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Operational Highlights
Pharmaceutical Products
- Successfully developed commercially viable levels of both
apolipoprotein AI (Apo AI) and apolipoprotein AI Milano
(Apo AI(Milano)) in safflower seed.
- Demonstrated the functional equivalence of the Company's proprietary
safflower-produced insulin to U.S. pharma grade human insulin in
animal models.
- Demonstrated with in vitro and in vivo assay studies that the
Company's safflower-produced insulin is chemically, structurally and
physiologically indistinguishable from U.S. pharma grade human
insulin.
- Confirmed the Company is eligible to pursue a Section 505(b)(2)
regulatory path for safflower-produced insulin after meeting with the
U.S. Food and Drug Administration (FDA).
- Continued the necessary preclinical work, including preparations for
an animal toxicology study, to submit an Investigational New Drug
application (IND) to the FDA in order to initiate a Phase I/II trial
for safflower-produced insulin in the second half of 2008.
Non-pharmaceutical Products
- Established Botaneco, a subsidiary dedicated to the commercialization
of SemBioSys' non-transgenic oilbody products for the cosmetics,
personal care and prescription topical dermatology markets.
- Commissioned Botaneco's 10,000 square foot, state-of-the-art,
commercial scale manufacturing facility located in Calgary.
- Launched Hydresia(TM), Botaneco's first branded line of natural
oilbody-based ingredients, and subsequently signed the Company's first
national brand customer, Burt's Bees, the largest natural personal
care company in North America. Subsequent to the end of the year,
Burt's Bees launched three pr
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| SOURCE SemBioSys Genetics Inc. Copyright©2008 PR Newswire. All rights reserved |