Ottawa, ON – January 29, 2004 – The following life sciences news briefs were published this week by Industry Canada.
1) Pharmaceuticals Update
Enzon and INEX Pharmaceuticals sign commercialization partnership
Enzon Pharmaceuticals (Bridegwater, NJ) and Inex Pharmaceuticals (Vancouver) announced a strategic partnership to develop and commercialize INEX’s proprietary oncology product Onco TCS. Under the terms of the agreement, Enzon receives the exclusive North American commercialization rights for Onco TCS for all indications. The lead indication is relapsed aggressive non-Hodgkin’s lymphoma (NHL) for which INEX is in the process of submitting a rolling new drug application to the US Food & Drug Administration (FDA), which is expected to be completed during the first quarter of calendar year 2004. The product is also in numerous phase II clinical trials for several other cancer indications, including first-line NHL.
Micrologix meets with FDA on MBI-226
Micrologix Biotech (Vancouver), a developer of anti-infective drugs, has met with the FDA to address the regulatory requirements for a new drug application (NDA) for MBI-226, a topical cationic peptide currently in phase III development for the prevention of catheter- related bloodstream infections. In summary, an NDA path forward for MBI-226 can be achieved without the requirement for a statistically significant reduction in catheter-related bloodstream infections as a primary endpoint. The NDA requirements for MBI-226, which may include a confirmatory second phase III study, will be established in consultation with an FDA representative over the next several months, using the secondary endpoints from a first phase III study completed in July 2003 as a basis for seeking approval.
Polydex Pharmaceuticals’ Ushercell completes phase I trials
Polydex Pharmaceuticals (Toronto) is pleased to provide this update on current research and development projects involving its Ushercell and Usherdex-4 products. Ushercell, a cellulous sulfate gel formulation developed by Polydex, is envisioned for topical vaginal use primarily in the prevention of unplanned pregnancies as well as the transmission of AIDS and other sexually transmitted diseases. With the assistance and financial support of its collaborative research partner Conrad, several phase I safety, tolerance and acceptability clinical trials were successfully completed in Cameroon, Uganda, Nigeria, India, Belgium, the US and the Dominican Republic during 2003. The data from these trials has shown consistent safety and tolerance with respect to the product, and the reports include recommendations to proceed with phase II and III efficacy trials.
Axcan Pharma reports positive pre-ind meeting for ITAX
Axcan Pharma (Mont Saint Hilaire) announced the outcome of the meeting it held with the FDA on January 20, 2004, regarding Itax (itopride hydrochloride). This meeting was held in preparation for the filing of an investigational new drug (IND) for Itax in the treatment of functional dyspepsia (also known as non-ulcer dyspepsia). During this meeting with the FDA’s division of gastrointestinal and coagulation drug products, the FDA endorsed Axcan’s proposal to conduct two phase III pivotal double-blind, placebo controlled clinical studies to demonstrate the safety and efficacy of Itax in the treatment of functional dyspepsia. After reviewing the data currently available on Itax, the FDA agreed that no additional phase II studies were required. Axcan therefore expects to commence the phase III studies in the second half of fiscal 2004 after filing an IND application. Assuming positive outcomes, the company expects to submit a new drug approval for the treatment of functional dyspepsia in the latter part of 2005 and obtain approval in fiscal 2006.
2) Diagnostics and Therapeutics Update
Procyon reports issuance of US patent on compounds
Procyon Biopharma (Montreal) announced that it has been granted US patent no 6,677,367 relating to its antiretroviral program. The patent protects a series of novel small molecules that demonstrate inhibitory activity against the HIV aspartyl protease and the whole virus in cell cultures. “As new protease inhibitors are constantly needed due to the resistance issue in HIV/AIDS, Procyon’s objective is to build a significant library of compounds in order to develop additional protease inhibitors in the near future,” said Hans J Mader, president and CEO of Procyon Biopharma Inc. “The issuance of this patent significantly strengthens our portfolio of HIV protease inhibitors, bringing the total to nine US patents on HIV protease inhibitors granted to Procyon and we greatly value this asset developed from our virology division,” he added. The new patent entitled “HIV protease inhibitors based on amino acid derivatives” describes various forms of Ne-amino acid substituted L-lysine derivatives that inhibit the HIV protease activity. Protease inhibitors are an essential component of the Haart (highly active anti-retroviral therapy) cocktail for the treatment of HIV/AIDS. In addition to their activity against the HIV protease, the amino acid derivatives form an important pool of compounds that can eventually serve to derive novel drugs for other potential applications.
Dr Brenda Milner – first foreign associate to receive award
Dr Brenda Milner will receive the 2004 Award in the Neurosciences from the National Academy of Sciences (NAS) headquartered in Washington, DC. The US$25,000 prize is awarded every three years in recognition of extraordinary contributions to progress in the fields of neuroscience. Dr Milner is the Dorothy J Killam professor, Montreal Neurological Institute (MNI), and a professor in the department of neurology and neurosurgery, faculty of medicine, McGill University. She is the first scientist outside of the US to receive this award which will be presented on April 19 at a ceremony in Washington, DC.
Neurochem reports interim positive results in Alzheimer’s patients
Neurochem (Montreal) reported additional positive interim data on cognitive function in the 30 patients with mild-to-moderate Alzheimer’s Disease. The results relate to patients who have completed both the three-month phase II clinical trial and an additional nine months of treatment in the open-label phase II extension study with the investigational product candidate, Alzhemed. The data is based on cognitive function as measured by the ADAS-cog test and follows upon earlier interim results published on patients who had completed either nine or 12 months of treatment.
3) Medical Devices
Nexia announces that Protexia meets military’s primary objective
Nexia Biotechnologies (Montreal) reported positive results from the Protexia in vivo efficacy studies conducted by the US Army’s Institute for Chemical Defense (ICD). The studies evaluated the ability of Protexia, a recombinant form of human butyrylcholinesterase (BChE), to protect laboratory animals from the toxic effects of nerve agents. The experimental program is a technical collaboration between ICD and Nexia. Nexia purified the Protexia from the milk of transgenic goats and ICD evaluated Protexia for its ability to protect animals from the toxic effects of organophosphate nerve agents. The results of these studies will be the subject of a peer reviewed, joint publication from the US Army Medical Research and Materiel Command and Nexia later this year.
Medisys subsidiary Medgate secures enterprise license agreement
Medisys Health Group (Montreal), a provider of healthcare services to corporations and insurance companies in Canada, has announced that its software subsidiary, Medgate, has secured an enterprise software license agreement with a Fortune 500 defense contractor. Under terms of the agreement, the defense contractor will utilize Medgate’s full suite of occupational health & safety software modules. Medgate also licensed its medical and health surveillance, disability management, industrial hygiene, employee
demographics, and incident claims management software modules to a major US-based manufacturer of water and sewer pipes. The company is one of the 500 largest privately owned companies in the US.
Galileo Genomics announces an additional C$7 million
Galileo Genomics, a Montral-based next generation genomics company, announced that Investissement Qubec is providing a C$7 million loan under its BioLevier program. Galileo will use these additional funds to accelerate the search for genes associated with more than 20 common and economically important diseases. Galileo had previously announced on January 7, 2004 an equity financing of $11.15 million. The objective is the discovery of GeneMaps, groups of common interacting genes that are directly and unequivocally involved in disease-causing biochemical processes. These are expected to lead to new drug and diagnostic targets that will accelerate the progression to personalized medicine, through the combined use of a gene-based drug and a genetic diagnostic to treat the root causes of common diseases, and not just the symptoms.
5) Industry Update
QLT (Vancouver) announced a temporary discount to physician customers that will allow the purchase of Visudyne at a reduced cost of $1,295, down from the current price of $1,350. This decision was made in response to the reduction in reimbursement for Visudyne by Medicare on January 1, 2004, as part of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003.
North Sound Capital announced that it acquired 500,000 common shares in the capital of ConjuChem (Montreal). North Sound now owns a total of 4,550,000 common shares of ConjuChem, representing approximately 11% of the issued and outstanding common shares of ConjuChem. Conjuchem’s common shares trade on the Toronto Stock Exchange.
AltaRex (Edmonton) would like to update shareholders of the proposed transaction involving Nova Bancorp Investments announced December 3, 2003. On December 22, 2003, the company received an interim order from the Court of Queen’s Bench of Alberta approving the proposed plan of arrangement.
Angiotech Pharmaceuticals (Vancouver) announced that shareholders of the company approved all matters at its special shareholders meeting including a two-for-one stock split and a new stock option plan.
World Heart (Ottawa) announced that it has established direct sales and support capability and responsibility for its Novacor LVAS product in Europe and Canada, while retaining the exclusive distributor relationship for Japan with Edwards Lifesciences from July 1st, 2000 until December 31st, 2003, Edwards was the exclusive distributor for Novacor LVAS outside the US and Japan. Sales and customer support in the US continues to be delivered directly by WorldHeart.
QLT (Vancouver) announced that its registration statement on Form S-3, with respect to the resale of its $172,500,000 aggregate principal amount 3.0% convertible senior notes (“Notes”) due 2023 and the common shares issuable thereunder, was declared effective on Friday, January 23, 2004, by the US Securities and Exchange Commission. QLT will not receive any proceeds from the resale of the notes and underlying common shares.
Mr Warren Jackson, president and CEO of Altachem Pharma (Edmonton) is pleased to introduce Altachem’s new director, Andrew Boddy. Mr Boddy comes to Altachem with a background in mechanical engineering.
(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: firstname.lastname@example.org).