Eland Oil & Gas Regulatory News (ELA)

4 Oct 2006 13:00

MISSISSAUGA, Ontario & DUBLIN, Ireland--Oct. 4, 2006--Biogen Idec Canada andElan Corporation, plc announced today that following a priority review process,Health Canada has granted approval to TYSABRI(TM) (natalizumab) for thetreatment of relapsing-remitting multiple sclerosis (MS).(2) TYSABRI is thefirst in a new therapeutic class of MS treatments (called selective adhesionmolecule inhibitors) and has been shown to significantly reduce the rate of MSrelapses as well as the progression of disability associated with theillness.(2) "TYSABRI has demonstrated a major reduction in relapses - by more thantwo-thirds - in clinical trials," said Dr. Paul O'Connor, AFFIRM PrincipalInvestigator and Chief of Division of Neurology, St Michael's Hospital, Toronto."Clinical trials that have looked at TYSABRI provide us with impressive evidencethat it is a highly effective treatment for patients with MS." A two-year, randomized, multi-centre, placebo-controlled, double-blind study(called AFFIRM) enrolled 942 patients and evaluated the effect of TYSABRI on therate of clinical relapses and the progression of disability.(3) The resultsfound that TYSABRI reduced the rate of clinical relapses by 68 per cent relativeto placebo (p less than 0.001), and the risk of sustained disability progressionassociated with MS by 42 per cent relative to placebo (p less than 0.001).(4)Treatment with TYSABRI also resulted in sustained and statistically significantreductions in brain lesion activity as measured by magnetic resonance imaging(MRI) scans.(4) In Canada, TYSABRI is indicated as monotherapy (i.e. single disease-modifyingagent for the treatment of patients with the relapsing-remitting form of MS toreduce the frequency of clinical relapses, to delay the progression ofdisability and to decrease the number and volume of active brain lesionsidentified on magnetic resonance imaging (MRI) scans.(4) TYSABRI is administeredonce every four weeks by intravenous infusion.(5) "TYSABRI's administration every four weeks also offers an additional benefitcompared to the currently available MS therapies, some of which are injected asoften as daily," said O'Connor. MS attacks the protective myelin covering of the central nervous system, causinginflammation and often destroying the myelin in patches. In its most commonform, relapsing-remitting MS, the illness is characterized as having welldefined attacks followed by complete or partial recovery.(6) Relapsing-remittingMS makes up 75% of all MS cases in Canada.(7) TYSABRI works by preventing the body's affected immune cells from migrating fromthe bloodstream into the brain where they can cause inflammation and potentiallydamage nerve fibers and their insulation.(8) "Canada has one of the highest rates of MS in the world.(9) The approval ofTYSABRI represents an important step forward for Canadians living with thisdisease," said Deanna Groetzinger, vice president of government relations andpolicy at the Multiple Sclerosis Society of Canada. "We are pleased there isanother approved treatment option for Canadians with relapsing-remitting MS." Paulette O'Leary, 36, has been living with MS for over half of her life. At onepoint a relapse left her without the use of her legs and numbness across theleft side of her body. After other therapy options failed to help her, O'Learyopted to travel to the United States to receive TYSABRI treatments when it wasapproved by the Food and Drug Administration (FDA) in the US. "My particular experience with MS was really terrible. The illness hit me veryhard, and I went from my normal, everyday life, to feeling awful physically andemotionally. After one relapse I was left in a wheelchair," said O'Leary. "Ieventually recovered, but did not escape some permanent residual disability. Itried several other therapies, but when I was on TYSABRI the results were quiteimpressive. For the first time in a long time, I could walk, I could do thethings that I love to do - I could actually live my life again." Independent safety evaluation published Biogen Idec and Elan Corporation, plc voluntarily suspended TYSABRI from the USmarket and from all clinical trials in 2005. This was based on three cases ofprogressive multifocal leukoencephalopathy (PML). A comprehensive, independent safety evaluation of more than 3,000 patientstreated with TYSABRI was completed. The detailed safety analysis of the data yielded no new confirmed cases of PMLbeyond the three previously reported. The results of this safety evaluation werepublished in the March 2006 issue of the New England Journal of Medicine.(10) "The safety data analysis that was carried by an independent panel of experts isreassuring. And getting an understanding of the benefit-risk profile of TYSABRIis an important step towards bringing this medicine to Canadian MS patients withconfidence," said Dr. O'Connor. "Any treatment decision should carefullyevaluated by patients and their physicians." Patients who are prescribed TYSABRI should enroll in the TYSABRI Care Program.The program ensures that appropriate physicians and infusion centres are able toprescribe or infuse the product.(11) The TYSABRI Care Program is a comprehensiveprogram that will support the safe and effective use of TYSABRI by physiciansand patients on an ongoing basis. It will optimize treatment through improvedcompliance, will standardize infusion treatment at clinics, will support safetythrough rigorous education and on-going surveillance, and, through support inareas like reimbursement and patient support, will ease the administrativeburden of physicians and patients, allowing patients and their treatment team tofocus on treating the illness. AFFIRM and SENTINEL Phase III study design and adverse events AFFIRM is a two-year, randomized, multi-center, placebo-controlled, double-blindstudy of 942 patients conducted in 99 sites worldwide (including ten sites inCanada with 101 MS patients), evaluating the effect of TYSABRI on theprogression of disability as measured by at least a one-point increase on theExpanded Disability Status Scale (EDSS) sustained for three months, and the rateof clinical relapses. Progression of disability is a sustained change that has along-term impact on a patient's functional and ambulatory performance. Patientsin AFFIRM were randomized to receive either a 300 mg IV infusion dose of TYSABRI(n=627) or placebo (n=315) every four weeks.(4) SENTINEL is a two-year, randomized, multi-center, placebo-controlled,double-blind study of 1,171 AVONEX(R)-treated patients in 123 clinical trialsites worldwide. AVONEX-treated patients who continued to experience diseaseactivity were randomized to add TYSABRI (n=589) or placebo (n=582) to theirstandard regimen.(12) The two-year adverse event profile in AFFIRM and SENTINEL were consistent withpreviously reported one-year results. Common events included headache, fatigue,urinary tract infection, depression, lower respiratory tract infection, limb andjoint pain, and pharyngitis.(4), (12) The rate and incidence of infections inpatients treated with TYSABRI and placebo-treated patients were similar. Seriousinfections occurred in 3.2 percent and 2.6 percent of patients treated withTYSABRI and placebo-treated patients, respectively. Use of TYSABRI has been associated with an increased risk of progressivemultifocal leukoencephalopathy (PML). PML can cause severe disability ordeath.(13) Cases of PML included patients who were treated with TYSABRI for over two yearsor who received intermittent doses of TYSABRI over an 18-month period. Inclinical trials, two cases of PML were observed in 1869 patients with multiplesclerosis treated for a median of 120 weeks; the third case occurred among 1043patients with Crohn's disease after the patient received 8 doses. These patientswere concomitantly exposed to immunomodulators (e.g. interferon beta) or wereimmunocompromised due to treatment with immunosuppressants (e.g.azathioprine).(14) TYSABRI has also been associated with hypersensitivity reactions, includingserious systemic reactions that occurred at an incidence of less than 1 percentof patients.(14) About Multiple Sclerosis Multiple sclerosis (MS) is a chronic, unpredictable and potentially disablingdisease of the central nervous system that affects approximately 55,000-75,000Canadians.(11) Canada has one of the highest rates of MS in the world - it isestimated that three Canadians are newly diagnosed with MS every day.(10), (11)It is known as a disease of young adults, with onset, usually in women, betweenthe ages of 15 and 40. It is characterized by symptoms such as vision problems,loss of balance, numbness, difficulty walking and even complete paralysis.(7) About Biogen Idec Biogen Idec (NASDAQ: BIIB) creates new standards of care in oncology, neurologyand immunology. As a global leader in the development, manufacturing, andcommercialization of novel therapies, Biogen Idec transforms scientificdiscoveries into advances in human healthcare. For press releases and additionalinformation about the company, please visit www.biogenidec.com. About Elan Elan Corporation, plc (NYSE: ELN) is a neuroscience-based biotechnology companycommitted to making a difference in the lives of patients and their families bydedicating itself to bringing innovations in science to fill significant unmetmedical needs that continue to exist around the world. Elan shares trade on theNew York, London and Dublin Stock Exchanges. For additional information aboutthe company, please visit www.elan.com. \* TATTENTION TELEVISION ASSIGNMENT/PRODUCERS: B-roll available via satellite:DATE OF FEED: Wednesday, October 4, 2006TIME OF FEED: 2:00pm - 2:30pmCO-ORDINATES: Anik F2 C, Transponder 3B Audio subcarrier 6.2 and 6.8 Downlink frequency 3820 vertical PATHFIRE Digital Media Gateway Coordinates:DATE OF FEED: Wednesday, October 4, 2006AVAILABLE AT: 10:00amCO-ORDINATES: CNW tab, Video Provider A, Digital Media GatewaySTORY NUMBER: CNW06HAK9\* T If there are any difficulties with the satellite transmission, please call (416)863-2112. (1) TYSABRI Product Monograph 2006, page 18 (2) TYSABRI Product Monograph 2006, page 3 (3) Polman, Chris H. et al. The New England Journal of Medicine. 2006; 354:899-910. (4) TYSABRI Product Monograph 2006, page 3 (5) TYSABRI Product Monograph 2006, page 12 (6) Multiple Sclerosis Society of Canada website,http://www.mssociety.ca/en/information/faq.htm#2 accessed September 21, 2006. (7) http://www.mssociety.ca/en/information/types.htm, accessed on September 21,2006. (8) TYSABRI Product Monograph, page 13-14 (9) Multiple Sclerosis Society of Canada Medical Update Memo, May 2, 2006 (10) Yousry, Tarek A. et al. The New England Journal of Medicine. 2006: 354:924-933. (11) Tysabri Product Monograph 2006, page 4 (12) Rudick, Richard A. et al. The New England Journal of Medicine. 2006; 354:911-923. (13) TYSABRI Product Monograph 2006, page 5 (14) TYSABRI Product Monograph 2006, page 7 \* T CONTACT: Hill & Knowlton Canada Peter Gay, 416-413-4732 Cell: 416-523-1420 peter.gay@hillandknowlton.ca or Farah Meghji, 416-413-4\* T Copyright Business Wire 2006