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CHMP adopts positive opinion for Celgene's Otezla as psoriasis, psoriatic arthritis therapy
21 November 2014 - 21 November 2014 - Celgene International Sarl, a wholly owned unit of US Celgene Corp (NASDAQ:CELG), said Friday that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) had adopted a positive opinion for Otezla (apremilast) in two therapeutic indications – for the treatment of psoriasis and as psoriatic arthritis (PsA) therapy.

The first indication of Otezla – as moderate-to-severe chronic plaque psoriasis therapy, concerns adult patients who failed to respond to or, who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen and ultraviolet-A light (PUVA).

The second indication of the drug - alone or in combination with Disease Modifying Antirheumatic Drugs (DMARDs), for the treatment of active PsA concerns adult patients who have had an inadequate response or who have been intolerant to a previous DMARD therapy.

Otezla is Celgene's oral small-molecule selective inhibitor of phosphodiesterase 4 (PDE4) specific for cyclic AMP (cAMP). PDE4 inhibition results in increased intracellular cAMP levels which is considered to indirectly modulate the production of inflammatory mediators.

Tuomo Patsi, president, Celgene Europe, the Middle East and Africa (EMEA), called the CHMP positive opinion a significant step forward for people with psoriasis and PsA in Europe. These immune mediated diseases are often debilitating, causing severe physical and emotional pain to the individual, he explained. Patsi noted that the company has moved a step closer to offering patients Otezla - a new, oral treatment approach which could help control their symptoms and make a substantial difference to their quality of life.

CHMP's positive opinion for Otezla in psoriasis was formed on the basis of the ESTEEM trials, in which treatment resulted in significant and clinically meaningful improvements in plaque psoriasis as measured by PASI-75 (a 75% improvement in the Psoriasis Area Severity Index) scores at week 16 - the primary goal. Furthermore, patients on Otezla also benefited from significant improvements in hard to treat areas, such as nail and scalp, and itch, known to have a marked impact on patients' quality of life and perception of disease severity.

In the PALACE programme, which forms the basis for CHMP's positive opinion for Otezla in PsA, treatment resulted in significant and clinically meaningful improvements in the signs and symptoms of PsA, as measured by the modified ACR-20 (a 20% improvement in the American College of Rheumatology disease activity criteria) response at 16 weeks, the primary goal. Patients treated with Otezla showed improvement across multiple disease manifestations specific to PsA, such as swollen and tender joints, as well as dactylitis, enthesitis and overall physical function.

In both two Phase III programmes - PALACE and ESTEEM, the clinical response of Otezla was maintained through week 52 across multiple endpoints.

Otezla was approved by the US FDA for the treatment of adults with active PsA in March and for the treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy in September. In Canada, the therapy was cleared for the treatment of moderate-to-severe plaque psoriasis in November. A New Drug Submission (NDS) for PsA was filed with the Canadian Health Authorities in the second quarter of 2013. Marketing authorisation applications are ongoing in other countries, among which Australia and Switzerland.

The European Commission, which generally follows the recommendation of the CHMP, is expected to make its final decision within two to three months.
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