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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 NorthBay Biz 1 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.” S 2 NorthBay Biz 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. NorthBay Biz 3 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.” 4 NorthBay Biz 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 —REPRINT— from July 2004 Page 68–73 Reprint from July 2004