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TECH
The Eyes
Have It
Ophthalmic
pharmaceutical
company Santen Inc.
sees a bright future in
Napa.
By Ellen Jakes Kelm
Imagine that you are an international
pharmaceutical company looking to
widen your global reach by opening a
new office somewhere in the United
States. Where would you choose: New
York? Boston? Chicago? San
Francisco? The Japanese corporation
Santen Pharmaceutical Company, Ltd.
made a wiser choice: Napa.
Call the choice divinely inspired if you like (in Japanese,
“santen” means “to act with the sanction of heaven”), but
regardless of its inspiration, it’s been a good fit for both the
company and the town. Santen Inc., the American subsidiary
of Santen Ltd., celebrated its 10th anniversary in Napa last year.
A venerable firm on the cutting edge
A
ILLUSTRATIONS BY ANA DURAN
Reprint from July 2004
lthough Santen is over one hundred years old, most
Americans have never heard of it. Founded in 1890
in Osaka, Japan, Santen is the oldest prescription
ophthalmic company in the world. Evolving
throughout the last century, the company focuses
on the development of ophthalmic pharmaceuticals and
medical equipment under the leadership of CEO Takakazu
Morita. Santen holds the top market share within the Japanese
market for ophthalmic pharmaceuticals. Other business
segments include anti-rheumatic pharmaceuticals, over-thecounter pharmaceuticals and ophthalmic medical devices. Net
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worldwide sales for FY2003 totaled $750.9 million, with year-end total assets
of more than $1.2 billion.
Dr. Adrienne Graves is president and CEO of the Napa subsidiary. Graves
joined the company in 1995 and was appointed to her present position in
2002. She brought over 25 years of experience in ophthalmic product
development and clinical research to the job. Under her leadership, Santen
Inc. has built a global clinical team that successfully tracked three products
through FDA approval and created a pipeline of ophthalmic products
representing major therapeutic categories.
Santen Inc. focuses primarily on ophthalmic pharmaceuticals, launching its
first products on the U.S. market in 2000, seven years after they first set up
shop in Napa. Seven years may seem like a long time between set-up and
market, but it represents a relatively quick lift-off in the pharmaceutical world.
Pharmaceutical research and development and the hoop-jumping required for
FDA approval are both exacting and time-consuming processes. “We’ve done
a great job of getting products on the market very quickly. It’s a great track
record, and we are very proud of it,” says Graves.
Santen’s brands in the U.S. are QUIXIN® (levofloxacin ophthalmic
solution) 0.5%, an anti-infective used for the treatment of bacterial
conjunctivitus (commonly known as “pink-eye”); IQUIX® (levofloxacin
ophthalmic solution) 1.5%, (same active ingredient as QUIXIN® with a
higher concentration); BETIMOL® (timolol ophthalmic solution) 0.25% and
0.5%, for the treatment of glaucoma; and ALAMAST® (pemirolast potassium
ophthalmic solution) 0.1%, a treatment for allergic conjunctivitis—the red,
swollen, watery eyes caused by allergies. All four brands were developed at
the Napa facility, but the drugs are actually manufactured by another Santen
subsidiary in Finland. Santen Inc. in Napa has a continuing responsibility for
clinical and regulatory activities associated with all four products.
“We’re fairly new to the U.S. ophthalmic pharmaceutical market and
smaller than most of the other U.S. companies. In a lot of ways, it is a huge
advantage. We’re not tied into the multiple levels of bureaucracy. Although
we are a relatively young player here, we have made an enormous impact
with three FDA approvals so far. The U.S. ophthalmic pharmaceutical market
is one of the largest in the world. We are committed to growing our presence
here,” says Graves.
An aggressive commitment to research and development
anten Inc. is located in the Napa Valley Gateway industrial park
within easy reach of universities and research facilities in the Bay Area
as well as Silicon Valley. The facility focuses on research and
development (R&D) as well as registration of new products. It works
very closely with Santen’s R&D team in Japan as well as the
manufacturing operations in Finland to develop products for global use.
“Santen’s objectives are global,” says Graves. “Our interaction with Japan,
Finland and other colleagues is based on helping us all meet our global
objectives: development of outstanding ophthalmic pharmaceutical products
that we manufacture and make available to our global markets.”
Santen has 2,500 employees worldwide; one hundred employees work at
Santen Inc. in Napa. The company’s research and development, regulatory,
clinical, strategic marketing, business development and executive staffs are all
based in Napa. Each member of the senior management team has 20 years of
industry experience in the ophthalmic field. “We have a great, experienced
staff with an entrepreneurial spirit. Many people were attracted to the
atmosphere because we are small and we were just starting out. You can see
concrete results from your own work. It’s very exciting to people to see their
product on the market and on a shelf,” says Graves. “We’ve just added a new
vice president of regulatory affairs, Mark Mannebach, who brings more than
20 years of ‘big pharma’ experience to our efforts. Mark reports directly to Jeff
Wells, our vice president of R&D. We also are in the process of hiring a VP of
strategic marketing and business development to further our new business
development focus.”
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Reprint from July 2004
What is Conjunctivitis (Pink eye)?
Conjunctivitis, also known as pink eye, is an infection of the outer
layer of the eye—the conjunctiva. Symptoms include:
• Red, watery eyes
• Inflamed inner eyelids
• A scratchy feeling to the eyes
• Watery discharge
• Sensitivity to light
• Swelling of the eyelid
Conjunctivitis can be caused by allergens, viruses or bacteria.
Bacterial conjunctivitis is very contagious and can be easily passed
from hands to eyes, particularly among children. Viral conjunctivitis
can occur with colds, sore throats or flu. Allergic conjunctivitis is a
reaction to allergens such as pollen, dust mites or cosmetics.
Bacterial conjunctivitis can be treated with antibiotic eye drops or
ointment. Symptoms generally clear within a few days; if not, an oral
antibiotic may be prescribed. Viral conjunctivitis usually runs its
course in one to two weeks. It does not respond to antibiotics,
though artificial tears may help relieve symptoms. Allergic
conjunctivitis can be treated with antihistamine or steroid eye drops.
How can you tell if your red, itchy eyes are caused by an allergy,
bacteria or a virus? In allergic conjunctivitis, the discharge from the
eye is clear and sometimes stringy or ropey. Watery, globular
discharge may be either allergic or viral while a mucusy, yellow or
pus-filled discharge points to a bacterial infection.
Don’t self-diagnose, however. Eyesight is precious; for any eye
problem, see your eye doctor.
Source: St.Lukes Eye.com
Reprint from July 2004
An eye on the future
A
s America ages, pushing the incidence of age-related
ocular diseases to new highs, the U.S. market for
prescription ophthalmic drugs is expected to boom. By
the year 2030, there’ll be a two-fold increase in the
number of people over 65. The number of Americans
with age-related eye disease and vision impairment is expected to
double as well.
“The key areas of growth are all age-related,” observes Graves.
“This is a major reason ophthalmics is a very hot market right now.
This is why companies like Johnson & Johnson and Pfizer are
moving into the arena.”
Santen Inc. is aggressively addressing these trends, and has
pharmaceutical applications and studies underway that will expand
its U.S. position in the treatment of infection, allergy, glaucoma and
treatment for dry eye. Several additional products will be advancing
through the pipeline over the next three to five years. “Santen is
actively involved with key ophthalmic organizations and opinion
leaders in the U.S. and throughout the world,” says Graves. “The
products we develop are strongly tied to the current and anticipated
physician and patient needs.
“Dry eye is extremely debilitating for people who suffer from it,
and it is definitely age-related. There are currently no adequate
therapies in this area, and it is a wide open area. In the field of
retinal disorders, there are virtually no effective treatments, and it is
also a wide open market. Retina problems are associated with
diabetes, and the diabetes situation in the U.S. is growing at a truly
alarming rate. Glaucoma is also age-related. None of the drugs
currently available addresses the causes, only the symptoms. There
are many unmet needs which is why ‘big pharma’ is moving into the
arena. The ophthalmic market is growing in the double digits every
year.”
The industry is expected to experience a spate of new products
and heavy competition as the U.S. prescription ophthalmic drug
Dr. Adrienne Graves is president and C.E.O.
of Santen Inc.
PHOTOGRAPH COURTESY OF SANTEN INC.
R&D is an essential part of all pharmaceutical companies; it’s the
main focus at Santen’s Napa facility. “Santen is strongly focused on
R&D, both in the U.S. and in Japan. Our R&D teams regularly work
with colleagues at our Nara Research Center in Japan, one of the
leading-edge, state-of-the-art ophthalmic research centers in the
world,” says Graves. “Both facilities identify and obtain new
compounds to be developed into new ophthalmic pharmaceutical
products. We have clinical trials taking place all over the country.”
Santen has recently turned over the sales, marketing and
distribution of its products to VISTAKON® Pharmaceuticals, LLC.,
owned by Johnson & Johnson. At present, Johnson & Johnson is
the world’s most comprehensive and broadly based manufacturer of
health-care products, pharmaceutical and medical devices, as well as
a provider of related services for the consumer and the diagnostic
markets. VISTAKON, a division of Johnson & Johnson Vision Care,
Inc., produces and markets the world-leading Acuvue® brand
contact lenses.
Graves says the choice to outsource sales and marketing was a
wise strategic choice. “We were competing with sales forces up to
five times ours, with greater resources and greater diversity in
specialties. Pediatrics is an example of a market we couldn’t reach.
For instance, when a child develops pink eye, a parent consults a
pediatrician. We needed to be able to market directly to those
physicians,” explains Graves.
“The recent decision to form a sales and marketing alliance with
VISTAKON allows us to focus on our core competencies—making
new drugs, and it allows us to go forward. We have produced
excellent products, but we felt we could more aggressively and
expansively market our products through this new channel and,
thus, fully leverage our products’ potential within the U.S. market.”
VISTAKON hired nearly all of Santen’s 60 experienced sales
representatives and managers as part of its division-building efforts.
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market advances. As a relative newcomer to the American
market, Santen Inc. faces competition from companies such as
Allergan, Alcon and Merck. “Santen has often been referred to as
‘David vs. Goliath.’ We obviously have found strong footholds to
compete, particularly in the successful development of three
ophthalmic products in a relatively short timeframe. Santen is
very successfully winning ground with the perceived Goliaths of
the U.S. ophthalmic pharmaceutical industry.”
Graves feels the company’s location in Napa gives it a leg up
on the competition. “We are a good fit with Napa. The Napa
area fosters an entrepreneurial spirit, and it is environmentally
forward and friendly. One of our reasons for choosing to locate
here is that it allows us to attract quality people. The
combination of quality of life and a great place to live make it a
good recruiting tool. Also, it is very easy for us to get key
doctors to come to meetings from all over the world. It is a huge
advantage for us.”
A broader vision
S
anten’s corporate motto “Protecting the joy of sight”
inspires its corporate philanthropy as well as its
business strategy. “Santen is very cause-conscious, both
on a corporate and employee level. We support a
number of ophthalmic causes, like the Prevent
Blindness Foundation, which raises funds and facilitates
pediatric eye screenings in the Bay Area,” says Graves. Santen
has also worked with the Prevent Blindness Foundation to
sponsor Prevent Blindness Day at the San Francisco Giant’s
PacBell Park.
“We also support a number of local causes, with employees
who walk in the Avon Breast Cancer Walk, local foster families
and children, the local Napa fire department and the Napa Valley
Land Trust,” says Graves. “Santen also supports academic and
professional programs through a variety of grants for educational
efforts.
“Currently, Santen is sponsoring Dr. Asa Morton, who
regularly arranges and leads humanitarian surgical missions to
provide much-needed help in Guatemala, Brazil, India, Mexico
and Pakistan. I am thrilled to be accompanying Dr. Morton to
Guatemala with the medical relief effort. The conditions that
exist there wouldn’t even be a problem in the U.S., and we can
make such a significant impact on people’s lives, particularly the
children. What has been really rewarding is the generosity that
has come from our employees. They are very moved and want to
be involved. We offered to match their donations with a
corporate donation, raising an additional $8,000.”
Eyes on the Prize
S
anten’s goal is to become an increasingly stronger player
in the U.S. and global market. “We underwent a
corporate reorganization in 2002, which enabled us to
streamline our focus and strengthen our presence in the
U.S. ophthalmic market. 2003 was our strongest sales
and marketing year,” says Graves. She anticipates an exciting and
challenging future for the company. “We will continue to
leverage our proven R&D strengths and to continue to identify
and develop important ophthalmic pharmaceutical products.
We’re here to improve people’s sight by providing exceptional
products for the physicians and patients around the world who
depend on us. Our new corporate advertising campaign —
‘Seeing Beyond the Ordinary’—really personifies our mission.”
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A Glaucoma Primer
Glaucoma is a group of eye diseases that gradually steals sight without
warning and often without symptoms. Vision loss is caused by damage to the
optic nerve, the nerve that carries the images we see to the brain. The two
main types of glaucoma are open angle glaucoma and angle closure
glaucoma.
Primary Open Angle Glaucoma. This is the most common form of
glaucoma, affecting about three million Americans. It happens when the eyes’
drainage canals become clogged over time. The inner eye pressure (also
called intraocular pressure or IOP) rises because the correct amount of fluid
can’t drain out of the eye. With open angle glaucoma, the entrances to the
drainage canals are clear and should be working correctly. The clogging
problem occurs inside the drainage canals, like the clogging that can occur
inside the pipe below the drain in a sink.
Most people have no symptoms and no early warning signs. This type of
glaucoma develops slowly and sometimes without noticeable sight loss for
many years. If open angle glaucoma is not diagnosed and treated, it can
cause a gradual loss of vision. It usually responds well to medication,
especially if caught early and treated.
Angle Closure Glaucoma. Also known as acute glaucoma or narrow angle
glaucoma, this type of glaucoma is much rarer and is very different from open
angle glaucoma in that the eye pressure usually goes up very fast. This
happens when the drainage canals get blocked or covered over, like the clog
in a sink when something is covering the drain.
With angle closure glaucoma, the iris and cornea are not as wide and open
as they should be. Symptoms may include headaches, eye pain, nausea,
rainbows around lights at night and very blurred vision. Treatment of angle
closure glaucoma usually involves surgery to remove a small portion of the
outer edge of the iris. This helps unblock the drainage canals so that the extra
fluid can drain. Usually surgery is successful and long lasting.
Source: The Glaucoma Research Foundation
Santen Incorporated
555 Gateway Drive
Napa, California 94558
707.254.1750
fax 707.254.3648
www.santeninc.com
3566 Airway Dr.
Santa Rosa, CA 95403
707-575-8282
Fax: 707-546-7368
www.northbaybiz.com
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from July 2004
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Reprint from July 2004