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