Life sciences news briefs (May 07, 2004)

Ottawa, ON – May 7, 2004 – The following life sciences news briefs were published this week by Industry Canada.

1) Pharmaceuticals Update

Alda Pharmaceuticals patent application receives positive review

Alda Pharmaceuticals (Vancouver) announced it has received a positive international preliminary examination report on its patent application for its proprietary infection control technology, including Viralex with T(3)6. The report was free of questions, comments or requests, which means that the company can immediately proceed to the next phase of patenting. The report can be used by the company to support national patent applications in countries that participate in the Patent Cooperation Treaty such as Canada, the US, EU and Asian countries. Alda will select countries with the most significant market opportunities and will apply for the national patents by February 20, 2005.

Biovail and DepoMed submit NDA for Glumetza – Metformin GR

Biovail (Toronto) and Depomed (Menlo Park) announced that they have submitted a new drug application to the US Food and Drug Administration (FDA) for 500mg and 1000mg tablets of Glumetza, once daily, extended release formulations of metformin. The submission occurred simultaneously as Biovail and Depomed amended their license agreement to cover both dosage strengths. The 500mg dosage strength was developed utilizing Depomed’s gastric retention (GR) drug delivery technology and the 1000mg dosage strength was developed by Biovail’s Smartcoat delivery technology. Depomed conducted two double-blind Phase III clinical trials for its 500 mg dose in over 1000 patients with Type II diabetes. Patients receiving the product demonstrated excellent glycemic control over 24 and 48 weeks, including substantial reductions in HbA1c that were maintained over that period. In addition, within one week, sizable reductions in fasting plasma glucose were achieved and maintained throughout the studies. Glumetza was well tolerated in terms of gastrointestinal adverse events and had an excellent safety profile. Biovail conducted multiple studies to demonstrate equivalency for its 1000mg dosage strength to Depomed’s 500mg dosage strength.

Celmed Biosciences announces interim results of Theralux

Celmed BioSciences (Montreal), a subsidiary of Theratechnologies that is active in the field of oncology, announced the interim results of an ongoing open-label clinical study using its ex vivo photodynamic therapy, Theralux, for patients with non-Hodgkin’s lymphoma. The results show that Theralux, a non-invasive process used outside the body (ex vivo) to treat disorders affecting the blood and bone marrow, was able to completely eradicate cancer cells from autologous stem cell grafts in 88% of patients. The objective of the present study was to determine the safety of the Theralux process and whether the process could eliminate lymphoma cells from a contaminated graft below detectable levels in at least 50% of patients. Fourteen patients have been enrolled in the trial to date. They all had histologically confirmed NHL with a documented molecular rearrangement (Bcl2) in the peripheral blood or bone marrow cells that could be detected at levels as low as 5 cells per million. The efficacy of Theralux to purge lymphoma cells from contaminated grafts to below detectable levels was 88% (7 out of 8) in fully evaluable patients.

Procyon reports profiles for its anti-HIV protease inhibitor

Procyon Biopharma (Montreal) reported the safety and pharmacokinetic profiles for its proprietary PL-100, a protease inhibitor for the treatment of drug-resistant HIV/AIDS. The latest preclinical studies show that oral treatment with PL-100 is well tolerated up to seven days at the highest doses possible. Combined with the complete lack of indication of genotoxicity in two standard, required tests, these results suggest the safe use of PL-100 in patients. Additional 14-day safety studies as required under regulations to support future investigational new drug filings have now commenced. The research work was conducted by Procyon scientists collaborating with internationally recognized contract-research organizations. Moreover, the company reported that a solid immediate-release tablet formulation of PL-100 has shown similar bioavailability to PL-100 when administered in liquid form. The half-life and circulating blood levels of PL-100 over multiple treatment days in animal with or without ritonavir co-administration, support the concept of adequate oral bioavailability in humans. Current work is in progress to prepare a delayed-release formulation for testing in humans as well.

2) Diagnostics and Therapeutics Update

AEterna/Zentaris and Solvay report headline positive data

AEterna Laboratories (Quebec City), and its wholly owned subsidiary Zentaris, announced statistically significant positive results from a recently completed Phase II clinical program. The program was designed to evaluate cetrorelix, a luteinizing hormone releasing hormone antagonist, in three different indications: endometriosis, pre-surgical treatment of uterine myomas and benign prostatic hyperplasia, that can benefit from a targeted and controlled decrease in sex hormones, including estrogen and testosterone. The positive results of six Phase II trials, which also demonstrated good tolerability in all indications, will form the basis for further development of cetrorelix in different indications through collaboration with Solvay Pharmaceuticals, the company’s worldwide (ex-Japan) exclusive development and marketing partner for cetrorelix for the above indications.

Neurochem receives fourth consecutive positive recommendation

Neurochem (Montreal) announced that its independent data safety monitoring board has issued a fourth unanimous recommendation to continue the company’s Phase II/III clinical trial with the orphan-product candidate Fibrillex for the treatment of Amyloid A (AA) Amyloidosis. This disorder is a serious consequence of chronic infectious and inflammatory diseases, including rheumatoid arthritis. No specific treatment currently exists for AA Amyloidosis and patients who suffer from it have a five-year survival rate of approximately 50%. Neurochem expects to complete the clinical trial by January 2005.

Canadian Biotechnology Advisory Committee releases annual report

Advances in biotechnology continue to emerge at an accelerating pace, producing powerful new tools, particularly in human and animal health, agriculture and the environment. While technology moves ahead, policy-making and regulatory systems worldwide struggle to keep pace, according to the Canadian Biotechnology Advisory Committee in its fourth annual report released this week. The report summarizes the committee’s work during the calendar year 2003.

Medical Devices

Ondine Biopharma – FDA agrees to combination product jurisdiction

Ondine Biopharma (Vancouver) has received confirmation from the US FDA that Ondine’s photodynamic disinfection technology for the treatment of microbial infections of the oral cavity will fall under combination product jurisdiction. Ondine is developing laser-activated antimicrobial technology, capitalizing on a decade of successful preclinical research. The technology is efficacious against the full spectrum of microbes including fungi, bacteria and viruses, and is expected to provide unprecedented depth of disinfection based upon a revolutionary non-antibiotic mechanism of action. Microbial suppression is so rapid that target organism resistance is minimized or eliminated. Ondine expects to first introduce this innovative technology into the multi-billion dollar periodontal disease market.

Andromed successfully completes third study on Androgram

Andromed (Montreal), a medical technology company, announced that the latest animal study on its non-invasive pulmonary artery pressure monitor, Androgram, was successfully completed. The resulting correlations with the currently most common appro
ach, pulmonary artery catheterization (PAC), were very significant. Androgram technology is a system that converts heart sounds detected on a patient’s thorax using Andromed’s Androsonix acoustic biosensor into estimates of pulmonary artery pressure. It is a non-invasive and affordable tool that can continuously monitor systolic, diastolic and mean pulmonary artery pressure and heart rate, allowing early detection and estimation of pulmonary hypertension. Thanks to all of these advantages, and the fact that it does not require any bulky and expensive equipment, Androgram can easily be applied to primary care settings. Conversely, the PAC is a costly and highly invasive procedure involving insertion of a catheter into a major vein in the neck or pelvis and guided through the right side of the heart to the pulmonary artery.

Medical Ventures receives CE mark approval for the Angiometrx

Medical Ventures (Richmond) announced that it has received CE mark approval for its Angiometrx Metricath System. Receipt of this approval allows the company to begin selling Metricath products in the European Union. The European Union is the second largest market in the world for medical technologies, and it is estimated that over 600,000 coronary stent implantation procedures are performed there annually. The Metricath System is a catheter-based technology that allows cardiologists to precisely measure arterial and in-stent size during stent implantation while treating coronary or peripheral artery disease.

WorldHeart Premarket approval application to be reviewed by FDA

World Heart (Ottawa) announced that the corporation’s premarket approval application for an expansion to the current indication for use of the Novacor LVAS (left ventricular assist system) will be reviewed at the meeting of the circulatory system devices panel of the US FDA to be held on June 8, 2004. The PMA application requests an expansion of the bridge to transplant indication for use of the Novacor LVAS to include certain heart failure patients who are not listed for transplant due to contraindications that may resolve with LVAS support.

Industry Update

Nanogen (San Diego) and SynX Pharma (Toronto) announced that Nanogen completed its acquisition of all of the common shares and debentures of SynX, pursuant to a plan of arrangement, in exchange for shares of Nanogen common stock. SynX is now a wholly owned subsidiary of Nanogen.

Vigil Health Solutions (Victoria) announced that it has received a signed sales contract from Covenant Retirement Communities for its Covenant Village of the Great Lakes campus in Grand Rapids, Michigan.

Iatra Life Sciences (Toronto) announced the election of Mr Samuel Wakim, QC to the board of directors at the annual and special meeting of shareholders.

Anormed (Vancouver) announced that Dr Felix Baker, managing partner of Baker Brothers Investments and a managing member of Baker Bros Advisors has been appointed to AnorMED’s board of directors.

Following a recent media article, Theratechnologies (Montreal) confirms that its subsidiary Celmed BioSciences is in discussions for a possible transaction with NewBiotics of San Diego, CA.

MedMira (Halifax) announced the signing of a second experienced distributor in the People’s Republic of China with an initial order of 100,000 MiraWell rapid HIV tests to be shipped within the next week.

Topigen Pharmaceuticals (Montreal), a biotechnology company engaged in scientific research and development of novel therapeutic drugs for asthma, allergic rhinitis and other respiratory diseases, announced today the appointment of Dr Paul K Wotton, MBA, PhD as president & chief executive officer and member of the board of directors. Dr Wotton was most recently head of global business development for SkyePharma.

Transition Therapeutics (Toronto) announced that its common shares will commence trading on the Toronto Stock Exchange at the market open on April 29, 2004, under the symbol TTH.

Chromos Molecular Systems (Burnaby) and its subsidiary Agrisoma Biosciences announced that Agrisoma has completed a Series A round of financing to advance the development of its chromosome-based gene delivery and expression platform in plants. Agrisoma will employ its technology for the development of value enhanced traits in crops and for the production of proteins in plant-based systems.

Viventia Biotech (Toronto) announced that the company has received the amount of $1,000,000 in the form of an unsecured demand loan from Mr Leslie Dan, a significant shareholder of the company.

Conjuchem (Montreal) and Dr Claude Vezeau announced that Dr Vezeau has resigned from Conjuchem’s board of directors. This decision was mutually agreed to in the best interest of Conjuchem.

VSM MedTech (Vancouver) announced that it has entered into an agreement to provide a 275-channel magnetoencephalography (MEG) system to University College London (UCL) in London, England.

Celmed BioSciences, (Montreal) a subsidiary of Theratechnologies, targeting niche applications in oncology, announced the sale of Celmed USA, a private company, and its neurology assets and technology platform, to Dr Michel Livesque. The terms of the agreement include payments of royalties on sales upon the eventual commercialization of this technology.

Tm Bioscience (Toronto), a developer of DNA-based diagnostic testing, announced that it has entered into a two-year contract with the Pharmacogenetics Diagnostic Laboratory (PGx) of the University of Louisville Medical School to supply it with the Tag-It P450-2D6 mutation detection kit. This kit identifies the presence or absence of important mutations common in patients with atypical drug metabolism, which can lead to adverse drug reactions.

(Life Sciences News Briefs 2004 is prepared by Armar International for the Life Sciences Branch of Industry Canada, contact: Sandy Vien; Tel: 613-941-6479; E-mail: vien.sandy@ic.gc.ca).