Exhibit 99(b)
FOR IMMEDIATE RELEASE
REGENERON ANNOUNCES CLINICAL, SCIENTIFIC, FINANCIAL PLANS FOR THE FUTURE
Focus on Current Clinical Trials, Rich Pipeline,
Over $95 Million in Cash
TARRYTOWN, New York (January 14, 1997) -- P. Roy Vagelos, M.D.,
Chairman of the Board of Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN), in
remarks to the investment community focusing on the five current and planned
clinical trials of Regeneron products, its rich preclinical pipeline, and the
financial soundness of the Company, described his vision of Regeneron's future.
Dr. Vagelos also discussed the recent announcement that a Phase 3 clinical
trial of subcutaneous delivery of brain-derived neurotrophic factor (BDNF) for
the treatment of amyotrophic lateral sclerosis (ALS, commonly known as Lou
Gehrig's disease) failed to achieve its primary endpoints.
The failure of BDNF is "obviously disappointing" not only to the
Company, said Dr. Vagelos, but to the ALS patients and their families, to the
clinicians who conducted the study, and to Amgen Inc., which sponsored the
trial on behalf of Amgen-Regeneron Partners, a partnership equally owned by
Amgen and Regeneron. The clinical trial data were not described, but will be
presented at an appropriate scientific forum after the investigators and Amgen
and Regeneron have completed their review and analysis.
The Phase 3 BDNF trial was initiated based on data from a Phase 2
trial and preclinical data. These data were not a "sure thing," Dr. Vagelos
observed, but in light of the desperate nature of the disease and the
information then available, "we continue to believe that the decision to move
forward into the Phase 3 study was correct."
"On the other hand," said Dr. Vagelos, "because of the risks of the
trial, Regeneron adopted a four-part plan to sustain the Company and advance
its other clinical and preclinical programs even if the study did fail." The
plan was:
o Bring to the clinic BDNF, neurotrophin-3 (NT-3), and other
neurotrophic factors for a variety of conditions of reasonable
market size that were supported by preclinical findings;
o Encourage Regeneron scientists to apply their technological
expertise to areas beyond neurotrophic factors;
o Expand vigorously discovery and development programs aimed at
small molecule, orally active drugs; and
o Build financial resources that could fund the Company's operations
for two to three years.
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Dr. Vagelos described the Company's current neurotrophic factor
clinical program as including three BDNF trials and two trials of NT-3. BDNF is
being tested by Amgen on behalf of Amgen-Regeneron Partners as a treatment for
ALS, delivered intrathecally (directly into the spinal fluid), a route of
delivery that may yield better results than subcutaneous delivery. Amgen is
also testing BDNF in early stage, small European trials on Guillain Barre
syndrome and diabetic neuropathy. Both these conditions involve peripheral
neurons, which may allow for successful treatment via subcutaneous delivery.
Amgen is conducting an early-stage NT-3 trial in diabetic neuropathy on behalf
of Amgen-Regeneron Partners and plans to start a trial in chemotherapy-induced
neuropathy during the first half of 1997. The Company anticipates announcing
preliminary results of the NT-3 diabetic neuropathy study later in 1997.
In addition, Dr. Vagelos said, Regeneron is developing its second
generation neurotrophic factor AXOKINE(R) for Huntington's disease and
retinitis pigmentosa. A chemical lesion in animals similar to that found in
Huntington's disease patients provides a model of the disease; AXOKINE has been
shown to prevent the lesion in the model. In collaboration with Medtronic,
Inc., Regeneron hopes to duplicate and extend these results and develop
appropriate delivery systems for AXOKINE to the central nervous system of
humans. In retinitis pigmentosa, animal models that duplicate the human
condition have been developed and, in collaboration with scientists at the
University of California, Regeneron has shown beneficial effects of AXOKINE in
these models. This genetic disease leads to blindness and affects approximately
100,000 people in the United States. "We are working diligently to move AXOKINE
into the clinic for this indication," said Dr. Vagelos, although there are
significant preclinical hurdles that must be cleared before any clinical study
could begin.
"Regeneron's scientists have led Regeneron and the world into several
new preclinical fields," said Dr. Vagelos. Most recently, Dr. George
Yancopoulos (Regeneron's Vice President, Discovery) and his team "broke open"
the family of molecules they dub the Angiopoietins, which Cell, the leading
molecular biology journal recently featured on its cover with three articles
and a review. The Angiopoietins, which were identified and cloned by Regeneron
after a significant international scientific race, may have a number of
therapeutic applications. Said Dr. Vagelos: "We have discovered a family of
Angiopoietins that includes both naturally occurring agonists and at least one
antagonist. Thus, they might be used as agonists to stimulate blood vessel
growth in situations of ischemia, where greater blood vessel flow is needed. As
antagonists, they might inhibit blood vessel growth and thereby potentially
inhibit cancer tumor growth. In addition, the receptors for these ligands are
also found on hematopoietic stem cells, which may imply blood cell
proliferation uses. We have a long (and exciting) way to go before we work out
the biology and possible uses for this family of ligands and receptors."
Regeneron has also been a leader in the understanding of muscle
atrophy, through its discovery of MuSK, a muscle-specific receptor that becomes
widely expressed on the surface of muscle that has been injured or inactivated,
a potentially significant unmet medical need. Dr. Yancopoulos and his team also
identified agrin as the specific ligand for MuSK. Regeneron and The Procter &
Gamble Company have entered into an exclusive worldwide agreement to discover
and develop therapeutics for muscle diseases and disorders. Procter & Gamble
invested $10 million in the Company and will support $3.75 million of annual
research at Regeneron for up to five years.
The third preclinical program Dr. Vagelos described was Regeneron's
cytokine traps, which are based on the Company's expertise in the surface
receptors of cells. These proprietary proteins block the activity of a variety
of cytokines, including IL-1, IL-4, and IL-6. They are very potent and
comprised of human components. While the Company has not decided which trap to
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develop first, Dr. Vagelos described the potential use of an IL-4 trap.
Interleukin-4, or IL-4, is involved in the control or production of the
immunoglobulin IGE that is involved in allergic diseases such as asthma.
Reduction of IL-4 could reduce IGE, which could control the allergic reactions
that lead to asthma attacks. If Regeneron's cytokine traps prove safe and
effective, they could have an important medical role in a number of medical
conditions.
Dr. Vagelos also discussed Noggin, a proprietary protein that recently
has been shown to be a natural antagonist for certain bone morphogenetic
proteins (BMPs). These BMPs initiate bone growth under normal conditions, such
as skeletal growth and repair, but can also contribute to pathologically
abnormal bone growth. For instance, spinal trauma or major burns are sometimes
complicated by inappropriate formation of bone leading to major disability.
Also, in approximately ten percent of hip replacement surgery, abnormal bone
formation is a major complication. BMPs are believed to be involved in such
pathological or abnormal bone formation. "Noggin might prevent such abnormal
bone formation and the attendant morbidity," said Dr. Vagelos.
"We believe that we could have two or three new product candidates in
the clinic by the end of 1998," said Dr. Vagelos.
"Our strategy also includes a focus on the discovery and development
of small molecule, orally active drugs, which can offer medical and patient
advantages over protein therapeutics," said Dr. Vagelos. Regeneron's strategy
is to combine the enormous potential in molecular biology of the Company's
discovery team with the skills of companies having combinatorial chemistry and
high-throughput screening capabilities. Regeneron has two established
relationships with such companies: Glaxo-Wellcome plc and Pharmacopeia, Inc.
During 1996, Dr. Vagelos said, Regeneron worked to secure adequate
financial resources to support the clinical and research pipeline. These
efforts resulted in $68 million of new equity investments from Regeneron's
corporate partners Amgen, Medtronic, and Procter & Gamble. In addition, annual
payments are expected from Procter & Gamble for research support and from Merck
& Co., Inc. for contract manufacturing of an intermediate for an approved Merck
pediatric vaccine. "We anticipate reporting that Regeneron had over $95 million
in cash and cash equivalents at the end of 1996. Based on our current plans and
information, we believe that these funds will enable us to continue operations
for two to three years. We will consider other funding opportunities as they
may arise in the future," said Dr. Vagelos.
Dr. Vagelos noted that Regeneron was founded for, and has historically
been dedicated to, the discovery and development of drugs for the treatment of
neurodegenerative disease, peripheral neuropathy, and nerve injury. These
conditions, he said, are among the most intractable in medicine. For the most
part, their mechanisms of action are unknown, and no surrogate markers of
progression or treatment are available to measure the potential impact of
therapeutic agents. On the other hand, preclinical data has accumulated over
the years that indicate that neurotrophic factors could provide treatments for
many of these conditions.
Dr. Vagelos said he had been attracted to join Regeneron, just over
two years ago, by the presence of a group of people that, he believed, included
"among the most talented scientific leaders I have ever encountered in my years
in the pharmaceutical industry," including Leonard S. Schleifer, M.D., Ph.D.,
President and CEO, George D. Yancopoulos, M.D., Ph.D., Vice President,
Discovery, and Ronald M. Lindsay, Ph.D., Vice President, Neurobiology. "The
entire management team is comprised of people I knew I could work with, and
whom I would bet on for success. My experience during the past two years has
reaffirmed that original rationale for my
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becoming Chairman of Regeneron." The Company's progress in the neurotrophic
factor field, in discovering protein-based drug candidates outside of
neurology, in entering into significant new collaborations, and in achieving
financial stability provide the foundation for an exciting and productive
future, he concluded.
Regeneron is a leader in the application of molecular and cell biology
to discover novel potential therapeutics for human medical conditions. The
Company is applying its technological expertise in protein growth factors,
their receptors, and their mechanisms of action to the discovery and
development of neurotrophic factors for the potential treatment of
neurodegenerative diseases, peripheral neuropathies, and nerve injury. More
recently, Regeneron has used its technological expertise to attempt to identify
treatments for diseases outside of the nervous system, such as inflammatory and
muscle diseases, angiogenesis, hematopoiesis, and cancer.
This news release discusses historical information and includes
forward looking statements about Regeneron's products, programs, finances, and
business, all of which involve a number of risks and uncertainties, such as
risks associated with preclinical and clinical development of drugs and
biologics, determinations by regulatory and administrative governmental
authorities, competitive factors, technological developments, the availability
and cost of capital, the costs of developing, producing, and selling products,
and other material risks. A more complete description of these risks can be
found in Regeneron's Form 10-K for the year ended December 31, 1995 and current
Form 10-Q, copies of which should be read before making any investment decision
regarding Regeneron common stock.
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Contacts: Murray A. Goldberg, Vice President Finance and Administration and CFO
Regeneron Pharmaceuticals, Inc.
(914) 345-7492
Michael Gross, Partner
Robinson Lerer & Montgomery
(212) 484-7721
Regeneron's recent news releases can be obtained by dialing (800) 311-0841 for
fax copies or by accessing the Internet at www.businesswire.com
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