Canadian Biotechnology Company hits key insulin and Apo AI(Milano)
milestones
TSX symbol: SBS
CALGARY, Aug. 5 /PRNewswire-FirstCall/ - SemBioSys Genetics Inc. (TSX:SBS), a biotechnology company developing a portfolio of therapeutic proteins for metabolic and cardiovascular diseases, today announced its 2008 second quarter financial and operational results.
Highlights
Insulin Program
- Submitted an Investigational New Drug Application (IND) for
safflower-produced insulin to the U.S. Food and Drug Administration
(FDA), subsequent to the end of the quarter.
- Met with the European Medicines Agency (EMEA) to agree upon a
clinical development strategy designed to allow simultaneous European
and U.S. submissions for safflower-produced insulin.
Apo AI Program
- Demonstrated that safflower-produced Apo AI(Milano) is functional, by
measuring increased cholesterol mobilization, in a widely accepted
animal model.
Botaneco
- Received $4 million in funding from Avrio Ventures Limited
Partnership in the form of a convertible debenture to accelerate the
commercialization of Hydresia(TM) products from Botaneco Specialty
Ingredients Inc., a SemBioSys subsidiary.
Outlook
SemBioSys intends to follow its recent IND application with the submission of a Clinical Trial Application (CTA) to the appropriate European authorities later in the third quarter of this year. In order to meet both FDA and EMEA requirements, the Company plans to conduct a Phase I/II clinical trial wherein safflower-produced insulin is compared to both U.S. and European-sourced reference insulin. The upcoming insulin milestone events include:
- Complete production of clinical grade insulin supply for use in Phase
I/II human clinical trials.
- Upon CTA approval, initiation of a single-dose Phase I/II clinical
trial of safflower-produced insulin in the United Kingdom in the
fourth quarter of 2008.
- Continuation of business development activities toward an insulin
partnership.
In 2007, SemBioSys successfully achieved commercial levels of both Apo AI and Apo AI(Milano) accumulation in safflower. With positive results demonstrating safflower-produced Apo AI(Milano) increased cholesterol mobilization in animals earlier this year, SemBioSys is continuing testing in animals to establish that safflower-produced Apo AI(Milano) is equivalent to microbial-produced Apo AI(Milano) with respect to plaque-remodeling and plaque regression. The upcoming milestone events include:
- Completion of in vivo efficacy studies of plaque remodeling with
safflower-produced Apo AI(Milano) followed by studies of plaque
regression using a mouse model.
- Continuation of the formal partnering process for safflower-produced
Apo AI(Milano). The Company has already initiated confidential
discussions with several potential large pharmaceutical partners.
In addition to its pharmaceutical milestones, SemBioSys also expects to collect milestone payments from Arcadia Biosciences, Inc., upon their successful commercial scale-up and market launch of High GLA Safflower Oil in late 2008 or early 2009.
Meanwhile, Botaneco is also advancing the development of its personal care ingredient products with the expansion of the commercial distribution of Hydresia(TM) and Hydresia(TM) G2. With the completion of the recent funding transaction with Avrio, along with the previously committed $2.4 million from AVAC Ltd., SemBioSys expects Botaneco to be self-financing moving forward.
'The progress we have made with our two lead pharmaceutical programs, insulin and Apo AI(Milano), over the past few months has transformed SemBioSys. We are now poised to have insulin enter the clinic later this year as the first recombinant human protein produced from safflower to advance into human trials, which addresses a component of the largest volume drug protein market in the world. The animal results we received demonstrating safflower-produced Apo AI(Milano) successfully increased cholesterol mobilization were a critical milestone for the Company. With these data in hand, we are now able to intensify our formal partnering process for Apo AI(Milano) in parallel to the execution of additional animal studies designed to show plaque remodeling and plaque regression. We are already engaged in discussions with several major pharmaceutical companies concerning this program,' said Andrew Baum, president and chief executive officer of SemBioSys. 'As we advanced each of our pharmaceutical programs we also made important operational progress with our subsidiary, Botaneco. The funding from AVAC and Avrio provides Botaneco with the financial independence to pursue commercial opportunities on its own, while SemBioSys focuses its resources on advancing the insulin and Apo AI(Milano) programs.'
Financials
Prior to the third quarter of 2007, SemBioSys operated under one segment. During the third quarter of 2007, Botaneco completed construction of its manufacturing facility and SemBioSys began to operate in two reportable segments: (i) the Biopharmaceutical, Animal Health and Nutritional Oils segment focused on the Company's lead pharmaceutical candidates, recombinant human insulin and Apo AI(Milano) and (ii) the Specialty Ingredients segment. As of October 1, 2007, Botaneco Specialty Ingredients Inc. was established as a separate legal entity, and SemBioSys' previously dormant U.S. subsidiary, SemBioSys Inc., was renamed as Botaneco Inc.
Total revenue for the three and six-month periods ended June 30, 2008 was $62,207 and $272,234 respectively, compared with $459,407 and $1,002,195 for the corresponding periods in 2007. The difference is due mainly to a license fee payment earned from the Company's collaboration agreement with Martek BioSciences Corporation in the first half of 2007 which is partially offset by 2008 product sales revenue from Hydresia(TM) and the option payment received from INDEAR S.A.
Total expenditures for the three and six-month periods ended June 30, 2008 were $6,542,258 and $11,799,869 respectively, compared with $4,046,723 and $7,990,131 for the corresponding periods last year.
Research and development expenses for the three and six-month periods ended June 30, 2008 were $3,357,683 and $6,151,786, compared with $1,924,745 and $3,668,717 for the corresponding periods last year. The difference is primarily related to the shift in the stage of development of the Company from research to preclinical development of two major drug candidates, which requires significant external resources to advance and prepare for the upcoming clinical trials.
