Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, is committed to doing everything possible to assist Gaucher patients and their physicians during the imiglucerase supply shortage. Shire is pleased to be able to provide velaglucerase alfa well over a year ahead of previously anticipated commercial launch world wide.
In the U.S., the velaglucerase alfa treatment protocol is currently open and enrolling patients. In the EU and other regions, Shire is engaging with national and regional authorities to seek pre-approval access using the fastest mechanisms available in each region. Shire will manage, on an ongoing basis, the overall global supply of velaglucerase alfa based on the evolving need as communicated to us by physicians.
Shire has accelerated its manufacturing timeline by almost 18 months in order to provide velaglucerase alfa for the long-term treatment of Gaucher patients during 2009 and beyond. Shire currently has supply of velaglucerase alfa for several hundred patients world-wide. The total number of patients Shire can treat is dependent on the patient weight, as well as the administered dose as recommended by their treating physician; Shire estimates this could translate into a range of 300 to 600 patients for uninterrupted treatment starting in September 2009. Shire also expects that several hundred more patients can be added throughout 2010; the range will again depend on patient weight, and doses.
Shire is working with a global group of experienced Gaucher physicians to ensure that physicians put in place guidelines that consider patients in the greatest need of treatment during the supply crisis. Individual treatment decisions will remain with the patient's physician.
In addition, Shire is working with regulatory authorities towards the approval of velaglucerase alfa and has announced, earlier last week, that based on the positive results from all phase 3 trials, it has submitted the New Drug Application to the U.S. Food & Drug Administration and is expected to submit the EU application by year end.