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From: lilsorg

Biogen Idec and Elan Announce FDA Acceptance of Supplemental Biologics License Application and Priority Review Designation for TYSABRI® in Multiple Sclerosis

17.11.2005 21:44:00

<NOSCRIPT> </NOSCRIPT>Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc(NYSE: ELN) announced today that the supplemental Biologics LicenseApplication (sBLA) for TYSABRI® (natalizumab) for the treatment ofmultiple sclerosis (MS) has been accepted and designated for PriorityReview by the U.S. Food and Drug Administration (FDA). The FDA grants Priority Review status to products that areconsidered to be potentially significant therapeutic advancements overexisting therapies that address an unmet medical need. Based on theFDA's designation of Priority Review for TYSABRI in MS, the companiesanticipate action by the Agency approximately six months from thesubmission date, rather than 10 months for a standard review. OnSeptember 26, 2005, the companies announced they had submitted thesBLA for the market re-entry of TYSABRI for MS and requested PriorityReview. The sBLA for TYSABRI in MS includes: -- final two-year data from the Phase III AFFIRM monotherapy trial and SENTINEL add-on trial with AVONEX® (Interferon beta-1a) in MS; -- integrated safety assessment of patients treated with TYSABRI in clinical trials; and -- revised label and risk management plan. "We are pleased that TYSABRI has received Priority Reviewdesignation, which we believe, reflects the unmet need in MS," saidBurt Adelman, MD, executive vice president, Development, Biogen Idec."We look forward to working with the FDA throughout the review processand are hopeful that we will be able to bring TYSABRI back to peopleliving with MS." "We believe that the acceptance of the sBLA for Priority Review isanother step in our ongoing commitment to provide TYSABRI as atreatment option for MS patients in need," said Lars Ekman, MD,executive vice president and president, Research & Development, Elan."We will continue to work closely with the FDA as they review thefiling so that TYSABRI can be made available with an appropriatebenefit-risk profile." On February 28, 2005, Biogen Idec and Elan announced that theyvoluntarily suspended TYSABRI from the U.S. market and all ongoingclinical trials based on reports of progressive multifocalleukoencephalopathy (PML), a rare and potentially fatal, demyelinatingdisease of the central nervous system. Biogen Idec and Elan recentlycompleted a comprehensive safety evaluation of more than 3,000 TYSABRIpatients in collaboration with leading experts in PML and neurology.The results of the safety evaluation yielded no new confirmed cases ofPML beyond the three previously reported. About Biogen Idec Biogen Idec creates new standards of care in oncology, neurologyand immunology. As a global leader in the development, manufacturing,and commercialization of novel therapies, Biogen Idec transformsscientific discoveries into advances in human healthcare. For productlabeling, press releases and additional information about the company,please visit http://www.biogenidec.com. About Elan Elan Corporation, plc is a neuroscience-based biotechnologycompany committed to making a difference in the lives of patients andtheir families by dedicating itself to bringing innovations in scienceto fill significant unmet medical needs that continue to exist aroundthe world. Elan shares trade on the New York, London and Dublin StockExchanges. For additional information about the company, please visithttp://www.elan.com. Safe Harbor/Forward Looking Statements This press release contains forward-looking statements regardingthe regulatory path forward of TYSABRI. The regulatory path forward ofTYSABRI is subject to a number of risks and uncertainties. Factorswhich could cause actual results to differ materially from thecompanies current expectations include the risk that concerns mayarise from additional data or analysis or that the companies mayencounter other unexpected delays or hurdles. There is no assurancethat the companies will be able to resume marketing and sales ofTYSABRI. Drug development and commercialization involves a high degreeof risk. For more detailed information on the risks and uncertaintiesassociated with the companies' drug development and other activities,see the periodic reports that Biogen Idec and Elan have filed with theSecurities and Exchange Commission. The companies assume no obligationto update any forward-looking statements, whether as a result of newinformation, future events or otherwise.

Quelle: Finanzen.net / Aktiencheck.de AG