Ottawa, ON March 5, 2003 The following life sciences news briefs were recently published by the Life Sciences Branch of Industry Canada.
1) PHARMACEUTICALS UPDATE
Dimethaid Enters Next Phase of European Mutual Recognition Procedure:
Dimethaid Research Inc. (Toronto) has formally submitted applications for regulatory approval of PENNSAID(R) in Belgium, Denmark, France, Germany, Greece, Iceland, Ireland, Liechtenstein, the Netherlands, Norway, Portugal, Spain and Sweden. PENNSAID is the company’s first patented product based on its transcellular technology. The drug is a topical solution for treating pain, stiffness and impaired physical function associated with osteoarthritis. An estimated 37 million Europeans have the disease. In September 2002, Dimethaid submitted an updated product dossier to the United Kingdom’s Medicines Control Agency (MCA). The MCA, acting as the company’s agent under the European Mutual Recognition Procedure, has now completed and will file its own assessment report with each state. PENNSAID has marketing approval in the U.K. and several European countries. It has been granted an approvable letter in Canada, and it is currently under review by the Food and Drug Administration in the United States.
Genpharm Announces Canadian Approval of Generic Clozaril(R):
Genpharm Inc. (Toronto) announced that it has just received approval for Gen-Clozapine, the first generic version of Novartis Canada’s Clozaril(R), and the first generic drug to be supported by a complete blood monitoring system as mandated by Health Canada. Gen-Clozapine is indicated in the management of symptoms of treatment resistant schizophrenia. Gen-Clozapine has been declared fully bioequivalent to Novartis Canada’s Clozaril by the Therapeutic Products Directorate of Health Canada. Sales of Clozaril(R) were almost $59 million in Canada last year. Gen-Clozapine is substantially less expensive than the Novartis product and could save the health care system over $11 million.
Study Validates Angiomax(R) (bivalirudin) as Angioplasty Treatment:
Results of REPLACE-2, one of the largest angioplasty clinical trials ever conducted are published in the February 19, 2003 issue of The Journal of the American Medical Association, Oryx Pharmaceuticals Inc. (Mississauga) announced. Results of REPLACE-2 validate Angiomax(R) (bivalirudin) as a new standard of care for coronary angioplasty, a procedure conducted on more than forty thousand Canadians annually, to clear restricted blood flow in coronary arteries. Angiomax, a synthetic product approved for use by Health Canada in 2002, is marketed as a replacement for heparin in coronary angioplasty. Heparin is a product discovered in 1916 that is manufactured from by-products of cow lungs or pig intestines and carries multiple clinical and practical limitations. Oryx Pharmaceuticals Inc. obtained Canadian marketing rights for Angiomax from The Medicines Company based in Parsippany, New Jersey, USA in 2002.
2) DIAGNOSTICS AND THERAPEUTICS UPDATE
Axcan Enters Into Strategic Alliance with Nordmark:
Axcan Pharma Inc. (Mont Ste Hilaire) announced that it has entered into an agreement with Nordmark Arzneimittel GMBH & Co. KG of Germany, the manufacturer of PANZYTRAT. Under the terms of the agreement, Axcan and Nordmark will create a joint venture to develop patent-protected novel enzyme preparations (NMK 150 for the treatment of pain in chronic pancreatitis and NMK 250 for the treatment of steathorrea). Once these products are approved, the joint venture will hold the right to manufacture the bulk active ingredients, while Axcan will hold worldwide marketing rights for all finished dosage forms. Financial terms of the agreement were not disclosed.
Aegera Therapeutics Announces Four Antibody Manufacturing Licenses:
Aegera Therapeutics Inc., (Montreal) announced the completion of a fourth license to manufacture and sell antibodies and kits targeted against Aegera’s proprietary Inhibitors of Apoptosis (IAP) gene family. Aegera has now out-licensed rights to antibodies targeted against XIAP, HIAP1, HIAP2 and NAIP. BD Biosciences Pharmingen, R&D Systems Inc, and MBL International have previously signed non-exclusive licenses in which Aegera grants them the right to manufacture and supply antibody products derived from Aegera’s IAP technology for research applications. A fourth company, who wishes their name to remain confidential, signed their license in Q4 2002.
ConjuChem Resumes DAC(TM):GLP-1 Clinical Program:
ConjuChem Inc. (Montreal) announced it has resolved the formulation issues which interrupted the Company’s DAC(TM):GLP-1 clinical program. The Company resumed its single-dose Phase I/II trial on February 20, 2003 and is planning to commence a multi-dose trial later in March 2003. ConjuChem also reported preliminary results from the DAC(TM):GLP-1 Phase I healthy volunteer protocol. A review of the data showed a single dose of DAC(TM):GLP-1 had, on average, a 10 to 12 day half-life. As well, the compound demonstrated good tolerability among the healthy volunteer population and produced encouraging insulin and glucose responses in the higher dose range. ConjuChem expects to report top-line preliminary data from patients before the end of the first half of this year.
QLT Temporarily Suspends New Patient Accrual:
QLT Inc. (Vancouver) announced that enrollment of additional patients in its ongoing Phase III studies of tariquidar in non-small cell lung cancer patients is being suspended for approximately three months pending the completion of the planned interim safety and efficacy analysis by an Independent Data and Safety Monitoring Committee (DSMC). The DSMC has recommended that accrual to the trials be temporarily halted until all patients currently enrolled have been followed for a minimum of three months and that the patients should continue to be treated and followed according to the protocol. The committee also stated that all data should remain blinded and that the intention of this halt in accrual is to permit, for those patients already entered, acquisition and review of additional data on safety and efficacy. The DSMC concluded that the recommendations above “provided the best opportunity for these trials to remain intact and to serve, in their entirety as pivotal registration trials for regulatory purposes.”
3) MEDICAL DEVICES UPDATE
VSM MedTech Ships Its First MEG System to China:
VSM MedTech Ltd. (Vancouver) announced that its wholly owned subsidiary, CTF Systems Inc., has shipped its first OMEGA 151-channel magnetoencephalography (MEG) system into the Peoples Republic of China, to be installed at the Tian Tan Hospital in Beijing. The previously announced sale was facilitated through CTF’s exclusive Chinese distributor, White Horse Medical. Tian Tan Hospital is widely regarded as one of the top three hospitals in China focusing on neurological disorders and is home to the Beijing Neurosurgical Institute. The device will be used mainly for non-invasive epilepsy localization and functional mapping prior to neurosurgery. Epilepsy affects more than 7 million people in China and the OMEGA MEG System will greatly improve screening and surgical planning for these patients. Like other imaging technologies in China, the MEG system is being installed on a user pay basis and is projected to generate significant profits for the hospital.
Angiotech Receives FDA OK for Premixed CoSeal(R) Configuration:
Angiotech Pharmaceuticals, Inc. (Vancouver) announced that it has received approval from the U.S. Food and Drug Administration for a new premixed configuration of CoSeal(R), the only fully synthetic vascular sealant approved by the FDA. The new premixed CoSeal(R) improves an already extraordinary product by turning the preparation into an even simpler process. Other advantages include extending the useable lifespan after mixing to two hours and allowing product to be stored at room temperature. The consistent nature and stability of the new preparation makes it an ideal platform for the intro
duction of a next-generation, drug-loaded CoSeal(R).
Angiotech Enrolls First Patient in Pulmonary Sealant Study:
Angiotech Pharmaceuticals, Inc. (Vancouver) announced that it has enrolled the first patient in a pulmonary sealant study, using CoSeal(R) to prevent air leaks in the lung after surgery. A 30-patient open-label study was initiated at four centers in Europe; three in the Netherlands and one in Switzerland. Patients undergoing a lung resection will have CoSeal(R) placed over the sutures or staples to prevent air leaks, a potentially fatal condition which can subsequently lead to a lung collapse. The primary endpoint of the study will be the presence or absence of an air leak and the secondary endpoint will be the amount of time a chest tube remains in the patient after the operation.
4) GENOMICS UPDATE
Genome Canada Gets Additional $49.5 Million:
Genome Canada said it has received an additional $75 million from the Canadian government for large-scale genomics and proteomics projects. “Today, the Government is acknowledging the importance of sustaining the momentum started 3 years ago with the creation of Genome Canada,” Martin Godbout, President and CEO of Genome Canada, said in a statement. “With this new investment, Canadian researchers will be able to achieve their objectives, create new knowledge, develop an innovative and leading research infrastructure and attract and retain the world’s best researchers.” Since its founding, Genome Canada has funded over CA$293 million ($193.3 million) in genomics and proteomics research projects across Canada.
5) INDUSTRY BRIEFS
Lorus Therapeutics Inc. (Toronto) announced that a patent was allowed by the Mexican Patent Office to protect the company’s intellectual property involving its lead immunotherapy drug, Virulizin(R)
Oncolytics Biotech Inc. (Calgary) announced the successful completion of its animal toxicology program examining the systemic delivery of REOLYSIN(R)
Cedara Software Corp. (Toronto), has signed a development agreement with award-winning Digital Radiography (DR) and Computed Radiography (CR) developer Alara Inc. of Hayward, California
Neurochem Inc. (Montreal) announced that the requisite majority of its disinterested shareholders approved the previously announced transaction by a subsidiary of Picchio Pharma Inc. for the acquisition of 1.2 million units of Neurochem at a cost of $6.79 per unit, for a total of $8.148 million
MedMira Inc. (Halifax) announced that it is seeking regulatory approval to issue up to 5,004,464 common shares to Mr. Stephen Sham, Chairman and CEO in full and final settlement of Mr. Sham’s shareholder loan of $8,507,589
VSM MedTech Ltd. (Vancouver) announced that it has closed its previously announced private placement financing. The Company received gross proceeds of $10,730,000, issuing 5,800,000 units at a price of $1.85 per unit
MedMira Inc. (Halifax) announced that it had received the Certificate of Registration for the ISO 13485 quality standard. The audit was conducted by the Quality Management Institute (QMI)
Adherex Technologies Inc. (Toronto) announced that William P. Peters, MD, PhD, MBA has been appointed CEO and Vice Chairman of the Board of Directors
GenSci Regeneration Sciences Inc. (Toronto), The OrthoBiologics Technology Company(TM), announced that during the fiscal year ended December 31, 2002, the Company completely upgraded and expanded its product offering by launching three new product lines effectively replacing former products that were the subject of previously disclosed patent litigation
Chronogen Inc. (Montreal) announced that Maha Katabi, Ph.D., has been named Executive Director of Business Development
Dragon Pharmaceuticals Inc. (Vancouver) announced that it has appointed James Harris as VP of Sales and Marketing, replacing Robert Walsh
Biovail Corporation (Toronto) announced that the United States Food and Drug Administration (FDA) has approved Teveten HCT for the treatment of hypertension (high blood pressure)
Altachem Pharma Ltd. (Edmonton) announced that Altachem’s U.S. Patent Application, titled “Perylenequinones for use as photosensitizers and sonosensitizers” has been allowed for its proprietary drug for cancer treatment
MDS Pharma Services, (Montreal) a premier provider of innovative drug discovery and development solutions, has named Pauline Gee, Ph.D., Vice President of Predictive Biology
Ondine Biopharma Corporation (Vancouver) announced that, effective January 1, 2003, Robert J. Morff, Ph.D. has joined the Company as its President and Chief Executive Officer
Medical Services International Inc. (Edmonton) announced that the Company has completed an initial sale of $122,000US of VScan product to West Africa
P.P. Luxco Holdings II S..r.l. (“P.P. Luxco”), a wholly-owned subsidiary of Picchio Pharma Inc., announced that it has purchased by way of private placement 1,200,000 units of Neurochem Inc.(Saint Laurent).
Life Sciences News Briefs is prepared by Armar International for the Life Sciences Branch of Industry Canada (contact: Paul Vaillancourt; Tel: 613-952-7700; E-mail: email@example.com).