Life sciences news briefs (September 17, 2003)

Ottawa, ON September 17, 2003 The following life sciences news briefs were recently published by Industry Canada.

1) Pharmaceuticals Update

AnorMED Phase I trial for AMD070, a CXCR4 HIV entry inhibitor

AnorMED (Vancouver) announced that it has initiated enrollment into a Phase I trial in healthy volunteers to evaluate the safety of AMD070 for the treatment of HIV infection. AMD070 targets the CXCR4 chemokine receptor and prevents HIV from entering and infecting healthy cells. CXCR4 and CCR5 inhibitors belong to the new investigational class of antiretroviral drugs known as HIV entry inhibitors. ACTG is the largest HIV trials organization in the world and has played a key role in providing important data for HIV/AIDS treatment and prevention strategies. The ACTG is composed of, and directed by, leading clinical scientists in HIV/AIDS therapeutic research that is supported by grants from the Division of AIDS, a division of the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health, US Department of Health and Human Services. CXCR4 is a chemokine receptor. Chemokine receptors expressed on the surface of immune cells are known to play a critical role in virus infection and transmission. CXCR4, and another chemokine receptor CCR5, are involved in HIV infection. In order to enter and infect cells, HIV must bind to either the CXCR4 or CCR5 chemokine receptor. Different strains of HIV prefer one receptor or the other, or may use either receptor to infect cells. An infected individual may harbor different levels of both CXCR4 and CCR5-using strains.

Axcan licenses ITAX from Abbott Laboratories

Axcan Pharma (Mont Saint Hilaire) announced that it has acquired an exclusive license for North America, the European Union (including the United Kingdom, France, Germany, Italy and Spain) and Latin America, from Abbott Laboratories to develop, manufacture and market, ITAX (Itopride hydrochloride), a patented oral gastroprokinetic drug with antiemetic properties for the treatment of gastrointestinal symptoms caused by reduced gastrointestinal motility. If ITAX is approved by health authorities, management believes that, based on the factors discussed below, within 3-5 years after full launch, sales of ITAX could generate annual revenue of approximately US $200-300 million and have a significant impact on net earnings. Cisapride was removed from the market in 2000 after achieving 1999 annual sales of over $1 billion, due to adverse events.

Theratechnologies enters agreement in diabetes with Johnson & Johnson

Theratechnologies (Montreal) announced that it has signed a research collaboration and licensing agreement with Johnson & Johnson Pharmaceutical Research & Development involving its ExoPep platform for the development of a therapeutic peptide in the field of diabetes. This partnership agreement with a major pharmaceutical company is the first based on this original platform technology. Under the terms of the agreement, which provides for research and regulatory milestone payments as well as royalties, the companies will collaborate to discover a lead compound for an undisclosed target. All development and marketing activities will be conducted by Johnson & Johnson Pharmaceutical Research & Development.

2) Diagnostics and Therapeutics Update

SYN X forms international heart failure research collaboration

SYN X Pharma (Toronto) announced that five of the world’s leading cardiologists and scientists have formed a congestive heart failure (CHF) advisory group to be known as the International Heart Failure Research Collaboration. Its purpose is to identify and communicate the highest standards of CHF research and diagnosis for practitioners in cardiac care in a global context. This initiative is part of SYN X Pharma’s overall goal to improve cardiac care around the world. SYN X has developed Nexus Dx CHF, a unique and powerful point-of-care diagnostic tool, soon to be marketed in Europe following regulatory approval. Nexus Dx CHF promises quicker results and the choice of either a quantitative or qualitative format. The group recently held its inaugural meeting in Toronto. Its founding members are: Dr Adolfo de Bold, Dr John Cleland, Dr Mark Richards, Dr Jean Rouleau, and Dr Eric Stanton.

Cardiome to present clinical data at heart failure meeting

Cardiome Pharma (Vancouver) reported that it will present clinical data from its Exotic clinical study at a satellite symposium to the Heart Failure Society of America meeting on September 21, 2003. The Exotic (European xanthine oxidase inhibitors trial in cardiac disease) study measures the impact of oxypurinol in reversing coronary arterial constriction associated with heart disease. The intravenous dosing, open-label study is being conducted in up to 20 patients at the Eppendorf Clinic at the University of Hamburg.In the Exotic study, subjects catheterized for other reasons are dosed with intravenous oxypurinol following administration of a vasoconstricting drug. Vasoconstriction is commonly associated with various forms of heart disease, including congestive heart failure. It has been suggested that xanthine oxidase inhibitors can to some degree restore normal vascular function in such vasoconstricted patients, thereby permitting greater supply of blood to the heart muscle. The Exotic study is intended to test that hypothesis using oxypurinol. Such activity of oxypurinol is expected to be additional to its direct effects in improving cardiac muscle performance.

Data from Biomira’s Theratope vaccine clinical trial

Biomira (Edmonton) announced that data from the final analysis of its Theratope Vaccine Phase III clinical trial in metastatic breast cancer will be presented at the 26th Annual San Antonio Breast Cancer Symposium (SABCS) being held at the Henry B Gonzalez Convention Center in San Antonio, December 3 – 6, 2003. This international symposium is the largest breast cancer medical conference in the world. David W Miles, MD, BSc, FRCP, senior lecturer and honorary consultant in medical oncology at Guy’s Hospital in London, England and principal clinical investigator in the trial will present the results in an oral presentation. The presentation is scheduled to be during general session No 5, on Saturday, December 6, 2003, which is planned to be held from 9:30 to 11:30 a.m. Central Time. Theratope is an investigational therapeutic cancer vaccine designed to stimulate an immune response to the tumour associated STn marker. Over 1,500 patients have been enrolled in clinical trials of the vaccine. Phase I and II clinical trials have tested the vaccine in a number of cancer indications, including breast, ovarian and colorectal cancers. The Phase III trial involved 1,030 women with metastatic breast cancer.

Cangene and Acambis to develop West Nile virus hyperimmune

Cangene (Toronto) announced that it has entered a collaborative research and development agreement with Acambis develop and manufacture a hyperimmune globulin for treating and preventing infection by West Nile virus (West Nile immune globulin; WNIG). The companies will share development and funding for the project. Acambis will provide its investigational ChimeriVax-West Nile vaccine, qualified product-assay technology and testing for efficacy of the WNIG. Cangene will collect plasma, and develop and manufacture the product using its established manufacturing process in its Winnipeg facility. A hyperimmune globulin against West Nile may be used to treat people who have become infected with the virus and to give immediate protection to immunocompromised individuals, such as the elderly, whose immune systems may not be able to generate a sufficient immune response.

3) Medical Devices

Cedara I-Reach, a new breakthrough in web-based PACS viewing

Cedara Software (Toronto), a leading independent developer of medical software technologies for the global healthcare market, today unveiled Cedara I-Reach v3.0, its new breakthrough medical image viewer for h
ealthcare professional who want full PACS (Picture Archive and Communications System) functionality over the Internet. I-Reach 3.0 enables hospitals and clinics to acquire, distribute and archive medical images and diagnostic reports across the Internet, representing a major step forward for hospitals seeking a fully web-based PACS implementation. Specialists can plan treatment whether working within the hospital or from a remote location. Referring physicians have instant access to patients’ images via I-Reach’s web viewing application which employs the DICOM digital format standard that enables medical imaging devices to exchange images and patient information. The addition of role-based access privileges ensure that physicians obtain access to authorized images only, preventing unwanted access to patient information.

TSO3 obtains FDA authorization

TSO3 (Quebec City) announced that the company has obtained the authorization of the US Food and Drug Administration (FDA) for the commercialization of its 125L ozone sterilizer as well as the chemical indicator that accompanies it. The sterilization process developed by TSO3 uses ozone as the sterilizing agent. The first product based on this technological platform is the 125L ozone sterilizer, intended for hospital sterilization units. The 125L ozone sterilizer (with a 125-litre / 4.3-cu ft capacity) was designed to allow the sterilization of the new generation of surgical and diagnostic instruments made of materials – especially polymers- that are not heat resistant. The ozone sterilization process is a safe, effective, fast and cost-effective response to new sterilization needs. The chemical indicator looks like a small sticker and has a chromaphore which changes colour when the required sterilization parameters have been met. This sticker, about 13 sq cm (2 sq in), is essential to the commercialization of the 125L ozone sterilizer from TSO3, as a method of validation is required by the authorities for any sterilization process.

4) Industry Update

MedMira (Halifax) announced that it has completed the first major milestone following the approval this past April of the Reveal Rapid HIV-1 antibody test for the US healthcare market. Last week, the company surpassed 250,000 units shipped to its American distributor.

World Heart (Ottawa) announced today that discussions are continuing with its lenders regarding a further extension of the September 2, 2003 maturity date of its senior and subordinated loans, and it expects to reach agreement on an extension, which will facilitate completion of permanent funding.

The Arthritis Society announced that a select group of researchers and specialists will get a funding infusion of $5.5 million in 2003-2004, through the society’s research and career development program. A total of 33 new grants were awarded this year to scientists and physicians across Canada, adding to the 57 awards that continue to be funded from previous years.

Angiometrx, a division of Medical Ventures (Vancouver), announced that it has entered into an agreement with GM Medical Pacific to distribute Metricath System products in Asia.

Isotechnika (Edmonton) Chairman and CEO, Dr Robert Foster announced today the appointment of Prakash Gowd as Director of Investor Relations and Corporate Communications.

Viventia Biotech (Toronto) announced that it has entered into an agreement with a European wholly owned subsidiary of Teva Pharmaceutical Industries providing for a private placement equity financing for $2.8 million (CDN).

Cardiome Pharma (Vancouver) announced that is has entered into a bought deal agreement with a syndicate of underwriters led by Orion Securities and Sprott Securities, and including BMO Nesbitt Burns, First Associates Investments, Raymond James, and Research Capital Corporation. Under the agreement, the syndicate has agreed to purchase 3,810,000 common shares at a price of $5.25 per common share, resulting in gross proceeds to the company of $20,002,500

Life Sciences News Brief is prepared by Armar International for the Life Sciences Branch of Industry Canada (contact: Paul Vaillancourt; Telephone: (613) 952-7700; E-mail: vaillancourt.paul@ic.gc.ca).