HOYA株式会社の取締役候補で、１７才で医学博士を取得した神童であるインド出身の眼科医であるBalamurali K. Ambati博士による、HOYA株式会社の経営陣に対する提案内容です。結論からいえば、加齢黄班変性症の新薬の優良候補を買収等で入手し、世界を席巻する事業戦略を取るべきです。このような世界の市場条件を理解せずに、対応が後手後手に回っている鈴木洋氏は、丹治宏彰氏と指名委員会のメンバーともども、早期に辞任するべきです。平均年齢が７０歳を越えた社外取締役候補はもはや株主の利益にならないのです。眼科ではBalamurali K. Ambati博士（ユタ大学准教授）と、Paul Ashton博士（サイビダ社社長兼最高経営責任者）、材料科学などエレクトロニクス分野ではCardinal Warde博士（MIT電子工学教授）の取締役就任への賛成をぜひともお願いします。
Strategic Vision For Hoya Ophthalmics’ US Market Entry
by Balamurali K. Ambati, MD, PhD, MBA (Associate Professor of Ophthalmology and Visual Sciences & Director of Corneal Research, University of Utah School of Medicine, A Candidate for a Board of Director of HOYA Corporation)
Understanding the Market
Vision loss is a devastating event and a significant risk for the aging. The numbers behind vision loss are staggering. Approximately 1 in 28 Americans over 40 is affected by low vision or blindness. Considering that the >80 cohort is rapidly growing and the coming of age of the baby boomer generation, prevalence of glaucoma and AMD are expected to more than double by 2020. Over 322 million people worldwide have blindness, visual impairment, or low vision, with even more having vision-threatening conditions.
A brief summation:
• US Ophthalmic Pharmaceutical Market 2011: $12B
• Vision Loss is expected to grow 70% by 2020
• Financial Burden of Vision Loss in the US is greater than $35B/yr
• Globally AMD - 30M; Glaucoma - 42M; Diabetic Retinopathy - 20M
Market Size: The total ophthalmic pharmaceutical market was $12 billion in 2007 and is expected to grow 4-11% through 2023. The primary drivers of this market are currently four indications: glaucoma (37.5%); ophthalmic anti-allergy/inflammatory/infective (31.2%); retinal disorder (14.6%), and dry eye (11.5%). The glaucoma and retinal markets are driven by large marketshare, blockbuster drugs; Xalatan/Xalacom $1.6B and Lucentis $1.7B, respectively in 2008. Growth in the retinal disease market is expected to maintain a robust clip between 9-29% through 2013 with glaucoma markets showing limited growth, but remaining the largest market through 2023.
Key Diseases:
AMD, the leading cause of blindness in the US, has 2 principal forms: “wet” or exudative (characterized by angiogenesis or growth of new blood vessels), and “dry” or non-exudative (characterized by geographic atrophy and drusen, and a steady rate of progression to “wet” disease). In the US, there are over 2 million people with advanced AMD (expected to double by 2020). Further, 7.5 million Americans are affected by intermediate AMD and thus at risk for developing advanced AMD. While present anti-angiogenic modalities offer significant benefit to many patients with neovascular AMD, indefinite monthly intravitreal injections are risky, unappealing, and burdensome to patients.
Current FDA-approved therapies include the anti-VEGF aptamer (pegaptanib (Macugen; OSI)) and the anti-VEGF Fab fragment (ranibizumab (Lucentis; Genentech)), and photodynamic therapy. Use of Macugen and photodynamic therapy has been eclipsed by intravitreal injections of Lucentis, as it is the first drug to demonstrate significant visual acuity improvement in patients with neovascular AMD. Lucentis costs approximately $2,500 per injection (prospective annual cost approximating $30,000), thus demonstrating the potential of a large market (Lucentis US sales in 2008 were $875M and $886M for the rest of the world). This has triggered a pipeline of 24 INDs (Investigational New Drugs) with at least 20 drug projects in preclinical stages. While the future space in pharmaceutical management of AMD may become crowded, drug delivery platforms are needed to improve ease of administration, convenience, and patient quality of life, for patients now accept monthly intravitreal injections only because there is no choice. In addition, off-label use of bevacizumab (Avastin® ; Genentech), an anti-VEGF antibody, has become common as it much less expensive, but nonetheless this requires regular intravitreal injections.
Glaucoma is the leading cause of blindness in the African-American community and in much of Africa. It affects 2-3 million Americans. Current therapy revolves around lowering eye pressure using topical eyedrops including latanoprost (Xalatan), brimonidine (Alphagan), timolol (Timoptic), and dorzolamide (Trusopt). Patient understanding of and adherence to complex medical regimens is often poor, resulting in need for costly and high-risk surgical drainage procedures, including trabeculectomy and tube shunt procedures. These have high rates of infection, choroidal hemorrhage, hypotony, and other vision-threatening complications.
Diabetic retinopathy could potentially occur in the 15 million Americans with diabetes as well as the hundreds of millions around the world. Diabetic vision loss (currently afflicting 4 million Americans) is generally due to macular edema (leakage from blood vessels causing swelling in the central retina) or proliferative diabetic retinopathy (growth of new blood vessels causing hemorrhage). The percentage of Americans with diabetic retinopathy is expected to skyrocket over the next 15 years due to aging and increasing obesity.
Market Analysis:
Individuals who live to age 65 have a 45% risk of eventually developing AMD, glaucoma, or diabetic retinopathy (all possible conditions for CDR usage, along with retinal vascular occlusions, uveitis, and other vascular or neurological disorders). As the >80 cohort is rapidly growing, prevalence of glaucoma and AMD are expected to more than double by 2020. Expected 2008 US sales for drugs such as Xalatan (glaucoma) or Lucentis (AMD) exceed $1 billion. The financial burden of vision disorders in the US exceeds $35 billion/yr. With nearly 3 million cataract surgeries performed annually in the US and with over a third of patients over 65 having had cataract surgery (15 million patients; ~25 million eyes), it is reasonable to expect that there would be great demand for products that can be targeted to cataract or post-cataract patients or co-marketed with intraocular lens technology.
The most important driver for growth during this period will be the increasing prevalence of ophthalmic disorders among an expanding older population. The two most rapidly expanding categories will be glaucoma and retinal disorders. The push for new superior technologies is especially evident in the growth of investment seen in the ophthalmic market. Continued increases in new targets and expanded delivery options signal growing interest in ophthalmics, resulting in nearly 40 deals since January 2007, led by Novartis AG’s $10.4 billion purchase of a 25% stake in Alcon Inc., and over $370 million in venture financing. Investors believe the sector is ripe for growth due to an aging population, unmet medical needs and increasing interest from large pharmaceutical companies. The amount of venture capital going into ophthalmic companies rose from $123 million in 2004 to $210 million in 2006. Over the same period, companies with an interest in the eye space raised in excess of $1.5 billion from all capital market sources.
Success in the ophthalmic market during 2008-2023 will be characterized by the launch of products with superior technology, particularly those technologies which increase clinical effectiveness or increase patient compliance. Considerable success is also likely for therapies that meet the large unmet needs.
Recommendations
Hoya’s entry into the US ophthalmology market can achieve its potential for exponential growth by targeting key niches with high margins and scope for expansion. The sectors I would recommend concentrate on would be the following:
(1) Near Term
• Aggressive Rollout of the iSert: A pre-loaded IOL insertion system is a felt need on the part of ophthalmic surgeons and ambulatory surgery centers. With a three-piece acrylic, centration should be excellent, posterior capsule opacification low, and insertion feasible even if placement in the ciliary sulcus is necessary. To compete with Alcon, Hoya will need to develop a far-sighted marketing strategy including the building of a significant sales-force, targeted campaigns to surgeons and facilities, educational events to residency programs & large conferences, and deals on surgical disposal supplies. The iSert itself could further be enhanced for surgical comfort by developing a one handed injector with a spiral stylus and cartridge to enable one-handed delivery with in the bag placement of both haptics & optic.
• Adjustable Intraocular Lens: Calhoun Vision (privately held) has developed a light-adjustable intraocular lens that is in clinical trials. This technology allows refinement using a UV light that modifies the polymers within the lens to desired refractive outcome. Once this is done, a second laser can lock in the refraction. Hoya could explore opportunities to partner (or purchase) Calhoun to develop and market this technology, as well as partner or purchase with an aberrometry company (e.g., the Orange system by Wavetec) to optimize the targeted light adjustment parameters.
• Toric Intraocular Lens: Current toric lenses suffer from either being a single piece silicone design (Staar) or possessing mediocre rotational stability (Alcon). A three-piece acrylic lens would avoid the problems of silicone and likely promote superior rotational stability and thus ease of surgical placement. This would add value to the ophthalmic market.
• Acquisition of Phacoemulsification Capacity: Hoya should explore the opportunity to acquire the cataract surgical business (phacoemulsification machines, surgical packs, instrumentation) of a competitive ophthalmic company (e.g., Abbott Medical Optics, B&L Surgical) to enable synergy in marketing of IOLs with surgical equipment.
• Physician Practice Enhancement: Hoya could partner with practice consultants and management companies to identify and cultivate business opportunities for ophthalmologists in single or group practice. This would dovetail with the rest of Hoya’s ophthalmic program and build brand awareness and goodwill among the ophthalmic community.
(2) Medium Term
• AMD Drug Candidates: Motesanib (a VEGFR/PDGFR inhibitor; Millenium Pharmaceuticals (a Takeda company). CEP-11981 (Cephalon’s VEGF-R/Tie2kinase inhibitor), VEGF-trap (Regeneron) and Macugen microspheres (long-acting pegaptanib; Eyetech) are potential drugs or drug candidates that could find broad application in AMD therapy. These represent promising licensing or partnership opportunities for Hoya
• Development of a Premium Intraocular Lens: The evolution of cataract surgery into a refractive procedure for large numbers of patients with presbyopia and high visual demands is still in its early stages. With the aging of the Baby Boomer population, this market will greatly expand, as this cohort has an affinity for elective medical “enhancement” procedures as well as being large. Hoya has the opportunity to use its materials science infrastructure to develop a novel intraocular lens that could be an injectable polymer with adjustable focus properties. Alternatively, Hoya could develop superior aspheric correcting lenses which correct for higher-order aberrations of the cornea and optical system.
• Drug Delivery Device: Ocular drug delivery has several “pretenders” but no devices which can be implanted by the general ophthalmologist, target glaucoma or wet AMD, or are refillable or versatile. Hoya can partner with pharmaceutical companies or early-stage delivery companies and use its polymer and materials science capabilities to launch an ocular drug delivery platform for the treatment of chronic eye disease (e.g., macular degeneration, glaucoma, diabetic retinopathy) which would eliminate the risks of chronic intravitreal injections and/or the inconvenience & inefficacy of complex topical eyedrop regimens.
(3) Long-Term
• Novel Wet-Field Adhesives: Ophthalmic surgical procedures suffer from an absence of adhesives which retain their coherence in a wet field such as the eye. Hoya could develop a novel adhesive that would have applications in corneal and retinal injury and ocular trauma (of great interest to military applications).
• Advanced BioImaging: Hoya’s internal capabilities in lens technology (both for IOLs and cameras) could be leveraged to develop novel imaging platforms to compete with Heidelberg and Zeiss. Truly 3-dimensional imaging of the cornea and retina remain elusive, and imaging of predictive biomarkers of disease is still the province of university laboratories. Both of these would represent terrific niches for Hoya to synergize its intrinsic strengths and introduce vanguard technology to the field.
• Drug Candidates: Potential drug candidates focusing on neuroprotection, reduction of inflammation, and novel anti-angiogenics are promising long-term opportunities from a pharmaceutical standpoint in ophthalmology.
Strategy for Hoya Growth in Ophthalmics
(1) Near Term
iSert
Physician Practice Enhancement
Adjustable & Toric IOLs
Cataract Surgical Division Acquisition
(2) Medium Term
Drug Delivery Device
Development of a Premium IOL
Acquisition of AMD Drug Pipeline
(3) Long Term
Novel Wet-Field Adhesives
Advanced Bioimaging
New Drug Candidates
By building on a foundation of excellence in lens, imaging, and materials technologies, Hoya Ophthalmics should be able to introduce several best-of-class products to the US market which truly make a difference to patients as well as raise Hoya’s market profile.
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