Ottawa, ON August 18, 2003 The following Life Sciences News Briefs were published recently by Industry Canada:
1) Pharmaceuticals Update
Axcan Receives FDA Approval for Photofrin
Axcan Pharma (Mont Ste Hilare) announced that it has received approval from the United States Food and Drug Administration for the use of Photofrin photodynamic therapy (PDT) in the ablation of high-grade dysplasia (HGD) in Barrett’s Esophagus patients who do not undergo esophagectomy. Photofrin PDT was also granted orphan drug designation for this indication, which guarantees a seven-year marketing exclusivity.
Isotechnika granted US patent for ISA247
Isotechnika (Edmonton) announced that the company has received an issue notification from the US patent and trademark office regarding its novel immunosuppressive compound ISA247. This application has been issued US patent number 6,605,593, and is entitled Deuterated Cyclosporine Analogs and their use as Immunomodulating Agents. The US becomes the fourth jurisdiction to issue a patent for ISA247 joining Australia, Canada and New Zealand. ISA247 is a next generation calcineurin inhibitor in Phase II clinical development as immunosuppressive therapy in organ transplantation and in the treatment of autoimmune diseases. Early studies indicate that ISA247 is considerably more potent and less toxic compared to other drugs in this class, such as cyclosporine. This compound would give a major therapeutic benefit over existing calcineurin based regimens. ISA247 is being developed under a global collaboration agreement with Roche.
Cardiome reports first dosing in Phase III atrial arrhythmia studies
Cardiome Pharma (Vancouver) announced that it has commenced patient dosing in its initial Phase III efficacy study of RSD1235 for the acute treatment of atrial fibrillation. The initial study, called ACT 1 (atrial fibrillation conversion trial 1), will measure the safety and efficacy of RSD1235 in 420 patients. The placebo-controlled study is being carried out in 45 centers in the US, Canada, and Scandinavia. ACT 1 is the first of an expected three Phase III studies required for FDA approval of RSD1235. Atrial fibrillation is an abnormal heart rhythm that affects the atria of the heart, lowering the heart’s pumping capacity and increasing the risk of stroke. Immediate symptoms are breathlessness and fatigue. Long-term effects include increased risk of both stroke and congestive heart failure. More than 6 million patients in North America, Europe and Japan suffer from atrial fibrillation.
Paladin receives orphan designation in Europe for Fidelin (DHEA)
Paladin Labs (Montreal), a leading Canadian specialty pharmaceutical company, confirmed today that the European Commission has granted orphan medicinal product designation for Fidelin (dehydroepiandrosterone / DHEA), currently in clinical trials for the treatment of adrenal insufficiency. Orphan drug designation provides Fidelin with market exclusivity in Europe for a period of ten years following marketing approval, and enables Paladin to receive pre-filing regulatory guidance as well as reduced filing fees. Paladin acquired the development and marketing rights to DHEA in 1999 through its acquisition of Neuroscience Pharma, a company focused on the discovery and development of novel therapeutics relating to DHEA. Paladin is continuing the development of this product for adrenal insufficiency, a rare chronic condition brought about by failure of the adrenal glands, which affects an estimated 115,000 patients in Europe. Current standard therapies frequently fail to restore full wellbeing, as such, patients with this disorder continue to suffer from a diminished quality of life.
Depomed’s study of Metformin GR reinforces positive Phase III results
Depomed (Menlo Park) and Biovail (Toronto) announced that Metformin GR, Depomed’s once daily, controlled-release formulation of leading diabetes drug metformin, successfully controlled glucose levels in an open label extension study of patients with Type II diabetes. These findings reinforce the results of Depomed’s 24-week, double-blind, placebo-controlled Phase III trial evaluating various doses of Metformin GR compared to Bristol Myers Squibb’s Glucophage (immediate release metformin). The Phase III results, announced in February 2003, indicated that all doses of once daily Metformin GR controlled glucose levels as effectively as Glucophage, which must be administered two to three times per day.
2) Medical Devices
MDS Sciex signs distribution agreement with LEAP Technologies
MDS Sciex (Toronto) the analytical instrumentation and technology solutions division of MDS Inc., and LEAP Technologies, a leading provider of comprehensive solutions to automation in the analytical lab, announced the signing of a distributorship agreement to deliver the new NanoLC proteomics system in the US.
MSI modifies the VScan test kit to be environmentally safe
Medical Services International (Edmonton) announced that it has modified its VScan test kit to be environmentally safe. Previously, the VScan test kit contained a resealable bag for disposal of the test cassette and lancet. Medical Services has added to the VScan test kit a container filled with a liquid chemical that is poured into the resealable bag after the used test cassette and lancet are placed in it. This chemical completely neutralizes the HIV virus if present therefore preventing contamination into the environment or spread of the virus through improper handling of the test kit. Improper handling or disposal of an HIV test kit where the individual has tested positive can result in the spread of HIV. The company feels that this addition is very important in relation to the proper and safe testing for HIV
Biorthex receives a second approval from US FDA
Biorthex (Montreal), a medical device company specializing in spine, is pleased to announce the second conditional approval obtained this year from the US Food and Drug Administration (FDA) for the initiation of a clinical trial this time for its Actipore ACF anterior cervical fusion device. This conditional approval grants Biorthex the right to immediately initiate the study on its cervical implant in the United States while adjusting its protocol to suit FDA requirements.
Pheromone Sciences signs chinese distribution agreement
Pheromone Sciences (Toronto), a biotech company and the developer of the Fertilit-OV monitoring device with proprietary technology in the field of non-invasive fertility and ovulation detection is pleased to announce that it has entered into a long-term definitive distribution and licensing agreement with Ningxia St Edenweiss. Under the agreement, Ningxia St Edenweiss, a public company whose shares are traded on China’s Shenzhen Stock Exchange (symbol 000982) has obtained marketing and distribution rights for Pheromone’s Fertilit-OV monitor in China, Hong Kong, Macau and Taiwan. Ningxia St Edenweiss is a manufacturing and marketing company with well-established relationships throughout the Chinese medical community. Pheromone shall receive up-front, milestone and royalty payments typical of a transaction of this nature.
WorldHeart provides FDA analyses for expanded indication review
World Heart Corporation (Ottawa) announced that it has provided the US Food and Drug Administration (FDA) with an amended submission in response to the FDA’s March 2003 request for additional data and statistical analyses. The FDA requested the information as part of its expedited review of WorldHeart’s Destination Therapy Premarket Approval (PMA) Supplement for its Novacor LVAS (left ventricular assist system). WorldHeart expects a decision from the FDA this year as to expanding the Novacor LVAS patient population to include a portion of end-stage heart-failure patients who, at the time of implantation of the device, are not candidates for transplantation.
TSO3 obtains a US patent for its chemical indicator
TSO3 (Quebec City) announced t
hat the company has obtained a patent, awarded by the director of the US patent and trademark office, for its chemical indicator a small sticker to show that all required sterilization parameters have been met during the sterilization cycle. The indicator looks like a small sticker and has a chromaphore substance that changes colour when the required sterilization parameters have been met. This sticker, about 5cm square, is essential to the commercialization of the 125L ozone sterilizer from TSO3, as a method of validation is required by the authorities for any sterilization process.
3) Industry Update
Health Canada announced the appointment of Dr Pierre-Gerlier Forest to the GDW Cameron Visiting Chair for Health Canada. Reporting to the deputy minister, Dr Forest will provide advice to the minister, the deputy minister and the department on a wide range of emerging health issues, participate in senior departmental committees and take part in developing policy. His appointment is for one year with the possibility of extending for an additional year.
GenSci Regeneration Sciences (Toronto) and Biosurgery company IsoTis (Amsterdam), announced that the US Bankruptcy Court, Central District of California, has entered an order dismissing GenSci Regeneration Sciences (GenSci Regeneration) from Chapter 11. This marks an important step towards completion of the proposed merger between IsoTis and GenSci announced in early June. Both companies further confirmed that reciprocal due diligence has now been successfully completed.
Labopharm (Laval) announced that, through its Labopharm Europe subsidiary, it has executed a definitive distribution and licensing agreement with Esteve for Spain and Portugal for its lead in-house product, a once-daily version of the analgesic tramadol.
Axcan Pharma (Mont St Hilaire) announced that it has filed a final base shelf prospectus in Canada and a related registration statement in the US pursuant to the multi-jurisdictional disclosure system, to qualify the resale of and register the resale by holders of the previously issued US$125.0 million aggregate principal amount of 4 1/4% convertible subordinated notes due 2008 and the common shares issuable upon their conversion.
Affinium Pharmaceuticals (Toronto), a leader in structure guided drug discovery, announced the appointment of Dr Charles “Bucky” Grier to the board of directors.
On August 20, the Canadian Medical Association (CMA) will present the 2003 FNG Starr Award to Dr Allan R. Ronald of Winnipeg. With this award, the CMA expresses its admiration for the professional commitment and personal vision that have marked Dr Ronald’s life and the honour that he has brought to his calling.
Spectral Diagnostics (Toronto) announced that it has retained Loewen, Ondaatje, McCutcheon in connection with an offering of up to approximately 2.35 million units at a price of $2.55 per unit for total gross proceeds of up to $6.0 million. Each unit will consist of one common share and one-half of one common share purchase warrant.
BioMS Medical (Edmonton) announced that, subject to regulatory approval, its board of directors has authorized the purchase of up to 500,000 of its Class A common shares (the “Common Shares”) representing approximately 1% of the company’s Class A common shares, under a normal course issuer bid pursuant to the rules of the Toronto Stock Exchange.
BCY LifeSciences (Toronto), announced that it has completed enrolment in its multi-centre Phase II clinical trial to assess the efficacy of its lead product, DCF 987, in the treatment of cystic fibrosis.
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: firstname.lastname@example.org).