Ottawa, ON June 5, 2003 The following life sciences news briefs were published this week by Industry Canada.
1) Pharmaceuticals Update
Salix rejects Axcan’s revised offer
Salix Pharmaceuticals, (Raleigh NC), a developer and marketer of prescription pharmaceutical products for the treatment of gastrointestinal diseases, today announced that after careful consideration, including its consultations with independent financial, legal and medical advisors, its board of directors has unanimously determined that Axcan Pharma’s (Mont St Hilaire) May 20, 2003 revised tender offer for all outstanding shares of Salix common stock at $10.50 per share remains grossly inadequate and not in the best interests of Salix’s stockholders.
Generex announces Canadian clinical trials for Oralin
Generex Biotechnology Corporation (Toronto) announced that, pursuant to authorization from the health products and food branch of Health Canada, this June Generex will begin phase-2B clinical studies in Canada for Oralin, the company’s proprietary oral insulin spray. These studies will evaluate the long-term efficacy of Oralin in a large number of patients with Type-1 and Type-2 diabetes enrolled at various Canadian clinical sites. The study protocol for patients with Type-1 diabetes will compare the metabolic effects and the reproducibility of the company’s oral insulin spray formulation at mealtimes (breakfast, lunch and dinner) with sc regular insulin. The goal of this study is to establish that mealtime injections of regular insulin can be successfully replaced by the use of Oralin thereby improving the quality of life of patients with diabetes.
Eli Lilly and Generex end diabetes collaboration
Generex Biotechnology (Toronto) announced that Generex and Eli Lilly (Chicago) have agreed to end their development and license agreement for the development and commercialization of a buccal delivery of insulin. Generex also announced today that, pursuant to the provisions of the development and license agreement, both parties are working on terms for Lilly to continue to supply a specified amount of insulin for Generex’s further development work. All of Generex’s intellectual property and commercialization rights with respect to the buccal spray drug delivery technology will revert to Generex, which will have the continuing right to develop and commercialize the product at its own expense.
Altachem Pharma initiates testing Bionex against coronavirus
Altachem Pharma (Edmonton) announced positive results from testing completed on Bionex disinfectant. To validate the effectiveness of the Bionex disinfectant formulations, testing has been completed by a level 3 bio-science laboratory which has received certification through the council for anti-microbial quality (CAQ) in its laboratory accreditation program as well as having memberships with the National Capital Area Regional Society of Quality Assurance (NCARSAQ) and the Society of Quality Assurance (SQA) in the US. Based on the positive results received, Altachem has contracted the same laboratory for validation of the lead compound on its viricidal effectiveness specifically against the human coronavirus (believed by some scientists to be SARS).
2) Diagnostics and Therapeutics Update
US National Cancer Institute confirms potential of Bioxel technology
Bioxel Pharma (St. Foy), a leading manufacturer of naturally derived taxanes and targeted oncology drugs, announced that a peer-reviewed article was published in Clinical Cancer Research, titled “P7 Antigen Expression in Human Breast Cancer(1).” The P7 antigen, originally identified by Bioxel in multi-drug-resistant ovarian and breast cancer cells, is the protein target of the company’s BCM-17 antibody. The article reported on studies, jointly carried out by the University of Southern California Cancer Center and School of Medicine, Johns Hopkins Oncology Center and the National Cancer Institute, which demonstrate that expression of the P7 antigen is associated with malignant tumors in primary breast cancers, especially those showing recurrent or metastatic disease.
Cardiome reports presentation of RSD1235 phase II data
Cardiome Pharma (Vancouver) announced that Dr Brian Rowe of University of Alberta presented the company’s phase II clinical trial data on the acute use of RSD1235 at the 2003 Annual Meeting of the Society for Academic Emergency Medicine held in Boston Massachusetts. The data supports the efficacy and safety of RSD1235 as a novel agent in the acute conversion of patients with atrial fibrillation. The company originally announced these clinical results at the European Society of Cardiology in September 2002. Dr Alan Ezrin, chief scientific officer at Cardiome stated: “Dr Rowe’s presentation was attended by almost 1000 emergency room physicians in North America who have the potential to eventually use this product. This is a particularly exciting time for Cardiome as we are meeting with the cardiologists and emergency room physicians to begin site selection for our phase III trial later this year.”
3) Genomics Update
Essential gene for male fertility found
A gene that belongs to a family of genes implicated in heart disease has been found to be essential for male fertility but has no impact on female fertility, researchers at the University of Toronto, along with colleagues in New York and Japan, have discovered. “This gene Fkbp6 is a member of a family of genes that have been implicated in immunosuppression and heart disease,” says Dr Josef Penninger, professor of medical biophysics and immunology at U of T and senior author of a new paper in the May 23 issue of Science. “That this gene would control male fertility was completely unexpected. We originally thought Fkbp6 was important for heart function but the only place we could find it was in sperm and oocytes.” Penninger and post-doctoral fellow Michael Crackower made the surprising discovery when they eliminated the Fkbp6 gene in genetically engineered mice. When the gene was removed, the oocytes (cells in the early phases of egg development) in female mice appeared normal but all the sperm cells in males had died, resulting in complete infertility. Penninger and Crackower realized their work bore striking similarities to some research by Japanese scientists who, over the past decade, have been studying a naturally occurring mutation in rats that also caused aspermia (lack of sperm). The U of T researchers recognized that the genetic mutation in their mice was similar to the spontaneous mutation seen in the rats.
4) Medical Devices
MIV Therapeutics announces proprietary stent coating breakthrough
MIV Therapeutics (Vancouver) announced it has achieved a significant milestone by successfully passing an independent thrombogenicity animal trial of its proprietary hydroxyapatite (HAp) coating. The trial, “Thrombogenicity Assay in Dogs”, conducted to evaluate any evidence of clotting in the blood stream, was performed by Toxikon in Bedford, MA, under the direction of Dr Chin Tay (PhD). The trial was compliant with US FDA 21 CFR, part 58 and good laboratory practices regulations. Stainless steel and cobalt-chromium stents coated with MIVT’s biocompatible HAp coating were implanted in the arteries of dogs. Dr Tay, Toxikon’s director of toxicology, stated, “The animal trial performed at Toxikon evaluated the thrombogenicity of MIV Therapeutics’ Hap coated stents in the blood stream. MIVT’s HAp coated stents performed well, with minimal to no significant thrombosis, thus successfully meeting the scientific and regulatory requirements.”
5) Technology Update
SAND launches healthcare analytics application suite
SAND Technology (Toronto) has chosen e-Health 2003, a joint conference sponsored by COACH: Canada’s Health Informatics Association and the Canadian Institute for Health Information (CIHI), as the venue to announce its new high-performance healthcare analytic server. The product is designed to make the information con
tained in electronic medical records more easily and inexpensively available to the full health care community, including researchers and administrators, with minimal need for involvement by IT resources.
CSTAR and Bell Canada collaborate on telemedicine services
CSTAR (Canadian Surgical Technologies & Advanced Robotics) (Toronto) and Bell Canada announced a strategic relationship to expand the availability of safe, accessible and cost-effective telemedicine services across Canada. As part of the new collaboration between the two organizations, a live demonstration of robotic telementoring assisted surgery was conducted today at e-Health 2003, a Toronto conference featuring the leading e-health innovators, policy-makers, practitioners, patient advocacy leaders, health informatics educators and researchers from across Canada and around the world.
Cedera signs agreement
Cedara Software (Toronto), a leading independent developer of medical software technologies for the global healthcare market, today announced that it has signed an engineering services agreement with Medtronic Surgical Navigation Technologies. Under the terms of this agreement, Cedara will assist in developing software for Medtronic’s Universal Navigated Orthopaedics program.
6) Industry Update
Bioniche Life Sciences (Belleville) announced the closing of a private placement of $13.5 million royalty-enhanced debentures to the Business Development Bank of Canada, and two other major Canadian financial institutions.
ChondroGene (Toronto) reported that it has closed on $2,000,000 of the private placement previously announced on April 29, 2003.
Transition Therapeutics (Toronto) announced the initial closing of its previously announced private placement of up to 6,250,000 common shares at a price of $0.32 per share. Transition raised gross proceeds of $664,000 today which will be used in the completion of clinical phase I studies and pre-clinical toxicity studies in preparation for the initiation of phase II studies in diabetes and multiple sclerosis.
CME Telemetrix (Waterloo), a developer of near-infrared instruments, announced that the company has settled a claim and counterclaim with NS Divestiture (formerly known as Neurosoft) and Marmon Wire & Cable for consideration of US$650,000 paid to CME. A consent order was issued on May 23, 2003 by the Ontario Superior Court bringing the action to a close.
Lorus Therapeutics (Toronto) announced that it has filed a preliminary prospectus in each of the provinces of Canada in connection with its proposed public offering of units.
Novartis Pharmaceuticals Canada (Montreal) announced that Health Canada has approved data that shows increased survival during the first two years of treatment among women taking Femara (letrozole) compared directly to those taking tamoxifen. Study data demonstrated that women who require hormonal treatment for advanced breast cancer will remain tumour free longer when taking Femara.
ID Biomedical (Vancouver) announced that it has closed its previously announced offering of 2,610,000 common shares. The offering price for the common shares was US$8.50 per share. In addition, the underwriters exercised their over-allotment option in full resulting in a total of 3,000,000 common shares issued for total gross proceeds of US$25,500,000.
ARC Pharmaceuticals (Vancouver) announced that it has received Eligible Business Corporation (EBC) status under section 28.2 of the Small Business Venture Capital Act from the Ministry of Competition, Science and Enterprise in the Province of British Columbia.
MethylGene, (Montreal) a privately held drug discovery and development company in cancer and infectious disease, announced the appointment of Dr Nafsika Georgopapadakou as vice-president of infectious disease.
Dimethaid Research (Toronto) has officially launched Pennsaid, what it says is North America’s first topical prescription anti-arthritic. In ceremonies at the company’s manufacturing plant in Varennes, QC, government dignitaries, healthcare community leaders and senior management hailed the new drug as a testament to Canadian ingenuity and an outstanding example of cooperation between French and English cultures. Pennsaid received final Health Canada approval on March 31 as a treatment for knee osteoarthritis.
GlycoDesign (Vancouver) and Inflazyme Pharmaceuticals (Toronto) announced that GlycoDesign shareholders voted overwhelmingly to approve the acquisition of the company by Inflazyme with a vote of 99.9% in favour of the transaction.
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: firstname.lastname@example.org).