`
`REFEflfififiE GDDE GDHCHSPIDR} PUBLICA-‘HON DATE-SEPTEM BER 2015
`
`
`
`GlobalData ))
`
`PharmaPoint
`
`ALLERGIC RHINITIS — 3.
`GLOBAL DRUGFORECAST AND MARKET ANALYSIS
`To 2924
`
`
`
`
`
`MEDA_APTX03503458
`C|P2053
`Argentum Pharmaceuticals LLC v. Cipla Ltd.
`|PR2017-00807
`
`PTX0397-00001
`
`CIPLA LTD. EXHIBIT 2026 PAGE 1
`
`CIPLA LTD. EXHIBIT 2026 PAGE 1
`
`CIPLA LTD. EXHIBIT 2026 PAGE 1
`
`

`

`GlobalData ))
`
`ALLERGIC RHINITIS —
`GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2024
`
`Executive Summary
`
`Allergic Rhinitis: Key Metrics in the Seven Major
`
`Markets. 2014—2024
`
`Number creases gift?
`Drug-treated population
`
`15523336
`35871112
`
`
`“S
`_
`_
`_
`_
`_
`_
`_
`$28“
`55o
`$2,5bn
`
`i
`Japan m
`$1.89bn
`T015“
`5113”"
`
`Number of drugs in Phase lib—III
`Number of first-in-class drugs
`
`Nascnex patent expiryin 2014
`Patanase patent expiry in 2014
`
`Astepro Palentexrliw in 2014 _ _ ___
`
`EH patentixl’i” in Japan i” 7:015 _
`Veramyst generic entryr in 2016
`HIP-3060 drug laonch in 2017
`
`Séfigsras launch in the US and Japan in
`
`Drugvtreated population
`
`US
`
`SEU
`
`Japan
`Total
`-;snuroe::-,elobalose
`9520 : FranCe,'_German Yr tlsly-;=-Spatna‘mi UK
`
`2
`2
`
`LN
`l
`
`L
`LL} _
`1.
`T
`
`T
`
`157 .426 .939
`354430.171
`
`$2an
`$2.5in
`
`$1.96bn
`smrtm
`
`The table above presents the key metrics for
`
`allergic
`
`rhinitis
`
`(AR)
`
`in
`
`the
`
`seven major
`
`pharmaceutical markets
`
`(7MM)
`
`(US, France,
`
`Germany. Italy, Spain. UK, and Japan) during the
`
`forecast period from 2014—2024.
`
`Allergic Rhinitis Market Will Grow to $7.3
`_
`Billion by 2024
`
`GlobaIData
`
`estimated
`
`the
`
`sales
`
`for
`
`AR
`
`(prescription drugs only) in 2014, the base year of
`
`the forecast period. at approximately $7.20 billion
`
`across the seven markets covered in this report.
`
`The US contributed 38% of these sales. generating
`
`an estimated $2.8 billion. This was mainly due to
`the much higher prices of AR medications in the
`
`(OTC)
`and the lack of overwthe—counter
`US,
`intranasal corticosteroids (lNCS)
`for AR in this
`market in the base year.
`
`By the end of the forecast period in 2024? AR sales
`in the 7MM are forecast
`to remain stagnant to
`
`$7.27 billion at a Compound Annual Growth Rate
`
`(CAGR) of 0.1% over the 10-year period. The
`
`second-generation H1 receptor antagonists and
`
`INCS are the leading drug classes in terms of
`
`market value The INCS currently capture almost
`_
`their market
`half the total AR market. however,
`share
`will
`shrink
`to
`34% as
`allergen
`immunotherapies
`(AlTs)
`for
`the treatment of
`moderate~to—severe AR enter the market over the
`
`forecast period and start dominating this space,
`
`growing from 14% to 26% of the total AR sales.
`
`The uptake of these novel drugs will be a major
`
`driver of AR market growth, and will offset the dip
`
`Allerglc Rhinitis - Global Drug Forecast and market Analysis 1021324
`E} GiobolData. Tl'IJS report IS a licensee product and !5 not TO be copied. reproduced. Sheree Ul' resale Ill any torn-l
`
`MEDA_APTX03503459
`
`CIPLA LTD. EXHIBIT 2026 PAGE 2
`
`PTXO397-00002
`
`CIPLA LTD. EXHIBIT 2026 PAGE 2
`
`CIPLA LTD. EXHIBIT 2026 PAGE 2
`
`

`

`GlobalData ))
`
`ALLERGIC RHINITIS —
`GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2024
`
` Executive Summary
`
`
`
`in
`
`sales caused by Nasonex’s
`
`(mometasone
`
`0
`
`increasing
`
`pressure
`
`for
`
`cost-effectiveness
`
`furoate) 2014 patent expiry. The US market size
`
`across all markets, which will limit the pricing of
`
`will shrink slightly compared to the other markets
`
`— at a negative CAGR of 0.1% — due to the
`
`expected surge in generic and OTC competition in
`
`this market, driven by the first approvais of OTC
`
`INCS.
`
`In 2024, the US will retain its AR market
`
`share, representing 38% of the total market.
`
`The major drivers of the growth of the AR market
`
`new products. and in some cases. prevent
`their reimbursement.
`
`The figure below illustrates the sales for AR in the
`
`US, 5EU. and Japan during the forecast period.
`
`Sales for AR by Region, 2814+2024
`2014
`Total:$7,181.3m
`
`over the forecast period include:
`
`26 4%
`
`.
`
`The introduction of several AlT tablets: Merck's
`
`Grastek (grass), Ragwitek (ragweed), and
`
`Mitizax (house dust mite [HDMD tablets, as
`
`well as Greer's Oralair
`
`(grass)
`
`in the US.
`
`the
`overcome
`products
`new
`These
`inconvenience of conventional subcutaneous
`
`immunotherapies (SCITs).
`
`-
`
`The increasing global prevalence of AR.
`
`The major barriers to the growth of the AR market
`include:
`
`- Generic erosion of the leading brands for AR
`
`treatment.
`
`such
`
`as Nascnex, Astepro
`
`(azelastine
`
`hydrochloride},
`
`and
`
`Singulair
`
`(montelukast sodium) in (Japan).
`
`.
`
`The increasing push for patients to self-
`
`medicate using OTC drugs will decrease the
`
`prescription AR drug market size.
`
`38.4%
`
`
`
`8.1%
`
`6.0%
`
`134%
`
`2024
`Tomlz$7,265.3m
`
`210%
`
`37.7%
`
`lUS
`
`l France
`
`lGerm any
`
`ll Italy
`
`ISpain
`IUK
`
`Idapan
`
`6.5% 6.9%
`
`1.4% " '7
`
`1 3.5%
`
`Source: GlobalData
`
`7.1%
`
`Allergic Rhinitis -— Global Drug Forecast and Market Analysis to 2024
`is? Glot‘a-slfiata This report IS a licensed prootic‘. and as no! to be copied. reproduced shares or tL'-:Sotd In any town.
`
`MEDA_APTX03503460
`
`CIPLA LTD. EXHIBIT 2026 PAGE 3
`
`PTXO397-00003
`
`CIPLA LTD. EXHIBIT 2026 PAGE 3
`
`CIPLA LTD. EXHIBIT 2026 PAGE 3
`
`

`

`GlobalData ))
`
`ALLERGIC RHINITIS —
`GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2024
`
` Executive Summary
`
`
`Companies are Diver-ting Their AR Portfolios to
`the OTC Market
`
`Historically, the AR market has been very large,
`
`with several companies
`
`launching drugs
`
`that
`
`gained blockbuster status,
`
`In particular, Merck &
`
`Co. has had a very strong presence,
`
`leading the
`
`AR market with its three franchises, Nasonex,
`
`Singulair,
`
`and Clarinex (desloratadine). Other
`
`players
`
`defining
`
`the
`
`AR market
`
`include
`
`GlaxoSmithKline
`
`(GSK),
`
`Sanofi.
`
`and
`
`Teva.
`
`the USA This is set to have a large impact on the
`
`prescription drug treatment rate. as patients are
`
`incentivized to self-diagnose and self-medicate
`
`using the growing number of OTC options. Direct-
`
`to-consumer
`
`{DTC}
`
`advertising,
`
`increased co-
`
`payments on prescription AR drugsI and stretched
`
`healthcare resourcesI as well as the increasingly
`
`competitive cost of OTCequivalent options, will all
`
`further the progressively increasing trend for AR
`
`patients to seek treatment independentiy.
`
`However, over the past decade. almost all the key
`
`GlobalData expects
`
`the large pharmaceutical
`
`drugs for the treatment of AR symptoms have lost
`
`companies with a previously strong foothold in the
`
`patent
`
`protection,
`
`including
`
`Sanofi’s Allegra
`
`AR market, such as GSK. to be increasingly less
`
`(fexofenadine hydrochloride), PfizerIUCB Phanna’s
`
`focused on AR drugs. instead, the major players
`
`Zyrtec (cetirlzine hydrochloride) and two of Merck's
`
`are investing in research and development (R80)
`
`blockbuster drugs. Singulair and Nasonex. As a
`
`for
`
`respiratory indications, but
`
`for asthma and
`
`chronic obstructive pulmonary disease (COPD),
`rather than for AR.
`
`result. AR, which was once a blockbuster-status
`
`therapy area,
`
`is
`
`now highly
`
`saturated and
`
`genericized, with companies seeing large declines
`
`in the sales of their respiratory portfolios due to
`
`generic erosion.
`
`In an attempt
`
`to retain a revenue stream from
`
`branded generics,
`
`companies have sought a
`
`successful strategy to convert their AR prescription
`
`drugs to OTC status, known as the Rx~toOTC
`
`switch,
`
`transferring
`
`these
`
`products
`
`to
`
`their
`
`respective consumer care units. The most recent
`
`examples
`
`of
`
`this
`
`are
`
`the Food
`
`and Drug
`
`Administration‘s (FDA‘s) approval of OTC status
`
`for Sanofi’s Nasacort Allergy 24HR (triamcinolone
`
`intranasal)
`
`and GSK's
`
`Flonase
`
`(fiuticasone
`
`propionate), the first INCS to be available OTC in
`
`Allerglc Rhinitis -— Global Drug Forecast and Market Analysis to 2024
`l9? Glob-sitters This report IS a licensed product and as no! to be copied. reproduces} shared or tL'-:Sutd IF‘I any iorrrr.
`
`MEDA_APTX03503461
`
`CIPLA LTD. EXHIBIT 2026 PAGE 4
`
`PTXO397-00004
`
`CIPLA LTD. EXHIBIT 2026 PAGE 4
`
`CIPLA LTD. EXHIBIT 2026 PAGE 4
`
`

`

`GlobalData ))
`
`ALLERGIC RHINITIS —
`GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2024
`
` Executive Summary
`
`
`The figure below provides an analysis of
`
`the
`
`Japanese pollen counts have grown five fold over
`
`company portfolio gap in AR during the forecast
`
`the past three decades. A primary cause of the
`
`period.
`
`Company Portfolio Gap Analysis in AR, 20144024
`
`
`
`
`StrengthofMarketedProducts
`
`
`
`Ch.
`
`‘91
`SANOFI
`
`WNW
`
`fl"
`
`@ ‘5?W
`
`Lew
`Stren-th of Pipeline
`Source:'GlobaiData
`
`There is a Growing Prevalence of AR Patients
`
`AR is
`
`becoming
`
`an
`
`increasingly
`
`prevalent
`
`condition, with the most common form being
`
`moderate to severe in nature (Baena-Cagnant et
`
`al., 2015). According to the European Academy of
`
`Allergy and Clinical Immunology (EAACI), 50% of
`
`Europeans will suffer from an allergy by 2027
`
`[Papadopoulos
`
`et
`
`al.,
`
`2012). A GlobalData
`
`epidemiological study estimated that about one in
`
`seven people in the US have been diagnosed with
`
`AR at some point in their life, or about 43 million
`
`people. This rate appears to be on the rise, and is
`
`expected to reach over 48 million by 2024.
`
`rising pollen levels is the afforestation policy of
`
`cedar.
`
`cypress,
`
`and birch
`
`trees. which was
`
`introduced during the post—World War ii are {1949—
`
`1954)
`
`to provide a steady supply of domestic
`
`lumber. Today, there are an estimated 4.5 billion
`
`cedar trees in Japan. in addition to the increasingly
`
`prevalent Japanese tree pollen. Asian dust events
`
`occur. where smog laden with fine particles less
`
`than 2.5 micrometers
`
`in diameter, known as
`
`PM2.5, enters Japan through from inland China —
`
`for example.
`
`from the Gobi Desert. where the
`
`yellow dust picks up dirt and pollen and carries it to
`
`South Korea and Japan via the westerly winds.
`
`increasing pollution from this region is contributing
`
`to the AR problem in Japan.
`
`Furthermore, studies have shown that pollen levels
`
`are rising in tandem with global warming. Global
`
`climate change is evidenced by the increasing
`
`average
`
`earth
`
`temperature.
`
`increasing
`
`anthropogenic (caused by humans) greenhouse
`
`gas levels, and elevated pollen levels. Pollutants of
`
`interest include carbon dioxide (002}, ozone (03),
`
`and nitrous oxide {N02). because they can
`
`enhance the allergic
`
`response
`
`and
`
`lead
`
`to
`
`increased
`
`symptoms
`
`of
`
`allergic
`
`respiratory
`
`diseases. Heightened CO; levels stimulate pollen
`
`production
`
`via
`
`photosynthesis
`
`and
`
`increased
`
`growth in multiple investigated plant species (Lin
`
`and Zacharek. 2012). Allergen patterns are also
`
`changing in response to climate change. and air
`
`Allergic Rhinitis - Global Drug Forecast and Market Analysis to 2024
`0;? Grommets This report Is a Ilc'ensctl producl and rs not to be copied. reproduced. Shared CH resctu many form
`
`MEDA_APTX03503462
`
`CIPLA LTD. EXHIBIT 2026 PAGE 5
`
`PTXO397-00005
`
`CIPLA LTD. EXHIBIT 2026 PAGE 5
`
`CIPLA LTD. EXHIBIT 2026 PAGE 5
`
`

`

`GlobalData ))
`
`ALLERGIC RHINITIS —
`GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2024
`
` Executive Summary
`
`
`pollution can modify the allergenic potential of
`
`antihistamines {AHs},
`
`INCS. and oral Ieukotriene
`
`poliens,
`
`especially
`
`undetr
`
`specific weather
`
`conditions. The prevalence of asthma and allergic
`
`receptor antagonists (LRAs). which are also known
`as leukotriene inhibitors and antileukotrienes. [NCS
`
`diseases has increased dramatically during the
`
`and AHs are the gold-standard, first-line therapies
`
`past few decades (D'Amato et at, 2013). This
`
`for AR patients. However, despite
`
`receiving
`
`notion
`
`is
`
`supported by
`
`the
`
`change in
`
`the
`
`maximum doses of evidence-based therapy as
`
`prevalence of AR in the US population, from 10%
`
`directed by the ARIA {Allergic Rhinitis and its
`
`in 1970 to 30% in 2000. It has been postuiated that
`
`impact on Asthma)
`
`guideiines,
`
`a
`
`significant
`
`the changing environment, particularly the trend of
`
`percentage (approximately 20%) of patients with
`
`global warming, may lead to increased pollen
`
`AR, particulady moderate to severe AR, have
`
`exposure and expanded environments for
`
`the
`
`inadequately controlled symptoms {Bousquet et a[.,
`
`growth of numerous plant species. An increase in
`
`2010). Refractory patients are often diagnosed with
`
`the growing season, with earlier flowering and
`
`severe chronic upper airway disease (SCUAD),
`
`possiny increased airborne pollen counts, could be
`
`and represent a therapeutic challenge clinically.
`
`the consequences of the projected rise in the
`
`Furthen'nore, AR is often undiagnosed; in Europe,
`
`earth's temperature
`
`longer and to
`
`as many as 25—60% of patients with AR are not
`
`diagnosed
`
`{Bauchau
`
`and Durham.
`
`2004).
`
`Pollen seasons are set
`
`to last
`
`become
`
`increasingly more
`
`intense.
`
`lf pollen
`
`seasons are going to overlap more frequently, the
`
`severity
`
`of
`
`symptoms
`
`experienced
`
`by
`
`polysensitized patients is set
`
`to increase. This
`
`increase in the AR prevalence will be a strong
`
`driver of the growth of this market, as the AR
`
`patient pool will
`
`increase,
`
`leading to higher
`
`consumption of medications used to treat
`disease.
`
`the
`
`There is a Large Unmet Need for the Treatment
`
`of Severe, Persistent AR That is Refractory to
`
`the Standard Therapies
`
`AR symptoms can be controlled in the majority of
`
`patients using the current standard therapies,
`
`which are based mainly on combinations of
`
`there are considerably high unmet
`Therefore,
`needs within the indication. which are both clinical
`
`and environmental in nature. Overall, these needs
`
`mainly reflect the primary care culture, which often
`
`dismisses AR as a minor condition, despite the
`
`huge
`
`socioeconomic
`
`and morbidity
`
`costs
`
`associated with the disease. This leads to poor
`
`diagnosis,
`
`lack of patient compliance with the
`
`standard therapies,
`related treatment.
`
`and inadequate symptom-
`
`The level of environmental unmet need in AR is
`
`high. Patients and primary care physicians (PCPs)
`
`alike have a low awareness of the impact of AR.
`
`This directly impacts the drug treatment rate, with
`
`many AR patients
`
`not
`
`taking any
`
`therapy.
`
`Allergic Rhinitis -— Global Drug Forecast and Market Analysis to 2024
`'93 GlOt‘J-EiIDEAlEt This [9.00:1 IS 'r'J licensed prOI’Jth‘. {Illd !5 HO! t0 DIE? cop-red. FEPlOdUUt-Ni Shilffifi (Jl' reSot-d IE‘I Bl‘l'y EUII'I'I.
`
`MEDA_APTX03503463
`
`CIPLA LTD. EXHIBIT 2026 PAGE 6
`
`PTXO397-00006
`
`CIPLA LTD. EXHIBIT 2026 PAGE 6
`
`CIPLA LTD. EXHIBIT 2026 PAGE 6
`
`

`

`GlobalData ))
`
`ALLERGIC RHINITIS —
`GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2024
`
` Executive Summary
`
`
`Physicians also often show an underappreciation
`
`There is little room for new entrants. as the market
`
`for the prevalence of mixed rhinitis, which consists
`
`is well-served
`
`by
`
`a wealth of
`
`symptomatic
`
`of a combination of allergic and non-allergic rhinitis
`
`therapies. Since the competition is increasing, the
`
`(NAR), and the challenges involved in its diagnosis
`
`market for AR therapies is becoming increasingly
`
`and treatment. Multiple patient-derived factors,
`
`less
`
`lucrative. Also.
`
`there are
`
`currently
`
`no
`
`combined with
`
`inadequate treatment options,
`
`breakthrough symptomatic therapy products
`
`in
`
`means that the majority of AR patients continue to
`
`clinical development. The remaining clinical unmet
`
`experience symptoms, even though they have
`
`needs in this market include the requirement for
`
`received
`
`treatment
`
`directed
`
`by
`
`the ARIA
`
`more efficacious products, and the underserved
`
`guidelines. Patients are often highly dissatisfied
`
`area
`
`of
`
`causative
`
`therapies,
`
`such
`
`as
`
`with their treatment options, are non-compliant,
`
`and often alternate their prescription medications
`
`with OTC products due to a lack of adequate
`
`efficacy or a perceived reduction in efficacy over
`
`time. Patients often try several medications, with
`
`approximately 75% of patients taking more than
`
`immunotherapies, which target
`cause of the disease.
`
`the underlying
`
`Clinical trials evaluating novel AR treatments are
`
`complicated by several factors,
`
`including variable
`
`allergy testing methods,
`
`fluctuations
`
`in pollen
`
`counts, and the timing and intensity of additional
`
`one symptomatic therapy simultaneously in search
`
`of a medication that actually “works" {Demoly et al.,
`
`2002)
`
`seasonal allergens. This is further complicated
`
`when
`
`assessing
`
`immunotherapies,
`
`as
`
`the
`
`treatment must be initiated prior to the onset of the
`
`Novel Symptomatic Products Will Struggle to
`
`following pollen season. Therefore, subjects are
`
`Enter This Large Genericized Market
`
`enrolled into trials based on their symptoms during
`
`The AR treatment paradigm is well-defined, and
`
`the AR market is mature and highly genericized,
`
`with numerous drug classes that target a number
`
`of nasal symptoms associated with AR. Following
`
`the
`
`high-profile
`
`patent
`
`expiries
`
`of
`
`several
`
`blockbuster drugs marketed
`
`by
`
`the
`
`leading
`
`the previous pollen season, which may vary over
`
`consecutive years and pollen seasons. Variable
`
`weather patterns, and hence fluctuating pollen
`
`counts. have thwarted the efforts of several drug
`
`manufacturers that are developing new treatments
`for AR.
`
`manufacturers in this area, a wealth of inexpensive
`
`Environmental exposure chambers (EECs) create
`
`generic
`
`options
`
`became
`
`available,
`
`both
`
`by
`
`stable and reproducible allergen exposure under
`
`prescription and OTC. As the market
`
`is very
`
`highly standardized environmental conditions, and
`
`saturated,
`
`the average daily cost of therapy is
`
`have been used to assess several AR drugs,
`
`exceedingly low for all the drug classes.
`
`including AHs
`
`such as Allegra
`
`and Claritin
`
`Allergic Rhinitis -— Global Drug Forecast and Market Analysis to 2024
`'93 Gioi‘r-ElIDEAlEl This I'E‘lilfll't IS 'r'J llCeflSL‘fl prouuct {Illd !5 HO! ii'J DIE? copied. FEPlOdUUt-Ni Silllffifi (Jl' issue ll‘l Bl‘l'y EUII'I'I.
`
`MEDA_APTX03503464
`
`CIPLA LTD. EXHIBIT 2026 PAGE 7
`
`PTXO397-00007
`
`CIPLA LTD. EXHIBIT 2026 PAGE 7
`
`CIPLA LTD. EXHIBIT 2026 PAGE 7
`
`

`

`GlobalData ))
`
`ALLERGIC RHINITIS —
`GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2024
`
` Executive Summary
`
`
`[loratadine). However,
`
`this method has been
`
`and Stallergenes will lead the way by introducing
`
`criticized, as it doesn't
`
`reflect
`
`the “real-world”
`
`their
`
`relevant ailergens in tablet
`
`form into the
`
`experience of patients with AR. Further validation
`
`Japanese and US markets
`
`through licensing
`
`of this study method will be required before it gains
`
`partners. Japan, a market previously not widely
`
`acceptance by the European Medicines Agency
`
`(EMA) and the FDA as a sufficient method to
`
`treated with SIT.
`standardized,
`
`is set to see a new range of
`
`clinically-evaluated
`
`products
`
`assess AR drug efficacy and safety.
`
`containing the two most prevalent allergens: HDM
`
`The challenges involved in evaluating novel AT
`
`pipeline agents using the current gold-standard
`
`clinical practices will affect the launch of new AR
`
`drugs, which could ultimately discourage drug
`
`companies from pursuing the development of
`
`pipeline candidates in this space.
`
`The
`
`Market
`
`Entry
`
`of
`
`Approved
`
`Immunotherapies Will Improve the Treatment
`
`Landscape
`
`for
`
`the Difficult-to-Treat AR
`
`Population
`
`One of the few remaining unmet needs in the AR
`
`market is for a causative therapy that is capable of
`
`providing
`
`[ong-tenn relief of
`
`symptoms. The
`
`allergen-specific immunotherapy (SIT) market
`
`is
`
`the clinical development of a new generation of
`
`tabiet form ulations, moving away from the standard
`
`SCIT injections and sublingual
`
`immunotherapy
`
`[SLlT) drops. Tablet formulations that have been
`
`evaluated according to a standardized stepwise
`
`algorithm in dose-finding studies and double-blind,
`
`placebo—controlled
`
`efficacy trials have gained
`
`marketing authorization (MA) via the traditional
`
`routes. These products will
`
`continue to add
`
`legitimacy to immunotherapy as an important
`
`treatment option for patients with AR. ALK—Abello
`
`and Japanese cedar pollen. These treatment
`
`options will
`
`inctude AlT formulations that were
`
`previously
`
`unavailabte
`
`in
`
`the
`
`market.
`
`Advancements in SlT, particularly the advent of
`tablet
`formulations, will
`increase the use of
`
`immunotherapy among the pediatric population.
`
`The introduction of AlTs will drive growth in the AR
`
`market, due to their high cost
`
`reiative to the
`
`standard subcutaneous (SC) allergen extracts,
`
`thereby decreasing the negative impact of
`
`the
`
`growing generlcized market.
`
`What Do Physicians Think?
`
`The key opinion leaders (KOLs)
`
`interviewed by
`
`GlobalData for this report highlighted the need for
`an increase in awareness of the evidence-based
`
`AR treatment
`
`guidelines
`
`among
`
`healthcare
`
`professionals, pharmacists, and patients. which
`
`would ideally lead to an increase in the number of
`
`patients with adequate symptomatic control. The
`current standard medications, such as AH and
`
`lNCS therapies, tackte only the symptoms; KOLs
`
`said they do not expect that novel drugs in these
`
`classes will fulfill this need. The immunotherapies
`
`in development will address these issues to some
`
`Allergic Rhinitis -— Global Drug Forecast and Market Analysis to 2024
`'93 Glob-sitters This l'tFIEFDl-T IS 'r'J “(@1883 product {Ilid !5 HO! tl'J DIE? copied. FEPlOdUUt-Ni Shilffifi (Jl' {ESQ-Ii IE‘I Bl‘l'y EUII'I'L
`
`MEDA_APTX03503465
`
`CIPLA LTD. EXHIBIT 2026 PAGE 8
`
`PTXO397-00008
`
`CIPLA LTD. EXHIBIT 2026 PAGE 8
`
`CIPLA LTD. EXHIBIT 2026 PAGE 8
`
`

`

`GlobalData ))
`
`ALLERGIC RHINITIS —
`GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2024
`
` Executive Summary
`
`
`“i think [the US-based practice parameters, and
`also
`the
`ARM
`
`guidetines}
`
`are
`
`pretty
`
`degree, but only in a very small proportion of AR
`
`sufferers, and they will be very costty.
`
`"There are quite a tot unmet needs [in AR]. First of
`
`aii, if you took at — actuaiiy, the quaiity of tits of
`
`these patients — there‘s stiii a debate.
`
`in reatity,
`
`optimai quatity of tits is reached by no more than
`
`one third of [AR] patients. No more than one third
`
`of our patients. This means that two thirdis] — they
`
`don't have the optimat quaiity of tits. There is stiti
`
`room for improvement And they recentiy did a
`
`survey of many societies, and in reality,
`
`the
`
`patients,
`
`independentiy of the prescription of the
`
`GP [general practitioner} or whatever,
`
`the vast
`
`majority are using two or three different treatments
`
`[at the same time] for the aiiergio rhinitis. This
`
`means that there is 3 tot to investigate, and a tot of
`
`[room for] improvement for treatment. "
`
`comprehensive, and i
`
`think they are iargeiy,
`
`heaviiy evidence-based, which makes it very usefut
`
`for me.
`
`i [have] found them [to be} very good; i
`
`think they are usefui.
`
`i don’t think they are widely
`
`distributed. But personaity, when i
`
`teach about
`
`aitergic rhinitis or research, or give patient care,
`refer to them and use them.”
`
`i
`
`US Key Opinion Leader
`
`“in
`
`the United States,
`
`the
`
`primary
`
`care
`
`doctors...see many, many patients in a day. They
`
`have very iittte time to get educated on {the}
`
`guideiines for [the] muititudes of diseases that they
`
`manage. And for a disease iike attergic rhinitis, the
`
`chances are [that]
`
`they are not up on [the]
`
`guideiines or the guideiine-driven care for it, so
`
`EU Key Opinion Leader
`
`overaii,
`
`in my opinion,
`
`they do a bad job at
`
`[managing] it. "
`
`US Key Opinion Leader
`
`“One of the ways in which we can heip patients
`
`with rhinitis is to promuigate the guideiines. We're
`
`just re-doing the evidence-based guidetines. i think
`
`the promuigetion »—« getting them down to patients,
`
`to GPs, [and] to practice nurses in a way that they
`
`can use them wiii be very heipfui to patients. ”
`
`EU Key Opinion Leader
`
`Allergic Rhinitis -— Globai Drug Forecast and Market Anaiysis to 2024
`'97 Giot‘ielfiala This report IS a licensed product and as no! to be CODE-Ed, reproduces} shared or negate In any form.
`
`L21
`
`MEDA_APTX03503466
`
`CIPLA LTD. EXHIBIT 2026 PAGE 9
`
`PTXO397-00009
`
`CIPLA LTD. EXHIBIT 2026 PAGE 9
`
`CIPLA LTD. EXHIBIT 2026 PAGE 9
`
`

`

`GlobalData ))
`
`ALLERGIC RHINITIS —
`GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2024
`
` Executive Summary
`
`
`“Welt, [in] the [AR] patient population,
`
`in generai,
`
`"Of course,
`
`it
`
`is easier to spend money on
`
`there’s a very significant [percentage] — perhaps
`
`antihistamines and nasai steroids. But the prohiem
`
`40% of patients seen wiii have mixed rhinitis. That
`
`is {that} in the future,
`
`if {the number or? this kind of
`
`is,
`
`they wiii have positive aitergy skin tests, some
`
`patient with severe aiiergic rhinitis increases,
`
`it is
`
`of which are ciinicaiiy significant, but the pathoiogy
`
`possibie that this kind of treatment is not sufficient
`
`underiying their disease is not iimited to aiiergy.
`
`and cannot satisfy the patient. For this reason,
`
`Aithough we ciessity them as having ailergic
`
`immunotherapy and the use at immunothsrapy
`
`rhinitis, they’re reaiiy mixed. So, {this means] that
`
`can, in a way, increase."
`
`they’ii have underiying triggers which are irritants,
`
`such as cigarette smoke. paint
`
`fumes,
`
`Jiand]
`
`weather conditions,
`
`as weti. These
`
`are
`
`the
`
`[Treatment-,1l resistant popuiation; it’s not the pureiy
`
`seasonai aiiergic rhinitis. A person who comes into
`
`this office with tree and grass poiien aiiergy iimited
`
`to the springtime is reaiiy a piece of cake. They’re
`
`very easy to treat. They respond aimost universatiy
`
`to therapy, and they’re not resistant. {Howevenj it’s
`
`a patient who comes into the office that has
`
`positive skin tests, and they also have seasonat
`
`aiiergic rhinitis, but
`
`they have an undertying
`
`pathoiogy rotated to non-aiiergic triggers as weii;
`
`they’re the resistant ones. ”
`
`EU Key Opinion Leader
`
`“We know that about over hatf the patients with
`
`nasai aiiergies never go see a physician; [instead]
`
`they treat it {using products soid] over the counter.”
`
`US Key Opinion Leader
`
`As i mentioned,
`
`the [AR patient} flow is,
`
`they
`
`usuaiiy go first to pharmacists, the second step is
`
`the GP, and the third step is the speciaiist. Usuatiy,
`
`when they come {to the speciaiist], [it's because}
`
`there's a speciai reasons {sic}, or [it’s] because
`
`they have atready got the disease. And, of course,
`
`[it’s] because with the usuai treatments, they don’t
`
`get
`
`the
`
`sufficient benefit,
`
`or because
`
`they
`
`US Key Opinion Leader
`
`specificaiiy want
`
`to have immunotherapy,
`
`for
`
`instance, and this is the {turning} point for them.
`
`EU Key Opinion Leader
`
`Allergic Rhinitis -— Globai Drug Forecast and Market Anaiysis to 2024
`'97 Giot‘ielfiala This report If. 3 “(611883 product and as no! to be copied. reproduces} shares or {Legato in any form].
`
`1E)
`
`10
`
`MEDA_APTX03503467
`
`PTX0397-00010
`
`CIPLA LTD. EXHIBIT 2026 PAGE 10
`
`CIPLA LTD. EXHIBIT 2026 PAGE 10
`
`CIPLA LTD. EXHIBIT 2026 PAGE 10
`
`

`

`GIObaIData ))
`
`ALLERGIC RHINITIS —
`GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2024
`
` Executive Summary
`
`"Ciearin if famiiy doctors cured [AR] patients
`
`enough, [aiiergyj specialists woutd not exist.
`
`[Yet]
`
`we exist stiii. This fact suggests they're [family
`
`doctors] incompetent when prescribing iatiergy]
`
`treatments, [and] are not foiiowing any guideiiries.“
`
`Japanese Key Opinion Leader
`
`Allergic Rhinitis u-Globai Drug Forecast and Market Anaiysis {0.2024
`[st Glob-smals This report is a licensee moons! and IE not to be copied. rapmducsd. shares or msoto‘ in any torn'i.
`
`1 1
`
`11
`
`MEDA_APTX03503468
`
`PTXO397-00011
`
`CIPLA LTD. EXHIBIT 2026 PAGE 11
`
`CIPLA LTD. EXHIBIT 2026 PAGE 11
`
`CIPLA LTD. EXHIBIT 2026 PAGE 11
`
`

`

`GIObaIData ))
`
`ALLERGIC RHINITIS —
`GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2024
`
`
`Table of Contents
`
`
`1
`
`Table of Contents
`
`
`
`2%":
`
`Introensign-
`2.1
`Catalyst ............................................................................................................................. 23
`
`2.2
`
`2.3
`
`Related Reports ................................................................................................................ 24
`
`Upcoming Related Reports ............................................................................................... 24
`
`
`
`
`
`3.1
`
`3.2
`
`3.3
`
`Etiology and Pathophysiology ........................................................................................... 25
`
`Symptoms ......................................................................................................................... 28
`
`Classification ..................................................................................................................... 29
`
`3.3.1
`
`Seasonal and Perennial AR .......................................................................................... 29
`
`3.3.2
`
`ARIA Classification of AR .............................................................................................. 29
`
`3.4 Diagnosrs30
`
`3.5
`
`Quality of Life .................................................................................................................... 32
`
`
`
`4.1
`Disease Background..........................................................................................................33
`
`4.2
`
`Risk Factors and Comorbidities ........................................................................................ 34
`
`4.2.1
`
`A family history of AR is a strong predictor for AR in children and adults ....................... 35
`
`4.2.2
`
`Exposure to allergens in the environment increases the risk for AR .............................. 36
`
`4.2.3
`
`Urban living elevates the risk for AR .............................................................................. 36
`
`Allergic' Rhinitis u-Global' Drug Forecast and Home Analysis «1.262.:
`E; Globalliiata. This report is 3 licenses product and IE not to be copied. reoroduceo. shared or resold in any isri‘n.
`
`12
`
`12
`
`MEDA_APTX03503469
`
`PTXO397-00012
`
`CIPLA LTD. EXHIBIT 2026 PAGE 12
`
`CIPLA LTD. EXHIBIT 2026 PAGE 12
`
`CIPLA LTD. EXHIBIT 2026 PAGE 12
`
`

`

`GIObaIData ))
`
`ALLERGIC RHINITIS —
`GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2024
`
`
`
`Table of Contents -
`
`4.2.4
`
`Comorbidities ................................................................................................................ 37
`
`4.3
`
`Global and Historical Trends ............................................................................................. 39
`
`4.3.1
`
`US ................................................................................................................................. 39
`
`4.3.2
`
`5EU ............................................................................................................................... 40
`
`4.3.3
`
`Japan ............................................................................................................................ 41
`
`4.4
`
`Forecast Methodology ....................................................................................................... 42
`
`4.4.1 SourcesUsed44
`
`4.4.2
`
`Sources Not Used ......................................................................................................... 47
`
`4.4.3
`
`Forecast Assumptions and Methods ............................................................................. 47
`
`4.5
`
`Epidemiological Forecast for AR (2013—2023) .................................................................. 50
`
`4.5.1
`
`Total Prevalent Cases of AR ......................................................................................... 50
`
`4.5.2 Age-Specific Total Prevalent Cases of AR .................................................................... 52
`
`4.5.3
`
`Sex-Specific Total Prevalent Cases of AR ..................................................................... 54
`
`4.5.4 Age-Standardized Total Prevalence of AR .................................................................... 56
`
`4.5.5
`
`Distribution of Total Prevalent Cases of AR by Severity ................................................ 58
`
`4.5.6
`
`Distribution of Total Prevalent Cases of AR by Type ..................................................... 59
`
`4.5.7
`
`Distribution of Total Prevalent Cases of AR Sensitized to Specific Allergens ................. 60
`
`4.6
`
`Discussion ........................................................................................................................ 61
`
`4.6.1
`
`Epidemiological Forecast Insight ................................................................................... 61
`
`4.6.2
`
`Limitations of the Analysis ............................................................................................. 61
`
`4.6.3
`
`Strengths of theAnaiy3|s62
`
`
`
`5.1
`
`Diagnosis and Treatment Overview .................................................................................. 63
`
`Allergic Rhinitis » Global Drug Forecast and Market Analysis b.2024
`[97 Stain-nitrate ThiS report IS El “(61139.5 perJUC‘. Ellid IS [10110 DE! CODE-Ed. prit‘JduCi—Jfi. SHFIEEC} Ul' [IL-230M Ir‘l 3'13! form.
`
`13
`
`13
`
`MEDA_APTX03503470
`
`PTXO397-00013
`
`CIPLA LTD. EXHIBIT 2026 PAGE 13
`
`CIPLA LTD. EXHIBIT 2026 PAGE 13
`
`CIPLA LTD. EXHIBIT 2026 PAGE 13
`
`

`

`GIObaIData ))
`
`ALLERGIC RHINITIS —
`GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2024
`
`Table of Contents
`
`
`-
`
`5.1.1
`
`5.1.2
`
`5.1.3
`
`5.2
`
`5.3
`
`5.4
`
`5.5
`
`5.6
`
`5.7
`
`Diagnosis .........