Ottawa, ON October 17, 2003 The following life sciences news briefs were recently published by Industry Canada.
1) Pharmaceuticals Update
Axcan receives “not approvable” letter for Helicide
Axcan Pharma (Mont Saint Hilaire) has announced that the US Food and Drug Administration has determined that the new drug application that Axcan re-submitted for Helicide for the eradication of Helicobacter pylori, continues to be “not approvable” at this time. Certain of the FDA inspection-related issues, communicated to Axcan in an August 12, 2002, action letter for one of the five manufacturing sites, remain unresolved and were the basis for this “not approvable” letter. As in the previous letter, the FDA has not raised any safety or efficacy issues. Helicide was approved in Canada in the second quarter of fiscal 2003. During the last year, Axcan has worked closely with the Italian manufacturer identified in the NDA to resolve all outstanding issues. However, the ability of this manufacturer of one of Helicide’s ingredients, biskalcitrate potassium (bismuth salt), to implement all required corrective action is severely limited due to its present financial status. Axcan will meet with the FDA in the coming weeks to discuss alternative plans and, shortly thereafter, intends to announce revised regulatory timelines.
Cangene files for GM-CSF approval in Canada
Cangene (Toronto) announced that it has filed a Canadian new drug submission for Leucotropin, a protein known as GM-CSF. The submission seeks approval from the Biologics and Genetic Therapies Directorate for use of the drug in enhancing recovery of certain white blood cells in patients with Hodgkin’s Disease and non-Hodgkin’s Lymphoma following stem cell transplantation. Cangene developed Leucotropin with the Apotex Group, which plans to market the product in Canada. Leucotropin is Cangene’s granulocyte-macrophage colony-stimulating factor (“GM-CSF”), which is a protein that stimulates the production of certain infection-fighting white blood cells. White blood cell levels can be depleted by cancer treatments and drug therapies for other conditions, possibly leaving patients susceptible to harmful infections and requiring cessation of treatment.
Dimethaid signs new UK distribution deal for Pennsaid
In2Focus Sales Development Services (Toronto) has signed an agreement with Markham-based pharmaceutical developer Dimethaid Research to distribute the Canadian company’s first prescription, anti-arthritic drug Pennsaid throughout the United Kingdom. Headquartered in Berkshire, near London, In2Focus specializes in pharmaceutical sales and marketing and regularly provides services to such companies as Eli Lilly, GlaxoSmithKline, AstraZeneca and Aventis. It will position topical Pennsaid directly against pills known as NSaids often used to treat osteoarthritis symptoms in the knees and superficial joints. Estimates, as of June 2003, value the UK market for NSaids at around S 356 million.
Axcan signs with Aventis to acquire a group of gastrointestinal products
Axcan Pharma (Mont Saint Hilaire) announced that it has signed an agreement to acquire the rights to a group of gastrointestinal products from Aventis. Under the terms of this agreement, Axcan will acquire Carafate and Bentyl for the US market and Sulcrate, Bentylol and Proctosedyl for the Canadian market for a cash purchase price of US $145 million. Axcan believes this acquisition will be immediately accretive, expecting to generate in excess of US 20 cents in earnings per share over the 12 months following closing from the sale of these products. The closing of this acquisition is subject to regulatory approval under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. During the past 12 months, Aventis’ combined net sales of acquired products in these territories were approximately US $42 million. The US $145 million purchase price is approximately 3.5 times the net sales of these products for the trailing 12 months. The purchase price will be paid out of Axcan’s cash on hand.
2) Diagnostics and Therapeutics Update
$2 Million NSERC research network to turn living cells into “factories”
Andrew Telegdi, member of parliament for Kitchener-Waterloo, announced $2 million in federal funding for the NSERC Research Network in Cell Bioprocessing (CellNet). Telegdi attended the event at the University of Waterloo on behalf of Allan Rock, Minister of Industry. The research, headed by Dr Murray Moo-Young at Waterloo, will seek ways of using “cells as factories” in order to develop health care bioproducts. "Large quantities of cells or tissues can be grown as ‘factories’ for producing useful molecules, such as human insulin from E.coli cells or edible vaccines from bananas,” explained Dr Moo-Young. “The network will build on the University of Waterloo’s core expertise and then link with selected university and industrial research centres across Canada to create the necessary critical mass and expertise.”
CME Telemetrix and Spectromedical sign cross-license agreement
CME Telemetrix (Waterloo), a leading-edge developer of near-infrared instruments, announced an agreement with Spectromedical of Cambridge, ON, whereby Spectromedical will grant CME a license to certain patents in exchange for an assignment of selected CME patents. Under the agreement between CME and Spectromedical, certain Spectromedical patents will be licensed to CME for exclusive use in in-vivo blood analyte monitoring applications. In addition, CME has a non-exclusive license to exploit the Spectromedical patents in the field of clinical in-vitro blood analyte testing. Under the agreement, CME will share in certain commercial benefits realized by Spectromedical.
Antibiotics may help stave off Alzheimer’s
A combination of two common antibiotics may help delay symptoms of Alzheimer’s disease, researchers said. In a 101-patient Canadian study, Alzheimer’s patients treated with antibiotics doxycycline and rifampin for three months had significantly less mental decline than those given dummy pills, said Dr Mark Loeb, associate professor at McMaster University in Hamilton, Ontario, and the study’s lead author. “The antibiotic regimen might allow a person suffering from Alzheimer’s disease to remain home and avoid having to go to a nursing home or other institution, at least for a period of time,” he added.
3) Medical Devices
Cedara joins Intel early access program
Cedara Software (Toronto), a leading independent developer of medical software technologies for the global healthcare market, announced that it has joined the Intel early access program. The Intel early access program helps Cedara accelerate the development and optimization of its products using the Intel architecture. Offering an extensive array of resources to program members (including training, technical support, early access to Intel pre-released platforms and peer networking opportunities), the Intel early access program is a forum for technology learning and expansion, allowing its diverse members to collaborate and provide innovative end-to-end customer solutions.
Angiotech receives Canadian approval for CoSeal surgical sealant
Angiotech Pharmaceuticals (Vancouver) announced that it has received approval from Health Canada to market a new premixed configuration of CoSeal; the same formulation that was approved by the US FDA and the European Community earlier this year. CoSeal is a novel, fully synthetic surgical sealing agent designed to optimize healing by rapidly sealing tissue surfaces, suture lines and synthetic grafts. The new premixed CoSeal affords more flexibility to surgeons; it is simpler to use, can be stored at room temperature, and has a two-hour lifespan once activated.
Integration of Andromed’s technology with Medcare for sleep disorders
Andromed (Toronto), a high-tech medical company, and Medcare, a producer of equipment and solutions for the diagnosis of sleep-related disorders, have concluded an agreement
under which the parties will evaluate the clinical advantages of integrating Andromed’s technology with Medcare’s sleep diagnostic instruments, thousands of which are currently used in sleep centers throughout the US and globally. If the benefits prove conclusive, the parties will agree upon the terms of a supply agreement for the i- stethos electronic stethoscope and the Androsonix, Andromed’s patented biological sound sensor.
4) Genomic Update
The genetics of blindness
Treatment for the most common inherited cause of blindness, retinitis pigmentosa, is one step closer, according to investigators at the Research Institute of the McGill University Health Centre (MUHC). They are the first to link two new gene mutations in two French- Canadian families to loss of vision in humans. Their findings are published in this month’s issue of the American Journal of Ophthalmology. This project was funded by the Canadian Institutes of Health Research (CIHR), le Fonds de la recherche en sant du Qubec (FRSQ) and the Foundation Fighting Blindness – Canada. Approximately 1.5 million people worldwide are affected by retinitis pigmentosa, which at the moment has no cure. This disease causes vision loss by progressive degeneration and death of the cells that make up the retina, the portion of the eye that responds to light.
5) Industry Update
Response Biomedical (Vancouver) announced that it is undertaking a non-brokered private placement of 3,500,000 units at a price of $0.43 per unit, each unit consisting of one common share and one-half of one common share purchase warrant.
ConjuChem (Montreal) announced it has successfully closed a financing of 5,220,000 common shares raising gross proceeds of $21,663,000. A syndicate of underwriters led by Orion Securities including Sprott Securities and BMO Nesbitt Burns purchased the shares on a bought deal basis.
MDS Sciex (Toronto) the analytical instrumentation and technology solutions division of MDS and K’ (Prime) Technologies, a company specializing in chromatography sales and support, announced the signing of a distributorship agreement to deliver the new NanoLC system in Canada.
Fytokem Products (Saskatoon), announced that Mr Mark Pasloski, CA vice-president – finance & administration will resign his position effective October 31, 2003. Mark has accepted a position with the federal government.
Response Biomedical (Vancouver), announced the successful conclusion of the critical first phase in the product development collaboration funded by a Global Fortune 500 multi-national healthcare company, aimed at miniaturizing the Ramp System for broad new market applications. This initial agreement was announced on February 13, 2003.
Angiotech Pharmaceuticals, (Vancouver) announced that it has successfully closed its previously announced over-allotment exercise of 750,000 common shares of Angiotech at a price of US$43.75 per common share (CDN$59.01 per share). The over-allotment option was granted to the underwriters by Angiotech pursuant to its recent public offering of 5,000,000 common shares. The completion of the offering, including exercise of the over-allotment option, has resulted in the total sale of 5,750,000 common shares with gross proceeds to Angiotech of US$251,562,500 (CDN$339,307,500).
VSM MedTech (Vancouver) announced that its CTF subsidiary has completed a definitive agreement with the University of California’s Lawrence Berkeley National Laboratory (Berkeley Lab) to license technology necessary for the development of VSM’s revolutionary hybrid MEG/MRI system.
Altachem Pharma Ltd. (Edmonton) announced that Altachem has relocated its head office to the Edmonton Research Park.
Nymox Pharmaceutical (Dorval) announced that a new drug candidate for neurodegenerative disease has recently been developed by the company. The new drug candidate NXD-5150, successfully completed important pre-clinical milestones and is on target for clinical testing in humans in the near term.
ID Biomedical (Vancouver) announced that it has entered into an agreement with a syndicate of investment dealers led by Canaccord Capital. Under the agreement, the syndicate has agreed to purchase 5,800,000 units at a purchase price of US$17.37 per unit on a “bought deal” basis for a total of $100 million.
CryoCath Technologies (Montreal), announced the closing of its previously announced bought deal of 4,500,000 common shares. The offering was sold through a syndicate of underwriters led by Orion Securities and including BMO Nesbitt Burns, National Bank Financial, RBC Capital Markets, and Dlouhy Merchant Group. Cryocath issued 4,500,000 common shares at a price of $5.60 per common share, resulting in gross proceeds to CryoCath of $25,200,000.
Dr Sam Hanash, current president of Human Proteomic Organization announced the election of Dr John M Bergeron to the position of incoming president of the organization.
MediSolution Ltd. (Montreal) announced that the early conversion of debt by Brascan Financial in the principal amount of $14.5 million announced on September 17, 2003 has now been completed.
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).