Ottawa, ON March 17, 2003 The following life sciences news briefs were recently published by the Life Sciences Branch of Industry Canada.
1) PHARMACEUTICALS UPDATE
YM BioSciences and FDA Agree On Pivotal Trial Protocol
YM BioSciences Inc (Mississauga) announced that the Division of Special Protocol Assessment of the Food and Drug Administration (FDA) has responded to the Company’s submission for a Special Protocol Assessment of its Phase III registration trial protocol for its lead drug, tesmilifene. The Phase III trial will compare the overall survival times of tesmilifene in combination with epirubicin/cyclophosphamide versus pirubicin/cyclophosphamide alone, for the treatment of advanced metastatic/recurrent breast cancer. The FDA’s positive assessment of the Phase III protocol for tesmilifene through the Special Protocol Assessment process has provided YM with an official evaluation in which the FDA has agreed with the pivotal trial design and primary endpoint. In the comments received, the FDA confirmed that the objectives of the study were adequate and the eligibility criteria, treatment and endpoints were appropriate for a Phase III study in metastatic breast cancer.
2) DIAGNOSTICS AND THERAPEUTICS UPDATE
Baxter Awarded Major Blood Product Contracts
Baxter Corporation Canada (Mississauga) has been awarded a multi-year purchase agreement to be a major supplier to Canadian Blood Services (CBS) and Hma-Qubec (HQ), the two agencies that manage Canada’s blood and blood product supply. Baxter’s BioScience division provides biopharmaceuticals derived from human plasma or genetic engineering to treat hemophilia, immune deficiencies, and other blood-related disorders. Under the terms of the contract, which begins in April 2003, Baxter will provide biological products used in the treatment of various bleeding disorders. Baxter, the first to develop concentrated clotting factor to treat hemophilia, will provide Recombinate, a recombinant Factor VIII therapy used to prevent and treat hemorrhagic episodes in people with hemophilia A, as well as other clotting factors, immune support therapies, and antithrombotics.
AnorMED Announces Approvable Letter from FDA for Fosrenol(R)
AnorMED Inc (Vancouver) announced that its licensee, Shire Pharmaceuticals Group plc, has received an approvable letter from the US Food & Drug Administration (FDA) for FOSRENOL(R) (lanthanum carbonate).The approvable letter asks for additional data and analysis to address a number of remaining questions. Shire is initiating a dialogue with the FDA to agree on the balance between pre- and post-approval commitments that will resolve the questions. Shire will provide further updates when it is in a position to be more specific about the timing of approval and subsequent launch. Until that point, Shire maintains its forecast of a US launch prior to the end of 2003.
3) MEDICAL DEVICES UPDATE
Medical Ventures Signs Letter of Intent to Acquire Angiometrx
Medical Ventures Corp (Richmond) announced that it has signed a letter of intent to acquire Angiometrx Inc, a privately owned medical technology company focused on the development and commercialization of the Metricath(TM) System. The Metricath(TM) System is an innovative catheter-based technology that allows cardiologists to measure arterial size and wall characteristics during interventional treatment of coronary and peripheral artery disease. The Metricath(TM) System was developed in response to the limitations of existing measurement technologies, which are either not sufficiently accurate or prohibitively expensive and time-consuming to gain widespread acceptance. The balloon angioplasty (PTCA) catheter market exceeds $500 million worldwide. MEV hopes to capture a significant share of this market by combining the Metricath(TM) measurement technology with treatment capability on the same PTCA balloon catheter, at a similar price point to existing standard treatment-only catheters. On this basis, the Metricath(TM) technology provides measurement capability to the cardiologist with insignificant additional time or expense to the angioplasty procedure. FDA approval of the Metricath(TM) measurement-only catheter is anticipated for mid 2004. Arrangements are underway to begin trials and obtain regulatory approval for the sale of Metricath(TM) in Europe.
WorldHeart Seeks Approval for Enhancements to Novacor(R)
World Heart Corporation (Ottawa) announced it has made a submission to Health Canada requesting approval for enhancements to its Novacor(R) 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 under review for approval in the US by the Food and Drug Administration (FDA), are the result of the evolution of extensive clinical experience with the Novacor(R) LVAS. Improvements that will directly benefit recipients include: quieter pump operation; new battery packs that are 40% lighter and operate for 60% longer; a smaller, and quieter battery charger.
CryoCath’s Freezor(TM) Catheter Recommended For Approval By FDA
CryoCath Technologies Inc, (Montreal) producer of cryotherapy products for treating cardiovascular disease, announced that its Freezor(TM) Cryoablation System was recommended for approval to treat AtrioVentricular Node Reentry Tachycardia (AVNRT), currently the most prevalently ablated cardiac arrhythmia, by the Food and Drug Administration’s (FDA) Circulatory System Devices Panel.
4) TECHNOLOGY UPDATE
Strategic Answers Signs QLT Inc to OncoAnswers(TM) toolkit
Strategic Answers Inc (Toronto) announced that it has secured its first contract for the new OncoAnswers strategic planning tool. QLT Inc, a Vancouver based global biopharmaceutical company, is the first company to purchase the unique oncology strategy planning toolset developed by Strategic Answers Inc. OncoAnswers consists of OncoEdge(TM), the company’s unique software model designed to assist pharmaceutical and biotech companies in the market potential analysis of specific oncology-related opportunities. The model is unique in that it incorporates tumor-specific patient demographics, competitive intelligence, staging and survival data as well as trends in cancer incidence and recurrence to assess the commercial revenue opportunity for a particular oncology drug in virtually any country around the world. All tumor treatment algorithms are independently validated by external oncology opinion-leader physicians.
Strategic Answers Signs QLT Inc to OncoAnswers(TM) toolkit
St Joseph’s Healthcare Hamilton and North Bay General Hospital announced that on Friday February 28th, Dr Mehran Anvari, Dr Craig McKinley and their respective surgical teams performed the world’s first hospital to hospital telerobotics assisted surgery. Located at St Joseph’s Healthcare Hamilton, Dr Anvari, founding director of the Centre for Minimal Access Surgery (CMAS), successfully collaborated with Dr McKinley, a General Surgeon at North Bay General Hospital, to complete a laparoscopic Nissen fundoplication (anti-reflux) surgery on a female patient located at North Bay General Hospital, nearly 400 kilometres away.
4) GENOMICS UPDATE
Tm Bioscience and bioMrieux Announce License Agreement
Tm Bioscience Corporation (Toronto) and bioMrieux SA (Marcy l’Etoile, France) announced a non-exclusive license agreement for the use of bioMrieux’s Factor II (prothrombin) and Factor V Leiden gene patents in Tm’s recently launched Tag-It(TM) Mutation Detection kits for coagulation disorders. The Tag-It(TM) coagulation kits are the first in a menu of Tag-It(TM) genotyping kits that Tm Bioscience will be launching over the course of 2003. The Tag-It(TM) series initially targets common genetic anomalies related to coagulation, cystic fibrosis and the cytochrome P450 drug metabolizing genes, with additional tes
ts to follow as more genetic markers gain clinical acceptance. The company’s rapid and flexible kit design and development process combined with its integrated manufacturing operations allow the production of accurate, low cost, high-throughput genetic tests for use by commercial diagnostic laboratories.
5) INDUSTRY BRIEFS
BCY LifeSciences Inc. (Toronto) announced the appointment of Robert K (Rob) Davidson, CMC, CA as chief financial officer of the company, subject to TSVX approval.
The shareholders of Angiotech Pharmaceuticals, Inc (Vancouver), at the company’s annual general meeting of shareholders held yesterday, approved a two-for-one stock split.
Dimethaid Research Inc (Toronto) has received final marketing approval from Italian regulatory authorities for Pennsaid, the company’s first commercial product based on its patented transcellular technology. Pennsaid is a topical, nonsteroidal anti-inflammatory drug (NSAID) for treating the pain, stiffness and impaired physical function associated with osteoarthritis. The drug will be available by prescription, only.
GenSci Regeneration Sciences Inc (Toronto), The OrthoBiologics Technology Company(TM), announced that it has entered into an agreement with AlloSource(R), one of the nation’s largest non-profit tissue bank cooperatives, for supply and distribution of key allograft materials.
SYN X Pharma Inc (Toronto) announced that after having completed the first in a series of milestones, the company has received a significant payment from Ortho-Clinical Diagnostics, Inc, a Johnson & Johnson company. The compensation stems from an exclusive worldwide licensing and development agreement reached last October by the two companies for SYN X’s Alzheimer’s disease technology for human in vitro diagnostic applications.
Oncolytics Biotech Inc (Calgary) has been granted US Patent 6,528,305 entitled “Method of Producing Infectious Reovirus”. This patent covers a method of producing infectious mammalian reovirus, which is developed to be suitable for clinical administration to mammals, including humans, on a cost effective basis.
BioMS Medical Corp (Edmonton), a leading developer in the treatment of multiple sclerosis, announced that the University of Alberta has received a patent in Australia regarding the company’s synthetic peptide therapeutic, MBP8298, for the treatment of multiple sclerosis (MS). BioMS Medical, through a subsidiary, licenses the MBP8298 patents on an exclusive worldwide basis from the University.
The Board of Directors of Angiotech Pharmaceuticals Inc (Vancouver) announced the promotion of Jeanne M. Bertonis, MBA, to the newly created position of Chief Business Officer, effective immediately.