Ottawa, ON November 14, 2003 The following life sciences news briefs were published this week by Industry Canada.
1) Pharmaceuticals Update
Biotech Holdings receives Mexico regulatory approval for Sucanon
Robert Rieveley, president of Biotech Holdings (Vancouver) reported that the company has received formal regulatory approval for the sale of Sucanon in Mexico. “We have now received the formal approval of the Mexican national regulator for the sale of Sucanon. Sucanon will be sold in Mexico as a treatment for Type II diabetes symptoms,” said Mr Rieveley. “This receipt of formal approval allows us to proceed expeditiously with finalizing marketing arrangements with a Mexican marketing group that will introduce Sucanon. We will now also proceed immediately with making arrangements for production of Sucanon pre-mix in Vancouver. Tableting will be carried out in Mexico City,” Mr Rieveley added. Sucanon is an insulin-sensitizing drug for the treatment of Type II diabetes. Prevalence of Type II diabetes in Mexico is estimated to be more than double rates in North America.
Stressgen presents longer-term Phase II data on HspE7 for RRP
Stressgen Biotechnologies (Victoria) presented interim data from its Phase II trial with HspE7 in recurrent respiratory papillomatosis (RRP), a seriously debilitating and sometimes life-threatening condition for children, at the meeting of the Society of Ear, Nose and Throat Advances in Children held in conjunction with the American Academy of Pediatrics. The primary endpoint of the Phase II trial evaluated the length of the interval to the next debulking surgery in the drug treatment period compared with the median inter-surgical interval of four surgeries prior to treatment. As reported previously in the overall population, the first post-treatment interval increased 78.6% over the pretreatment interval. The increase in the first post-treatment intersurgical interval is statistically significant (p less than 0.01). Now, with 50% of the study population completing the follow-up period, the median of all post-treatment inter-surgical intervals compared to pretreatment has increased to 95.9 days (compared to 83.1 days previously reported and 55.3 days at baseline). This increase remains statistically significant (p=0.03). The median interval reported here after treatment suggests that this group of 27 children will experience at least 70 fewer surgeries during the first year post-treatment.
YM BioSciences cleared by FDA to initiate Phase III trial
YM BioSciences (Mississauga), a cancer drug development company with an advanced-stage portfolio, announced that it has received written confirmation from the US Food and Drug Administration (FDA) that it may initiate a pivotal Phase III, or registrational trial, for its lead small-molecule anti-cancer therapeutic, tesmilifene. The planned multi-center international trial will compare the overall survival times of advanced metastatic/recurrent breast cancer patients receiving tesmilifene in combination with epirubicin (an anthracycline) and cyclophosphamide versus epirubicin/cyclophosphamide alone. The primary endpoint of this pivotal trial is survival.
2) Diagnostics and Therapeutics Update
Generex to begin studies in teenagers with diabetes
Generex Biotechnology (Toronto), a leader in the area of buccal drug delivery, announced that it will begin studies in adolescent youths between 12 and 19 years of age with diabetes. The studies will be conducted in North America and Europe. The protocols for these studies have been approved by applicable regulatory agencies and REBs. The target population includes youths failing oral hypoglycemic agents therapy as well as patients on multiple daily injections. The Oralin will be introduced in the treatment plan as a replacement for sc injections.
Magistral Biotech announces asset acquisition
Magistral Biotech (Montreal) announced that it proceeded, on October 30, 2003, to the acquisition of assets from Magistral Manufacturing consisting of certain intellectual property rights which will allow Magistral to finalize the settling of its product line. This acquisition puts an end to the license concluded last January 24 and which provided for the grant by Magistral Manufacturing in favor of Magistral of an exclusive exploitation and marketing license of the intellectual property rights which are the object of the acquisition, in consideration of the payment of an amount of $5,000 per month. The acquisition price for these assets is of $260,000 and has been paid in full to Magistral Manufacturing.
Susceptibility to malaria
Approximately 40% of the world’s population is at risk of malaria infection. New research from McGill University and the Research Institute of the McGill University Health Centre (Montreal) suggest that some individuals may be naturally resistant to this infection. Their findings, published in the December issue of Nature Genetics, show that mice that lack a metabolic enzyme are protected from the malaria parasite. “Malaria, together with HIV/AIDS and TB, is one of the major public health challenges in developing countries,” said Dr Philippe Gros, professor in McGill University’s Faculty of Medicine and senior author. “Our findings are an important step toward the development of innovative prevention and treatment strategies for this disease.” This study was supported by research grants from the Canadian Institutes of Health Research and from the Canadian Genetic Diseases Network.
Royalmount Pharma initiates Phase II trial for Herpes using Resveratrol
Royalmount Pharma (Montreal), a privately held development-pharmaceutical company, today announced that it received approval from Health Canada to initiate a Phase II trial for Herpes Simplex Virus 1 (HSV-1) using Resveratrol, its patented synthetic compound. The trial will be conducted at six sites across Canada and will evaluate the efficacy of Royalmount’s anti-viral and anti-inflammatory treatment Resveratrol, in approximately 120 patients with recurrent HSV-1, commonly known as cold sores. Final results of the trial are expected by fall 2004.
Shire continues the development of its vaccine business
Shire Biologics (Laval), part of Shire Pharmaceuticals Group announced it is investing C$46.5 million in the expansion of its vaccine production facility located in Quebec City. This project will potentially create 100 new jobs on completion. The new state-of-the-art building will be located alongside Shire’s existing vaccine production facility in the Quebec Metro High Tech Park. Construction begins this week, and the facility is expected to be operational in 2006. Shire also announced that construction of its new global vaccine research centre in Canada has started in the Laval Biotech City. As previously announced in December 2002, this new facility represents an investment of C$28 million and should be completed in December 2004; a team of nearly 100 researchers will ultimately staff it.
3) Medical Devices
WorldHeart announces randomized destination therapy trial
World Heart (Ottawa) announced that, subject to approval of the FDA, it intends to conduct a pivotal trial in approximately 30 centers in the US, in which Novacor LVAS (left ventricular assist system) is compared to HeartMate XVE LVAS (left ventricular assist system) in use as destination therapy for patients suffering from irreversible left ventricular failure who are not transplant candidates. an investigational device exemption (IDE) and category B were approved by the FDA in connection with the feasibility study for destination therapy, named INTrEPID (investigation of non-transplant-eligible patients who are inotrope dependent). Devices implanted pursuant to a category B IDE are considered non-experimental and are generally eligible for Medicare coverage. WorldHeart expects to receive approval for the pivotal trial and will commence enrollment of patients during the first quarter of 2004.
4) Genomic Update
McGill researcher halts, reverses growth of breast cancer in mice
Dr William J Muller, a Canadian microbiologist and CBCRA-funded researcher, has just presented pivotal research which demonstrates that it is possible to block genetic switches in mice that turn cancer on and off thereby preventing and even reversing the growth of breast cancer. The research was presented Sunday morning at the 24th Congress of the International Association for Breast Cancer Research in California. Dr Muller and his team of international researchers have discovered that removing a gene known as beta-1 integrin halts breast cancer growth in laboratory mice. Beta-1 integrin is a principal regulator of normal breast tissue growth, but if it malfunctions, it can have a direct effect on breast tumor growth. Dr Muller’s research shows that if the gene is eliminated, it has a preventative effect on cancer-prone mice, and stops further tumor growth in mice that have already developed breast cancer. Although the research is pre-clinical and has not yet been tested on humans, the implications for the future study of breast cancer are very encouraging.
5) Industry Update
ConjuChem (Montreal) announced that under the terms of its bought deal financing completed on October 6 2003, the underwriters syndicate led by Orion Securities and including Sprott Securities and BMO Nesbitt Burns, has exercised, in full, its over-allotment option. Accordingly, ConjuChem has issued an additional 780,000 common shares at a price of $4.15 for gross proceeds of $3,237,000. The exercise of the over-allotment option increases total gross proceeds from the offering to approximately $24.9 million.
SMC Ventures (Vancouver), previously GenSci Regeneration Sciences, announces that, as a result of the completion of its plan of arrangement, and the acquisition of substantially all of its assets by IsoTis, its common shares were delisted from the Toronto Stock Exchange (the “TSX”) at the close of trading on October 30, 2003.
Tm Bioscience (Toronto) announced the successful certification of its quality management system to both the ISO 13485:1996 standard and the requirements of the Canadian medical devices conformity assessment system (CMDCAS). The scope of this certificate covers processes for developing, manufacturing and distributing tests for genetic mutations related to hematology, toxicology, cystic fibrosis and other debilitating genetic disorders; analyte specific reagents (ASR), in-vitro diagnostic medical devices (IVDD) and software used for testing for genetic mutations.
MIV Therapeutics (Vancouver) announced that Dr Arun Chockalingam, BE, MS, PhD, FACC, FACEP has accepted our invitation to act as special advisor on scientific and international affairs.
NeuroMed Technologies, (Vancouver) a biopharmaceutical company developing next-generation chronic pain drugs, today announced the closing of a series C financing of US$32 million.
A $2.9 million, six-year partnership between the US-based National Alliance for Autism Research (NAAR) and the Institute of Neurosciences, Mental Health and Addiction (INMHA) of the Canadian Institutes of Health Research (CIHR) aims to train the next generation of researchers and uncover the mysteries of autism a brain disorder with no known cure. The partnership includes $300,000 from the Fonds de la recherche en sant du Qubec (FRSQ).
Paladin Labs (Montreal), a leading Canadian specialty pharmaceutical company, announced that it has entered into a distribution agreement with PanGeo Pharma for a portfolio of prescription drug products consisting of Sandomigran, Sintron, and Zaditen. According to IMS Canada, these products had combined Canadian sales of approximately $2 million in 2002.
GW Pharmaceuticals and Bayer HealthCare, Pharmaceuticals Division Canada announce a marketing agreement to bring Sativex, GW’s cannabis-based medicinal extract product, to the Canadian market.
Labopharm (Laval) announced that, through its European subsidiary, Labopharm Europe, it has secured a licensing and distribution agreement with Austria-based CSC Pharmaceuticals Handels GmbH for 14 Eastern European countries for its lead in-house product, a once-daily version of the analgesic tramadol.
Cepheid (Sunnyvale) announced that Cepheid and Infectio Diagnostics (Quebec) have executed a series of new agreements resulting in a restructuring of their previously existing collaborative relationship. The ARIDIA joint venture no longer fulfilled the strategic objectives of either Cepheid or IDI and has been dissolved.
Hemosol (Toronto) announced up to $8.625 million private placement. Loewen, Ondaatje, McCutcheon and Vengate Capital Partners will act as agents to sell on a best efforts basis up to 11.5 million units of Hemosol at a price of $0.75 per unit.
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).