User talk:Lulla01

Elan Corporation, plc is a neuroscience-based biotechnology company that is focused on discovering, developing, manufacturing and marketing advanced therapies in neurology, autoimmune diseases, and severe pain.

On June 5, 2006, Elan and Biogen Idec announced the approval of a supplemental Biologics License Application (sBLA) by the U.S. Food and Drug Administration (FDA) for the reintroduction of TYSABRI® (natalizumab) as a monotherapy treatment for relapsing forms of multiple sclerosis (MS) to slow the progression of disability and reduce the frequency of clinical relapses.

The FDA granted approval for re-introduction based on the review of TYSABRI clinical trial data; revised labeling with enhanced safety warnings; and a risk management plan (TOUCH Prescribing Program) designed to inform physicians and patients of the benefits and risks of TYSABRI treatment and minimize potential risk of progressive multifocal leukoencephalopathy (PML). Because of the increased risk of PML, TYSABRI monotherapy is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, alternate MS therapies.

TYSABRI became commercially available in the US in July 2006. Under the TOUCH Prescribing Program, only prescribers, infusion centers, and pharmacies associated with infusion centers registered in the TOUCH program are able to prescribe, infuse or distribute TYSABRI. Elan has contracted with a single distributor, ICS, a division of AmerisourceBergen Specialty Group, and 12 specialty pharmacies: Caremark, CuraScript, PharmaCare, PrecisionRx Specialty Solutions, Medmark, BioScrip, McKesson Specialty, Option Care, Cigna Tel-Drug Specialty Pharmacy, Aetna Specialty Pharmacy, Prescription Solutions, and Accredo NovaFactor. ICS and the 12 specialty pharmacies have been trained on the TOUCH Prescribing Program and are obligated to follow the requirements of the program in order to purchase and distribute TYSABRI to authorized infusion sites and central pharmacies. On June 29, 2006, Elan and Biogen Idec announced that they received approval from the European Commission to market TYSABRI® (natalizumab) as a treatment for relapsing remitting multiple sclerosis (MS) to delay the progression of disability and reduce the frequency of relapses. TYSABRI is indicated as a single disease modifying therapy in highly active relapsing remitting MS for patients with high disease activity despite treatment with a beta-interferon or in patients with rapidly evolving severe relapsing remitting MS.

TYSABRI was launched in Germany, Ireland, U.K. and Sweden in July 2006, and will be launched in other EU countries over the next 12 months.

On December 28, 2004, the U.S. Food and Drug Administration (FDA) approved PRIALT® (ziconotide intrathecal infusion) for the management of severe chronic pain in patients for whom intrathecal (IT) therapy is warranted, and who are intolerant of or refractory to other treatment, such as systemic analgesics, adjunctive therapies or IT morphine. PRIALT is approved for use only in the Medtronic SynchroMed® EL, SynchroMed® II Infusion System and CADD-Micro® ambulatory infusion pump.

On February 22, 2005, the European Commission granted Elan marketing approval for PRIALT™ (ziconotide) for the treatment of severe, chronic pain in patients who require intrathecal (IT) analgesia.

Elan's focus on improving the health of patients suffering from chronic and debilitating conditions is exemplified by its breakthrough research program in Alzheimer's disease, where it has developed three novel therapeutic approaches:

Immunotherapy In collaboration with Wyeth, this approach targets the clearance of beta-amyloid, the peptide responsible for the build-up of amyloid plaques in the brain

Beta secretase inhibitors Targets a distinct enzyme associated with the production of beta-amyloid

Gamma secretase inhibitors Targets a distinct enzyme associated with the production of beta-amyloid In neurology, Elan is focused on building upon its breakthrough research and extensive experience in the area of neuropathology-based disorders. In addition to Alzheimer’s disease, Elan is also studying other neurodegenerative diseases, such as Parkinson's disease.

In autoimmune diseases, Elan’s primary emphasis is studying and developing ways to provide disease-modifying therapies for a wide range of diseases.

In severe pain, Elan’s research efforts focus on inflammatory and neuropathic pain.

For more information about Elan’s research and development program, please click here.

Elan’s marketed products in the the United States include: