Ottawa, ON – March 31, 2004 – The following life sciences news briefs were published today by Industry Canada.
1) Pharmaceuticals Update
BioMS Medical announces 17 additional patents for MS drug
BioMS Medical (Edmonton), a leading developer in the treatment of multiple sclerosis (MS), today announced that the University of Alberta has received 17 additional patents for the company’s synthetic peptide therapeutic, MBP8298, for the treatment of multiple sclerosis (MS). BioMS Medical, through a subsidiary, licenses these patents on an exclusive worldwide basis from the University of Alberta. The additional countries granting patents included Austria, Belgium, the Czech Republic, Denmark, Finland, France, Greece, Germany, Ireland, Luxembourg, Monaco, Netherlands, Spain, Sweden, Switzerland, Ukraine and the United Kingdom. In total, 50 patents have been granted to the University of Alberta for MBP8298 in 29 countries worldwide, including three patents issued in the United States.
AnorMED sells global patents for Fosrenol
AnorMED (Vancouver) announced that it has agreed to sell the global patents for Fosrenol to Shire Pharmaceuticals Group, and one of its wholly owned subsidiaries, for up to US$31 million in milestone payments to be made upon regulatory approval in the United States, the European Union, and Japan. Michael Abrams, president and CEO of AnorMED, said the proceeds of the sale will be used to drive development of the company’s two leading product candidates now in clinical trials and to aggressively pursue preclinical studies for several other product candidates in cardiac tissue repair, oncology, and HIV. Under the terms of the agreement, Shire will pay AnorMED US$18 million when Fosrenol is approved in the United States and US$7 million when Fosrenol is approved in the relevant EU countries. In consideration of these payments, Shire’s royalty obligations to AnorMED shall cease throughout the world, except for Japan. The agreement also provides Shire a 12-month option to purchase the Japanese patents for US$6 million to be paid upon approval in Japan. On the exercise of the option, Shire’s royalty obligations to AnorMED for Fosrenol sales in Japan also cease. If the option is not exercised, AnorMED will continue to be entitled to Fosrenol royalties in Japan. The title to the patents will be transferred from AnorMED to Shire upon payment of milestones.
Forbes Medi-Tech Signs Reducol Licensing/Distribution Agreement
Forbes Medi-Tech (Vancouver) announced that it has signed a licensing and distribution agreement for its cholesterol-lowering ingredient, Reducol, with Marco Hi-Tech JV LLC of New York, N.Y. Under the terms of the co-exclusive four-year contract, Forbes will supply Reducol to Marco Hi-Tech for distribution to dietary supplement manufacturers. These manufacturers are expected to incorporate the ingredient into a variety of cholesterol-lowering supplements to be sold in natural health food stores across the United States.
2) Diagnostics and Therapeutics Update
Cangene to initiate clinical study to assess WinRho as treatment
Cangene (Toronto) announces that it plans to initiate a clinical trial to investigate a new indication for WinRho SDF in a new patient population. Findings from a pilot study indicate that administration of WinRho SDF may improve patient survival in severe cases of dengue hemorrhagic fever (DHF). In the pilot study, conducted at Philippine Children’s Medical Center and three other hospitals, critically-ill young patients showed rapid improvement and were discharged from hospital soon after receiving treatment with WinRho SDF. The company plans a six-month trial in two hospitals in the Philippines, where DHF places a severe burden on the medical system. DHF is characterized by fever and an extremely low platelet count, which causes increased bleeding and can lead to circulatory failure and shock (dengue shock syndrome).
Dimethaid launches Pennsaid long-term safety and add-on therapy trials
Pharmaceutical developer Dimethaid Research (Toronto) has begun enrolling patients in two post marketing clinical trials to confirm the long-term safety of Pennsaid anti-arthritic lotion and investigate the product’s advantages in combination with a conventional analgesic. A 12-week trial will look at the effects of using the topical drug simultaneously with an oral nonsteroidal anti-inflammatory drug. The longer-term study will follow patients for up to 52 weeks. Health Canada approved Pennsaid in March 2003 as a prescription treatment for knee osteoarthritis symptoms. Dr Zev Shainhouse, Dimethaid’s medical director, said, “Patients who take an oral for disease in several joints might want to add Pennsaid, if a knee was still painful. At the moment, we don’t have data about add-on therapy. Nor may we offer guidance to Canadian doctors who want to continue a patient on Pennsaid for long periods of time.”
Immune cells grown in a dish
Scientists have found a way to grow a bountiful supply of disease-fighting cells that might one day boost therapy for cancer and HIV. The cells, called T cells, normally patrol the body and kill infected or cancerous cells. But chemo- or radiotherapy, and the HIV virus, destroy them. Now a Canadian team have grown potentially limitless T cells in the laboratory. “We’re very excited,” says immunologist Juan Carlos Ziga-Pflcker of the University of Toronto. The T cells were made from mouse embryonic stem cells, which normally form all the tissues in a mouse embryo. Researchers have converted mouse and human embryonic stem cells into blood, nerves and muscle. But they did not know how to coax them into making T cells. Ziga-Pflcker and his team succeeded by identifying a molecule, called DL1, that is essential in T-cell production. They genetically engineered cells to make DL1, and then grew embryonic stem cells on top of this concoction.
3) Medical Devices
MedMira Ships 100,000 Rapid HIV test kits to China
MedMira (Halifax) announced that the company has completed an initial shipment of 100,000 MiraWell Rapid HIV Tests to the People’s Republic of China. The shipment is the first portion of an annual commitment of 1.3 million kits from a new distributor, which replaces the agreement previously announced with Long Hao Healthcare Technology, of Guangzhou, China. This marks the first Canadian commercially available Rapid HIV test to ever be shipped to China. The new distributor is highly experienced in the distribution of medical products and devices. This agreement covers the eight provinces they serve in southwestern and northeastern China.
CME Telemetrix changes strategy
CME Telemetrix (Waterloo) is putting development of a device that is designed to make life easier for diabetics on the backburner while it pursues other opportunities that are more likely to bring in money sooner. The cash-strapped Waterloo company disclosed the change in strategy yesterday when it announced plans to raise up to $2.5 million in an offering of securities. It said it will use the money to commercialize products that use the same technology as the glucose monitoring device it has been working on for more than 10 years. In particular, it hopes to win the approval of the US Food and Drug Administration for a device that measures hemoglobin levels in blood without the use of chemical reagents. CME says it hasn’t given up on the glucose monitoring device, and is talking to manufacturers of medical diagnostic equipment in hope of securing a licensing deal that will provide the funds it needs to finish the project.
Researchers identify new disease gene associated with Rett Syndrome
Scientists at the Hospital for Sick Children (Sick Kids), the Centre for Addiction and Mental Health (CAMH) and the University of Toronto (U of T) have identified an alternate form of the disease gene and protein for the neurodevelopmental condition Rett syndrome. This discovery is being incorporated into a new molecular test that will aid n
ot only in the diagnosis of Rett syndrome, but also for other developmental disabilities. This research is reported in the April issue of the scientific journal Nature Genetics (available online March 21, 2004). “The previously identified gene MECP2 was only found in approximately 80 per cent of patients with Rett syndrome,” said Dr Berge Minassian, the study’s principal investigator, a Sick Kids neurologist and scientist, and an assistant professor in the Department of Paediatrics at U of T. “Our discovery suggests that a defective alternate form of the MECP2 gene causes Rett syndrome.” The protein produced by the new alternate gene is different than the protein that was first associated with Rett syndrome in 1999. In the current work, this novel molecule was found to be disrupted in some Rett syndrome patients while the original form of the protein remained intact. The new protein is also the predominant form in the brain, strongly indicating that it is the disease-relevant protein.
5) Industry Update
Haemacure (Montreal) announced that it has completed a private placement issuing a total of 10,400,000 special warrants for aggregate gross proceeds to the corporation of $5.2 million.
TSO3 (Quebec City) has appointed Ann Hewitt, a former Steris sales and marketing executive, as vice president, sales – US market.
Infectio Diagnostic (Quebec City) has just received clearance from the US Food and Drug Administration (FDA) to market its new ultra-rapid test (IDI-MRSA) for detecting methicillin-resistant Staphylococcus aureus (MRSA).
Bioxel Pharma (Ste Foy) announced that it has reached an agreement with certain holders of convertible debentures representing in the aggregate $1,000,000 of principal amount of debentures.
Draximage (Mississauga) has concluded a distribution agreement with Isotope Products Laboratories (IPL), a California based producer of radioactive sources for nuclear medicine and radiography.
MIV Therapeutics (Vancouver) announced that it has raised funds necessary for completion of the next stage of its research and development program leading towards commercialization of its proprietary biocompatible coating technology developed for cardiovascular stents and other medical devices.
Microbix Biosystems (Toronto) announced it has entered into an agreement to raise $500,000 in the form of an 8% convertible debenture, in a non-arms length transaction with an existing shareholder.
Oncolytics Biotech (Calgary) announced that it has entered into a private placement with a European institutional investor. Subject to regulatory approval and upon completion of the transaction, Oncolytics will issue 1,077,100 common shares and 538,550 common share purchase warrants for aggregate gross proceeds of $6,731,875.
Dragon Pharmaceutical (Vancouver) announced that it has entered into a letter of intent to combine with Oriental Wave Holding and its subsidiary in a merger by which Dragon shareholders would own 31.65% of the new entity and Oriental Wave Holding shareholders would own 68.35% of the new entity.
Adherex Technologies (Ottawa) announced that is has received orphan drug designation for sodium thiosulfate (STS) from the US Food and Drug Administration (FDA). The designation was granted for the prevention of platinum-induced ototoxicity in pediatric patients.
Procyon Biopharma (Montreal) announced that it has filed with the securities commissions in British Columbia, Alberta, Manitoba, Ontario and Quebec, a final short form prospectus relating to a Unit offering for total gross proceeds of $15 million.
Generex Biotechnology (Toronto) announced that a letter of intent has been signed for the establishment of a joint venture between Generex and PharmaBrand, a distributor of pharmaceutical products in Central & Latin America.
Sonomax Hearing Healthcare (Montreal) announced that it has completed the issuance of $8,000,000 of 10% convertible unsecured subordinated notes pursuant to its previously-announced private placement.
Life Sciences News Briefs 2004 is prepared by Armar International for the Life Sciences Branch of Industry Canada (contact: Paul Vaillancourt; Tel: 613-952-7700; E-mail: email@example.com).