is to remove excess cholesterol from arteries. HDL-targeted therapies are emerging as an important new class of pharmaceuticals, which for the first time may reduce plaque already deposited in arteries by elevating HDL and reverse cholesterol transport. Based on clinical results, patients will require 5 to 6 grams of Apo AI per treatment. This high dose combined with the millions of patients that could potentially benefit from such therapy creates an enormous projected demand for Apo AI. We believe that a plant source of Apo AI may be the only cost effective solution to the supply of Apo AI because of the scale and economic advantages that plant production may offer.

We have achieved commercial levels of expression of native Apo AI and Apo AI(Milano) in both our model plant system, Arabidopsis, and our commercial plant system, safflower. We have established that Arabidopsis derived Apo AI and its variant maintains the same size and physico-chemical characteristics of native Apo AI. Our next steps are to demonstrate the functional equivalence of first Arabidopsis-produced Apo AI and then safflower-produced Apo AI to serum-derived Apo AI in animal trials. Our aim is to initiate clinical trials in 2009.

We anticipate our first Apo AI product candidate reaching the market as early as 2014 or 2015.

Our core technology is based on the genetic manipulation or physical manipulation of plant seed oilbodies. Oilbodies are protein-coated lipospheres that naturally form in plant seeds to function in triglyceride (oil) storage. We have developed proprietary technologies based on both transgenic and non-transgenic oilbodies.

Transgenic Technology

Based on the genetic engineering of oilbodies and oilbody-associated proteins, or oleosins, our transgenic technologies offer compelling biomanufacturing advantages and are uniquely positioned to enable the development of recombinant proteins that face cost and capacity barriers to commercialization. SemBioSys is leveraging this technology to address high-value market opportunities,
including human biotherapeutics, animal
health products and industrial applications.

Non-transgenic Technology

SemBioSys is using its proprietary oilbody extraction process to develop non-transgenic oilbodies for topical applications. Our extracted oilbodies naturally form a surfactant-free, oil-in-water emulsion suitable for a broad range of topical personal care and pharmaceutical formulations. The inherent functionality of intact oilbodies enables their use as a high-value topical ingredient and carrier or delivery system for therapeutic actives. In 2004 we commercialized our first non-transgenic oilbody product, the DermaSphere® Oleosome Technology.

SemBioSys Genetics Inc. is a publicly traded (TSX:SBS) biotechnology company developing insulin and other protein-based pharmaceuticals that address critical unmet needs in metabolic and cardiovascular diseases. SemBioSys is aggressively building clinical drug development capabilities to advance its lead pharmaceutical products, insulin and apolipoprotein AI (Apo AI), a development-stage cardiovascular therapy. SemBioSys is also developing a series of non-pharmaceutical products addressing human topical markets, nutritional oils and animal health.

Platform
Our proprietary protein production system addresses major commercialization challenges associated with the production of recombinant proteins including overcoming limitations in scale and reducing capital and production costs. SemBioSys’ proprietary technology harnesses the natural ability of plant seeds to produce, extract and purify proteins in large quantities and at low cost, while dramatically reducing downstream purification costs. 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.

Products
SemBioSys’ pharmaceutical pipeline is focused on metabolic and cardiovascular disorders. Our two lead pharmaceutical products, insulin and Apo AI target the US$7.5 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 arrival of alternative insulin delivery technologies, such as Pfizer’s new Exubera® inhaled insulin. Apo AI, the predominant protein of high density lipoprotein (HDL) or “good cholesterol”, 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 pharmaceutical products), nutritional oil and animal health markets. Our first commercial product, DermaSphere®, is generating product revenue from the sale of personal care topical oilbody products. Our second non-pharmaceutical product, ImmunoSphere™, 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 aquaculture market. SemBioSys is also developing nutritional oils and animal vaccines. 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.

Partners
SemBioSys is developing and commercializing its products in partnership with leading industry partners. Partnering with companies that bring financial resources and complementary development, manufacturing and commercialization skills is a central component of our business strategy.

SemBioSys is developing insulin to serve the expanding diabetes market and to facilitate the commercialization of alternative insulin delivery technologies. Until recently, insulin could only be administered through injection;  however, with the recent approval of Pfizer’s inhaled insulin (Exhubra®) and progress in other delivery technologies, insulin will soon be increasingly administered through non-injected means.

The global market for insulin in 2005 was estimated to be US$7.3 billion and is projected to grow to US$11.8 billion by 2010. Subsequently, demand for insulin is expected to increase from the current 6,000 kilograms to 16,000 kilograms by 2012 due to growth in the incidence and diagnosis of diabetes and the commercialization of alternate delivery technologies, that require between five to twenty times more insulin per dose. Access to a new high volume supply of insulin at a reasonable price will be a key issue to meet this expansion in demand. We believe that our safflower-produced insulin will allow us to supply this expanding market and reduce the cost of insulin production compared with current production methods. We project safflower-produced insulin will reduce unit costs by 40% or more and capital costs by up to 70% through a system that can be easily scaled as demand increases.

SemBioSys has achieved commercial levels of insulin production in its commercial plant, safflower and has demonstrated its chemical, structural, and functional equivalence to US pharmaceutical grade insulin in animals. Our objective is to initiate clinical trials in late 2007 or early 2008 and then enter into one or more development or commercialization partnerships.

SemBioSys recently held a pre-IND meeting with the FDA, in which in was confirmed that the safflower-produced insulin is eligible to follow an abbreviated 505b2 drug approval process.  Discussions with the FDA also established that there were no unexpected issues about the use of safflower as a production system.  With the confirmed regulatory path to commercialization in place, we project that our safflower-produced insulin could reach the market as early as 2010.