Ottawa, ON March 28 2003 The following life sciences news briefs were recently published by the Life Sciences Branch of Industry Canada.
1) PHARMACEUTICALS UPDATE
Axcan Pharma Receives Canadian Approval For PHOTOFRIN
Axcan Pharma Inc. (Mont Saint-Hilaire) announced that it received approval from the Therapeutic Products Directorate of Health Canada for PHOTOFRIN in the treatment of High-Grade Dysplasia (“HGD”) associated with Barrett’s Esopaghus. PHOTOFRIN in the treatment of HGD associated with Barrett’s Esophagus will be launched in Canada by the end of the third quarter of fiscal 2003. In 2003, Axcan also expects to receive approval for the U.S. and European markets, where Orphan Drug designation has been granted. The entire North American market for PHOTOFRIN for the treatment of this indication is estimated to be U.S. $30-50 million annually. This market is estimated to be of a similar size in Europe. Barrett’s Esophagus is a condition that results from prolonged heartburn in which the normal lining of the lower part of the esophagus is replaced, over time, by another type of lining normally present in the stomach. Barrett’s Esophagus is clearly recognizable at endoscopy.
Axcan Receives Canadian Approval for Helicide
Axcan Pharma Inc. announced that it received approval from the Therapeutic Products Directorate of Health Canada for HELICIDE, a patented single capsule triple therapy, for the eradication of Helicobacter pylori which is a bacterium now recognized as being the main cause of gastric and duodenal ulcers. Each HELICIDE capsule contains the equivalent of 40 mg of bismuth biskalcitrate (bismuth), 125 mg of metronidazole and 125 mg of tetracycline hydrochloride (tetracycline), and is administered in combination with a proton pump inhibitor. Helicobacter pylori are now recognized as the primary cause of gastric and duodenal ulcers, which affect at least 10% of the North American population at some point. Existing ulcer treatment regimens lead to high recurrence rates. Gastric and duodenal ulcers respectively recur in approximately 40% and 80% of patients within a year if they receive short-term treatment with acid suppression therapy, but without Helicobacter pylori eradication.
H3 Pharma Licenses in Phase II Product for Stomach Cancer
H3 Pharma Inc. (Montreal) announced today that it has finalized a licensing and an investment undertaking with OncoMab(TM) GmbH, a start-up biotech drug discovery company based in Wurzburg, Germany. The deal is a multimillion-dollar transaction including an exclusive royalty-bearing license for the first product and its molecular target, an exclusive option for a license on three other products targeting other forms of cancer and the purchase of an equity stake in the company. H3 Pharma will take charge of the clinical development and worldwide registration for the four products. The first product, SC-1, is a fully human monoclonal IgM antibody targeting a specific isoform of CD55 present in 60% of stomach carcinomas. In a prospective study, the antibody was administered prior to surgery in 51 patients and was shown to specifically induce tumour apoptosis. Moreover, two-year survival after SC-1 treatment and curative resection was 75% versus less than 60% in a comparable patient population. This statistically significant survival benefit was further increased after three years.
2) DIAGNOSTICS AND THERAPEUTICS UPDATE
BioAxone Therapeutic Inc. Signs Out-License Deal Worth $30 Million
BioAxone Therapeutic Inc. (Montreal) has entered into a license and supply agreement with an American biotechnology company, worth approximately $30,000,000 to BioAxone. The deal consists of a mixture of cash, equity and royalties over the next 5 years. In exchange, BioAxone has granted its partner a restricted license, and BioAxone will provide both research and GMP-grade quantities of one of BioAxone’s proprietary compounds. In addition, BioAxone will provide pre-clinical data, as well as technical know-how on activity assays and assay development. The deal provides BioAxone’s partner with a compound shown to be highly effective for treatment of the partner’s target medical condition, and accelerates their development program. The name of the company cannot be released because of a confidentiality agreement and the highly competitive nature of the field. BioAxone Therapeutic Inc., established April 2000, is a privately owned company. The company specializes in the development and commercialization of proprietary technologies that target Rho signaling. Rho signaling is applicable to medical indications that include central nervous system (CNS), cancer and related fields.
ConjuChem’s DAC(TM):GLP-1 Clinical Program Advances
ConjuChem Inc. (Montreal) announced it has initiated, on schedule, the multi-dose component of its DAC(TM):GLP-1 Phase I/II clinical trial program. As per the protocol for this trial, the multi-dose component has been divided into two parts. In the first part, 3 cohorts each consisting of both healthy volunteers and patients will receive 2, 4 or 8 mcg/kg/day of DAC(TM):GLP-1 for 14 days. These subjects will then be followed and assessed on safety, pharmacokinetic and preliminary efficacy parameters. The objective of the first part of the program is to build the plasma concentration of DAC(TM):GLP-1 to an efficacious level with minimum unwanted side-effects. Once the target plasma concentration has been achieved, the second part of the study will focus on determining the dosage required to maintain the efficacy with longer intervals between administrations. ConjuChem expects to report top-line preliminary data from the first part of this study in the first half of this year and to commence the final portion of this study immediately thereafter.
Angiotech Announces Positive Phase 1 Psoriasis Results
Angiotech Pharmaceuticals Inc. (Vancouver) announced positive results in its Pilot Phase 1 Psoriasis Study. The National Cancer Institute completed a study evaluating the systemic use of PAXCEED(TM) (a Cremophor(R) EL-free paclitaxel formulation) in a challenging group of patients with severe psoriasis. Eligible patients had a PASI (Psoriasis Area and Severity Index) Score of 20 or greater (severe disease), and had been treated with at least two other systemic agents. No concomitant therapies were allowed during the trial. Patients were treated with either 75 mg/m2 of PAXCEED(TM) every four weeks for six treatments or a second protocol of 37.5 mg/m2 every two weeks for three treatments followed by six doses of 50 mg/m2 every two weeks. Nine patients completed the study. All patients had a positive response to PAXCEED(TM). In the optimal dose regime group utilizing 75 mg/m2 monthly, the average PASI score improvement was 64 percent. The study also demonstrated that once the patients came off therapy, there was no rapid rebound effect or exaggerated recurrence of disease, as typically displayed with traditional immunosuppressive agents or steroids. The safety and side effect profile was excellent and consistent with all other previous systemic PAXCEED(TM) programs.
Oncolytics Biotech Inc. Announces Results of Reovirus Treatment
Oncolytics Biotech Inc. (Calgary) reported that Dr. Don Morris and his research group with the Alberta Cancer Board and the University of Calgary published the results of their work with the human reovirus for the removal of contaminating cancer cells from autologous (harvested from the patient themselves) blood stem cells in model systems. The results were prepublished online in the March 13th, 2003 issue of Blood. Hematological (derived from blood) stem cell rescue following high-dose chemotherapy is extensively used clinically for both solid tumors and tumors of the blood. Globally, the number of autologous blood and bone marrow transplants surpasses the number of donor-derived transplants. It has been estimated that as many as 30% of these autologous stem cell transplants are contaminated by cancer cells. Dr. Morris and his collea
gues demonstrated that reovirus purged contaminating cancer cells present in these stem cells derived from bone marrow.
Medical Services Vscan HIV Test Kit Receives Endorsement In Hong Kong
Medical Services International Inc (Edmonton) announced that its Vscan HIV Rapid Test Kit has received independent endorsement in Hong Kong. Tagalder Asia our sole distributor in SE Asia, based in Hong Kong has been working with The Society for Aids Care (SAC) to complete independent testing of the VScan HIV test kit. As a result of the excellent test results achieved, The Society for Aids Care (SAC) has agreed that they will endorse our VScan HIV rapid test kits as the test kit of choice for testing for HIV in Southeast Asia. SAC is prepared to recommend to Corporations, Government Agencies and individuals that the Medical Services VScan rapid test kits for HIV should be used for initial testing for HIV. All testing done by SAC will be with VScan HIV test kits. SAC is a charitable organization providing quality healthcare for people living with HIV/AIDS.
3) GENOMICS UPDATE
Bioniche Life Sciences Announces Additional Bladder Cancer Results
Bioniche Life Sciences Inc. (Belleville) made three important presentations on the company’s lead proprietary technology MCC (Mycobacterial Cell Wall DNA Complex) to the delegates of the 18th Congress of the European Urology Association meeting held in Madrid Spain. Dr. Stephanie Reader, Proteomics Project Leader, Bioniche Therapeutics, presented data showing that MCC treatment of bladder cancer cells results in a significant decrease in the levels of a number of intracellular enzymes that participate in cell cycle progression and cell division. These results are consistent with the observation that MCC causes cell cycle arrest and inhibits the division of cancer cells. Dr. Nigel Phillips, Chief Scientific Officer, Bioniche Life Sciences Inc. presented data showing that exposure of bladder cancer cells to sub-optimal concentrations of MCC did not result in the generation of resistance to itself or to two other unrelated cancer chemotherapeutic agents, Mitomycin C and Doxorubicin, and did not result in the enhanced expression of proteins associated with multidrug resistance in cancer cells.
PROCREA and Galileo Announce Collaboration for Endometriosis
PROCREA BioSciences Inc. (Montreal) and Galileo Genomics Inc. announced that they have initiated a collaboration to identify gene mutations that predispose women to endometriosis. This collaboration is expected to lead to the discovery of new diagnostic agents and therapeutic targets that will allow for the development of new pharmaceuticals, hence providing superior alternatives to current hormonal therapy and surgery to millions of women suffering from endometriosis. The research project will use samples collected by the Division of Research and Development at PROCREA in collaboration with Quebec hospitals and gynecologists during the development of PROCREA’s MetrioTest(TM), the first minimally invasive diagnostic tool for this disease, marketed in March 2002.
4) INDUSTRY BRIEFS
MDS Pharma Services (Montreal) has resumed business at the area where a minor incident involving a low-energy emitting isotope occurred. The company contacted the regulatory agency, the Canadian Nuclear Safety Commission, on March 14 at which time the facility was closed for clean up. Today the Canadian Nuclear Safety Commission has authorized the company to resume activity in approximately 90 per cent of the building – in all but the basement laboratories where the incident occurred.
Celmed BioSciences (Montreal) announced the departure of Mr. Jacques M. Saint-Denis as President and Chief Executive Officer of Celmed BioSciences. Dr. Andre de Villers, Vice Chairman of the Board and Special Advisor of Theratechnologies will replace him on an interim basis… Biomira Inc. (Edmonton) announced that data from the Company’s Phase II Theratope(R) vaccine trial in metastatic colorectal cancer will be presented as a poster presentation at the 2003 Annual Meeting of ASCO.
Angiotech Pharmaceuticals, Inc. (Vancouver) was notified by its corporate partner, Boston Scientific that BSC has started its TAXUS V clinical trial, which plans to evaluate more than 1,100 patients at up to 70 sites in the U.S. The first patients were enrolled earlier this month in the de novo lesion portion of the trial… Cedara Software Corp. (Toronto) announced that it received a Nasdaq Staff Determination on March 19, 2003 indicating that the Company fails to comply with the minimum bid price and the minimum stockholders’ equity requirements for continued listing.
Angiotech Pharmaceuticals, Inc. (Vancouver) is scheduled to participate in the Banc of America Securities Healthcare Conference.
IVP Technology Corporation (Toronto) announced that its MDI Solutions group, which provides medical data integration services in Canada and the United States, through IVP’s wholly owned subsidiary Springboard Technology Solutions Inc., has received multiple contracts with four of the Toronto area’s largest hospitals… A Canadian scientist has made a small but vital step toward providing clinicians with the ability to reverse spinal cord injury. Dr. Molly Shoichet, an associate professor of chemical engineering at the University of Toronto, recently demonstrated that an artificial bridge constructed across a break in the spinal cord can serve as a conduit for new nerve cells originating in the brain. “What’s most exciting about this work is that we determined that some of the new nerve cells or axons that were growing in our rats were drawing from the brain. The reason that’s so exciting is that you can get tissue growing. But you also want to get the right tissue. And in this case it’s the cells in the brain that are regenerating their axons,” says Dr. Shoichet, of the as yet unpublished research.