`
`GROSS
`LINGUAL
`
`CROSSLINGUAL, LLC
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`Saishin no shinyaku_2001
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`CROSSLINGUAL, LLC
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`before me, EM-2 $30335 KQVQE l’~—’&K-‘L.
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`Page 1 of 11
`
`DAVID STURROCK
`COMM. #2019014
`
`..'M;»
`
`NOTARY PUBLIC .cAuroRNiA§
`co
`2017;
`'h’uV1%h
`
`5
`
`SENJU EXHIBIT 224-8
`
`LUPIN V. SENJU
`IPR20l5-01100
`
`
`
`
`
`
`PROPEKTY OF THE
`
`NATIONAL
`LIBRARY OF
`
`MEDICINE
`
`r
`"N .
`av-
` _
`
`
`Yakuji Nippo Limited
`
`
`I
`
`Page 2 of 11
`
`Sankm no sh:n'yaku New drugs in Japan.
`2001
`General COIICCUOFI
`QV 7'72 8132
`2001-09-07 1357 43
`
`
`
`Maw [Drug fim1fl@g@@£m
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`n
`
`'.-ar5-‘,',_
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`'_‘.;
`
`Yakuji Nippo Edition
`Year 2001 Edition
`
`
`
`Preface to “New Drugs in Japan 2001”
`
`During the half-century since 1949, “New Drugs in Japan” has annually collated, edited and published
`information on newly approved and newly marketed pharmaceuticals (for prescription and non-prescription use) in
`the broadest possible scope.
`On the occasion of the 50th anniversary of the inaugural issue in 2000, the character of a “new drug yearbook”
`introducing pharmaceuticals newly put on the market during the previous year was more sharply defined, and a new
`start was made by updating listing methods, classifications, and appearance, as well as enlarging the format to B5-
`size. “New Drugs in Japan 2001” — the second volume since the relaunch — is an introductory new drug yearbook
`which collects, classifies, and arranges in the broadest possible scope the new drugs (for prescription and non-
`prescription use) that were approved and newly marketed during the previous year (2000) within Japan.
`The editorial guidelines are as follows.
`1. Classification method
`Listed pharmaceuticals are broadly classified into: I. pharmaceuticals containing new active ingredients (new
`substances) (excluding new administration routes and new standards); II. newly marketed prescription drugs
`(excluding the pharmaceuticals containing new active ingredients of I); and III. non-prescription drugs. Prescription
`drugs are arranged by pharmacoefficacy classification in conformity with the Japan Standard Commodity
`Classification (June 1990 Revision), and non-prescription drugs broadly conform to the order of the “Standards for
`manufacturing (importation) approval of non-prescription drugs” with suitable adjustments.
`2. Listing system
`With respect to pharmaceuticals containing new active ingredients, not only are package inserts (including
`reference literature) recorded for the pertinent pharmaceuticals, but also the development background,
`reexamination period, basis for drug price calculation, and so on.
`With respect to other prescription drugs, there is listing of efficacy/effects, usage,/dosage, foreign name of
`pertinent product, regulation, manufacturing (import sales) origin / sales (marketing) origin, approval date, sales
`initiation date, date of price listing, price standard listing pharmaceutical code, and packaging, and this is done by
`unit of generic name classified/arranged in the order of pharmacoefficacy classification.
`Beginning with this issue, we have created a page for introducing pharmaceuticals with newly added efficacies
`(prescription drugs that have been given added efficacy during January-December 2000).
`With respect to non-prescription drugs, there is listing of manufacturing (import sales) origin / sales (marketing)
`origin, approval date, sales initiation date, product characteristics, ingredients and quantities, additives, usage/dosage,
`and packaging,
`3. Descriptive content
`“Cautions for use” pertaining to pharmaceuticals containing new active ingredients are in principle recorded as
`in the description of the package insert, and are omitted with respect to other new drugs. The method of referring to
`back issues of this publication was discontinued. The so-called commentary which had been included up to the 50th
`issue is not included in the editing of package insert compliance documentation.
`
`
`As described above, this publication was created as a “new drug yearbook” of what was newly approved and
`marketed over a one-year period, and we await the comments and requests of all our readers with respect to this
`volume.
`This volume was edited based on the studies and information gathering conducted by our company with respect
`to the various pharmaceutical manufacturing / sales (marketing) companies. Hereafter, we will request a still greater
`number of pharmaceutical companies to cooperate with our studies.
`Finally, we would like to express our deep gratitude to all our readers and all the pharmaceutical companies that
`have cooperated with our studies over this past half-century to the present, and to Tohoku University Honorary
`Professor Mitsuru Ozawa who has written for us over the half century since the inaugural issue, and who also
`provided useful advice on the occasion of this edition.
`We appeal for the cooperation and support of everyone as we seek to further enhance this publication.
`
`May 2001
`
`Yakuji Nippo Limited
`
`– i –
`
`
`
`Page 3 of 11
`
`
`
`Acitazanolast Hydrate
`
`(Remarks)
`Product characteristics
`(1) It is an ophthalmic solution of Acitazanolast which is
`an in viva activating metabolite of the oral anti-
`allergic agent Tazanolast.
`
`(2) Improves subjective and objective symptoms such as
`pruritus and conjunctival chemosis due to allergic
`conjunctivitis.
`(3) Inhibits release of platelet-activating factors (PAF),
`histamine. leukotriene B4, leukotriene D4 (in vitro;
`rat. guinea pig).
`
`Bromfenac sodiu hydrate
`
`J an Standard Co 871319 Classlficanon No
`Non-steroidal antr—inflarnmatory ophthalmic agent
`Bronuck ophthalmic solution — Bronuck (Instructions) (Notations) Senju Pharmaceutical. Co. (manufacture) /
`Takeda Pharmaceutical Co. (marketing)
`j Drug price listed
`- March 10.2000
`Jul 3,2000
`Ma 2,2000
`
`Drug price code
`13197431025
`
`2l200AMZ00l68
`
`
`3
`
`[Development Background]
`With respect to treatment of ocular inflammation.
`both steroidal ophthalmic agents and non-steroidal anti-
`inflammatory drug (NSAID) ophthalmic agents are
`currently in general use. However. compared to steroidal
`ophthalmic agents.
`there are fewer types of NSAID
`ophthalmic agents. and options are limited. Thus.
`development of NSAID ophthalmic agents having broad
`eflicacy and strong anti-inflarnmatory action relative to
`inflammatory ailments of the external eye and anterior
`eye is desirable.
`Bromfenac sodium hydrate. which is the active
`ingredient of Bronuck
`ophthalmic
`solution, was
`discovered by the A. H. Robins Co. (now the Wyeth-
`Ayerst Co.) as a novel NSAID that powerfirlly inhibits
`production of prostaglandin which is an inflammatory
`mediator. By modifying bromine at the 4"‘ position of the
`benzoyl group of Amfenac, which is the basic skeleton.
`this drug strives to reinforce anti-inflammatory action
`and sustain analgesic action.
`Focusing on this strong prostaglandin production
`inhibiting action. Senju Pharmaceutical Co.. Ltd.
`proceeded with development of this drug from 1987.
`Bronuck ophthalmic solution was approved in March
`2000 as a symptomatic therapeutic agent that is effective
`with two ocular instillations per day with respect to
`blepharitis.
`conjunctivitis.
`scleritis
`(including
`episcleritis), and postoperative inflammation.
`[Reexamination Period] 6 years
`
`[Contraindications (do not administer to the following
`patients)]
`
`ingredients of this drug
`
`Patients with a previous history of hypersensitivity to the
`
`Co 1:
`
`- sition / Pro - erties
`
`Ingredients / content Bromfenac sodium hydrate 1 mg
`in 1 ml
`
`Boric acid. borax, dry sodium
`sulfite. sodium edetate, povidone.
`polysorbate 80, benzalkonium
`chloride
`
`[Eflicacy / Effects]
`Symptomatic treatment of inflammatory ailments of
`external
`eye
`and
`anterior
`eye
`(blepharitis,
`the
`conjunctivitis,
`scleritis
`(including episcleritis),
`and
`postoperative inflammation)
`[Usage I Dosage]
`Ordinarily. 1-2 drops per administration, and 2
`ocular instillations per day.
`[Cautions for Use]
`1. Important Basic Cautions
`(1)Keeping in mind that
`treatment by this drug is
`symptomatic treatment rather than causal treatment.
`and that
`it
`is reported that serious liver damage
`(including death) has been observed in patients
`subjected to long-term administration of 1 month or
`more with the oral agent of bromfenac sodium.
`continuous administration for 4 weeks or more is not
`
`conducted in principle. Although the aforementioned
`adverse effects observed with the foreign oral agent
`were due to long-term administration exceeding the
`approved usage
`and dosage.
`sales have been
`voluntarily suspended.
`(2)As there is risk that eye infection may become
`subclinical, in case of use on inflammation resulting
`from infection. administration is to be conducted
`carefully with adequate observation.
`
`Page 4 of 11
`
`_27_
`
`
`
`Novel Substances 0 Dmgs Affecting Sensory Organs
`
`Inucln--nu
`
`I0‘
`
`_§
`5 Io:
`g
`§
`3 not
`
`2
`% 1o :
`as
`
`2. Adverse Effects
`
`At the time of approval. adverse effects had been
`observed in 16 out of a total of 423 cases (3.78%).
`With respect to the content of adverse effects, there
`were
`3 cases of blepharitis
`(0.71%),
`3
`cases of
`conjunctival hyperemia (0.71%), 3 cases of stinging
`(0.71%). 3 cases of ocular pain (temporary) (0.71%).
`2 cases of comeal
`inflammation (0.47%).
`1 case of
`conical epithelial abrasion (0.24%). 1 case of superficial
`punctate
`keratitis
`(0.24%),
`1
`case of
`follicular
`conjunctivitis (0.24%), 1 case of prulitus (0.24%), and 1
`case of buming sensation (eyelids) (0.24%) (at the time
`of approval).
`The following adverse effects were observed in the
`foregoing study.
`0.1% to less than 5%
`
`hyperemia,
`conjunctiva]
`blepharitis,
`Ocular*
`stinging. ocular pain (temporary), corneal inflammation,
`corneal epithelial abrasion, superficial punctate keratitis,
`follicular conjunctivitis, pmritus, and buming sensation
`(eyelids)
`*When manifested. administration is suspended.
`3. Administration to Pregnant, Parturient, and
`Nursing Women
`Administration is to he conducted to pregnant
`woman or women who may have conceived and to
`women who are nursing only when it is judged that the
`benefits of treatment outweigh the risks.
`(The safety of administration during pregnancy and
`lactation has not been established.)
`4. Administration to Children
`
`Safety relative to children has not been established
`(there is little experience with use).
`5. Cautions for Use
`
`(l)Administration route: only to be used for ocular
`instillation
`
`(2) At time of administration: during ocular instillation,
`take care so that the lip of the container does not
`directly contact the eye.
`[Pharmacokinetics]
`(Reference)
`Intraocular Migration <rabbits>1)
`In testing wherein ocular instillation of 0.05 mL of
`0.1% “C-bromfenac sodium hydrate ophthalmic solution
`was conducted once a day is both eyes of rabbits. and
`radioactivity was measured afier 15 minutes, 30 minutes.
`and 1. 2. 4, 8, 32, 24. 48. and 72 hours. elevated values
`were observed in the cornea. conjunctiva, and anterior
`sclera.
`At 72 hours after ocular instillation. all ocular tissue
`except for the lens was below the detection limit (0.1 ng
`eq./g or ml).
`
`, . C
`_
`o-o : conjunctiva
`
`0-0 I Anlaiorsdera
`0-41 : Antcriorvitteoushnmor
`---A tIBlood
`s.\\\\\\\ : -Belowdetection limit
`"=3
`
`N“/1
`
`"'
`
`.‘
`
`
`
`5
`
`"-
`\\ \\\\Nl\\\\'e-\\‘...] -\ ;.-w-n.\- .\..-
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`4
`‘
`o
`:2
`24
`¢o(lIouIs)
`flours alter ocuhr instillation
`
`°‘ '
`o
`
`[Clinical Results]
`A summary of results with respect to 291 cases
`including double-blind comparative testing are shown in
`the table.
`
`For the most part. daily dosage and administration
`period were
`1
`drop per
`administration
`and
`2
`administrations per day over a 2-week period.
`Table. Clinical Effects b Ailment
`
`eflectiveness
`
`[Pharmacoefficacy and Pharmacology]
`1. Pharmacological Action
`(1) Anti-inflammatory action relative to experimental
`conjunctiva] chemosis in rats”
`It was observed that Bronuck ophthalmic solution
`exhibited
`anti—inflammatory
`action
`relative
`to
`experimental acute conjunctiva] chemosis in rats
`induced by arachidonic acid and carageenin.
`(2) Inhibitory effects relative to increases in aqueous
`humor protein concentration in rabbits after anterior
`chamber paracentesis or after laser irradiationz)
`It was observed that Bronuck ophthalmic solution almost
`completely inhibited increases in aqueous humor protein
`concentration
`in
`rabbits
`afier
`anterior
`chamber
`
`paracentesis or after laser irradiation.
`2. Mechanism of Action
`
`iris-ciliary bodies” and bovine
`In tests using rabbit
`seminal vesicles. it was confirmed that inhibitory action
`was exhibited against production of prostaglandin
`inflammatory mediators via cyclooxygenase (in vitro).
`[Physicochemical
`Findings Relative
`to Active
`Ingredients]
`Generic name: Bromfenac Sodium Hydrate (JAN)
`
`Page 5 of 11
`
`-23-
`
`
`
`Dorzolamide Chloride
`
`Chemical name: sodium 2-amino-3-(4-bromobenzoyl)
`phenylacetate sesquihydrate
`Molecular formula: C15H11BrNNaO3 · 1½ H2O
`Molecular weight: 383.17
`Structural formula:
`
`
`Properties: Bromfenac Sodium Hydrate is an odorless
`crystalline powder of yellow-orange color.
`It is freely soluble in water, soluble in methanol, slightly
`soluble in ethanol anhydride, and practically insoluble in
`acetonitrile or ether.
`[Packaging]
`5 mL × 10, 5 mL × 50
`[Principal Literature]
`1) Mitsuyoshi Isaka et al : Pharmacokinetics, 14 (1) 32, 1999
`2) Takahiro Ogawa et al : Journal of Japan Ophthalmology Society, 99, 406, 1995
`[Storage Method] Room temperature storage
`[Expiration] To be used by the expiration date displayed
`on the exterior package (even before expiration, to be
`used promptly after opening).
`
`
`
`●According to package insert prepared in May 2000
`[Drug Price] 0.1% 1 mL 139.00 yen, price
`determination by comparable drug (comparable drug:
`Niflan ophthalmic solution (Pranoprofen))
`[Comments]
`Product Characteristics
`to
`respect
`(l) Efficacy has been confirmed with
`inflammatory ailments of the external eye and the
`anterior eye (efficacy rate 77.3%)
`(2) Anti-inflammatory action is exhibited against post-
`operative inflammation, and it inhibits occurrence of
`aqueous humor protein (flare).
`(3) Remission of symptoms is observed by the third day
`of administration with respect
`to
`inflammatory
`ailments of the external eye.
`(4) Anti-inflammatory action is exhibited with respect to
`experimental conjunctival chemosis
`(rats) end
`experimental post-operative inflammation (rabbits).
`(5) Cyclooxygenase is blocked, and production of PG
`inflammatory mediators beginning with prostaglandin
`(PG) E2 is inhibited (rabbit, bovine in vitro).
`(6) Efficacy is observed with 2 ocular instillations per
`day.
`
`
`
`– 29 –
`
`Page 6 of 11
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`Page 11 of 11