Ottawa, ON May 8, 2003 The following Life Sciences News Briefs were published this week by Industry Canada.
1) Pharmaceuticals Update
FDA grants orphan drug designation to Celmed’s photodynamic therapy
Celmed BioSciences, (Montreal) a subsidiary of Theratechnologies, which is engaged in the field of cell therapy, announced today that the US Food and Drug Administration (FDA) has granted orphan drug designation for Theralux when used to treat patients with chronic myeloid leukemia (CML). Theralux is Celmed’s photodynamic therapy technology being developed to destroy cancer cells in bone marrow or blood outside the body (ex vivo), using a proprietary drug, TH9402, which selectively kills cancer cells when exposed to light. Orphan drug designation is granted to products that have the potential to treat life-threatening diseases that affect fewer than 200,000 patients in the US. It gives the designated drug or biological product seven years of market exclusivity in the US and also provides access to potential grant funding for clinical research and other cost savings. Celmed is already conducting a Canadian pilot clinical study using Theralux in CML patients and expects to announce results of this trial in the course of 2003.
Lorus stock surges on expanded treatment hopes
Lorus Therapeutics (Toronto) roared past year-high levels recently, extending a run of sharp gains sparked by reports that the company’s flagship treatment for pancreatic cancer could also be used to fight breast, ovarian, and prostate cancers. Lorus, whose fortunes are tied closely to the success of its Virulizin cancer treatment, was up 29 Canadian cents at C$1.89 Monday afternoon on the Toronto Stock Exchange after earlier surging as high as C$1.95. The stock has nearly doubled in value since reporting earnings on April 11, and has shot up since last Wednesday, when the company said its Virulizin treatment had shown “significant” results in a study on mice infected with human tumors.
Biovail acquires four cardiovascular pipeline products from Athpharma
Biovail Corporation (Toronto) announced that it has entered into an agreement with Athpharma of Ireland to acquire four new cardiovascular products under development, which complement Biovail’s most recently launched product, Cardizem LA for the treatment of hypertension (see more below). This agreement allows Biovail to participate in the development of these products while Athpharma will undertake the management and completion of the development of these four products. Two of these developmental programs, Bisochron (bisoprolol), a beta blocker for the treatment of hypertension, and Isochron (isosorbide-5-mononitrate), a long acting nitrate for the treatment of angina, are designed to offer better protection against the increased risk of cardiovascular events caused by the early morning surge in blood pressure. Hepacol I (pravastatin) and Hepacol II (simvastatin) are both medications for the treatment of high cholesterol (lipid lowering agents) that target the delivery of the active drug to the liver, where cholesterol breaks down. Because of this mechanism, the liver-selective delivery maintains efficacy at a lower dose, while maintaining or even improving the product’s safety profile. Bisochron and Isochron will allow Biovail to expand and complement its cardiovascular franchise. As well, the two lipid lowering medications will offer physicians effective cholesterol-lowering medications.
2) Diagnostics and Therapeutics Update
BC researcher delving into the rise in non-Hodgkin’s lymphoma
Dr John Spinelli, an epidemiologist/biostatistician at the BC Cancer Agency, has been awarded a three-year $563,000 grant from the Canadian Cancer Society to try to pinpoint possible causes of non-Hodgkin’s lymphoma. While incidence rates in Canada for the majority of cancer sites have stabilized or declined since 1988, new cases of non-Hodgkin’s lymphoma have more than doubled in the last 30 years. “Relatively little is known about the risk factors for this disease,” says Dr Spinelli, “But we think that most cases may be caused by an interaction between genetic susceptibility and environmental exposure.” Dr Spinelli and his team will collect blood samples from 1,500 Canadians half of whom have NHL and half of whom do not. These samples will be used to determine genetic information and to measure exposure to organochlorines, a class of environmental contaminants that includes PCBs and DDT. They will also gather information on the research subjects’ exposure to ultraviolet radiation and other possible risk factors.
New study supports statin drugs potential in Alzheimer patients
A newly published study has added support to the potential of statin drugs for Alzheimer’s disease (AD). Nymox Pharmaceutical Corporation (Dorval) holds a US patent and global patent rights for the use of statin drugs for the treatment and prevention of AD. The study is reported in the current issue of the Archives of Neurology (April 21, 2003; 60:510-515) and was authored by Drs Gloria Vega, Myron Weiner, Anne Lipton, Klaus von Bergmann, Dieter Lutjohann, Carol Moore and Doris Svetlik at the University of Texas Southwestern Medical Center at Dallas and at the University of Bonn Medical Center, Bonn, Germany. In the study, 31 people with AD were given one of three different statin drugs for six weeks. The study found that the patients taking statins lowered levels of an important product of brain cholesterol metabolism by 21.4%. Other recent reports indicated that this form of cholesterol was elevated in patients with AD. The authors concluded that statin drugs “may be potentially beneficial in treatment of AD”.
Biovail reports positive Cardizem LA launch results
Biovail Corporation (Toronto) reported on the progress of Cardizem LA (diltiazem HCl), the recently launched once daily controlled release medication for the treatment of hypertension. Cardizem LA provides true 24-hour blood pressure coverage and delivers optimal levels of medication in the early morning when patients may be at greater risk of an adverse cardiac event. Launched April 2, 2003, over 20,000 prescriptions have been written for Cardizem LA, more than 45,000 pharmacies over 80% of the chain and independent pharmacies in the US now have Cardizem LA in stock and Biovail is in active negotiations with 16 of the largest managed care organizations that collectively represent more than 90% of total lives covered in the US.
3) Medical Devices
CryoCath updates arctic Circler progress
CryoCath Technologies (Montreal) announced that two presentations were made documenting the clinical experience of two leading European cardiovascular centres using CryoCath’s Arctic Circler, a minimally invasive catheter with a curvilinear tip designed to treat patients with atrial fibrillation (AF). The two presentations were delivered by Dr HF Pitschner of the Kerckhoff Clinic in Bad Nauheim, Germany, and Dr Juergen Vogt of the North Rhine-Westphalia Heart Center, Bad Oeynhausen, Germany. Combined, the two centers have used the Arctic Circler to treat 147 veins in 43 patients with AF, refractory to drugs, representing approximately one half of the total European experience with Arctic Circler. Acute success rates reached 98% in one study and 92% in the second. Three month chronic success rates were reported to be 67% for patients (n equals 12) in which 3 or more of the pulmonary veins (PV) were successfully isolated. From a safety perspective, there were no adverse events in any of these patients and most notably, no reported incidences of stenosis (a thickening of the vessel wall that may cause obstruction or blockage). This key safety result contrasts sharply with well-documented radiofrequency (RF) ablation procedures that report high rates of stenosis (ranging from 1% to 42%). The relatively high rate of complications has limited the broad use of RF to treat AF. PV stenosis may cause stroke, pulmonary hypertension and even death.
4) Genomic Update
ome Qubec and CGI partner on bioinformatics platform
Gnome Qubec, a genomics and proteomics investment organization, and CGI Group (Montreal), a provider of information technology and business processing services, are working together to provide new solutions that will help reduce costs and speed time-to-market for researchers. As part of the five-year agreement, CGI will create a comprehensive and integrated bioinformatics platform for Gnome Qubec, based on CGI’s bioinformatics and development expertise. This partnership will allow important jump-start capabilities in bioinformatics for researchers. The ultimate goal of this partnership is to give researchers access to technology solutions that they would not have otherwise therefore reducing significantly research time and costs. Other benefits to researchers include obtaining access to world experts, a commercialization agreement and sharing knowledge.
ProMetic and Aldevron expand collaboration on purification technology
ProMetic BioSciences (Montreal), the Canadian wholly owned subsidiary of ProMetic Life Sciences and Aldevron today announced the expansion of their collaboration to develop and market a new technology for the purification of gene therapy and DNA vaccine products. The agreement leverages ProMetic’s strengths in designing purification resins with Aldevron’s expertise in the field of plasmid DNA manufacturing.
5) Industry Update
Novadaq Technologies (Toronto), a developer of medical devices that facilitate diagnosis and treatment in a variety of medical disciplines, has appointed Arun Menawat as president and chief executive officer.
ChondroGene (Toronto) reported that it will raise up to $3 million by way of a private placement. The company has retained Dundee Securities to act as its financial advisor and agent.
Response Biomedical (Vancouver) announced that it has closed $750,000 of the private placement being undertaken by the company as announced on April 9, 2003.
Biomira (Edmonton) announced that it has arranged a US $5.5 million financing with Rodman & Renshaw of New York acting as exclusive placement agent.
Forbes Medi-Tech (Vancouver) announced that it has sold its pharmaceutical fine chemicals business which centered on process technologies for the production of the steroid intermediates androstenedione (AD) and androstadienedione (ADD). Forbes will receive gross proceeds of US$1.9 million for the sale.
Cryopak Industries (Vancouver) announced the successful completion of testing with Aventis Pasteur, which has led to a products and services partnership to improve the company’s temperature-sensitive packaging systems for the shipment of vaccines worldwide.
Orbus Pharma (Toronto), a subsidiary of BOVAR Inc., announced the completion of a drug development agreement with a multinational European pharmaceutical company, Alfred E Tiefenbacher.
Biomira (Edmonton) announced that following examination of its re-issue application by the US Patent and Trademark Office (USPTO), the company’s US patent 5,798,090 was re-issued (RE 38,046) with additional claims. These additional claims represent broader patent coverage in the area of therapeutic use of carbohydrate-based vaccines, as well as specific coverage for the use of carbohydrate vaccine formulations comprising such vaccines and adjuvants in cancer therapy.
Gamma Dynacare Medical Laboratories (Toronto) and Cogient (Toronto), a Canadian clinical practice management software Application Service Provider (ASP), announced a strategic alliance that covers joint development and co-marketing of enhanced services to physicians, patients and the biopharma sector based on ClinicalLogic, Cogient’s secure, Internet-based clinical practice management system.
SemBioSys Genetics (Calgary) and AVAC announced that AVAC will invest up to $2.5 M in SemBioSys. The AVAC funding will be used to complete development of SemBioSys’ StratoCapture Protein A purification system.
Merck Frosst Canada (Montreal) announced that Health Canada has approved Canadian-discovered VIOXX (rofecoxib) for the relief of signs and symptoms of rheumatoid arthritis (RA) in adults.
Biomira (Edmonton) announced the promotion and appointment of Marilyn Olson to the position of vice-president, regulatory affairs.
Global Path Inc. (Toronto) announced the signing of a definitive agreement to acquire nine significant patented bioscience products from General Cosmetics, based in Munich. The acquisition is anticipated to close later this week subject to certain conditions being met.
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).
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