Baxter Home
Conditions Therapies Products Services About Baxter
Training and Education Sustainability Contact Us
 

News Release

BAXTER AND PHARMING START CLINICAL STUDY WITH RECOMBINANT HUMAN C1 INHIBITOR FOR HEREDITARY ANGIOEDEMA

DEERFIELD, Ill., USA, and LEIDEN, the Netherlands, March 9, 2001 - Baxter Healthcare Corporation and Pharming Group N.V. announced the start of a Phase I clinical study with recombinant human C1 inhibitor in asymptomatic patients with hereditary angioedema. This study will be the first clinical study with any form of recombinant human C1 inhibitor. In this study the safety, tolerability, clearance and activity of the product will be investigated.

"We are very excited with the start of this clinical study", said Philippe van Holle, Pharming's executive vice president Biotherapeutics. He continued, "Genetic disorders receive special attention within Pharming. Recombinant human C1 inhibitor has been developed through our breakthrough transgenic technology and we hope it will prove to be a highly effective therapeutic modality in hereditary angioedema. This disorder has a strong impact on quality of life, due to its unpredictable nature, the potential severity of the attacks, which can be life-threatening, and the possible side effects of some currently available therapies."

"Advancing our recombinant human C1 inhibitor into the clinic is an important milestone for people impacted by the rare but serious disease of hereditary angioedema", said Norbert Riedel, Ph.D., president of Baxter BioScience's recombinant business unit. "In addition, it is a key milestone for Baxter as we continue to build an innovative research pipeline to accelerate future business growth. We are particularly excited to be developing a transgenic product that complements our portfolio of plasma-derived and recombinant therapeutic proteins."

Hereditary angioedema is characterized by acute attacks of localized swelling of soft tissues, which can become extremely painful or even life-threatening, depending on the actual location of the attack. The patients enrolled in this trial are asymptomatic, i.e. they are diagnosed with hereditary angioedema, but are at present in a stable condition without active symptoms of the disease. Currently, subsequent clinical studies are being designed, which are aimed at evaluating the efficacy of this novel agent in patients suffering from acute attacks.

Two Orphan Drug designations from the FDA have previously been issued for the application of recombinant human C1 inhibitor in acute treatment and prophylaxis of hereditary angioedema.

Baxter Healthcare Corporation is the U.S. subsidiary of Baxter International Inc. (NYSE:BAX). Baxter's medical products and services include blood therapies, medication delivery and renal therapy, and are used by health-care providers and their patients in more than 100 countries. The Hyland Immuno division of Baxter develops and produces therapeutic proteins from plasma and through recombinant methods to treat Hemophilia, immune deficiencies and other blood-related disorders. Hyland Immuno's portfolio of therapies includes coagulation factors, immune globulins, albumin, wound management products and vaccines.

Pharming Group N.V. (EASDAQ: PHAR / AEX: PHAR) focuses on the development, production and commercialization of human therapeutic proteins to be used in highly innovative therapies. The company's product portfolio is aimed at treatments for genetic disorders, blood-related disorders, infectious and inflammatory diseases, tissue and bone damage, and surgical and traumatic bleeding. Pharming's proprietary technologies include the production of biopharmaceuticals in the milk of transgenic animals, as well as the purification of biopharmaceuticals from milk, formulation and application of these biopharmaceuticals. Pharming has operations in Belgium, Finland, the Netherlands and the USA and currently employs more than 200 people. The manufacturing of recombinant human C1 inhibitor from the milk of transgenic rabbits is based at Pharming's facilities in Geel, Belgium. The human C1 inhibitor project is supported by the Flemish Institute for Industrial Science and Technology.

This press release contains forward-looking statements about potential therapeutic uses and effects of recombinant human C1 Inhibitor for hereditary angioedema. Actual results may differ materially depending on the actual therapeutic effect of recombinant human C1 Inhibitor, the actual timing and results of clinical trials, the actual timing and content of regulatory submissions and decisions of the FDA, the EMEA or any other regulatory authority.

FOR ADDITIONAL INFORMATION:

Media Contacts:
Deborah Spak, Baxter, (847) 948-2349
Tonua Fedusenko, for Pharming,
Vector Communications, (302) 328-3347
 
Investor Contacts:
Neville Jeharajah, Baxter, (847) 948-2875
Mary Kay Ladone, Baxter, (847) 948-3371
Bert Stok, Pharming, 31 (0) 71 5247 432
 

 

 
Copyright & Legal Disclaimer  |  Privacy  |   Print this page