Following Complete Review of Phase 2 Trial Data Amgen Confirms Decision to Halt GDNF Study; Comprehensive Review of Scientific Findings, Patient Safety, Drove Decision
Company Confirms Commitment to Parkinson's Disease Research
THOUSAND OAKS, Calif., Feb 11, 2005 (BUSINESS WIRE) -- Citing patient safety concerns and scientific findings, Amgen Inc.
(Nasdaq:AMGN) announced today that it has confirmed its previous
decision to halt clinical trials of the experimental drug GDNF
(Glial-cell-lined-derived neurotrophic factor). Amgen halted studies
of GDNF when scientific results indicated that allowing patients to
continue treatment could potentially cause permanent harm,
complicating an already devastating disease.
As part of that decision, and based on thorough scientific review,
Amgen has also concluded that it will not provide GDNF to the 48
patients who participated in clinical trials that were terminated in
the fall of 2004.
"We've looked at this decision from every perspective --
scientific, medical and ethical. Our hearts truly go out to trial
patients and their families, but we simply cannot allow trials to
continue given the potential safety risks and the absence of proven
benefit. Encouraging patients to continue in the GDNF study deters
them from pursuing potentially helpful Parkinson's disease therapies
that are already approved and available," said Kevin Sharer, Amgen's
chairman and chief executive officer. "Our desire is to actively
pursue GDNF in a meaningful way that may benefit all Parkinson's
"We are deeply disappointed in the outcome of the trial and have
enormous respect for the trial patients who struggle courageously to
deal with the terrible effects of the disease," stated Roger M.
Perlmutter, executive vice president, Research and Development, Amgen.
"After careful review, we stand behind our decision to stop providing
GDNF to patients due to potential safety risks observed in preclinical
studies, including irreversible brain damage, and the absence of any
demonstrated medical benefit. We adhered to the same high standards of
practice we apply to all our clinical trials in making this decision."
"A team of Amgen researchers, clinicians and executives spent
several months reviewing the company's initial decision to halt GDNF
clinical trials. After exhaustive deliberation and input from trial
investigators, patients, the FDA and consulting experts and ethicists
we confirmed our decision to halt the GDNF study," added Sharer.
Amgen has actively studied Parkinson's disease therapies for more
than a decade and will continue to support GDNF and the Parkinson's
disease community by continuing to conduct additional research to
better understand the potential of GDNF in the treatment of this
Discussions have been initiated with patient advocacy groups and
research funding agencies to make Amgen's GDNF and other proprietary
GDNF-related materials available to qualified pre-clinical
researchers. Additionally, Amgen will pursue publication of both the
Phase 2 study and toxicology data to further scientific understanding.
Amgen will also expand the toxicology studies and work on discoveries
to improve delivery of the drug.
Amgen is a global biotechnology company that discovers, develops,
manufactures and markets important human therapeutics based on
advances in cellular and molecular biology.
SOURCE: Amgen Inc.
Amgen, Thousand Oaks
Andrea Rothschild, 805-447-4587 (media)
Arvind Sood, 805-447-1060 (investors)