Here's the PRNewswire report on the GLFD deal:
Amgen Acquires Rights From Guilford Pharmaceuticals
For Breakthrough Neurotrophic Agents
PR Newswire - August 21, 1997 08:49
GLFD AMGN %MTC %JVN V%PRN P%PRN
Jump to first matched term
/REPEATING DUE TO GARBLE/
BALTIMORE, Md. and THOUSAND OAKS, Calif., August 21 /PRNewswire/ --
Guilford Pharmaceuticals Inc. (Nasdaq: GLFD) and Amgen (Nasdaq: AMGN) today
announced that they have entered into an agreement granting Amgen worldwide
rights for Guilford's FKBP-neuroimmunophilin ligands, a novel class of small
molecule neurotrophic agents that may represent a new approach in the
treatment of neurodegenerative disorders.
Neuroimmunophilin ligands are a novel class of small molecule orally
active neurotrophic agents, which are being developed to promote nerve
regeneration and repair in neurodegenerative disorders.
Under the terms of the agreement, Amgen will receive worldwide rights to
FKBP-neuroimmunophilin compounds for all human therapeutic and diagnostic
applications. Amgen will conduct and pay for all clinical development and
manufacturing of products, and will market products worldwide.
Under the terms of the agreement, Amgen will pay Guilford in several
phases. Guilford will receive a total of $35 million in rights payments upon
closing, in the form of a $15 million cash signing payment, $15 million for
purchase of Guilford equity, plus a $5 million purchase of 700,000 warrants
exercisable at 150% of the purchase price.
Amgen will also provide $13.5 million over three years to support research
activities at Guilford on the neuroimmunophilin program. The agreement
contemplates milestone payments for up to in ten specified indications, seven
neurological (Parkinson's Disease; Alzheimer's Disease; Stroke; Peripheral
Neuropathies; Traumatic Brain Injuries; Traumatic Spinal Cord Injuries; and
Multiple Sclerosis), and three non-neurological indications. Guilford would
receive development milestone payments for each indication and could receive
up to $392 million in milestone payments if all ten indications are
successfully developed to approval.
Guilford will also receive royalties on product sales. Guilford also has
the option in the future to conduct Phase I and Phase II clinical development
of one product in one indication, and to co-promote one product in the U.S.,
for which certain costs would be paid by Amgen. If Amgen elects to exercise
its warrants this would represent an additional equity investment of
approximately $25 million in Guilford.
"We are extremely pleased and enthusiastic to collaborate with Guilford on
the development and commercialization of this important class of potential
neurological medicines," Said Gordon Binder, Amgen's Chairman and Chief
Executive Officer. "The science supporting Guilford's work holds the promise
of yielding breakthrough treatments for a variety of neurological disorders
and complements Amgen's expertise and commitment to neuroscience and small
molecule drug research and development programs," he said.
"This is another major milestone for Guilford. Amgen is a leader in the
development of innovative therapies for neurological disorders. We believe
that our neuroimmunophilin ligands could potentially be one of the most
important new developments in the treatment of neurodegenerative disorders in
many years. If we are able to substantially slow the rate of or reverse the
progression of neurodegenerative disorders in patients, this would represent a
major breakthrough in the treatment of these serious diseases", commented Dr.
Craig R. Smith, President and Chief Executive Officer of Guilford.
"We received a great deal of interest from many companies for our
neuroimmunophilin program. We chose Amgen because we were impressed with their
commitment to the area, and their demonstrated capability in pre-clinical and
clinical development. We appreciate being able to work with such an
outstanding partner in the development of innovative neurological products,"
continued Dr. Smith.
Amgen is a global biotechnology company that discovers, develops,
manufactures and markets human therapeutics based on advances in cellular and
molecular biology.
Guilford Pharmaceuticals Inc. is a biopharmaceutical company engaged in
the development of polymer-based therapeutics for cancer, and novel products
for the diagnosis and treatment of neurological diseases, including
Parkinson's disease, Alzheimer's disease, stroke, severe head trauma, spinal
cord injuries, multiple sclerosis, peripheral neuropathies, and cocaine
addiction.
This press release contains forward-looking statements that involve risk
and uncertainties, including those described in the section entitled "Risk
Factors" from Guilford Pharmaceuticals registration statement on Form S-3,
declared effective April 7, 1997, that could cause the Company's actual
results and experience to differ materially from anticipated results and
expectations expressed in these forward-looking statements. Among other
things, there can be no assurance that any of the compounds which are the
subject of this collaboration will earn milestone payments or that such
compounds can be successfully developed into safe and effective FDA-approved
drugs, and consummation of this transaction is subject to compliance with
Hart-Scott-Rodino requirements.
Background Information - Neuroimmunophilin Ligands
August 21, 1997
Guilford Pharmaceuticals, Inc. discovered a novel class of compounds, the
neuroimmunophilin ligands, that may be capable of regenerating nerves damaged
by injury and neurodegenerative diseases such as Alzheimer's Disease and
Parkinson's Disease. These neuroimmunophilin ligands consist of small organic
molecules which have activity that is comparable or superior to NGF, BDNF, and
other protein neurotrophic factors, but are active following oral
administration.
Neuroimmunophilin ligands appear to have several advantages over previous
nerve-regeneration compounds. NGF, BDNF and other neurotrophic factors are
proteins, very large molecules that cannot pass into the brain. They cannot be
taken orally as a pill, and therefore must be administered by injection
directly into the brain. Guilford's small molecule neuroimmunophilin ligands
can be administered orally and are capable of going from the bloodstream into
the brain. Their mechanism of action appears to specifically target damaged
nerve cells while leaving healthy cells alone, making it likely that these new
compounds should have fewer side effects than earlier generations of drugs.
Immunosuppressive drugs such as cyclosporin A and FK-506 are known to bind
to intracellular proteins called immunophilins. Starting in 1990, scientists
at Guilford and Johns Hopkins University, under Dr. Solomon Snyder, Director
of the Department of Neuroscience, made the seminal discovery that
immunophilin binding proteins are enriched at up to 50-fold higher
concentrations in the brain than in immune tissue. In addition, it was
discovered that drugs that bind to immunophilin binding proteins, such as FK-
506 and cyclosporin A, widely used immune suppressive drugs used by organ
transplant recipients, can produce nerve growth in vitro (in test tube
experiments) and in vivo (in animal experiments) (i.e. they are neurotrophic).
Guilford scientists, utilizing state-of-the-art structure-based drug design
techniques, synthesized a series of novel small molecule neuroimmunophilin
ligands which possess the neurotrophic activity of FK-506, but are devoid of
the undesired immunosuppressive activity of FK-506.
Parkinson's Disease Experimental Models
Some of Guilford's work in this area was published earlier this year
(Proceedings of the National Academy of Sciences, Volume 94 pp. 2019-2024,
March 1997; Nature Medicine, Volume 3, Number 4 pp. 421-428, April 1997),
presentations at the American Academy of Neurology and American Chemical
Society meetings in April 1997, and other scientific abstract presentations in
1995. These studies showed that one of Guilford' s novel compounds, GPI-1046,
promoted both morphologic and functional recovery in animal models of both
peripheral nerve injury and Parkinson's disease. The studies showed that in a
mouse model of Parkinson's disease, GPI-1046 showed potent neuroprotective and
regenerative effects on the nigral-striatal dopamine system, an area of the
brain damaged in Parkinson's disease.
In these studies, the neurotoxin MPTP was administered to severely damage
nigral-striatal dopamine neurons and mimic the damage caused by Parkinson's
disease, simultaneously with GPI-1046. Compared with the MPTP/control group,
GPI-1046 protected more than 80% of the nigral-striatal dopamine neurons.
The studies went one step further in an attempt to more accurately model
human Parkinson's disease by administering GPI-1046 after damage of the
nigral-striatal dopamine neurons had taken place. This "modeling" was
accomplished by administering two different neurotoxins, either MPTP or 6-
hydroxydopamine. In these experiments, GPI-1046 was administered up to one
month after striatal dopamine neurons were destroyed by the neurotoxin. GPI-
1046 significantly increased the number of functional dopamine terminals in
the striatum at doses a low as 4 mg/kg. Administration of GPI-1046 was also
shown to significantly improve both neuronal dopamine levels and turnover,
indicating physiological recovery. Furthermore, administration of GPI-1046 was
also shown to significantly improve functional behavior in the rats, as
measured by apomorphine or amphetamine induced rotational behavior.
Guilford has conducted studies which have looked at other neurological
models in addition to Parkinson's Disease, and found protective and
regenerative effects using GPI-1046. In animals whose sciatic nerves were
crushed, GPI-1046 accelerated functional recovery of the damaged nerves. The
compound was able to regenerate the myelin sheath over the nerves, a
characteristic critical to nerve re-growth, and functional recovery.
Potent Neurotrophic Effects
Very low doses of these neuroimmunophilin ligands have been shown to
markedly stimulate nerve growth, repair, and re-myelination in a wide variety
of cell culture and animal models. The compounds have been shown to be both
orally and systemically active and to cross the blood brain barrier. Guilford
has made major breakthroughs in chemistry, and has successfully synthesized
small molecule neurotrophic factors with low picomolar or even femtomolar
potency (GPI-1046 in vitro ED50=53 pM; GPI-1216 in vitro ED50 = 0.25 pM).
Potential Clinical and Commercial Applications
The neuroimmunophilin program is conducting research to explore the
potential utility of these compounds in a number of potential applications of
serious and life-threatening neurodegenerative disorders:
. Alzheimer's Disease
. Parkinson's Disease
. Multiple sclerosis
. Peripheral neuropathies -- i.e. diabetic neuropathy; cancer
chemotherapy induced neuropathy, hereditary sensory and motor
neuropathies; motor neuron disorders such as ALS
. Traumatic head injuries
. Traumatic spinal cord injuries
. Stroke - aiding recovery following stroke or other cerebral ischemic
events.
There are also several non-neurological potential applications which are
being studied with the neuroimmunophilin ligands.
Guilford has filed over 20 composition of matter and use patents covering
five distinct chemical structural series of novel neuroimmunophilin compounds.
One patent has been issued in the U.S., and several others published in
Europe. Several extremely potent series of compounds have been identified,
including GPI-1234, GPI-1305, GPI-1308, GPI-1312, GPI-1216, GPI-1152, and
GPI-
1046, which are under pre-clinical development.
SOURCE Guilford Pharmaceuticals, Inc.
CONTACT: Angela Webber of Guilford, 410-631-6449, Brad Miles (media), or
Jonathan Fassberg (investor) of BMC/The Trout Group, 212-477-9007; or Denise
Powell (investor/media), 805-447-4346, David Kaye (media), 805-47-6692, or
Jeanne Flynn, Pharm. D. (patients) 805-447-3390, all of Amgen
In DCTH009, Amgen Acquires Rights From Guilford Pharmaceuticals For
Breakthrough Neurotrophic Agents, moved earlier today, the phone number listed
for David Kaye in the contact should read "805-447-6692" rather than the
incomplete number listed incorrectly by PR Newswire.
PRNewswire -- Aug. 21 |
