24th Oct 2006 13:00
TYSABRI Data Support Maintenance Efficacy In Patients Who Had Previously Failed Infliximab Therapy Elan Corporation, plc (NYSE:ELN) and Biogen Idec (NASDAQ:BIIB) announced todaydata that show TYSABRI(R) (natalizumab) maintained remission in Crohn's diseasepatients (CD) treated for longer than 2 years. These data, presented this weekat the 14th United European Gastroenterology Week (UEGW) in Berlin, Germany, andat the Annual American College of Gastroenterology (ACG) in Las Vegas, Nevada,were part of an open label extension study of patients who participated in theENACT-2 trial. Ninety-three percent (93%) of TYSABRI patients who were in remission at month 12of ENACT-2, were still in remission following 6 additional TYSABRI infusions inthe open-label extension study (OLE) and 86% were still in remission after 12additional infusions. These results were based on approximately 90 patients who were in remissionafter 15 months of continuous TYSABRI therapy in the ENACT-1 and ENACT-2 trialsand elected to enroll in an open-label extension trial. A subpopulation of 22patients was previously exposed to infliximab therapy. In this subpopulation,91% were in remission after additional 6 and 12 infusions of TYSABRI, and 82%who had previously failed therapy with infliximab were in remission at the sametime points. "What is truly exciting is that patients who enter remission on TYSABRI mayremain in remission in the long-term without loss of efficacy over time. Thesedata are a significant advance for the field and suggest that TYSABRI may be analternative biologic outside the anti-TNF class for patients suffering fromCrohn's disease," said Remo Panaccione MD, Director, Inflammatory Bowel DiseaseClinic, University of Calgary, Calgary, Canada, who presented the data at UEGW. Incidence of adverse events (AE's) and infection was similar to CD clinicaltrials, in which most common adverse events were headache, nausea,nasopharyngitis, and abdominal pain. In short-term controlled studies in CD, theincidence of serious infection was comparable between TYSABRI and placebotreatment groups. In longer-term, open-label clinical trials, one case ofprogressive multifocal leukoencephalopathy (PML) was observed. ENACT-2 OLE Study Trial Design Patients who completed the ENACT-2 trial were eligible to enroll in anopen-label extension study. The primary objective of the two-year OLE study wasto examine the long-term safety and tolerability of TYSABRI. Secondary efficacyendpoints included evaluation of the ability of TYSABRI to maintain remission.This analysis included patients who were in remission after 15 months ofcontinuous TYSABRI therapy in both ENACT-1 and -2 trials and elected to enrollin the OLE study and receive additional TYSABRI therapy. Approximately 90patients met the criteria for analysis, 22 of which had previous exposure toanti-TNF. Remission rates were calculated using last observation carriedforward. About TYSABRI In the US, TYSABRI is approved as a monotherapy treatment for relapsing forms ofMS. TYSABRI increases the risk of progressive multifocal leukoencephalopathy(PML), an opportunistic viral infection of the brain that usually leads to deathor severe disability. Patients should be monitored at regular intervals for anynew or worsening signs or symptoms suggestive of PML. Because of the increasedrisk of PML, TYSABRI is generally recommended for patients who have had aninadequate response to, or are unable to tolerate, alternate MS therapies. It isavailable in the US only through a restricted distribution program called theTOUCH Prescribing Program. According to product labeling, after two years,TYSABRI treatment led to a 67% relative reduction (p less than 0.001) in theannualized relapse rate compared to placebo and reduced the relative risk ofdisability progression by 42% (p less than 0.001). TYSABRI treatment alsoresulted in sustained and statistically significant reductions in brain lesionactivity as measured by MRI. Changes in MRI findings often do not correlate withchanges in the clinical status of patients (e.g., disability progression). Theprognostic significance of the MRI findings in these studies has not beenevaluated. In the European Union, TYSABRI is indicated as a single disease-modifyingtherapy in highly active relapsing-remitting MS patients. Because of theincreased risk of PML, it is for patients with high disease activity despitetreatment with a beta-interferon or in patients with rapidly evolving severerelapsing-remitting MS. According to product labeling in the EU, after twoyears, TYSABRI treatment led to a 68% relative reduction (p less than 0.001) inthe annualized relapse rate compared to placebo and reduced the relative risk ofdisability progression by 42-54% (p less than 0.001). Serious adverse events that occurred in TYSABRI-treated patients includedhypersensitivity reactions (e.g., anaphylaxis), infections, depression andgallstones. In MS trials, the incidence and rate of other serious and commonadverse events, including the overall incidence and rate of infections, werebalanced between treatment groups. Herpes infections were slightly more commonin patients treated with TYSABRI. Serious opportunistic and other atypicalinfections have been observed in TYSABRI-treated patients, some of whom werereceiving concurrent immunosuppressants. Common adverse events reported inTYSABRI-treated patients include headache, fatigue, infusion reactions, urinarytract infections, joint and limb pain, lower respiratory infections, rash,gastroenteritis, abdominal discomfort, vaginitis, and diarrhea. For more information about TYSABRI please visit www.tysabri.com,www.biogenidec.com or www.elan.com, or call 1-800-456-2255. About Crohn's Disease Approximately one million people worldwide have Crohn's disease, a chronic andprogressive inflammatory disease of the gastrointestinal tract, which commonlyaffects both men and women. The disease usually causes diarrhea and crampyabdominal pain, often fever, and at times rectal bleeding. Loss of appetite andweight loss also may occur. Complications include narrowing of the intestine,obstruction, abscesses, and fistulas (abnormal channels connecting the intestineand other organs, including the skin), malnutrition and decreased growth rate inchildren. Source: CCFA About Elan Elan Corporation, plc is a neuroscience-based biotechnology company committed tomaking a difference in the lives of patients and their families by dedicatingitself to bringing innovations in science to fill significant unmet medicalneeds that continue to exist around the world. Elan shares trade on the NewYork, London and Dublin Stock Exchanges. For additional information about thecompany, please visit www.elan.com. About Biogen Idec Biogen Idec creates new standards of care in oncology, neurology and immunology.As a global leader in the development, manufacturing, and commercialization ofnovel therapies, Biogen Idec transforms scientific discoveries into advances inhuman healthcare. For product labeling, press releases and additionalinformation about the company, please visit www.biogenidec.com. Safe Harbor/Forward Looking Statements This press release contains forward-looking statements regarding TYSABRI. Thesestatements are based on the companies' current beliefs and expectations. Thecommercial potential of TYSABRI is subject to a number of risks anduncertainties. Factors which could cause actual results to differ materiallyfrom the companies' current expectations include the risk that we may be unableto adequately address concerns or questions raised by FDA or other regulatoryauthorities, that concerns may arise from additional data, that the incidenceand/or risk of PML or other opportunistic infections in patients treated withTYSABRI may be higher than observed in clinical trials, or that the companiesmay encounter other unexpected hurdles. Drug development and commercializationinvolves a high degree of risk. For more detailed information on the risks anduncertainties associated with the companies' drug development and otheractivities, see the periodic and current reports that Biogen Idec and Elan havefiled with the Securities and Exchange Commission. The companies assume noobligation to update any forward-looking statements, whether as a result of newinformation, future events or otherwise. MEDIA:ElanDavia B. Temin, 212-407-5740Elizabeth Headon, 353-1-498-0300orBiogen IdecAmy Brockelman, 617-914-6524orINVESTOR:ElanEmer Reynolds, 353-1-709-4000Chris Burns, 800-252-3526orBiogen IdecEric Hoffman, 617-679-2812 Copyright Business Wire 2006Related Shares:
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