Life sciences news briefs (January 15, 2004)

Ottawa, ON – January 15, 2004 – The following life sciences news briefs were published this week by Industry Canada:

1) Pharmaceuticals Update

Paladin enters into licensing agreement with Watson for Oxytrol

Paladin Labs (Montreal), a Canadian specialty pharmaceutical company, today announced that they have entered into a Canadian licensing agreement with Watson Pharmaceuticals to market Oxytrol, (oxybutynin transdermal system), Watson’s transdermal patch for the treatment of overactive bladder, with symptoms of urge urinary incontinence, urgency, and frequency. According to the Canadian Continence Foundation, approximately 1.5 million Canadians suffer from overactive bladder and, according to IMS Canada, the total Canadian market for overactive bladder is estimated to exceed $42 million in 2003. Terms of the agreement were not disclosed.

Lorus announces initiation of Phase II clinical program for GTI-2501

Lorus Therapeutics (Toronto) announced that the clinical study for GTI-2501 for the treatment of hormone refractory prostate cancer has been initiated at the Toronto Sunnybrook Regional Cancer Centre. GTI-2501 will be administered in combination with docetaxel. The principal investigator for this study is Dr Scott Berry, and the co-investigator is Dr Laurence Klotz. Both clinicians are considered to be leaders in prostate cancer research.

2) Diagnostics and Therapeutics Update

Axcan Receives a CPMP positive opinion in Europe for PHOTOBARR

Axcan Pharma (Mont St Hilaire) announced that the Committee of Proprietary Medicinal Products of the European Agency for the Evaluation of Medicinal Products has issued a positive opinion related to Axcan’s marketing authorization application for the use of its photodynamic therapy, Photobarr (porfimer sodium), in the treatment of high-grade dysplasia associated with Barrett’s Oesophagus, and therefore recommends the granting of the marketing authorization. The committee states in its opinion made public today, that “Photobarr is the first conservative treatment of HGD in BO with a documented effect on progression to cancer”. Photobarr PDT was also granted an orphan medical product status at the time of its submission, which guarantees the grant of exclusive marketing rights for a ten-year period. Final approval is expected in the next three months.

Bio-ID Diagnostic says it has come up with a quick test to pinpoint SARS.

The Saskatoon-based company says it used its patented DNA sequencing technology the same technology it used to develop a test for West Nile virus last summer to develop the test. The test could provide an effective global early warning system for the disease, said Moorthy, who said the company completed its work on the test just before Christmas. Bio-ID released news of its testing method this week, shortly after the Chinese government confirmed a new case of SARS in a journalist in southern China. A doctor taking a throat swab from a patient could deliver that sample to a lab using Bio-ID’s DNA-based test and have the results back within hours.

GB Therapeutics’ GT 1061 proceeds to human safety testing

GB Therapeutics (Mississauga), announced that the United States Food and Drug Administration (FDA) has reviewed GBt’s first IND which will proceed to human safety testing, in a phase 1a trial in healthy, aged volunteers. The molecule is targeted for mild to moderate Alzheimer’s Disease. GT 1061 is a compound, which specifically targets the brain and mimics certain activities of Nitric oxide. Nitric oxide is a naturally occurring gaseous element with multiple and significant roles in the human body. In models of cognitive compromise GT 1061 demonstrated the potential to reverse memory loss and rescue brain cells from further compromise. The phase 1a study for safety begins on January 14, 2004. It is a single escalating dose study with a randomized, double blind and placebo controlled design. Healthy volunteers will be both male and female between 50 and 70 years of age.

Generex subsidiary antigen express, presents promising data

Generex Biotechnology (Toronto), which focuses on buccal drug delivery, announced that its wholly owned subsidiary, Antigen Express, recently presented a poster on its DNA vaccine technology for cancer at the NIH Conference. The poster was entitled “Innovative Administrative Systems for Vaccines,” and it was delivered by Robert Humphreys, MD, PhD, executive VP and chief scientific officer of Antigen Express. The presentation illustrated the benefits of using Antigen Express’s proprietary and patented Ii protein antisense reagents to induce a T helper cell response to prostate cancer antigens. The therapy cured about half of the mice with an aggressive, poorly immunogenic cancer. The conference also highlighted several methods of mucosal vaccination. Generex’s technology, with RapidMist administration of vaccines, was identified as potentially proving useful in therapies for autoimmune diseases such as multiple sclerosis or in the control of asthma. In such a scenario, doctors and patients could prefer use of RapidMist, the company’s needle-free technology.

3) Medical Devices

Xillix officially closes Onco-LIFE clinical trial

Xillix Technologies (Richmond), a world leader in fluorescence endoscopy, announced that it has completed internal audits of the clinical trial sites and officially closed the Onco-Life lung cancer clinical trial. The company also announced that it has submitted a request to the FDA which, if approved, will allow those US physicians involved in the clinical trial continued access to Onco-Life while the company prepares its pre-market approval supplement submission and awaits FDA approval. Concurrent with Xillix’s request for continued access, the company is preparing its PMA supplement submission, which it expects to deliver to the FDA in the next few weeks.

DiagnoCure acquires assets of imaging developer Samba Technologies

DiagnoCure (Quebec), a leading developer of molecular diagnostic tests for the early detection of cancers, announced today a crucial step in its strategy for future growth and profitability. By acquiring the assets of Samba Technologies Sarl, its customer lists, and its intellectual property in digital imaging and information technology, DiagnoCure creates numerous possibilities for new applications in cancer diagnostic immunoassays. Digital imaging is necessary for automation of immunopathology assays, which is a requirement for clinical laboratories performing large volume testing. This purchase is in accordance with DiagnoCure’s business plan.

Chiron licenses technology from IDI for bacterial detection system

Chiron (Emery, CA) and Infectio Diagnostic (Quebec) announced that Chiron has licensed IDI’s proprietary nucleic acid-based technology for the rapid detection of bacterial contamination in platelets and blood products. Under the terms of the agreement, Chiron will obtain a license to all current and future products for the detection of bacteria in platelets and blood for transfusion based upon the technology. In addition, IDI will transfer the technology including R&D and manufacturing to Chiron over the next two years. Financial terms of the agreement were not disclosed.

FDA approves engineering enhancements to WorldHeart’s Novacor

World Heart (Ottawa) announced that the FDA has approved the company’s pre-market approval supplement submission to incorporate several engineering enhancements to the implanted and external components of its Novacor LVAS (left ventricular assist system). The refinements are intended primarily to enhance recipients’ quality of life by having a quieter device and smaller, lighter, longer-lasting battery packs. These enhancements, which are commercially available in Europe and which were recently approved by Health Canada for use in Canada, are the result of the evolution of extensive clinical experience with the Novacor LVAS. The refinements have no impact on the Novacor LVAS establi
shed and market-leading reliability and durability. The implantable components of the system already carry a three year warranty and this warranty remains unchanged.

4) GENOMIC

Galileo Genomics announces C$11.15 million in equity funding

Galileo Genomics, a Montreal-based next-generation genomics company, announced it raised C$11.15-million in additional equity funding in December 2003. New investor Carnegie Fund II (Stockholm) acted as co-lead for this round which included existing investors HBM BioVentures (Zurich), MVI (Geneva) and Biofund (Helsinki). Galileo will use these funds to identify disease (GeneMaps) and drug targets for economically important diseases. These products will be either taken downstream internally or licensed to pharma and biotech partners. The company will also use the funds to generate revenues from pharmacogenomics contracts servicing a growing demand in the market to improve the safety and efficacy profiles of existing drugs and those under development.

5) Industry Update

Isotechnika (Edmonton) announced that Dr David Kinniburgh was named to the newly created position of vice-president, laboratory operations.

TSO3 (Quebec) announces that 3,194,147 of its 3,335,247 warrants have been exercised, allowing the company to cash in an additional $9,582,441.

BCY LifeSciences (Toronto) provided the following update on corporate activities: Consistent with its business strategy, the company is moving ahead with full-scale efforts to partner or license DCF 987 for the further clinical development of the compound. Accordingly, the company has retained BioCatalyst Yorkton to assist in the licensing process.

BioMS Medical (Edmonton), a developer in the treatment of multiple sclerosis (MS), today announced it has purchased an 18% interest in BioCyDex, a private company based in Edmonton.

Axcan Pharma (Mont St Hilaire) announced a revision and increase in the diluted income per share for its second and third quarters and in the diluted income per share excluding certain items presented in the management’s discussion and analysis of financial condition and results of operations for the third and fourth quarters and fiscal year ended September 30, 2003 (all amounts are stated in US dollars).

World Heart (Ottawa) has confirmed with the Nasdaq that the change in the company’s stock symbol on the over-the-counter bulletin board from “WHTOF” to “WHTOE” instituted by Nasdaq on January 6, 2004 was the result of an administrative error in the electronic filing of the company’s 2002 annual Form 20-F.

Genomics One (Laval) announced changes to its board of directors. Mr Rainer Gunther, a Canadian chartered accountant, who is presently a board member, has been appointed as the secretary of the corporation. Genomics One is also pleased to have Dr Zofia Zukowska join its board of directors.

Transition Therapeutics (Toronto) announced the issuance of its third US patent (US 6,558,952) and its first European patent (EP 0752882) protecting Transition’s islet neogenesis therapy.

BioMS Medical (Edmonton), a developer in the treatment of multiple sclerosis (MS), today announced it has purchased an 18% interest in BioCyDex, a private company based in Edmonton.

Viventia Biotech (Toronto) announced that Dr Anthony Schincariol has tendered his resignation as president and CEO. Dr Nick Glover formerly vice president corporate development and product operations has been appointed as president and chief executive officer.

ProMetic Life Sciences (Montreal) announces that following the closing on December 24, 2003 of its offering of 10,526,316 subordinate voting shares for gross proceeds of $20 million, the underwriters have given notice of their exercise in full of their over-allotment option. The option entitles them to purchase 1,578,947 additional subordinate voting shares for aggregate proceeds of approximately $3,000,000.

VSM MedTech (Vancouver) announced a number of senior management changes and the formation of a new customer services business unit. The division will be led by Paul Murdoch, the newly hired vice president of customer services. Other new additions to VSM’s executive management team include Brian Prejna, vice president of North American MEG sales; Frank Iafrato, vice president of vital signs monitoring sales; and Ryan Males, who will be promoted to vice president of marketing & communications. All the new vice presidents will report to the CEO.

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: vaillancourt.paul@ic.gc.ca).