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Posted on December 11th, 2008

PROjEN’s Project management key to GSK’s Drug Approval

PROjEN, the award winning Project Management Company based in Cheshire are pleased to announce that the project management work that they have carried out at GSK’s Tonbridge site has helped enable GlaxoSmithKline in getting the new product “ PROMACTA ® (eltrombopag)” approved by the FDA.

GSK have announced that the United States Food and Drug Administration (FDA) granted accelerated approval for PROMACTA ® (eltrombopag) for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP) who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy. – or in layman’s terms – patients whose blood does not clot and an accidental bump or bruise may lead to bleeding.

PROjEN project managed the replacement of an existing filter drier which had become inappropriate for continued used within the pilot plant. The enabling scope of the project covered the de-commissioning of the existing plant, equipment and services. The project specified, installed, commissioned and validated a new Charles Thompson Filter Dryer and all associated services to a successful completion. The quality of the installation enabled GSK to put the Filter Dryer into immediate beneficial use and embark on an 8 month campaign. At a total project cost of £1.5million the new filter drier has been used in continuous production of PROMACTA ® (eltrombopag) and has been an integral part in the drugs successful approval.

Speaking today, John Taylor, PROjEN’s MD said “Sometimes we forget the big picture and the impact that our “day job” has on a wider audience. I am very proud to see that PROjEN’s project management expertise used in the replacement of the filter drier has gone some way to improving the lives of patients who suffer from ITP by way of producing the PROMACTA ® (eltrombopag) drug. We have been assisting GSK with project delivery for some 5 years, particularly through the successful design and installation of pilot plant equipment. We hope to be involved with many more success stories for GSK in the years to come.”

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