- Canadian Biotechnology Company takes next significant step towards advancing its product to the clinic -
CALGARY, Jan. 10 /PRNewswire-FirstCall/ - SemBioSys Genetics Inc. (TSX: SBS ), a biotechnology company developing a broad pipeline of protein-based pharmaceuticals and non-pharmaceutical products, today announced that its proprietary plant-produced insulin has been demonstrated in animal models to be chemically, structurally and functionally equivalent to U.S. pharma grade human insulin. The results of analytical, in vitro and in vivo assays confirm that insulin produced in safflower, SemBioSys' commercial crop, is indistinguishable from human insulin analytically and physiologically.
"Establishing insulin equivalence is the second major scientific milestone from our insulin program in the past six months. By exceeding our commercial target levels of human insulin accumulation in safflower last July and now confirming that safflower-produced insulin is physiologically equivalent to human insulin we believe we have substantially lowered the scientific risk of our insulin program," said Andrew Baum, President and CEO. "As a result of these achievements we expect that we will be able to submit an Investigational New Drug Application (IND) later this year and initiate a Pharmacokinetic/Pharmacodynamic study of safflower-produced insulin late in the fourth quarter of 2007 or early in the first quarter of 2008, leading to an end of Phase II meeting with the FDA in 2008."
SemBioSys has confirmed the equivalence of safflower-produced insulin through analytical, in vitro, and in vivo animal assays. Chemical and structural authenticity have been confirmed through mass spectrometry and peptide fingerprint analysis. Functionality of safflower-produced insulin has been demonstrated using in vitro receptor phosphorylation assays, confirming biological activity in human cells. Finally, SemBioSys has demonstrated functional equivalence through conducting insulin tolerance testing in mice, which monitors blood glucose levels as the assay variable, confirming that there is no statistically significant difference in the pharmacodynamic response of safflower-produced insulin in comparison to Eli Lilly's Humulin® and U.S.P. insulin treatments.
"The equivalence results demonstrate that we have done what we said we were going to do, when we said we would do it, which continues to build our confidence in the insulin program. With the achievement of commercial levels of insulin accumulation in safflower and confirmation of equivalence, our ability to execute continues to be critically important, however, the overall insulin program risk has now been significantly reduced. Insulin is a well-characterized compound for which a great deal of data already exists. With these high-risk scientific achievements behind us, we now transition to the execution stage of our clinical development plan for insulin," said Mr. Baum.
The results from the equivalence testing are the most recent achievement in a series of four significant milestones events for the insulin program. In July 2006, SemBioSys exceeded its target level of insulin accumulation in safflower. In November, SemBioSys signed an agreement with Cangene Corporation to purify safflower-produced insulin from SemBioSys' seed lines under cGMP for clinical trials. Finally, earlier this month SemBioSys announced that after meeting with the U.S. Food and Drug Administration (FDA) it would proceed with an abbreviated regulatory path for safflower-produced insulin under a 505(b)(2) application. The Company expects to be in a position to submit an IND to the FDA in the second half of 2007 and to initiate a PK/PD bioequivalence study in late 2007 or early 2008 to be followed by a Phase III study in support of an NDA.
Demand for insulin for the treatment of diabetes reached an estimated 5,000 to 6,000 kilograms in 2005 and is projected to increase to 16,000 kilograms by 2012. Demand for insulin is expected to grow due to a number of issues including; earlier diagnosis of diabetes; increased diabetes incidence in the developed world due to demographic trends, as well as consumption and behavioural habits; increasing incidence in the developing world due to increasing affluence and changing dietary habits; new alternative delivery methods that require between five and ten times the amount of insulin as injection methods; and the use of insulin as a treatment for type 2 diabetes patients earlier in the treatment protocol as recommended by the consensus statement from the American Diabetes Association and the European Association for the Study of Diabetes.
SemBioSys believes its safflower-produced insulin can reduce capital costs compared to existing insulin manufacturing by up to 70% and product costs by 40% or more. Insulin currently produced using fermentation is estimated to require $200 to $250 million in capital investment for 1,000 kilograms of production capacity. 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. SemBioSys has five years of experience growing transgenic safflower in Canada, the U.S., Mexico and Chile under permits issued by the pertinent regulatory authorities.
Conference Call
SemBioSys will hold a conference call to discuss its insulin results today, January 10, 2007 at 8:30am 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) 732-6179 or 1 (416) 644-3425. A live audio webcast of the call will be available at www.sembiosys.com. The webcast will be archived for 90 days.
A replay of the conference call will also be available by telephone on January 10, 2007 through January 17, 2007. To access the replay, dial 1 (877) 289-8525 or 1 (416) 640-1917 and enter reservation number 21215902 followed by the number sign.
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. <<
[There’s no CC because SemBioSys recently held a CC to discuss the results of their transgenic-insulin program that led the FDA to allow this program to go forward via a 505b2 pathway (#msg-16099086).]
- Canadian Biotechnology Company provides update on Pharmaceutical and Non-pharmaceutical Pipeline Products -
CALGARY, March 15 /PRNewswire-FirstCall/ - SemBioSys Genetics Inc. (TSX:SBS), a biotechnology company developing insulin and other metabolic and cardiovascular protein-based pharmaceuticals and a series of non-pharmaceutical products, today announced its operational and financial results for the fiscal year which ended on December 31, 2006.
2006 Highlights
Pharmaceutical Products
- Commercial viability achieved by exceeding the Company's commercial target levels of human insulin (insulin) accumulation in safflower by 20% with 1.2 percent of total seed protein.
- Functional equivalence results demonstrated the Company's proprietary safflower-produced insulin is functionally equivalent to U.S. pharma grade human insulin in animal models, subsequent to the end of the fiscal year. The Company also announced in vitro and in vivo assay results that demonstrate the Company's safflower-produced insulin is chemically, structurally and physiologically indistinguishable from U.S. pharma grade human insulin.
- Regulatory path confirmed as 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), subsequent to the end of the fiscal year.
- Preclinical and clinical material processing secured through a Technology Transfer and Manufacturing Agreement with Cangene Corporation to prepare batches of the Company's safflower-produced insulin in preparation for the preclinical and early stage clinical development.
- Increased levels of Apo AI expression in Arabidopsis, the Company's model plant system, and continued development progress in safflower, the commercial plant system.
Non-Pharmaceutical Products
- Continued the commercial scale-up of the Company's proprietary transgenic safflower-produced ImmunoSphere(TM) Feed Additive in the U.S. and Chile in preparation for product launch expected in late 2007 or early 2008.
- Announced the completion of key milestones in its gamma linolenic acid (GLA)-rich safflower oil project with Arcadia Biosciences, Inc. with the delivery of safflower seeds from plant lines containing GLA transformed utilizing Arcadia's proprietary genes.
- Announced an agreement to acquire technology assets and in-license intellectual property from Syngenta Crop Protection AG related to the manufacture of biopharmaceuticals in safflower, which allows SemBioSys to further increase its efficiency in the development of transgenic safflower.
- Announced the Company will continue to manufacture and supply DermaSphere® to its customers in the personal care market after reaching an agreement to conclude the distribution relationship with Lonza Inc.
- Amended the collaboration agreement with Martek Biosciences Corporation, subsequent to the end of the fiscal year. SemBioSys has received a one-time license fee payment in relation to the amended agreement and agreed to a potential additional license fee and royalty payments from Martek, which in return is entitled to select an alternative seed oil production system to meet its future docosahexaenoic acid (DHA) supply.
"Over the course of 2006 and into 2007 we have delivered on four critical scientific, operational and regulatory milestones within our insulin program. In our view the insulin expression and the insulin equivalence results represent an important achievement and position us to address a large and growing market for insulin. While other projects have produced pharmaceutical proteins in plant systems, no one, to our knowledge, has been able to develop plant-produced insulin at commercially viable levels," said Andrew Baum, President and CEO of SemBioSys Genetics Inc. "We believe that with these scientific results in hand and the outcome of our meeting with the FDA that clarified the regulatory path for our plant-produced insulin, the risks associated with our insulin program have decreased significantly. Our team is now scaling-up our insulin production and completing the preclinical work necessary to file an Investigational New Drug Application (IND) later this year. We intend to initiate a Phase II trial for our safflower-produced insulin in late 2007 or early 2008 with pharmacokinetics and pharmacodynamics as the primary endpoints."
Financials
Total revenue for the fiscal year ended December 31, 2006 was $523,258 compared to $2,459,202 for the corresponding period in 2005.
The $523,258 of revenue for the fiscal year period ended December 31, 2006 consisted entirely of contract research revenue compared with contract research revenue of $1,696,171 in 2005. The difference in contract research is a result of the completion of collaboration agreements with Arcadia Biosciences Inc. and Dow AgroSciences LLC in late 2006, such that the contract research revenue from the 2006 fiscal year relates solely to the ongoing collaboration agreement with Martek Biosciences Corporation. In 2006 there were no license fees earned, as a result of the agreements with Lonza Inc. and Arcadia moving from a research and development stage to a commercialization stage, compared with license fees of $763,031 generated during the 2005 fiscal year.
Total expenditures for the year ended December 31, 2006 were $15,082,560 compared with $9,734,220 for the year ended December 31, 2005.
Research and development expenses for the fiscal year ended December 31, 2006 were $5,480,972, an increase of $1,060,086 from $4,420,886 for the 2005 fiscal year. This difference is primarily from increased personnel and the related support costs in all areas of research and development with an expanded focus on insulin. This included an enhanced quality control and assurance program and further development of a stronger preclinical and clinical team.
General and administrative expenses for the year ended December 31, 2006 were $4,013,653 compared with $3,516,871 for the 2005 fiscal year. The difference is due mainly to the expansion of the Company's indoor plant growth facilities resulting in increased operating costs such as utilities. Increases also resulted from increased staff costs, including additional support costs.
Intellectual property costs for the year ended December 31, 2006 were $3,467,045 compared with $1,586,788 for the year ended December 31, 2005. The difference is primarily due to the $1,516,906 non-cash expense in the second quarter of 2006 for the acquisition of intellectual property from Syngenta Crop Protection AG in exchange for warrants to purchase 550,000 common shares of the Company, and the US$500,000 payment to re-acquire the rights to the DermaSphere® Oleosome Technology from Lonza at the end of the fourth quarter of 2006. Excluding these one-time items, intellectual property costs decreased modestly.
Net loss for the year ended December 31, 2006 was $14,127,086 or ($0.85) per share, compared to a net loss of $6,824,545 or ($0.54) per share for 2005.
As at December 31, 2006 the Company had cash and cash equivalents totaling $16,328,459 compared to $28,513,095 at December 31, 2005. Total long-term debt at December 31, 2006 was $2,084,103 compared with $1,877,330 at December 31, 2005.
As at December 31, 2006 the Company had 16,781,890 common shares outstanding, 3,102,796 warrants, and 1,056,144 options.[It would be helpful if all companies disclosed this in their PR’s.]
Subsequent to the end of the year, on February 20, 2007 the Company completed an underwritten public offering of 4,251,496 common shares at a price of $3.00 per share, for total gross proceeds to SemBioSys of approximately $12,750,000. Concurrent with the public offering, certain shareholders of the Company sold 2,748,504 previously issued common shares of the Company at a price of $3.00 per share by way of a secondary offering. On March 7, 2007, the underwriters of the public offering exercised the entire over-allotment option and purchased an additional 1,050,000 common shares from treasury at $3.00 per common share, resulting in an additional $3,150,000 in gross proceeds to SemBioSys, raising the total gross proceeds to the Company from the transaction to $15,900,000.
Outlook
The Company has completed the major scientific milestones necessary to proceed into first-in-man clinical trials of safflower-produced insulin in late 2007 or early 2008. Upcoming milestone events expected in 2007 include:
- Complete scale-up and preclinical work of safflower-produced insulin
- Complete the technology transfer and production of clinical grade material for early stage human trials
- Initiate business development activities toward an insulin partnership
- Submit insulin IND to FDA and initiate Phase II trial
- Achieve commercial levels of Apo AI expression in safflower
- Increase production capacity of personal care topical oilbody products and establish distribution channels for commercialization
- Complete scale-up of ImmunoSphere(TM) product for commercial launch
- Achieve key DHA proof-of-concept milestone
- Initiate a new pharmaceutical product development program
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 developing insulin and other protein-based pharmaceuticals for metabolic and cardiovascular diseases. The Company's lead candidate is recombinant human insulin derived from genetically engineered safflower to serve the expanding diabetes market in the developed and developing world and to facilitate the commercialization of inhalation and other alternative insulin delivery technologies. The Company's other protein-based pharmaceutical candidate is a cardiovascular drug called Apo AI. SemBioSys is also developing a series of non-pharmaceutical products addressing animal and aquaculture health, nutritional oils and human topical markets. <<
Market Data 
Markets 
AI
