Ottawa, ON – July 11, 2003 — The following life sciences news briefs were published this week by Industry Canada:
1) Pharmaceuticals Update
FDA committee agrees on efficacy of Axcan’s Photofrin
Axcan Pharma (Mont St Hilaire) announced that the gastrointestinal advisory committee of the US Food and Drug Administration has agreed that Axcan’s investigational drug, Photofrin PDT, demonstrated efficacy and safety in the ablation of high-grade dysplasia associated with Barrett’s esophagus. The announcement was made following a review by the committee of clinical data on Photofrin (porfirmer sodium) with photodynamic therapy (PDT) in this indication. Axcan received an approvable letter from the FDA in the first quarter of fiscal 2003 and Photofrin PDT was recently approved in Canada for the same indication. The advisory committee reviewed efficacy and safety data from studies with Photofrin PDT. Axcan submitted the results of three clinical trials in which Photofrin PDT was used for mucosal ablation of high-grade dysplasia. Photofrin is an approved photosensitizing agent that is administered intravenously and is innocuous until activated by light. When target tissues are exposed to laser light at 630 nm, tissue necrosis occurs by at least two mechanisms, oxygen radical damage and anoxia due to thrombosis of capillaries.
MDS Pharma Services acquires clinical research facility in New Orleans
MDS Pharma Services (Montreal), a leading provider of innovative drug discovery and development solutions, is expanding the scale and scope of its early clinical research business with its acquisition of the Clinical Research Center, a Phase I-IV study facility in New Orleans, Louisiana, specializing in renal, hepatic, hypertension, diabetes, acute pain and osteoarthritis research. Jerry Merritt, senior vice president and general manager of early clinical research, said the acquisition enhances the company’s capabilities in specialized patient populations while further establishing MDS Pharma Services’ position as the largest early clinical research provider in the industry with more than 900 beds.
Neurochem recommends initiation of phase III for Alzhemed
Neurochem (Montreal) announced that its clinical advisory board for Alzhemed, the company’s investigational drug candidate for the treatment of Alzheimer’s disease (AD), has reviewed the preliminary findings of the phase II trial on Alzhemed and has given its unanimous recommendation to proceed with phase III efficacy studies, pending regulatory approvals for the initiation of such trials in the United States, Canada and Europe. Neurochem’s clinical advisory board is made up of leading scientific authorities in the fields of aging and dementia from both North America and Europe.
H3 Pharma licenses in Sanvar (vapreotide) from Debiopharm
H3 Pharma (Montreal) and Debiopharm (Lausanne, Switzerland) announced an agreement, which gives H3 Pharma the worldwide research, development, and commercialization rights to Sanvar (vapreotide). The agreement provides H3 Pharma with an advanced second product in its pipeline following the in-licensing agreement for SC-1 monoclonal antibody with OncoMab GmbH,Wurzburg, Germany in February 2003.
2) Diagnostics and Therapeutics Update
IMI says skin cholesterol shown to be reliably measurable in children
Skin cholesterol levels can be measured reliably and safely in children, according to results of a new study presented this week at the 85th annual meeting of the Endocrine Society. Skin cholesterol has been shown in adults to be an independent risk factor for coronary artery disease, and this new study is first ever conducted with pediatric subjects. International Medical Innovations’ (Toronto) cholesterol 1,2,3 is said to be the world’s only non-invasive test system for cholesterol, and is cleared for sale in the US, Canada and Europe. The test measures cholesterol in the skin, by placing two drops of liquid on the palm of the hand and generating a color-change reaction. As cholesterol accumulates on artery walls it also accumulates in other tissues, including skin. High levels of skin cholesterol are correlated with higher incidence of coronary artery disease.
Tropical Oils Beat Fat
A blend of tropical oils used for cooking can actually fight fat and cholesterol, say researchers at McGill University in Montreal. They’ve completed two studies on the cooking oil blend that includes 67% tropical oils, 13% olive oil, 6 percent coconut oil and 5% flaxseed oil. It is called functional oil, and was developed by McGill scientists. The functional oil is composed of medium-chain triglycerides while vegetable cooking oils have long-chain triglycerides. When a person consumes functional oil, it is directed towards the liver, where it is burned for energy. It heightens a person’s metabolism. The oil is not stored in the body as fat. The McGill researchers say there is even some data that suggests functional oil may reduce appetite. The two studies included men and women about 25 pounds overweight. They ate a normal diet, but used functional oil instead of other cooking oils. The studies found that men using functional oil lost an average of a pound over a month. Women in the studies did not lose weight but did experience heightened metabolic rates. Cholesterol levels in both the men and women dropped by an average of 13%.
Researchers identify clotting protein which causes hepatitis B
A team of scientists from Toronto General and St Michael’s Hospitals has identified a protein molecule that contributes to the severity of chronic viral hepatitis in humans, and which may also be implicated in SARS. The protein, called Fgl2/fibroleukin prothrombinase, is a newly discovered protein that causes blood to clot in the livers of humans with viral hepatitis. In animal trials, this same protein causes blood to clot in the livers of mice that are exposed to the corona virus. Blood or fibrin clots are the clumps that result from coagulation of the blood, and may cause partial or complete blockage of a blood vessel. This deprives the tissue of normal blood flow and oxygen, resulting in damage or death of the tissue. Corona viruses are named for their corona-like (halo) appearance in electron micrographs. They account for 50% of all upper respiratory infections in humans, and a mutant form of the virus is a cause of Severe Acute Respiratory Syndrome (SARS). The virus can be fatal and has been shown to cause liver damage in mice. The research in this study provides compelling evidence of the role of the clotting protein molecule fgl2 in viral chronic hepatitis, and also raises the question of whether the same protein molecule is also important in SARS infection of human lung tissue.
3) Medical Devices
Andromed and Hewlett-Packard partner
Andromed (Montreal), an innovative high-tech medical company, and HP healthcare solutions, a leading manufacturer of IT solutions for healthcare professionals, have agreed to promote the hp iPAQ Pocket PC h5450/STG/i-stethos diagnostic mobility solution in a joint effort with physicians to support medical professionals in North America. Under the terms, Hewlett-Packard and Andromed will partner for co-marketing efforts to introduce the hp iPAQ Pocket PC h5450/STG/i-stethos diagnostic mobility solution to physicians and healthcare facilities. The solution will allow healthcare professionals to obtain, visualize, interpret, transmit, store and email heart and lung sounds. For the first time, this gives healthcare professionals the ability to use their stethoscope as a diagnostic test by visualizing, storing and interpreting their patient’s signals.
Biorthex receives FDA approval for study on Actipore PLFx
Biorthex (Montreal) a medical device company specializing in spine, announced the conditional approval from the American Food and Drug Administration (FDA) for the initiation of a US clinical study for its Actipore PLFx posterior lumbar fusion device. This conditional approval grants B
iorthex the right to immediately initiate its study in the US while adjusting its protocol to suit FDA requirements. The Actipore PLFx device is indicated for patients suffering from back pain associated with degenerative disc disease (DDD) in the lumbar spine. This study, to be initiated this summer, will be a randomised, prospective, multi-center clinical trial designed to determine the safety and efficacy of the Actipore PLFx interbody fusion device.
Draxis Health and Bristol-Myers Squibb medical imaging
Draxima GE, the radiopharmaceutical division of Draxis Health has extended and expanded its existing strategic partnership with Bristol-Myers Squibb Medical Imaging for the marketing and distribution of radiopharmaceutical products in Canada. Under the new five-year agreement, Draximage products will continue to be marketed directly to hospital-based radiopharmacy departments through a cooperative partnership promoting the two companies’ product lines.
Medical Ventures announces FDA clearance to sell the Metricath
Medical Ventures (Richmond) announced that the Angiometrx Metricath System has received US Food and Drug Administration 510 (k) marketing approval. This approval allows the company to sell the Metricath 1000 console and Metricath measurement catheters in the United States. Commercialization and US launch of these products is being planned for late 2003. The Metricath system is a catheter-based technology that allows cardiologists to measure arterial size for stent implantation during treatment of coronary artery disease.
4) Industry Update
Inex Pharmaceuticals (Vancouver) announced that it has filed a preliminary prospectus relating to the recently announced agreement with an underwriting syndicate led by BMO Nesbitt Burns and including Raymond James, Desjardins Securities and Orion Securities under which the underwriters have agreed to buy 4,600,000 common shares from the company and sell to the public at a price of $5.45 per common share, representing an aggregate amount of the issue of $25,070,000.
Medical Services International (Edmonton) announced that during the month of June, 2003 it shipped 17,000 test kits at an average price of $3.37 per kit. Based on contracts and existing orders the company will ship 150,000 VScan Rapid test kits in July, 2003.
Tm Bioscience (Toronto), a leading developer, manufacturer and supplier of genetic diagnostics, announced that it has closed its previously announced private placement of 23,175,200 units priced at $0.22 for total gross proceeds of $5,098,544.
ConjuChem (Montreal) announced it has successfully closed a private placement financing of 7.5 million of the company’s common shares raising gross proceeds of $12 million. The shares were purchased on a bought deal basis by a syndicate of underwriters led by Orion Securities (formerly Yorkton Securities Inc.).
Labopharm (Toronto) said it will raise $22 million in a share issue and use the proceeds to help fund the launch of its once-daily Tramadol pain medicine in Europe. The pharmaceutical company said it will issue 4.5 million shares at $4.90 per share, in a bought deal arrangement with a syndicate led by National Bank Financial. The issue is expected to raise $22.05 million and Labopharm said the underwriters have an option to buy an additional 15%.
Biovail Corporation (Toronto) announced that it has submitted a supplemental new drug application to the FDA for an angina indication for Cardizem LA.
Forbes Medi Tech (Vancouver) announced it will receive a US$3 million advance payment from Phyto-Source LP, its manufacturing joint venture with Chusei (USA).
Dimethaid Research (Toronto) has been notified that Greece, Iceland and Portugal are prepared to grant marketing authorization for Pennsaid under the mutual recognition procedure. Formal authorization will be issued after the product labelling has been finalized, adding to existing approvals in Austria, Finland, Italy, Luxemburg and the United Kingdom.
PP Luxco Holdings II, (Montreal) a wholly-owned subsidiary of Picchio Pharma, announced today that it has acquired an additional 200,000 common shares of Neurochem (NRM.TO) through a private purchase, representing 0.86% of the outstanding common shares of Neurochem Inc., for a cash consideration of $2.8 million.
Cedara Software (Toronto) announced that it has not been able to meet the minimum shareholders’ equity requirement established in the Nasdaq Listing Qualifications Panel decision issued on May 8, 2003. As a result, Cedara’s common shares will no longer trade on Nasdaq effective with the opening of business on July 7, 2003.
Vasogen (Mississauga), a developer of immune modulation therapies for the treatment of cardiovascular and other inflammatory diseases, announced it has completed a private placement totaling US$37.5 million, resulting in the issuance of 9.375 million shares at a price of US$4.00 per share.
ProMetic Life Sciences (Montreal) announced that Genevive Poulin has tendered her resignation as the company’s vice-president finance and chief financial officer.
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).