Ottawa, ON November 5, 2003 The following life sciences news briefs were published this week by Industry Canada.
1) Pharmaceuticals Update
ConjuChem initiates enrolment in Phase II trial for DAC(TM): GLP-1
ConjuChem (Montreal) announced it has begun European enrolment in its first Phase II trial for DAC(TM):GLP-1, developed to treat Type 2 diabetes. North American sites are expected to open soon. This monotherapy study will have data from no less than 150 evaluable diabetic patients. The study is designed to assess the reduction of the HbA1c level after three months of treatment and determine the optimum subcutaneous dosage regimen. Results from this study are expected before the end of June 2004. ConjuChem also announced the successful completion of a Phase I/II single dose trial with an intravenous (iv) formulation of DAC(TM):GLP-1. All primary endpoints were met. The study’s safety, tolerability and pharmacokinetic/pharmacodynamic parameters were consistent and similar to those reported from the subcutaneous formulation Phase I/II trials reported on August 21, 2003. The maximum tolerated dose (MTD) was not reached as a function of the drug being well tolerated, even at the highest dose level of 12 mcg/kg.
Health Canada approves Gleevec
Newly diagnosed adult patients with Philadelphia chromosome positive, chronic myeloid leukemia (Ph+ CML), will now benefit from a significant treatment advance. Health Canada has approved Gleevec(*) (imatinib mesylate) for the treatment of Ph+ CML in newly diagnosed adult patients. Gleevec(*), the first cancer treatment in the world specifically targeting a cancer-producing molecule and ‘switching off’ the malfunction, leaving healthy cells intact, has been recently awarded the 2003 Prix Galien for most innovative drug product. A jury of leading Canadian specialists involved in medical and pharmaceutical research selected Gleevec(*) for this award, which represents the most prestigious prize for medical innovation in Canada.
2) Diagnostics and Therapeutics Update
Cangene enters marketing and distribution agreement with BioGeneriX
Cangene (Toronto) announced that it has entered an exclusive marketing and distribution agreement with BioGeneriX of Mannheim, Germany, for Cangene’s recombinant human growth hormone. Under the agreement, BioGeneriX will be the sole distributor of the product in Europe, giving Cangene significant access to the European market, especially through the sales force of BioGeneriX’ parent company, one of the largest generic drug companies in Europe. Cangene and BioGeneriX will pursue regulatory approval from the European Agency for the Evaluation of Medicinal Products and any other authority necessary for sales in the region. Financial terms of the agreement have not been disclosed.
Dyax and URRMA Biopharma to co-develop AIDS antibodies
Dyax (Cambridge) and privately held URRMA Biopharma (Montreal) announced that they have entered into an agreement for the discovery and development of fully human monoclonal antibodies to the R7V antigen, a specific epitope found on all types and clades of the human immunodeficiency virus (HIV). Anti – R7V neutralizing antibodies have potential to efficiently control the progression of AIDS in HIV-infected patients. Per the agreement, Dyax will utilize its state-of-the-art antibody libraries to identify anti-R7V candidates, at which time URRMA will evaluate the identified leads for their ability to neutralize HIV. Under the terms of the agreement, both companies will assume joint development of any product candidates that may be identified and will equally share commercialization rights and profits from any marketed products. The companies also have the option to jointly develop URRMA’s existing anti-R7V antibody as a therapeutic product candidate. Should the companies proceed with joint development of the URRMA antibody, Dyax will pay URRMA a one-time license fee in return for a 45% financial interest in any marketed products.
Methicillin-resistant Staphylococcus aureus: new diagnostic test
Infectio Diagnostic (Quebec City), has just submitted its ultra-rapid screening test for methicillin-resistant Staphylococcus aureus (MRSA) to the Food and Drug Administration in the United States and to Health Canada for their authorization for sale. MRSA is one of the most important causes of infection in hospitals. The dissimination, often resulting from contaminated hands of someone carrying Staphylococcus aureus, can spread very rapidly. Furthermore, the incidence of MRSA infections is increasing almost everywhere in the world. The consequences can be severe (high rates of mortality and morbidity). Also, the use of antibiotics and extended hospitalization required to treat the infection can be very expensive. It has been demonstrated in a number of countries that the best way to control MRSA infections in hospitals is through regular, rapid screening. The new test developed by IDI will enable detection of MRSA in one hour, whereas existing methods require two to three days. This is the only known test that enables immediate diagnosis. This test will help control MRSA infections, considerably reduce the cost of treatment with antibiotics, and limit the need for isolation to only those patients presenting a real risk. The company says this product will be commercialized as soon as it receives authorization from the regulatory agencies.
Folic acid a ready weapon against birth defects
A worldwide epidemic of birth defects could be prevented by fortifying flour and grains with folic acid. That’s the claim of a Canadian study in the current issue of Birth Defects Research, Clinical and Molecular Teratology. The study calls the continuing global epidemic of spina bifida and anencephaly that affects more than 200,000 newborns each year a tragic failure of global health policy. The study found the rate of neural tube defects in Canada was reduced by 32% after the federal government mandated that flour be fortified with folic acid. In addition, mandatory fortification of flour with folic acid in Canada and the US reduced concentrations of homocysteine in adults and could have prevented up to 25% of heart attacks and strokes that occurred before the folic acid requirement, the study says. Even with flour fortification, the study suggests the rate of neural tube defects in North America is about twice what it should be.
Procyon reports issuance of US patent for its HIV compounds
Procyon Biopharma (Montreal) announced that it has been granted US patent no 6,638,921 relating to its antiretroviral program. The small molecule compounds described in the patent entitled “Pyridoxal-5-phosphate derivatives as HIV integrase inhibitors” constitute a novel family of compounds that demonstrate dual inhibitory activity against both the purified enzyme and HIV in infected cell cultures.
Oncolytics and the US National Cancer Institute collaborate
Oncolytics Biotech (Calgary) announced that the drug development group of the division of cancer treatment and diagnosis, US National Cancer Institute has approved support for multiple clinical trials to evaluate the efficacy of Reolysin in a range of cancers. The NCI approved Reolysin for collaborative development after an analysis of preclinical, GLP toxicology and clinical data. Oncolytics and the NCI will collaborate to select cancer indications and suitable development programs for a number of clinical trials. Oncolytics will provide Reolysin for all clinical trials conducted and sponsored by the NCI under a clinical trials agreement.
3) Medical Devices
Angiotech commences endometriosis anti-adhesion study in Canada
Angiotech Pharmaceuticals, (Vancouver) announced that it has commenced enrollment in Canada using Adhibit adhesion prevention gel to reduce the incidence and severity of adhesions following laparoscopic surgery in severe endometriosis (Stage 3 & 4). Endometriosis is a condition that develops when the lining of the uterus (endometrium) gr
ows outside the uterus on other organs such as the ovaries, bowel, bladder, and pelvic lining. Adhesions occur when normally separate tissues scar together. At the time of surgery, there is damage to tissue, which can lead to abnormal connections between tissues and organs. Potential serious complications of adhesions include conditions such as chronic pain, bowel obstruction and infertility. Adhibit is designed to bind directly to the tissue and form a temporary barrier between surfaces, preventing contact and adhesions from forming. Adhibit only takes one to two minutes to prepare and is easily applied with a spray system making it uniquely suitable for endoscopic applications. The product is a completely synthetic, self-polymerizing liquid hydrogel that is resorbed by the body in less than 30 days.
IMI LungAlert test added to international lung cancer screening study
Predictive medicine company IMI International Medical Innovations (Toronto) announced that its LungAlert test for detection of early-stage lung cancer has been added to a major international study on lung cancer screening. IMI signed an agreement to join the Toronto site of the international early lung cancer action program (I-ELCAP), currently underway at sites around the world, and sponsored by the National Cancer Institute and several medical imaging companies.
4) Industry Update
Active Pass (Vancouver) announces the addition of three new members to the company’s
scientific advisory board: Dr Leslie Z Benet of the dept. of biopharmaceutical sciences at UCSF, Dr Geoffrey Chang of the deptartment of molecular biology and the Skaggs Institute for Chemical Biology at the Scripps Research Institute, and Dr Alan Verkman of the depts. of medicine and physiology at UCSF.
ID Biomedical (Vancouver) announced that it has closed its previously announced US$100 million bought deal financing. ID Biomedical sold a total of 5,800,000 units at a price of US$17.37 per unit for total gross proceeds of US$100,746,000.
World Heart (Ottawa) today announced the addition of Mr John M Marinchak to the position of director of sales, North America.
BioMS Medical (Edmonton) announced it has received proceeds of $825,000 from the exercise of approximately 330,000 broker warrants.
Quintiles Transnational announced the appointment of Francois Charette, MD, as general manager, senior vice president, Quintiles Canada. In this newly created position, Dr Charette will have responsibility for Quintiles’ full line of clinical research services throughout Canada.
World Heart (Ottawa) announced that the registration statement on Form F-3 (File No. 333-109876) filed by the company on October 22, 2003 was declared effective by the US Securities and Exchange Commission.
Dimethaid Research (Toronto) announced that it has successfully completed the previously announced private placement of 14,377,688 special warrants. The offering was led by Paradigm Capital and included Vengate Capital Partners Company. Special warrants are being sold at a price of $1.00 per special warrant, providing Dimethaid with $14,377,688 million in gross proceeds.
Delex Therapeutics (Mississauga) a clinical stage drug delivery company, announced the appointment of David T Howard to the company’s board of directors. Mr Howard is currently chairman of the board of Angiotech Pharmaceuticals of Vancouver, British Columbia and chairman of the board of SCOLR, of Redmond, Washington.
TSO3 (Quebec City) has signed an agreement with the prestigious Cleveland Clinic enlisting them as a technology showcase for its new ozone-based process for sterilizing medical instruments. This follows the recent clearance from the US Food and Drug Administration for the product to be commercialized in the US.
Medical Services International (Edmonton) announced that the company has agreed to begin live testing of its VScan HIV 1&2 rapid test kit in Florida.
MIV Therapeutics (Vancouver) announced the company’s listing application has met all admission requirements and its regulation s stock has been accepted for listing on the Frankfurt Stock Exchange (Frankfurt WKN: 911285, MIV1.FSE). MIVT will continue to trade on the Nasdaq OTC board.
BioSyntech (Laval) says it has entered into an engagement letter with a Canadian underwriter which has agreed to act as agent of the corporation for an initial public offering in Canada of a yet to be determined number of units for total minimum proceeds of $5 million and maximum gross proceeds of $10 million.
Haemacure (Montreal) announced that it has decided to re-orient its operations so as to focus on the development of its proprietary Hemaseel HMN fibrin sealant. Effective mid-November 2003, Haemacure will discontinue the distribution of Hemaseel APR, sold under license from Baxter Healthcare, SA. Virtually all of Haemacure’s revenues are derived from the sale of Hemaseel APR.
Hemosol (Toronto) announced that the company received a Nasdaq staff determination on October 23, 2003, indicating that the company was not in compliance with the minimum bid price of US$1.00 per share which is a requirement for continued listing on the Nasdaq national market.
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)