Ophthalmic Drugs – Data,
`Analysis and Forecasts to 2024
`
`Pharmaceutical, Commercial & Strategic Developments in the Global Ophthalmology Market
`to 2024
`
`
`
`
`
`
`
`GMRData.com
`
`
`
`Page 1 of 17
`
`SENJU EXHIBIT 2158
`LUPIN v. SENJU
`IPR2015-01099
`
`

`
`Causes of Uveitis:
`
`Infectious causes
`
`Non-infectious/ autoimmune causes
`
` Lyme disease
` Syphilis
` Toxocariasis
` Tuberculosis
` Brucellosis
` Leptospirosis
`
` HLA-B27 related uveitis
` Fuchs Heterochromic Iridocyclitis (FHI)
` Sympathetic Ophthalmia (SO)
`
`
`Treatment:
`Uveitis treatment differs on a case by case basis, typical treatments include:
`
` Glucocorticoid steroids (e.g. Indomethacin/Methotrexate)
` Oral therapy
` Topical eye drops
`Injection in or around eye depending on the severity of the inflammation
`
`
`Ophthalmic Anti-inflammation Market – Global
`
` Globally less than a million people are affected with uveitis, and in the US alone it affects
`less than 200,000 people.
` Uveitis occurs in males and females in equal numbers.
` Uveitis is common between the ages of 20 and 60.
` Anterior uveitis is the most common uveitis, affecting more than 75% of the uveitis cases
`worldwide.
`
`Table 2.4.5.1: Major Ophthalmic Anti- inflammation Drugs
`
`Drug
`
`Bromday
`
`Nevanac
`
`Drug Type
`Non-steroidal anti-
`inflammatory drug
`(NSAID)
`(NSAID)
`
`Acular
`
`(NSAID)
`
`Restasis
`
`Immunosuppressive
`agent
`
`Generic
`Name
`
`Bromfenac
`
`Company
`
`Therapeutic
`Class
`
`ISTA
`Pharmaceuticals
`
`Eye drop
`
`Nepafenac
`
`Alcon, Inc.
`
`Eye drop
`
`Ketorolac
`tromethamine Allergan, Inc.
`Cyclosporine
`Allergan, Inc.
`
`Eye drop
`
`Eye drop
`
`Page 2 of 17
`
`

`
`Suprofen
`
`Flurbiprofen
`sodium
`
`Diclofenac
`ophthalmic
`
`
`Bromfenac
`
`Alcon Laboratories,
`Inc.
`
`Eye drop
`
`Allergan, Inc.
`
`Eye drop
`
`Novartis
`
`Eye drop
`
`ISTA
`Pharmaceuticals,
`Inc.
`
`Eye drop
`
`Profenal
`
`Ocufen
`
`(NSAID)
`Sterile topical
`nonsteroidal anti-
`inflammatory
`product
`
`Voltraren
`Ophthalmic
`
`(NSAID)
`
`Xibrom
`
`(NSAID)
`
`GMR Data 2014
`
`
`
`2.4.6 Ophthalmic Infections
`
`Many of the viruses, bacteria, parasites, and fungi that can attack the human body and are also
`capable of attacking the surface or interior of the eye.
`
`Types of ophthalmic infections:
`
` Blepharitis - is a non-contagious disorder that affects all ages and both men & women.
`Blepharitis is an inflammation of the eyelids which causes the eyelids to become
`reddened, swollen or itching. Symptoms can include eye dryness due to the
`inflammation of moisture producing tissues.
`
`Blepharitis presents in two forms;
`
`
`• Anterior Blepharitis: affects the outside front edge of the eyelid.
`• Posterior Blepharitis: affects the meibomian glands.
`
` Corneal opacities – occurs after injury to the cornea. Once an injury occurs, bacteria
`begin attacking the wound, which leads to infection and corneal ulcers.
`
` Trachoma – is caused by the chlamydia trachomatis bacterium which produces a
`characteristic roughening of the inner surface of the eyelids. It spreads through contact
`with eye discharge from an infected person.
`
`
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`Page 3 of 17
`
`

`
`Chapter 5: Ophthalmic Anti-Allergy / Inflammatory / Infective
`Market 2014 – 2024
`
`Primarily itchy eyes, unusual puffiness around eyes, redness or a burning sensation within the
`eye are caused by allergy, inflammation or infection. Allergies/inflammations/infections are
`treated with anti-infective, anti-allergy and anti-inflammatory drugs.
`
`Anti-infective drugs are frequently used to treat bacterial, viral and, less commonly, fungal
`infections of the eye. Anti-inflammatory drugs are also used to treat the redness and puffiness
`of the eyes that may develop as a result of infection, allergic reactions, or autoimmune disorders
`in which the immune system attacks the body’s own tissues. Anti-allergy drugs are commonly
`used to treat allergy reactions primarily caused from insect stings or pollen. Minute amounts of
`an allergen may be used to pacify a person who has a severe allergy to a particular substance.
`The treatment is usually given as a series of weekly injections containing gradually increasing
`doses.
`
`
`
`5.1 Key Trends / Issues in the Global Anti-allergy / Inflammatory / Infective
`Market
`
` Quality of life - Allergic eye diseases are one of the fastest growing health problems
`worldwide. The cause of an allergic eye disorder, such as conjunctivitis, is due to the
`reaction of a patients’ immune system to an allergen. Allergic conjunctivitis is common
`in people who have other allergic disease such as hay fever, asthma and eczema.
`
`Due to ever changing life styles increasing numbers of people are exposed to common
`allergens that cause conjunctivitis, such as; pollen from trees, grass and ragweed; animal
`skin & hair; secretions such as saliva; perfumes, cosmetics, skin medicines, air pollution,
`smoke, dust mites etc. Increasing pollution in urban areas is also a major cause of eye
`infections / irritations.
`
`
`
`
`
`
`
`Increasing Number of Eye Allergy / Inflammatory / Infection cases: In the US
`alone approximately 25m people are affected from various eye allergies every year.
`Globally 100m people are affected from eye allergy every year. Uveitis occurs most
`frequently in people ages 20 to 50. It is estimated that more than 300,000 people in the
`US are affected by uveitis each year. The increase in the number of cases will drive the
`market for drugs across our forecast period.
`Increased exposure to pets: In the US alone more than 35% of allergies are caused
`due to pets/animal skin and their secretions, such as saliva.
`
`Increased use of contact lenses: More than 55% of people that use contact lenses
`suffer from an eye allergy. Allergens can be trapped under a contact lens, prolonging the
`contact with the ocular surface, and potentially causing infection. Globally more than
`125m people wear contact lenses
`
`
`Page 4 of 17
`
`

`
`
` R&D pipeline: There are of number of ophthalmic drugs in phase 2 and 3 stages for the
`treatment of eye allergy, inflammatory and infective conditions. It is expected that these
`drugs will hit the market post 2014.
`
`Key ophthalmic drugs in the R&D pipeline are:
`Table 5.1.1 Ophthalmic Anti-Allergy/Inflammation/Infective R&D Pipeline
`
`Manufacturer/Drug Name
`
`Indication
`
`Phase
`
`Nova Bay Pharmaceuticals, Inc. (NVC
`422)
`
`Adenoviral conjunctivitis
`
`Foresight Biotherapeutics (FST-100)
`
`Adenoviral conjunctivitis
`
`ESBA105
`
`Bausch+Lomb (Mapracorat)
`
`InSite Vision (Dexasite)
`
`AMD, non-infective inflammatory
`diseases
`
`Anterior segment condition,
`symptoms of allergic conjunctivitis
`
`Symptoms of non-infectious
`blepharitis, blepharo conjunctivitis
`
`
`Phase 2
`
`Phase 3
`
`Phase 2
`
`Phase 3
`
`Phase 3
`
`InSite Vision (AzaSite Plus)
`
`Blepharitis
`
`Double Phase 3
`
`
`GMR Data 2014
`
`
`
`5.2 Market Size & Forecast
`
`The global ophthalmic anti-allergy/inflammatory/infective drug market is primarily dominated
`by the US and Japan because of the large number of pollen, bacterial and infective cases in these
`countries, alongside a mature healthcare
`system. The global ophthalmic anti-
`allergy/inflammatory/infective drug market is diverse, with a large number of companies that
`bring their products to the market.
`
`
`
`anti-
`ophthalmic
`global
`the
`company which dominates
`only
`the
`is
`Alcon
`allergy/inflammatory/infective drug market and accounts for more than 22% of global
`ophthalmic drug sales. Patanol, Vigamox, TobraDex and Pataday by Alcon will account for
`approximate sales of $1.3bn during 2013, making Alcon the market leader in this category.
`
`
`
`Page 5 of 17
`
`

`
`Table 5.2.1 Ophthalmic Anti-Allergy/Inflammation/Infective Market Size & Forecast ($/bn)
`
`
`
`2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
`
`5.4
`
`2%
`
`5.5
`
`2%
`
`5.6
`
`2%
`
`5.8
`
`4%
`
`6.0
`
`3%
`
`6.1
`
`2%
`
`6.3
`
`3%
`
`6.4
`
`2%
`
`6.5
`
`1%
`
`6.6
`
`2%
`
`10 yr
`CAGR
`2.14%
`
`
`
`5.3
`
`5.3
`
`$ bn
`%
`0%
`1%
`Growth
`GMR Data 2014
`
`
`
`Figure 5.2.2 Ophthalmic Anti-Allergy/Inflammation/Infective Market Size & Forecast ($/bn)
`$7
`5%
`4%
`$6
`4%
`$5
`3%
`$4
`3%
`2%
`$3
`2%
`$2
`1%
`$1
`1%
`$0
`0%
`
`2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
`
`Market Value in Billion
`
`Growth YoY
`
`GMR Data 2014
`
`GMR Data forecasts that global ophthalmic anti-allergy/inflammatory/infective drug market
`will reach $6.55bn by 2024. Sales will be driven by the US, the Japan and the EU Markets. The
`ROW, China and India will gain traction, across the forecast period, due to the rapidly changing
`living conditions, which will instigate allergies in many people.
`
`Alcon, Allergan, Santen will be the global ophthalmic anti-allergy/inflammatory/infective drug
`market leaders to 2024. The global ophthalmic anti-allergy/inflammatory/infective drug market
`will grow at a 10 year CAGR of 2.1%, claiming worldwide revenue of $5.3bn in 2014 rising to
`$6.55bn by 2024. The low CAGR of 2.1% will be as a result of patent expiry of major drugs
`(Patanol, Vigamox & TobraDex) leading to significant revenue erosion due to generics,
`particularly in the US market, however these reduced sales revenue will be offset, marginally, by
`the
`Japanese
`and EU markets
`along with
`the Chinese
`ophthalmic
`anti-
`allergy/inflammatory/infective drug market.
`
`
`
`Page 6 of 17
`
`

`
`5.3 Major Drugs & Forecast
`
`5.3.1 Patanol by Alcon
`
`Patanol was approved in 1996 by the FDA for the treatment / relief of inflammation, itching,
`watering, and burning associated with allergic conjunctivitis. Patanol ophthalmic solution was
`the first ocular allergy product with a dual-action active ingredient, which acts as both an
`antihistamine and a mast-cell stabilizer. Patanol sales are largely driven by the prevalence of
`airborne pollen; consequently increased sales revenue in 2013 was largely attributed to the
`increased number of airborne pollen.
`
`Patanol was approved in Japan, the second largest ophthalmic allergy market, in 2006. Alcon
`and Kyowa Hakko Kirin Co. Ltd. have a co-marketing agreement in Japan, where Kyowa
`endorses Patanol to non-eye care physicians and Alcon endorse to eye care physicians. Globally
`Patanol is available in more than 105 countries, Patanol is known as Opatanol in the EU
`countries. Patanol’s patent will expire in December 2015 in the US.
`
`
`Table 5.3.1.1 Patanol Market Size & Forecast: 2012-2024 ($/m)
`
`
`
`2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
`
`10 yr
`CAGR
`
`190
`-3%
`
`186
`-2%
`
`-7.6%
`
`
`$ m
`AGR
`
`
`
`410
`1%
`
`420
`2%
`
`310
`-26%
`
`255
`-18%
`
`230
`-10%
`
`210
`-9%
`
`202
`-4%
`
`200
`-1%
`
`196
`-2%
`
`405
`380
`7%
`-7%
`GMR Data 2014
`
`Sales of eye allergy relief products, such as Patanol largely depends on the increase or decrease
`in the amount of airborne pollen in the atmosphere. If airborne pollen is high in any particular
`year, the number of cases will be high resulting in increased sales of Patanol, if airborne pollen is
`low that will result in fewer cases of eye irritation and therefore fewer sales globally.
`
`As of 2012, there were fewer incidents of eye allergies recorded in the US and Japan due to less
`airborne pollen, this resulted in a decline in sales revenue in these two key markets. In 2013
`sales revenue is expected to post an increase as there was a higher amount of airborne pollen
`recorded in the US and Japan.
`
`Page 7 of 17
`
`

`
`Figure 5.3.1.1 Patanol Market Size & Forecast: 2012-2024 ($/m)
`
`
`$450
`$400
`$350
`$300
`$250
`$200
`$150
`$100
`$50
`$0
`
`10%
`5%
`0%
`-5%
`-10%
`-15%
`-20%
`-25%
`-30%
`
`2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
`
`Market Value
`
`Growth YoY
`
`GMR Data 2014
`
`
`GMR Data forecasts that sales of Patanol will decline at a CAGR of -7.6% between 2014 and
`2024, reaching $186m by 2024. After losing its patent in the US in 2015, sales of Patanol will
`decline by more than 50%, in three years, to reach $230m in 2018, however GMR Data forecast
`that sales will stabilise, post 2018, due to growth in the second largest ophthalmic allergy market
`Japan. Across 2013 approximately 25% of Patanol sales revenue was generated in Japan.
`
`
`
`5.3.2 Vigamox/Vegamox by Alcon
`
`Vigamox was approved in the US by the FDA in 1999. Vigamox is a fourth generation
`fluoroquinilone antibiotic specified for the treatment of bacterial conjunctivitis instigated by
`susceptible strains of bacteria. Moxifloxacin, the principal component in Vigamox, is licensed to
`Alcon by Bayer Schering Pharma AG.
`
`Moxifloxacin was discovered in 1996. Moxifloxacin is a fluoroquinilone antibiotic which kills
`certain bacteria or stops their growth. In 2006, Alcon received approval for Vigamox in Japan
`under the trade name Vegamox ophthalmic solution. The US patent of Vigamox will expire in
`March 2020.
`
`Table 5.3.2.1 Vigamox/Vegamox Market Size & Forecast: 2012-2024 ($/m)
`
`2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 10 yr
`CAGR
`365
`357
`355
`363
`371
`383
`394
`401
`287
`243
`220
`205
`196
`-5.77%
`6%
`-2%
`-1%
`2%
`2%
`3%
`3%
`2%
`-28%
`-15%
`-9%
`-7%
`-4%
`
`GMR Data 2014
`
`
`
`
`
`$ m
`AGR
`
`Page 8 of 17
`
`

`
`Figure 5.3.2.1 Vigamox/Vegamox Market Size & Forecast: 2012-2024 ($/m)
`
`$200
`$180
`$160
`$140
`$120
`$100
`$80
`$60
`$40
`$20
`$0
`
`2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
`
`Market Value
`
`Growth YoY
`
`0%
`
`-1%
`
`-2%
`
`-3%
`
`-4%
`
`-5%
`
`-6%
`
`-7%
`
`
`
`GMR Data 2014
`
`GMR Data forecasts that sales of Vigamox will generate revenue of $357m in 2013, down 2%
`from 2012 sales of $365m. This is due to the low volume sales in first and second quarter of
`2013 in the US.
`
`
`
`GMR Data forecast that Vigamox sales will decline at a 10 year (2014-2024) CAGR of 5.8%,
`reaching $196m by 2024, down from $355m in 2012. Vigamox’s patent will expire in the US in
`March 2020, which will result invariably in reduced sales revenue in this key market. GMR Data
`forecast that Vigamox peak sales will be in 2019 with $401m.
`
`
`
`5.3.3 TobraDex by Alcon
`
`TobraDex was the first antibiotic/corticosteroid combination approved by the FDA in 1998. The
`US patent for TobraDex expired in 2008, sales declined by 35% from 2008 to 2009. However in
`2009 a new formulation, a more advanced product, TobraDex ST replaced TobraDex. TobraDex
`ST suspension was formulated to enhance bio-availability to targeted tissues, aimed at treating
`conditions such as acute Blepharitis and other inflammatory conditions.
`
`
`
`Table 5.3.3.1 TobraDex Market Size & Forecast: 2012-2024 ($/m)
`
`
`
`$ m
`AGR
`
`2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 10 yr
`CAGR
`180
`170
`162
`155
`150
`146
`142
`137
`130
`124
`118
`113
`109
`-3.89%
`-5%
`-6%
`-5%
`-4%
`-3%
`-3%
`-3%
`-4%
`-5%
`-5%
`-5%
`-4%
`-4%
`
`GMR Data 2014
`
`Page 9 of 17
`
`

`
`
`Figure 5.3.3.1 TobraDex Market Size & Forecast: 2014-2024 ($/m)
`
`
`$200
`
`$150
`
`$100
`
`$50
`
`$0
`
`0%
`-1%
`-2%
`-3%
`-4%
`-5%
`-6%
`-7%
`
`2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
`
`Market Value
`
`Growth YoY
`
`GMR Data 2014
`
`
`GMR Data forecasts that sales of TobraDex will reach $170m across 2013, down 6% from 2012
`sales of $180m. TobraDex will decline at a 10 year CAGR of -3.9% reaching $109m by 2024.
`After losing its patent in the US, in 2008, sales of TobraDex declined across 2008 and 2009,
`however after the launch of a new formulation ‘TobraDex ST’, sales revenue increased by approx.
`10% in 2010. However that rise was short lived; thereafter sales declined every year in the US
`market, which is the largest for TobraDex. In other regions sales revenue of TobraDex is on an
`upward trend, however due to the marginal share of the non-US markets in its total sales, these
`increases are currently not impacting the overall sales of TobraDex.
`
`
`5.3.4 Pataday by Alcon
`
`Pataday was initially approved in the US in 1996. Pataday solution is used for the treatment of
`ocular itching associated with allergic conjunctivitis. In the US, Pataday was reintroduced, in
`2007, with a new formulation, notably an increased concentration of Olopatadine, the active
`ingredient in Pataday. Another new formulation of Pataday (presently in Phase III) is expected
`to be filed in H2 2014. Pataday’s patent will expire in Dec 2015 in the US. Daiichi Sankyo uses
`Ranbaxy’s sales network to market Pataday in countries such as Romania, India and South
`Africa.
`
`
`Table 5.3.4.1 Pataday Current Market Size & Forecast: 2012-2024 ($/m)
`
`
`
`$ m
`AGR
`
`2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 10 yr
`CAGR
`380
`398
`412
`420
`305
`250
`220
`200
`186
`175
`167
`159
`153
`-9.43%
`6%
`5%
`4%
`2%
`-27%
`-18%
`-12%
`-9%
`-7%
`-6%
`-5%
`-5%
`-4%
`
`GMR Data 2014
`
`Page 10 of 17
`
`

`
`
`
`Figure 5.3.4.1 Pataday Market Size & Forecast: 2012-2024 ($/m)
`
`
`$450
`$400
`$350
`$300
`$250
`$200
`$150
`$100
`$50
`$0
`
`2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
`
`Market Value
`
`Growth YoY
`
`10%
`5%
`0%
`-5%
`-10%
`-15%
`-20%
`-25%
`-30%
`
`
`
`GMR Data 2014
`
`GMR Data forecasts that sales of Pataday will reach $398m across 2013, up 5% from the 2012
`figure of $380m. Pataday will decline at a CAGR of -9.4% between 2014 and 2024, to reach
`$153m by 2024. With the expectation of a loss of patent in the US in December 2015, GMR Data
`forecast that sales of Pataday will decline by more than 55% across three years to reach $220m
`in 2018. Watson Pharma has already filed its application for approval of a generic version of
`Pataday and is waiting for FDA approval. In 2011, Alcon filed a petition with the FDA for a stay
`on the final FDA approval of Watson's ANDA until October 29, 2013.
`
`
`
`5.3.5 Cravit by Daiichi Sankyo Company, Limited (Japan)
`
`Generic versions of Johnson & Johnson's blockbuster antibacterial drug Levaquin (levofloxacin)
`is marketed in Japan by Daiichi Sankyo as Cravit. Cravit’s generic name is Levofloxacin hydrate,
`which is a synthetic antibacterial agent. Cravit 0.5% ophthalmic solution is an antibacterial
`formulation, which was approved & marketed for the treatment of ocular infections in Japan in
`2000. In 2011, Cravit 1.5%, an ophthalmic solution with a broad spectrum anti-bacterial
`formulation was launched in Japan. Levaquin patent expired in Jun 2011.
`
`Table 5.3.5.1 Cravit Sales 2009-2013 ($/m)
`
`
`$ m
`AGR
` GMR Data 2014
`
`
`2009
`835
`-10%
`
`2010
`656
`-21%
`
`2011
`503
`-23%
`
`2012
`450
`-11%
`
`2013
`427
`-5%
`
`Page 11 of 17
`
`

`
`
`
`Figure 5.3.5.1 Cravit Sales 2009-2013 ($/m)
`
`$1,000
`$800
`$600
`$400
`$200
`$0
`
`2009
`
`2010
`
`2011
`
`2012
`
`2013
`
`Sales in $ Million
`
`% growth
`
`0%
`-5%
`-10%
`-15%
`-20%
`-25%
`
`
`
`GMR Data 2014
`
`
`Cravit is a registered trademark of Daiichi Sankyo Company Ltd in Japan. Santen Pharma has
`received the licence authority from Daiichi Sankyo Company Ltd to sell Cravit in Japan. In June
`2011, with a strong demand for higher concentration anti-infective ophthalmic pharmaceuticals,
`Santen launched the higher concentration Cravit Ophthalmic Solution 1.5%, which contains a
`higher solubility of levofloxacin. Cravit sales saw a substantial sales decline in Japan, as well as
`seeing export sales decrease in certain Asian, African and European markets. Despite the overall
`decline in sales, China’s share in the overall Cravit export market remained high. Major sales
`decline across 2009 to 2013 are attributed to the loss of sales exclusivity in many markets, along
`with the impact of a stronger Yen.
`
`
`
`Table 5.1.2 Cravit Market Size & Forecast: 2014-2024($/m)
`
`
`
`2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 10 yr
`CAGR
`$ m
`410
`395
`385
`376
`367
`355
`345
`333
`321
`310
`298
`-3.14%
`AGR
`-4%
`-4%
`-3%
`-2%
`-2%
`-3%
`-3%
`-3%
`-4%
`-3%
`-4%
`
`GMR Data 2014
`
`
`
`Page 12 of 17
`
`

`
`0%
`-1%
`-2%
`-3%
`-4%
`-5%
`
`
`
`Figure 5.3.5.2 Cravit Market Size & Forecast: 2014-2024 ($/m)
`
`
`$500
`$400
`$300
`$200
`$100
`$0
`
`2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
`
`Market Value
`
`Growth YoY
`
`GMR Data 2014
`
`
`
`GMR Data forecasts that sales of Cravit will decline at a CAGR of 3.1% between 2014 and 2024.
`Cravit sales will suffer in light of competition from generic products, this drop will be offset by
`much smaller sales declines in Japan and the five major EU markets (France, Germany, Italy,
`Spain, and the UK), in which levels of generic erosion are much less pronounced. Because of low
`levels of generic erosion and marketing exclusivity in Japan, Cravit sales will decline marginally
`year on year across our forecast period.
`
`
`
`5.3.6 Xibrom/Bromday/Bromfenac (ophthalmic solution) by ISTA Pharma
`
`Xibrom was initially developed by Senju Pharmaceuticals Company Ltd. and was launched in
`Japan in 2000. In May 2002, Ista Pharma acquired the marketing rights for Xibrom in the
`United States under a license agreement with Senju. Xibrom’s patent expired in the US in 2009.
`
`By Feb 2011, Ista Pharma stopped production of Xibrom. The primary reasons for ceasing
`production of Xibrom was the successful launch of Bromday, an improved formulation of
`Xibrom, in 2010, and the expiry of Xibrom’s marketing exclusivity in the US in 2009. In 2010,
`Bromday recorded sales of $9.4m. Bromday (bromfenac) is a topical non-steroidal anti-
`inflammatory drug used for treatment of postoperative inflammation and ocular pain following
`cataract extractions. Bromday was granted a three-year market exclusivity period under the
`Hatch-Waxman Act until October 2013.
`
`
`Table 5.3.6.1 Xibrom/Bromday/Bromfenac ophthalmic solution Sales 2009-2013 ($/m)
`
`2009
`81.1
`35%
`
`2010
`105.8
`30%
`
`2011
`115
`9%
`
`2012
`110
`-4%
`
`2013
`107
`-3%
`
`
`$ m
`AGR
`GMR Data 2014
`
`
`
`Page 13 of 17
`
`

`
`Figure 5.3.6.1 Xibrom/Bromday/Bromfenac ophthalmic solution Sales 2009-2013 ($/m)
`
`$140
`$120
`$100
`$80
`$60
`$40
`$20
`$0
`
`2009
`
`2010
`
`2011
`
`2012
`
`2013
`
`Sales in $ Million
`
`% growth
`
`40%
`
`30%
`
`20%
`
`10%
`
`0%
`
`-10%
`
`
`
`GMR Data 2014
`
`
`Xibrom was Ista Pharmaceuticals’ major revenue contributor, accounting for more than 75%
`of their annual revenue
`in 2009. After Xibrom patent expiry
`in 2009, Mylan
`pharmaceuticals launched the first generic version of Xibrom ophthalmic solution in May,
`2011. Sales for Xibrom did not decline substantially directly after its patent expiry in 2009
`primarily due to the non-availability of a generic in the market. In 2010 Xibrom sales grew
`by 30% to reach $106m compared to $81m in 2009. However, sales declined by 4% in 2012
`due to the launch of a generic version by Mylan Pharma in 2011.
`
`In May 2013 ISTA Pharmaceuticals was found guilty in the Western District of New York to
`criminal charges that the company had conspired to illegally represent and had misbranded
`Xibrom, into interstate commerce. Under the FDA, it is illegal for a drug company to use a
`drug not approved by the FDA for a particular treatment.
`
`
`
`Table 5.3.6.2 Xibrom/Bromday/Bromfenac Market Size & Forecast: 2014-2024 ($/m)
`
`
`
`$ m
`
`2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
`
`106
`
`105
`
`103
`
`100
`
`96
`
`90
`
`84
`
`80
`
`76
`
`74
`
`70
`
`10 yr
`CAGR
`-4.06%
`
`-2%
`
`-3%
`
`-4%
`
`-6%
`
`-7%
`
`-5%
`
`-5%
`
`-3%
`
`-5%
`
`
`
`AGR
`
`-1%
`-1%
`GMR Data 2014
`
`
`
`Page 14 of 17
`
`

`
`Figure 5.3.6.2 Xibrom/Bromday/Bromfenac Market Size & Forecast: 2014-2024 ($/m)
`
`
`$120
`$100
`$80
`$60
`$40
`$20
`$0
`
`0%
`-1%
`-2%
`-3%
`-4%
`-5%
`-6%
`-7%
`-8%
`
`2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
`
`Market Value
`
`Growth YoY
`
`GMR Data 2014
`
`
`GMR Data forecasts that sales of Xibrom/Bromday/Bromfenac ophthalmic solution will decline
`at a 10 year CAGR of -4.06%; to reach $70m by 2024. Xibrom lost its patent exclusivity in 2009,
`post which Bromday was launched in 2010 for which the company received marketing
`exclusivity in the US till October 2013. The first generic version of ISTA’s Xibrom (bromfenac)
`was launched by Mylan Pharmaceuticals, based on a development and supply agreement with
`Coastal Pharmaceuticals, in May 2011.
`
`
`
`
`
`Page 15 of 17
`
`

`
`
`10.4 Bausch & Lomb
`
`Bausch & Lomb was established 1853 by John Jacob Bausch & Henry Lomb in Rochester, New
`York. In 2007, Bausch & Lomb was acquired by Warburg Pincus LLC for $4.5bn. In 2012,
`Bausch & Lomb acquired ISTA pharmaceuticals for a total consideration of $500m. In 2013,
`Bausch & Lomb was acquired by Valeant Pharmaceuticals for $8.7bn. Bausch & Lomb will retain
`its brand name and will become a division of Valeant’s existing ophthalmology businesses, with
`2013 estimated pro forma net revenues of more than $3.5 bn.
`
`Table 10.4.1: Bausch & Lomb Key Ophthalmic Drugs Portfolio 2014
`
`Product
`
`Indication
`
`Soothe (range of drops / ointments)
`
`Relieves dryness of the eye
`
`Muro 128 5% solution
`
`Muro 128 5% ointment
`
`Corneal edema
`
`Corneal edema
`
`Alaway
`
`Opcon-A
`
`Relieves itchy eyes due to pollen, grass,
`animal hair
`
`Relives from redness of eyes due to itching
`
`Advanced Eye Relief (Maximum Relief)
`
`Relieves irritated eyes
`
`Advanced Eye Relief (Instant Relief)
`
`Relives minor eye irritations
`
`Alrex
`
`Bepreve
`
`Bromday
`
`Istalol
`
`Relief from symptoms of seasonal allergic
`conjunctivitis
`
`Itching associated with allergic conjunctivitis
`
`Reduction of ocular pain in patients
`
`Elevated intraocular pressure in patients with
`ocular hypertension or open-angle glaucoma
`
`Lotemax (loteprednol etabonate ophthalmic
`suspension)
`
`Bulbar conjunctiva & allergic conjunctivitis
`
`Lotemax(loteprednol
`gel)
`
`etabonateophthalmic
`
`Post-operative inflammation & pain following
`ocular surgery
`
`Lotemax (loteprednal etabonate ophthalmic
`ointment)
`
`Post-operative inflammation & pain following
`ocular surgery
`
`Page 16 of 17
`
`

`
`Prolensa
`
`Retisert
`
`Zirgan
`
`Zylet
`
`Besivance
`
`Collysium
`
`Treatment of post-operative inflammation &
`pain after cataract surgery
`
`Chronic non-infectious uveitis affecting the
`posterior segment of the eye
`
`Acute herpetic keratitis (dendritic ulcers)
`
`Superficial bacterial ocular infection or the
`risk of bacterial ocular infection exists
`
`Bacterial conjunctivitis
`
`Eye wash; cleanses & relieve irritation
`
`PreserVision eye vitamin AREDS 2 formula
`
`Age Related Eye Vitamins
`
`PreserVision eye vitamin AREDS formula soft
`gels
`
`Age Related Eye Vitamins
`
`PreserVision eye vitamin Lutein formula soft
`gels
`
`Age Related Eye Vitamins
`
`PreserVision eye vitamin AREDS formula
`tablets
`
`Age Related Eye Vitamins
`
`Ocuvite eye vitamin adult 50+ formula
`
`Vitamins for general eye health
`
`Ocuvite Lutein & Zeaxanthin eye vitamin and
`mineral supplements
`
`Vitamins for general eye health
`
`Ocuvite Lutein eye vitamin and mineral
`supplement
`Bausch & Lomb 2014
`
`Vitamins for general eye health
`
`
`
`10.5 Bayer Healthcare Pharmaceuticals
`
`Bayer was established in 1863 in Barmen, Germany by Friedrich Bayer and Dyer Johann
`Friedrich Weskott. Bayer’s products are marketed in more than 100 countries and are a division
`of Bayer Healthcare AG.
`
`Bayer Healthcare Pharmaceuticals concentrate primarily on the following therapeutic areas:
`ophthalmology, oncological diseases, women’s healthcare and cardiovascular / blood diseases.
`
`The company recorded sales of €18,612m ($25.6bn) in 2012, up 8.4% compared to 2011.
`
`
`
`Page 17 of 17