Ottawa, ON — September 5, 2003 — The following life sciences news briefs were recently published by Industry Canada:
1) Pharmaceuticals Update
Biovail receives administrative inquiry
Biovail (Toronto) announced that it has received notification that the US Office of the Inspector General (OIG) of Health and Human Services has initiated a preliminary administrative inquiry into the company’s clinical experience and marketing programs related to Cardizem LA. Biovail will be working with the OIG to respond appropriately to this request for information. Biovail said that it has a warranty from the internationally prominent organization that developed and implemented the program that it complies with all laws and regulations, as well as opinions from both legal and other advisors that the program is compliant. Accordingly, Biovail said that it and its advisors are confident that its clinical experience and marketing programs are fully compliant with all regulatory guidelines and requirements.
Resverlogix expands intellectual property portfolio for tumour suppression
Resverlogix (Calgary), announced that it has been assigned a filed patent application covering a promising cancer therapeutic technology. Due to the advanced research stage of this important new technology, Resverlogix will be able to immediately commence licensing opportunities in a timely and efficient manner. Resverlogix’s other major technology, upgrading cholesterol reduction through red wine compounds, is also set to move into commercial licensing discussions early this fall.
US start-up NemaRx relocates to Calgary
Inno-centre Alberta (ICA) has reeled in a highly promising US pharmaceutical start-up to its business development mentoring program. NemaRx Pharmaceuticals (formerly NemaGain) pushes the number of firms accepted into the program to nine in less than two years. With less than five employees, NemRx possesses intellectual property with an impressive pedigree, including a Nobel Prize winner amongst its co-founders. Dr Robert Horvitz is co-recipient of the 2002 Nobel Prize for physiology or medicine. Co-founder Dr Andreas Wissmann has relocated to Calgary and will serve as the new firm’s president/CEO. NemaRx’s technology platform is based on screening technology considered well suited to treating neurodegenerative diseases. It is currently used to test compounds of nematodes. According to ICA president/CEO Susan Miller, the firm’s founders decided upon relocation based on her firm’s mentoring program, as well as potential support from Genome Prairie, the Industrial Research Assistance Program and the Alberta Heritage Foundation for Medical Research.
Paladin receives FDA orphan drug designation for Fidlin
Paladin Labs (Montreal), a leading Canadian specialty pharmaceutical company, announced today that it has received orphan drug designation for Fidelin (dehydroepiandrosterone /prasterone / DHEA) for adrenal insufficiency from the US Food and Drug Administration. Fidelinwas granted orphan drug designation in Europe earlier this month. The FDA’s orphan drug program is intended to encourage research, development and approval of products for diseases that affect fewer than 200,000 patients in the US. Orphan drug designation will provide Fidelin with seven years of market exclusivity following regulatory approval. Paladin acquired the development and marketing rights to DHEA in 1999 through its acquisition of Neuroscience Pharma, a company focused on the discovery and development of novel therapeutics relating to DHEA. Paladin is continuing the development of this product for adrenal insufficiency, a rare chronic condition brought about by failure of the adrenal glands, which affects an estimated 100,000 patients in the US. Current standard therapies frequently fail to restore full well-being, and as such, patients with this disorder continue to suffer from a diminished quality of life.
2) Diagnostics and Therapeutics Update
Spectral Diagnostics announces Elan termination agreement
Spectral Diagnostics (Toronto) announced that it has paid Elan Corporation $1.2 million owing to it under the joint venture termination agreements. As a result of the payment, the development loan of $4.8 million and accrued interest has been extinguished, as previously agreed. Under the terms of the joint venture termination agreements, Elan has rights to a royalty of future sales of the Endotoxin Activity Assay. Spectral Diagnostics regains all intellectual property and marketing rights associated with the EAA, and the sepsis diagnostics system.
Generex reports details of studies
Generex Biotechnology (Toronto), which works in the area of buccal drug delivery, has reported the details of data from studies it sponsored and presented at the 18th International Diabetes Federation Congress in Paris, France. The studies further indicate that the company’s Oralin insulin formulation has the potential to be used safely and effectively in place of injected insulin to treat patients with Type-1 and Type-2 diabetes. Oralin is delivered as a fine spray to the buccal (oral) cavity via the company’s Rapidmist device where the formulation is rapidly absorbed through the buccal mucosal lining.
SYN X finalizes Alzheimer’s clinical agreement with Ortho-Clinical
SYN X Pharma (Toronto) announced that the company has finalized an agreement with Ortho-Clinical Diagnostics regarding a pivotal clinical trial for the first in-vitro diagnostic test kit for Alzheimer’s disease (AD). The AD technology for human in-vitro diagnostic applications using glutamine synthetase as a marker was exclusively licensed to Ortho last October. This new agreement provides financial support to SYN X to complete an ongoing clinical trial, which may be submitted to the US FDA for approval.
Drugs halt brain connections: University of Lethbridge study
Taking amphetamines or cocaine could stop cells in key areas of the brain linking up normally. This, warn experts, could explain why it is feared that long-term use of the drugs could affect memory or mood. The latest research was carried out by scientists from the University of Lethbridge in Canada. Rats would be expected to generate new brain connections if put in a stimulating environment but after being given drugs this did not happen. However, experts have warned that results in rat brains may not correspond exactly to human brains. While there are concerns about the long-term effects of amphetamines and cocaine on the brain, it remains a controversial area. While some researchers point to studies that suggest mood problems in some users, others maintain that firm evidence for a link has still not emerged. The study looked at brain connections in the nucleus accumbens, and the neocortex. The nucleus accumbens has been linked by other studies to mood, while the neocortex has some bearing on memory, it is thought. The rats were all put into a stimulating environment cages with plenty of ramps, wheels and tunnels. Some of them had repeatedly been given cocaine or amphetamines a few months earlier. Animals not given the drugs showed an expected response to their exciting new home their brains showed signs of increased connections between brain cells in the key areas. But the rats who had been given either drug showed no sign of these changes.
ARIUS anti-cancer antibody targets important cancer antigen CD44
ARIUS Research (Toronto) revealed that CD44, an important and prevalent cancer antigen, is the target for its lead novel anti-cancer antibody, ARH460-16-2. New efficacy data in breast cancer and research findings on the target were presented at the 2nd International Congress on Targeted Therapies, August 28-31, 2003 in Washington DC. ARH460-16-2 by itself significantly delays the growth of established human breast cancer tumours in animal models of cancer and produces an increase in survival compared to untreated animals that is similar to the maximum tolerated dose of cisplatin, a standard chemotherapy dr
ug. Importantly, ARH460-16-2 recognizes a target located on the surface of cancer cells that is present in the majority of breast cancer patients. This target, now shown to be CD44, is believed to play a critical role in the behaviour of cancer cells such as cellular adhesion, migration, invasion, metastasis and tumorigenicity.
IMI signs collaborative research agreement with AtheroGenics
Predictive medicine company IMI International Medical Innovations (Toronto) announced that it has signed a collaborative research agreement with AtheroGenics. IMI’s cardiovascular risk assessment test, Cholesterol 1,2,3, will be added to AtheroGenics’ international ARISE trial, providing IMI with valuable primary event data and broad exposure to leading cardiac centers around the world. The ARISE study (Aggressive Reduction of Inflammation Stops Events) will be conducted in over 180 cardiac centers in the US, Canada, the United Kingdom and South Africa. ARISE is a Phase III study designed to evaluate the impact of AGI-1067, an oral anti-inflammatory agent developed by AtheroGenics to target atherosclerosis. The study will enroll 4,000 patients who will be followed for an average of 18 months or until a minimum of 1,160 primary events have occurred, such as heart attack or stroke.
3) Information Technology
Clinton Group and MDA receive Health Canada contract
MacDonald, Dettwiler and Associates (Richmond) announced that the company’s information system group, teamed with the Clinton Group, has been awarded a multi-year contract by Health Canada. The contract aims at defining new processes and business systems to support healthcare workers in obtaining all the tools and information they need to do their jobs — wherever they are. MDA is responsible for the architecture design and prototyping of information systems. The Clinton Group is responsible for strategy formulation, business process transformation and implementation. This project is part of a $17.3 billion initiative announced in the 2003 Canadian Federal Budget to address the concerns of Canadians about their health care systems. These investments are meant to improve the access to and the quality and sustainability of the public healthcare system, with a focus on the healthcare provided to First Nations and Inuit communities. The Clinton Group is a strategic management consulting firm located in Pickering, ON.
Cytochroma discovers new retinoic acid metabolizing Cytochrome P450
Cytochroma (Markham), announced that it has discovered a new gene named CYP26C which encodes a retinoic acid metabolizing enzyme. Cytochroma demonstrated that CYP26C, and not CYP26A or CYP26B, metabolizes 9-cis retinoic acid. All three members of the CYP26 family metabolize all-trans retinoic acid. It is well known that 9-cis and all-trans retinoic acid function as potent inducers of cell differentiation and inhibitors of cell proliferation. By developing compounds which act on the CYP26 gene family, treatment of diseases such as cancer, as well as skin diseases such as acne and psoriasis, may be possible.
4) Industry Update
Jamieson Laboratories’ (Windsor) board of directors announced that Victor Neufeld, President of Jamieson, will assume the role and responsibilities of chief executive officer effective immediately.
Medisys Health Group (Montreal), a provider of healthcare services to corporations and insurance companies, announced the appointment of Mark Wallace as president & CEO of Medgate, Medisys’ occupational health & safety software subsidiary. Leslie Glazerman, former president of Medgate, has left the company to pursue other opportunities.
MedX Health (Oakvile) announced the signing of a partnership agreement with Dr Manfred Hubert and partner Steven Martin. This technology team is recognized as experts in the field of photonics and are augmenting MedX’ Research and Development department. It is anticipated that Dr Hubert and Mr Martin will enhance MedX’ capabilities to rapidly design, develop, manufacture and bring to market superior, innovative light based products.
VSM MedTech (Vancouver) announced that its subsidiary, CTF Systems, has completed a contract with Southern California-based MS Technologies for the sale of a mobile Omega magnetoencephalography (MEG) system.
The leading federal health research agencies in Canada and the US the Canadian Institutes of Health Research (CIHR) and the National Institutes of Health (NIH) have formed a partnership to advance research of cardiovascular and respiratory diseases. Three research programs are being launched collaboratively between CIHR’s Institute of Circulatory and Respiratory Health (ICRH) and NIH’s National Heart, Lung and Blood Institute (NHLBI). The programs will address novel strategies to resuscitate heart attack and trauma patients; cellular and molecular imaging of heart, lung, and blood systems; and management of thrombotic disorders such as heart attack, stroke, deep vein thrombosis, and pulmonary embolism. Each program will be conducted at multiple sites in Canada and in the US for several years, beginning in 2004.
Drugmaker Bristol-Myers Squib is considering pulling its antidepressant drug Serzone from the Canadian market amid worries about liver damage. The drug has been linked to liver damage and Bristol-Myers is currently in discussions with Canada’s drug-safety overseer Health Canada about the risk-benefit ratio of Serzone.
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: email@example.com).