Life Sciences News Brief
Vol. 5 no.35 - November 9, 2005

Labopharm Removes Uncertainty Related to Commercialization

Labopharm Inc. (Laval) announced an agreement that will help expedite the commercialization of its once-daily tramadol (Tramadol OAD) product in the U.S. Labopharm, together with its U.S. marketing and distribution partner Purdue Pharma Products L.P., has agreed to grant a license to Ortho-McNeil Inc. (OMI), a wholly owned subsidiary of Johnson and Johnson, under certain Purdue patents covering extended release tramadol formulations. As a result, Labopharm has secured the right to a waiver, allowing the U.S. Food and Drug Administration (FDA) to grant approval of Labopharm's Tramadol OAD based on its merits, notwithstanding the three-year Hatch-Waxman exclusivity period granted to OMI's extended release formulation of tramadol, recently licensed from Biovail Corporation. Under the terms of the arrangement, Labopharm will also receive a right of reference to OMI's previously filed tramadol data.

Transition Therapeutics Acquires State-of-the-Art Drug Discovery Engine

Transition Therapeutics Inc. (Toronto) has acquired the Optimol(TM) small-molecule drug discovery technology and capital assets of Protana Inc., the result of more than $200 million of investment over the last six years. In addition, Transition has acquired a pipeline of lead drug candidates for the treatment of osteoporosis and cancer, and a discovery program identifying lead compounds to five of the most sought-after drug targets in clinical development . These assets broaden Transition's current product pipeline and should provide a steady flow of high-value drug candidates for clinical development.

REPLICor's Antiviral Drug Promises Potent Activity against H5N1

REPLICor (Laval) has discovered a family of compounds which have broad spectrum antiviral activity. REPLICor's lead compound, REP 9, has been shown to effectively treat influenza infections in mice. REP 9 has potent activity against influenza when given either in prophylaxis or as therapy. In tissue culture, REP 9 showed potent activity against over 10 strains of influenza tested to date including H1N1, H3N2 (similar to the 1918 Spanish flu and the 1968 Hong Kong flu respectively) and influenza B, demonstrating its potential application against other emergent viruses like avian flu H5N1. REP 9's mode of action is distinct from the marketed drugs Tamiflu(TM) and Relenza(TM). REP 9 prevents the entry of viruses into cells by targeting a portion of the virus common to all influenza viruses. This novel mechanism of action promises to prevent the development of drug resistant strains of influenza.

QSV Biologics and Helix Biopharma Sign Letter of Intent

QSV Biologics (Edmonton) and Helix Biopharma Corp. (Aurora) have signed a letter of intent to enter into an agreement for the process development and cGMP manufacturing of Helix's lead product L-DOS47, a novel lung cancer therapeutic currently under development. QSV will be responsible for technology transfer, process development, scale up and cGMP production in their Edmonton manufacturing facility.

ID Biomedical Provides Update on Vaccine Development Programs

ID Biomedical Corporation (Vancouver) provided an update on two of its lead vaccines in clinical development: FluINsure(TM), a non-living intranasally delivered influenza vaccine, and StreptAvax(TM), a subunit protein-based vaccine against group A streptococcal diseases. ID Biomedical announced that it has obtained clearance from Health Canada to begin the first pediatric study of the FluINsure vaccine. This Phase II study will be conducted at three centers in Canada in 160 healthy children, aged 3 to 12 years old. The study will be blinded, randomized, and placebo-controlled and will evaluate safety and immunogenicity of one-dose and two-dose regimens of the vaccine. Enrollment for the study has begun.

PREVU study to examine skin sterol and risk of heart attack

PreMD Inc. (Toronto) announced the start of a 600-person study that will further examine the relationship between skin tissue cholesterol (sterol) and carotid intima media thickness (CIMT), which is an established predictor of heart attack and stroke. The study, Predictor of Advanced Subclinical Atherosclerosis (PASA), is expected to provide data to support broader regulatory clearance for PREVU Point of Care (POC) Skin Sterol Test as a tool to identify asymptomatic patients at risk of a primary event, such as heart attack.

Cheek Cells Used to Identify Lung Cancer

A novel test for lung cancer uses inner cheek cells to identify the disease in high-risk patients. In a new study presented at CHEST 2005, the 71st annual international scientific assembly of the American College of Chest Physicians (ACCP), scientists found that buccal mucosa, or cells scraped from the inner part of the cheek, may contain information that separates patients with lung cancer from high-risk negatives, a finding that may support cheek cell analysis as a simple and inexpensive early screening method for patients at risk for lung cancer. "Previous research has shown that cell nuclear changes can extend a significant distance from the site of a malignancy. We have already conducted a successful clinical trial for our sputum test for lung cancer. New data suggest that the effects of lung cancer can also be measured as far away as skin cells in the mouth," said lead researcher Bojana Turic, MD, Director of Clinical and Regulatory Affairs, Perceptronix, Inc, Vancouver, BC, Canada. "Although a clinical test based on buccal cells is still in development, the method of analyzing cheek cells to detect cancer is showing interesting results."

WorldHeart announces first Novacor(R) LVAS implant in Greece

World Heart Corporation (Ottawa), a global technology leader in mechanical circulatory support systems, announced that at the Onassis Cardiac Surgery Center in Athens, Greece, a heart-failure patient became the first Greek patient to be implanted with the Novacor LVAS and discharged to his home while waiting for a heart transplant. On August 2, 2005, a 53 year old male diagnosed with dilated cardiomyopathy and pulmonary hypertension became the first patient in Greece implanted with a Novacor LVAS. Following an uneventful period of recuperation the patient was recently discharged with the Novacor LVAS.

WorldHeart Announces Ethics Committee Approval

World Heart Corporation (Ottawa), a global technology leader in mechanical circulatory support systems, announced that it was notified by the Ethics Committee of St. Luke's Hospital, Thessaloniki, Greece of its approval to proceed with the clinical feasibility study of WorldHeart's rotary ventricular assist device (VAD). The clinical trial is expected to begin in early 2006, pending completion of preclinical testing and acceptance of the clinical investigation application by the Greek Ministry of Health. The feasibility study will primarily evaluate the hemodynamic performance of WorldHeart's next-generation rotary system.

Angiotech to acquire vascular graft product line from Edwards Lifesciences

Angiotech Pharmaceuticals, Inc. (Vancouver) announced that it has entered into a definitive agreement to acquire the Lifespan(R) ePTFE vascular graft business, located in Laguna Hills, California, from Edwards Lifesciences Corporation for $14 million in cash. The transaction is subject to approval from Edwards Lifesciences' board of directors. The agreement includes a distribution arrangement with Edwards, whereby Edwards will retain certain rights to distribute the existing Lifespan product line globally for a period of up to five years as well as become the exclusive distributor of Angiotech's Vascular Wrap(TM) paclitaxel-eluting mesh products as packaged in combination with the Lifespan vascular graft products in the European Union for a period of up to three years following regulatory approval.

Norgen Expands its DNA Purification Product Line

Norgen Biotek Corp., (St. Catherines) an innovative Canadian biotechnology company focusing principally on advancing powerful tools for nucleic acid and protein purification, announced the expansion of its nucleic acid line of products by launching four new kits: Urine DNA Isolation Kit, Low-Copy Plasmid MiniPrep Kit, BAC DNA MiniPrep Kit, and Bacterial Genomic DNA Isolation Kit. Norgen now offers nearly two dozen kits for genomics and proteomics research applications. In particular, the Urine DNA Isolation Kit provides a fast, reliable and simple procedure for isolating DNA from urine.

DiagnoCure signs license agreement with Genzyme

• Patheon Inc. (Toronto) announced that it will be proceeding to put in place new credit facilities in the aggregate amount of $290 million to refinance existing debt of Patheon Inc. and its U.S. subsidiaries including its subsidiaries in Puerto Rico……
• AnorMED Inc. (Vancouver) announced that the United States Securities & Exchange Commission has declared the Company's registration statement on Form 40-F effective on November 3, 2005. In addition, AnorMED has received approval for the listing of its common shares on the American Stock Exchange. AnorMED's shares will begin trading on the AMEX on November 4, 2005 under the stock symbol AOM…….
• Biophage Pharma Inc. (Montreal), a leading innovator of phage-based biosensors for live pathogen diagnostics, announced that it has received notification from the Natural Sciences and Engineering Research Council of Canada (NSERC) of an important award as part of a consortium of co-investigator headed by Ecole Polytechnique de Montréal (Campus of the University of Montreal) with Dr Sylvain Martel acting as the Principal Investigator. The total cost of the project is estimated at $748,500……
• Isotechnika Inc. (Edmonton) announced that effective immediately the Company will separate the position of Chairman and Chief Executive Officer, currently held by Dr. Robert Foster and reduce the number of insiders on the Board of Directors……
• Vasogen Inc. (Toronto), a leader in the research and commercial development of technologies targeting chronic inflammation underlying cardiovascular and neurological disease, is pleased to announce the appointment of Terrance H. Gregg as Vice Chairman of its Board of Directors. Mr. Gregg joined Vasogen's Board of Directors in 1999 and has been the Chair of the Company's Compensation, Nominating, and Corporate Governance Committee for the past several years…….
• The Westaim Corporation (Calgary) announced that it is planning to pursue an initial public offering of the common shares of its NUCRYST Pharmaceuticals subsidiary. It is anticipated that all of the shares will be newly issued shares sold by NUCRYST and that Westaim will not sell any of its NUCRYST shares. NUCRYST plans to raise capital through the offering for: construction of new production facilities and purchase of equipment; clinical trials and other research and development; working capital and other general corporate purposes; and to repay a portion of its debt owed to Westaim. Westaim expects that the offering will occur within the next six months and will be made primarily in the United States. Westaim also expects that it will continue to maintain a controlling interest in NUCRYST following the offering……
• Lorus Therapeutics Inc. (Toronto), a biopharmaceutical company specializing in the development and commercialization of pharmaceutical products and technologies for the management of cancer, announced the reduction of staff by approximately 35%……
• Response Biomedical Corp. (Vancouver), announced that, upon the expiry of its current US$1,000,000 revolving demand credit facility effective on December 30, 2005, the Company has made provisions with Mr. Hans E. Moppert, its largest shareholder who owns approximately 10% of the Company's issued and outstanding shares, to guarantee another otherwise identical line of credit established under the same terms with a six month expiry date effective June 30, 2006……
• Stressgen Biotechnologies (Victoria) announced that it has completed its previously announced offering of 7,500,000 units. The Company sold a total of 7,645,000 units for gross proceeds of $2,675,750. ….
• VSM MedTech Ltd. (Vancouver), world leader in the emerging clinical market for magnetoencephalography (MEG) functional brain imaging systems, is the fastest growing technology company in British Columbia, according to the October 25, 2005 issue of the weekly newspaper Business in Vancouver. The first place finish is based on VSM's outstanding five-year revenue growth.

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