Ottawa, ON – March 1, 2004 – The following life sciences news briefs were published this week by Industry Canada:
1) Pharmaceuticals Update
Isotechnika – FDA agrees to manufacturing plans for ISA247
Isotechnika (Edmonton) announced that the manufacturing process for its lead drug, ISA247, has been finalized. This process enables the company to manufacture large-scale batches of the active pharmaceutical ingredient (API) in a cost-effective manner. Process optimization took approximately one year to complete. “Overall, optimization is an important step in manufacturing an API for the pharmaceutical industry,” stated Dr Robert Foster, chairman & CEO. “Large scale batches of ISA247 can now be made in a consistent manner. When we initiated this process, ISA247 was approximately an equivalent mixture of two geometric isomers (called, trans and cis), where just one of the isomers (trans) carried most of the desired activity of immunosuppression. The other isomer (cis) could, from a pharmacologic point of view, be considered more as ‘isomeric ballast’. We have now moved our manufacturing to a mixture where the drug is predominantly the more active trans isomer.”
Phase II clinical trial for Tectin approved in China
International Wex Technologies (Vancouver) announced that it has received approval from the State Food and Drug Administration (SFDA) of PR China to initiate the phase II clinical trial for Tectin in late-stage cancer patients who are already receiving and are tolerant to opioid therapy for their underlying persistent and severe cancer pain. The SFDA states that the “phase II clinical trial for this drug is permitted according to the drug administration act of PR China as it complies with the relevant regulations for examination and approval of new drugs”. Tectin, a parenteral formulation, is classified by the SFDA as a class I chemical drug, which means it is a new chemical entity that must undergo full drug development.
Axcan sees period of strong growth for fiscal 2004 and beyond
During the Axcan Pharma (Mont Saint Hilaire) annual shareholders’ meeting held in Montreal, president and chief executive officer, Mr Lon F Gosselin, cited recent major acquisitions and a 30% increase in the fiscal 2004 research and development budget as key factors that should drive Axcan’s future growth. “We have been very successful over the past year in broadening our product portfolio through the acquisition of gastroenterology products that were immediately accretive to our revenue. We have also been successful in bolstering our product development pipeline by acquiring products and technologies that will provide strong potential for growth in the near- to mid-term,” said Mr Gosselin. “In addition, a 30% increase in our research and development budget for fiscal 2004 is designed to ensure the rapid progression of our rich pipeline of product candidates to market.”
2) Diagnostics and Therapeutics Update
IDI signs partnership agreement with bioMrieux
Following on its agreement with Chiron of Emeryville, CA, Infectio Diagnostic (Quebec City) has entered into partnership with clinical microbiology company bioMrieux. The agreement specifically stipulates that bioMrieux will receive a licence providing access to part of IDI’s intellectual property in the area of identification and bacterial-resistance markers.
Procyon reports positive clinical results with PCK3145 therapeutic
Procyon Biopharma (Montreal) reported additional positive results from the phase IIa clinical trial currently ongoing in the UK with PCK3145, its therapeutic peptide indicated for metastatic hormone-refractory prostate cancer. The new data from the third cohort confirms PCK3145’s safety profile as well as potential therapeutic effect on the reduction of metastasis as suggested by the results of the first two cohorts released last September. The results from the total of 12 patients so far confirm PSA (prostate specific antigen) reduction or stabilization in nine patients and reduction or normalization of plasma MMP-9 (Matrix metalloproteinase 9, an enzyme involved in tumor invasion) in all of the patients. The company also reported that studies conducted in the laboratory of its collaborator Dr Shafaat Rabbani of the McGill University Health Centre have shown that PCK3145 significantly reduced skeletal metastasis as well as hypercalcaemia in an experimental rat prostate cancer model. These studies validate PCK3145’s potential to reduce and/or prevent tumor metastasis.
Bioxel announces Paclitaxel purchase agreement with CTI
Bioxel Pharma (Sainte-Foy), a manufacturer of naturally derived taxanes, today announced that it has entered into a purchase agreement for cGMP paclitaxel with Cell Therapeutics of Seattle WA. The agreement value is at least $1.2 million for cGMP paclitaxel originating from Bioxel’s new large-scale paclitaxel manufacturing unit.
Medsurge Medical to purchase Cryo-Genomics
Medsurge Medical Products (Vancouver) announced that it has entered into an agreement to purchase Cryo-Genomics and all its rights, patents, and proprietary technologies with regards to 2 tier faecal occult blood testing (FOBT). FOBT is the gold standard for colo-rectal cancer prevention with studies indicating that one third of all colo-rectal cancer deaths can be prevented through yearly FOBT testing. Further investigation reveal an enormous market size whereby every person over the age of 50 should have FOBT done annually as compared to hemorrhoid banding which affects one in four people over age 55 in their lifetime. The sell price of the slides and reagents for testing would sell for a similar price as the O’Regan Ligator. The potential estimated market size is therefore in excess of $15 billion per year. The product is complimentary and ideal for colo-rectal health clinics and Medsurge’s existing world distribution network, as hemorrhoids that usually bleed, should be banded before FOBT is performed.
GeneMax announces license from UBC
GeneMax (Vancouver) announced that the company’s wholly owned subsidiary, GeneMax Pharmaceuticals has obtained the worldwide exclusive license from the University of British Columbia for a novel assay technology that can be used to screen and select new drugs that regulate immune responses. Professor Wilfred Jefferies at the Biomedical Research Centre and Biotechnology Laboratory in Vancouver, Canada developed the technology. The new technology has relevance to both cancers and viral diseases and in modulating transplant rejection and autoimmune diseases.
Quebec research team announces successful trial of DMD treatment
The results of the first clinical trial on three people from Quebec affected by Duchenne Muscular Dystrophy raise the possibility of a treatment for this debilitating disease. A Quebec research team, directed by Dr Jacques-P Tremblay of the CHUL Research Centre, part of the Centre hospitalier universitaire de Quebec, has developed an experimental treatment based on the transplantation of cells called myoblasts. These cells are obtained from a close relative donor and grafted in a muscle of those affected by Duchenne Muscular Dystrophy. When the myoblasts fuse with existing muscle fibres, they introduce the normal dystrophin gene in these fibres. Muscular dystrophy is a group of hereditary diseases characterized by a progressive muscle weakness. One of them, Duchenne Muscular Dystrophy (DMD), affects one boy out of 3,500. There is currently no treatment for this disease. Dr Tremblay’s team is the only one worldwide to develop a treatment.
3) Medical Devices
World Heart receives largest order in its history
World Heart (Ottawa) announced the sale of 20 Novacor LVAS systems to the Heart and Diabetes Center in Bad Oeynhausen, Germany. The Bad Oeynhausen Center is the largest user of ventricular assist devices (VADs) in the world and a recognized leader in the use of leading edge technologies in the treatment of heart disease. Dr Aly El-Banayosy, depa
rtment for thorax and heart surgery at the Heart and Diabetes Center said “Our center uses about 70 VADs annually in the treatment of our patients. We have implanted more than 100 Novacor LVAS systems over the past 10 years and have experienced a perfect record of reliability. Since the introduction of the ePTFE inflow conduit, we have also had excellent results in freedom from stroke. This year we expect to substantially increase the share of our total VAD requirements that will be met by the Novacor LVAS.” So far this sale is the largest single order for Novacor LVAS systems by a center. The sale equals more than one-third of the total sales in Europe last year and comes after the sale of eight units to the same center in December 2003.
4) Industry Update
MedMira (Halifax) announced that they have reached agreement with Channel Financial Group of Montreal to act as an advisor for the company to raise capital of up to $3 million through the issuance of convertible debentures, in a transaction that will close on or about March 31st, 2004.
Dr Nick Glover, president and CEO announced the appointment of Dr Michael Cross as chief operating officer of Viventia Biotech (Toronto).
Bioniche Life Sciences (Belleville) announced that it has completed a private placement offering of 5,000,000 units at a price of $2.00 per unit for gross subscription proceeds of $10,000,000.
Theratechnologies (Montreal) announced that it has successfully completed its recently announced offering of 3,950,000 common shares to a group of underwriters led by Desjardins Valeurs Mobilires at a price of $3.45 per share thereby raising $13 627 500.
GB Therapeutics (Mississauga), announced that issuance of US patent No 6,677,374 had been obtained from the US patent office for the company’s proprietary nitric oxide mimetic compounds as they relate to effecting neurodegeneration, mitigating neurodegeneration and/or effecting cognition enhancement.
YM BioSciences (Mississauga), announced that it has received a final receipt from the Ontario Securities Commission for its prospectus. This prospectus qualifies for distribution the common shares and warrants underlying the 10,895,658 special warrants sold to investors for total proceeds of $19,067,402 by way of the company’s previously announced private placement on December 15, 2003. The special warrants will be deemed exercised at 5:00 pm (EST) on Feb 19, 2004.
Lorus Therapeutics (Toronto) announced that it has been approved for trading on the American Stock Exchange under the symbol LRP, subject to the fulfillment of certain conditions. Trading was expected to commence on Monday, February 23, 2004.
Neuro Discovery (Vancouver) announced that it will cancel the private placement of shares by NDI Life Sciences (VCC) Fund.
Inflazyme Pharmaceuticals (Vancouver), announced that the enrollment of patients into the phase IIa asthma study AVE0547/2001 with IPL512,602 has been completed. The study is being conducted by Aventis under the collaboration agreement between Inflazyme and Aventis.
Helix BioPharma (Aurora) announced that its drug distribution subsidiary, Rivex Pharma, and Anika Therapeutics have extended their Canadian distribution agreement for Orthovisc for a further five years.
Micrologix Biotech, a developer of anti-infective drugs (Vancouver), has entered into a firm underwriting with Canaccord Capital in which the underwriter has agreed to buy five million units at a price of $1.00 per unit, with an option to purchase up to 2.5 million additional units for total gross proceeds of up to $7.5 million.
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).