about bpl

Bio Products Laboratory Ltd.

PRESS RELEASE April 2012

Date added: Friday 27th April 2012

Gammaplex has Marketing Authorisation extended with new clinical indications

BPL is delighted to announce that the UK Marketing Authorisation for Gammaplex has been extended to include the following new indications: ITP (Immune thrombocytopenic purpura), GBS (Guillain Barré syndrome), Kawasaki disease and Hypogammaglobulinaemia in patients after allogeneic haematopoietic stem cell transplantation (HSCT).

In a recent, open label, Phase 3, single arm, multicentre study of 29 patients aged 6-69 years with
chronic immune thrombocytopenic purpura, Gammaplex::

  • Raised the platelet count to a threshold of 50 x 109/L or greater in 83% of Patients 1
  • Maintained the platelet count in 66% of patients, at 50 x 109/L or greater for at least 5 days 1
  • Reduced bleeding manifestations after treatment 1

Dr Tim Aldwinckle (Medical Director BPL) commented, “BPL can now offer patients with ITP a licensed treatment option to improve and maintain the platelet count and reduce the bleeding episodes. Regulatory acceptance of these results as a model for Guillain Barré syndrome and Kawasaki disease allows additional patients to benefit from this product'”

References:

  1. Bio Products Laboratory. Gammaplex Clinical Study Report, March 2011.

Note to Editors

  1. Bio Products Laboratory Limited (BPL) is committed to provide a continuous supply of safe, reliable, high quality plasma-derived products and forging commercial alliances worldwide
  2. BPL supplies intravenous immuno-globulin (IVIG) Factor VIII and Factor VIII and Albumin products to the NHS and over 45 countries worldwide.

For more information contact:
Jackie Lawton
Bio Products Laboratory Limited
Contact number: 07881 920408
Code UK/Gx/0212/0015b
Date of preparation March 2012.

For full Press Release and Prescribing Information:

Patient information leaflets