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tely 50 countries. Comtan (entacapone) is also indicated for the treatment of PD patients who experience end-of-dose wearing off. Both products are marketed by the company under a licensing agreement with the Orion Corporation (Orion). Integrated Hospital Care Zortress/Certican (everolimus) is an oral inhibitor of the mTOR pathway, indicated for certain transplant indications. Under the trade name Certican, it is approved in approximately 90 countries to prevent organ rejection for renal and heart transplant patients, and in addition, is approved in the EU, Chile, the Philippines, and Argentina to prevent organ rejection for liver transplant patients. In the U.S., under the trade name Zortress, the drug is approved for the prophylaxis of organ rejection in adult patients at low-moderate immunologic risk receiving a kidney transplant. Everolimus is also available from the company in different dosage strengths and for different uses in non-transplant patient populations under the brand names, Afinitor and Votubia. It is also licensed to Abbott and sublicensed to Boston Scientific for use in drug-eluting stents. Ilaris (canakinumab) is a human monoclonal antibody that binds and neutralizes interleukin-1b (IL-1b), a pro-inflammatory cytokine. Ilaris has been approved in approximately 60 countries for the treatment of children and adults suffering from cryopyrin associated periodic syndrome, a group of rare disorders characterized by chronic recurrent fever, urticaria, occasional arthritis, deafness, and life threatening amyloidosis. In January 2013, the Committee for Medicinal Products for Human Use issued an opinion supporting the approval in the EU of Ilaris for the treatment of acute gouty arthritis (GA) in patients who cannot be managed with standard of care. Neoral (cyclosporine, USP Modified) is an immunosuppressant to prevent organ rejection following a kidney, liver, or heart transplant. Neoral is also approved for use in lung transplant in various countries outside of the U.S. This micro-emulsion formulation of cyclosporine is also indicated for treating selected autoimmune disorders, such as psoriasis and rheumatoid arthritis. Myfortic (enteric-coated formulation of mycophenolate sodium) is approved in approximately 90 countries for the prevention of acute rejection of kidney allografts, and is indicated in combination with cyclosporine and corticosteroids. Critical Care Xolair (omalizumab) is the humanized monoclonal antibody approved for the treatment of moderate to severe persistent allergic asthma in the U.S. in adolescents (aged 12 and above) and adults. It is approved for severe persistent allergic asthma in the EU in children (aged six and above), adolescents, and adults. Xolair is approved in approximately 90 countries, including the U.S. and the EU. A liquid formulation of Xolair in pre-filled syringes has been launched in various European countries. The company co-promotes Xolair with Genentech/Roche in the U.S. The company records all sales of Xolair outside the U.S. TOBI Podhaler (tobramycin inhalation powder) is an inhaled dry powder formulation of the antibiotic tobramycin, delivered using a device that reduces administration time by 72% relative to TOBI (tobramycin nebulizer solution). TOBI Podhaler is available in various European countries, as well as in Canada and some Latin American countries. It is indicated for the management of cystic fibrosis patients aged six years and older with Pseudomonas aeruginosa infection in their lungs, whose lung function is within a certain range. Compounds in Development ACZ885 (canakinumab) is filed in the EU and the U.S. for the treatment of acute attacks in GA. AFQ056 (mavoglurant) is a metabotropic glutamate receptor 5 antagonist in Phase III development for the treatment of PD levodopa- induced dyskinesia. AIN457 (secukinumab) is a human monoclonal antibody selectively inhibiting interleukin-17A, a key pro-inflammatory cytokine. Proof-of-concept and Phase II studies in moderate-to-severe plaque psoriasis and arthritic conditions (psoriatic arthritis, ankylosing spondylitis, and rheumatoid arthritis) have suggested that AIN45