[SemBioSys is interesting for a couple of reasons: 1) the project to make insulin in safflower plants (#msg-12155688); and 2) the venture to help MATK lower the cost of making docosahexaenoic acid (DHA), which MATK now produces from algae at high cost.]
- Canadian Biotechnology Company on track to demonstrate bio-equivalence of safflower-produced insulin -
CALGARY, Aug. 4 /PRNewswire-FirstCall/ - SemBioSys Genetics Inc. (TSX:SBS), a biotechnology company developing a broad pipeline of protein-based pharmaceuticals and non-pharmaceutical products, today announced its 2006 second quarter operational and financial results.
Second Quarter Highlights
- Achieved its commercial target levels of human insulin accumulation in safflower with 1.2 percent of total seed protein, exceeding its target of one percent total seed protein by 20 percent, subsequent to the end of the quarter.
- Announced the completion of key milestones in its GLA rich safflower oil project with Arcadia Biosciences, Inc. with the delivery of safflower seeds from plant lines containing gamma linolenic acid (GLA), transformed utilizing Arcadia's proprietary genes.
- Announced an agreement with Syngenta Crop Protection AG to acquire technology assets and in-license intellectual property related to the manufacture of biopharmaceuticals in safflower, which allow SemBioSys to further increase its efficiency in the development of transgenic safflower.
- Successfully planted safflower in the United States as part of the commercial scale-up of ImmunoSphere(TM) Feed Additive.
"Achieving commercial levels of insulin accumulation in safflower is the most significant milestone for the Company to date. We expect to have results from bioequivalence studies in animals comparing safflower-produced insulin to commercially available insulin in the fourth quarter of this year," said Andrew Baum, President and CEO of SemBioSys Genetics Inc. "We believe safflower-produced insulin can dramatically impact the economics of insulin manufacturing and act as an enabling technology in two ways. Safflower-produced insulin has the potential to be a cost-effective method to meet the increased demand for insulin required by new delivery methods, such as inhalation, which requires five to ten times the insulin as injectable methods. Safflower-produced insulin also has the potential to provide insulin to people in the developing world, who otherwise would not have access to it because there is not enough supply or they cannot afford it."
Financials
Total revenues for the three-month and six-month periods ended June 30, 2006 were $167,445 and $267,531 respectively, compared with $561,697 and $1,048,414 for the corresponding periods in 2005. In 2006 there were no license fees earned compared with $248,126 and $375,304 generated during the three-month and six-month periods ended June 30, 2005 as a result of the agreements with Lonza Inc. and Arcadia Biosciences, Inc. moving from a research and development stage to a commercialization stage. In addition, the difference related to contract research is a result of the completion of collaboration agreements with Dow AgroSciences LLC and Arcadia since 2005, such that the contract research revenue from the second quarter of 2006 relates primarily to only the ongoing collaboration agreement with Martek Biosciences Corporation.
Total expenditures for the three-month and six-month periods ended June 30, 2006 were $5,007,483 and $7,756,437 respectively, compared with $2,233,213 and $4,225,619 for the corresponding periods last year.
Research and development expenses for the three-month and six-month periods ended June 30, 2006 were $1,375,635 and $2,483,161, compared with $1,202,242 and $2,079,568 for the corresponding periods last year. The difference is primarily related to the continued development of a stronger preclinical and clinical team to allow the Company to further advance the insulin program, and prospective future pipeline candidates. The Company also expanded the plant growth team and infrastructure both indoors and in the field.
General and administrative expenses for the three-month and six-month periods ended June 30, 2006 were $819,659 and $1,791,919 respectively, compared with $857,973 and $1,698,388 for the corresponding periods last year.
Intellectual property costs for the three-month and six-month periods ended June 30, 2006 were $2,081,258 and $2,344,295 respectively, compared with $240,160 and $448,760 for the corresponding periods last year. This difference is primarily attributable to the acquisition of technology assets and in-licensing of intellectual property from Syngenta. In exchange for these assets the Company issued warrants that allow Syngenta to purchase an aggregate of 550,000 common shares of SemBioSys at an exercise price of $13.21 per share. This resulted in a charge to intellectual property expense of $1.52 million during the second quarter, which is consistent with the Company's accounting policy of expensing these costs as incurred. The term of the warrants is five years. The warrants are not listed on the Toronto Stock Exchange.
Business development costs for the three-month and six-month periods ended June 30, 2006 were $267,292 and $452,097 respectively, compared with $181,191 and $238,490 for the corresponding periods last year. The difference is primarily related to accelerated activities related to the commercialization of the Company's products and a further assessment of new product candidates.
Net loss for the 2006 second quarter was $4,608,182 or ($0.28) per share, compared to a net loss of $1,558,076 or ($0.12) per share for the same period last year. Net loss for the six-month period ended June 30, 2006 was $7,112,521 or ($0.43) per share compared with $2,953,934 or ($0.23) for the same six-month period last year.
As at June 30, 2006 the Company had cash and cash equivalents totaling $22,874,534 compared to $28,513,095 at December 31, 2005.
Outlook
The Company's priorities for 2006 are to complete bioequivalence studies of safflower-produced insulin and to advance the development of its non-pharmaceutical products, including ImmunoSphere(TM) and docosahexaenoic acid (DHA) rich safflower oil. With the experience gained from the successful completion of insulin accumulation in safflower the Company now expects commercial levels of expression results in safflower of apolipoprotein AI (Apo AI) in late 2006 or early 2007. The upcoming milestone events expected in 2006 include:
- Bioequivalence results comparing safflower-produced insulin to commercially available insulin products
- Initiation of a new pharmaceutical product development program
- Scale-up of ImmunoSphere(TM) product in the United States and Chile for commercial launch in late 2007
- Achievement of key DHA proof-of-concept milestone
Additional information about the Company, including the MD&A and financial results may be found on SEDAR at www.sedar.com.
About SemBioSys Genetics Inc. (www.sembiosys.com)
Calgary, Alberta-based SemBioSys Genetics Inc. is a biotechnology company focused on the development, commercialization and production of biopharmaceuticals and non-pharmaceutical products based on its plant genetic engineering skills and proprietary oilbody-oleosin technology platform - the Stratosome(TM) Biologics System. Its two lead pharmaceutical product candidates are insulin and a developmental cardiovascular drug called Apo AI. It also has a series of non-pharmaceutical products addressing animal and aquaculture health, nutritional oils and human topical markets. SemBioSys currently has funded partnership agreements with Martek Biosciences Corporation, Lonza Inc. and Arcadia Biosciences, Inc. <<
FDA OKs 505b2 Pathway for Transgenic-Plant Insulin
[SemBioSys is trying to do with transgenic plants what GTCB is doing with transgenic mammals: produce drugs more cheaply than is possible with conventional manufacturing. However, a key difference between SemBioSys’ lead program and GTC’s programs is that SemBioSys is making insulin, a simple protein that is non-glycosylated, while GTC is making complex proteins. In other words, SemBioSys’ path to approval ought to be relatively simple, but its technology platform is much more limited in scope than GTC’s.]
>> SemBioSys to proceed with abbreviated regulatory path for plant-produced insulin after meeting with the FDA
Wednesday January 3, 7:00 am ET
- Canadian Biotechnology Company shortens clinical timelines by eliminating duplicative insulin trials -
CALGARY, Jan. 3 /PRNewswire-FirstCall/ - SemBioSys Genetics Inc. (TSX: SBS ), a biotechnology company developing a broad pipeline of protein-based pharmaceuticals and non-pharmaceutical products, today provided an update on the expected regulatory strategy for the Company's plant-produced insulin after a recent meeting with the U.S. Food and Drug Administration (FDA). The preparatory meeting for the Company's Investigational New Drug Application (IND) for plant-produced insulin was scheduled as part of the normal development process. SemBioSys approached the FDA to confirm the viability of submitting plant-produced insulin under Section 505(b)(2) of the Food, Drug, and Cosmetic Act in order to achieve approval for a New Drug Application.
"Based on the discussions with the FDA and the agreed upon minutes from the meeting we will continue to pursue a 505(b)(2) regulatory path for our plant-produced insulin," said Andrew Baum, President and CEO of SemBioSys Genetics Inc. "When we completed our initial public offering in 2004, the regulatory path for follow-on proteins remained relatively uncertain. Insulin is a comparatively simple protein for which an extensive amount of clinical data on safety and efficacy already exists. Providing that our plant-produced insulin is sufficiently pure and clinically equivalent to commercially available insulin, the meeting confirmed the 505(b)(2) regulatory approach is an appropriate path for approval. During our discussion with the Agency we also established that there were no issues precluding the use of safflower as a production vehicle. Now that the regulatory path for our safflower-produced insulin candidate is established, another element of risk has been removed from our development plan."
In July 2006, SemBioSys exceeded its targeted levels of insulin expression in safflower, the Company's commercial crop system, by achieving 1.2 percent insulin accumulation of total seed protein. In November, the Company announced that it had executed a preclinical and early stage clinical manufacturing supply agreement with Cangene Corporation. SemBioSys expects to receive in vivo and in vitro biochemical and functional equivalence results comparing insulin produced from safflower to commercial insulin products early in 2007. The biochemical and functional equivalence results together with additional preclinical work underway will form the basis of SemBioSys' IND which it expects to submit to the FDA in the fourth quarter of 2007. SemBioSys intends to initiate a Phase II trial of safflower-produced insulin in late 2007 or early 2008 with pharmacokinetics and pharmacodynamics as the primary endpoints.
Demand for insulin for the treatment of diabetes reached an estimated 5,500 kilograms in 2005 and is projected to increase to 16,000 kilograms by 2012. SemBioSys believes its safflower-produced insulin can reduce capital costs compared to existing insulin manufacturing by 70% and product costs by 40% or more. In addition, because of the ease in scaling-up crop acreage, plant-produced insulin offers significant improvements in the flexibility and speed of scale-up.
About 505(b)(2) Application
An application submitted under section 505(b)(2) of the Food, Drug, and Cosmetic Act comprises an application for approval for a drug for which one or more of the investigations relied on by the applicant were not conducted by or for the applicant and for which the applicant has not obtained a right of reference or use from the sponsor applicant by or for whom the investigations were conducted. The 505(b)(2) pathway is intended to encourage innovation in drug development without requiring duplicative studies to demonstrate what is already known about a drug while protecting the patent and exclusivity rights for the approved drug. Eliminating the need to conduct certain duplicative clinical studies can reduce the number of clinical studies, number of human patients and/or clinical timelines in comparison to the clinical program required. An example of a 505(b)(2) is a naturally derived or recombinant active ingredient application for a drug product containing an active ingredient(s) derived from animal or botanical sources or recombinant technology where clinical investigations are necessary to show that the active ingredient is the same as an active ingredient in a listed drug.
About SemBioSys Genetics Inc. (www.sembiosys.com)
Calgary, Alberta-based SemBioSys Genetics Inc. is a biotechnology company focused on the development, commercialization and production of biopharmaceuticals and non-pharmaceutical products based on its plant genetic engineering skills and proprietary oilbody-oleosin technology platform - the Stratosome(TM) Biologics System. Its two lead pharmaceutical product candidates are insulin and a developmental stage cardiovascular drug called Apo AI. It also has a series of non-pharmaceutical products addressing animal and aquaculture health, nutritional oils and human topical markets. <<
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