CENTER FOR DRUG EVALUATION AND .
`RESEARCH
`
`APPLICA TION NUMBER:
`
`NDA 22-253 & 22-254
`
`ADMINISTRATIVE and CORRESPONDENCE
`
`DOCUMENTS
`
`

`

`Food and Drug’Administration
`
`:
`
`I
`
`"re following Is Framed In amrdam With Semi! 505M and 1°) (if the Federal Food, Drum and Come"? Act .
`TRADE NAME (OR PROPOSED TRADE NAME)
`-
`‘
`‘
`
`ACTIVE INGREDIENT(S)
`LACOSAMIDE
`
`STRENGTH(S)
`
`
`
`
`
`
`This patent declaration form is required to be submitted to the Food and Drug Administration (FDA) with an NBA application,
`amendment. or 'sup‘p'temerit as required by 21 'CFR 31453 at the address prOVided In 21' CPR 314.53(d)(4).> ‘
`.-
`-
`.
`'
`'
`'
`'
`Within thirty (30) days after approval of an NBA or supplement, or within thirty (30) days of Issuance of a new patent. a new patent
`declaration masthesummwtnursuant 39 .21 9E9 ,314.-53l91(2i(i9.with 9", 91 the. requires? inlprmatlon based :91! the approvedfipb
`or supplement..The intonn'ationsubmitted in the declaration torm'suhmitted upon 'or after approval; will be the only information relied
`upon by FDA for listing a patentin the Orange Book. '
`‘I
`-~ >
`~
`
`F" hand-Wrifiténdi HEM“??? ‘(él‘sflomflonm ,0? this; report; :ii‘adtiifiqnal.Spaééhfltéiiuwéd '9! €09 nérrntlve_efiswéri.‘(i.e., ”one
`
`thatdoes not require a 'Yes' or "No" responSe). please attach an additionaigp'ag'e referencing the questionnumber. -
`'
`'
`'
`
`
`
`
`
`
`
`
`
`
`
`
` Department oi‘HeaiIhandHumanSeNlces .
`
`’ Forth-Approved: OMB No. 0910-0513
`Exviration. Date: 7/31/06
`-_
`
`See OMB Statement on Page 3.
`
`PATENT INFORMATION SUBMITTED WITH THE
`
`
`NBA NUMBER '
`
`22-253
`FILING OF AN NDA, AMENDMENT, OR SUPPLEMENT
`
`
`NAME OF APPLICANT/ NDA HOLDER
`For Each Patent That Claims a Drug Substance
`
`
`Schwarz Bioecienoes, Inc.
`(Active ingredient), Drug Product (Formulation and
`
`
`
`(wholly-owned subsidiary of Schwarz Pharma AG)
`Composition) and/or Method of Use
`
`
`
`50, 100, 150, 200. 250 & 300 mg Nut—coated tablets
`
`
`FDA will not list patent information if you submit an incomplete patent declaration or the patent declaration indicates the
`patent is not eligible for listing.
`———-—————__._______________________________
`
`For each patent submitted for the pending NDA, amendment, or supplement referenced above, you must submit all the
`information described below. I! you are not submitting any patents for this pending NDA, amendment, or supplement,
`complete above section and sections 5 and 6
`
`a. United States Patent Number
`
`I). Issue Date of Patent
`
`
`
`c. Expiration Date of Patent
`03/17/2017
`
`it. Name of Patent Owner
`
`Address (of Patent Owner)
`
`
`
`City/State
`
`4
`
`
`
`ZIP Code
`85711
`
`FAX Number (liavalhble)
`
`Telephone Number
`(520) 7484400
`Address (of agent or representative named in 1.9.)
`
`E-Mail Address fitavailable)
`
`
`
`
`
`
`
`
`
` 9. Name of e an! or
`resentative who resides or maintains
`
`
`a piece oi business wlthln the United States authorized to
`
`
`receive notice of patent certification under section 505(b)(3)
`
`
`and (i)(2)(B) oi the Federal Food, Drug, and Cosmetic Act
`
`City/State
`and 21 CPR 314.52 and 314.95 ‘(ll patent owner or NDA
`
`
`
`applicant/holder does not reside or have a place at
`
`business within the United States)
`
`
`ZIP Code
`'
`FAX Number (it available)
`I?
`
`
`E-Maii Address (iiavallabie)
`Telephone Number
` t.
`is the patent referenced above a patent that has been submitted previomiy tor the
`‘
`approved MBA or suppIement referenced above?
`If No
`
`9. lithe patent referenced above has been submitted previously for listing. Is the expiration
`
`
`a No
`E Yes
`date a new expiration date?
`'
`
`FORM FDA 3542a (7/03)
`‘
`Page 1
`mmmmnmrn EF
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`D Yes
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`

`

`
`
`7
`
`1
`3
`
`l i lr l l
`
`! l
`
`E i
`
`Forthepatent referencedabove, provide the followinginfomatlonon thedrugsubstance, drug product and/ormethodof
`use that is thesubjecto! the pending NDA, amendment, or supplement.
`
`2.1 Does the patentclaimthe drug substance that is the active ingredientIn the drug product
`described In the pending NDA. amendment, or supplement?
`
`2.2 Does the patent claim a dmg substance that is a different polymorph oi the active
`ingredient described in the pending NDA. amendment, or supplement?
`
`2.3 it the answer to question 2.2 is 'Yes,’ do you certify that, as of the date of this declaration. you have test
`data demonstrating that a drug product containing the poiymorph will perform the same as the drug
`product described in the NBA? The type of test data required is described at 21 CFR 314.58th).
`
`'
`
`2.4 Specify the polymorphic ionn(s) claimed by the patent for which you have the test results described in 2.3.
`The patent claims the form of the drug substance described in the paneling application, among others. and is submitted for listing on that basis.
`Accordingly, no further testing is required.
`
`2.5 Does 'the patent claim 0th ametabolite of the active ingredient pe'n‘fing‘ in the NDA of suppleme’ht’t
`(Complete the iniorrnation in section4.below it the patent claims"a pending method of using thependng
`drug product to' administer the metabolite.)
`'
`..
`,
`.
`
`2.6 Does the patent claim onlyan lnterrrledidté? -'
`
`'
`
`‘
`
`'
`
`‘ ”
`
`2.1‘-imie‘pae.‘neeienceu:mzit-st.producibmaoagpamsmesmegma-mm -
`patent novel? (An answer is‘required only it the patent is a product-by-pmcees patent.)
`
`r
`
`-'
`
`3.1 Does the patent claim the drug product, as defined in 21 CPR 314.3, in the pending NDA,
`amendment. or supplement?
`
`3.2 Does the patent claim only an intermediate?
`
`33 ii the patent referenced in 3.1 is a productby-procees patent, is the product claimed in the
`patent novel? (An answer is required only it the patent is a product-hypnotic: patent.)
`
`
`
`Sponsors must submit the interruption In section 4 separately for each potem claim claiming a method of using the pending drug
`product for which approval is being sought. Foreach method of use claim referenced, provide the following information.-
`4.1 Does the patent claim one or more methods oi use torwhich approval is being sought in
`the pending NDA, amend'nent, or supplement?
`
`D No
`
`Yes
`
`4.2 Claim Number (as listed in the patent) Does the patent claim referenced in 4.2 claim a pending method
`of use for which approval is being sought in the pentfing NDA,
`amendment, or supplement?
`
`Claims "’13
`
`Yes
`
`4.2a If the answer to 4.2 Is
`fifimmfimpa}i'
`to the PM
`i
`labeling for the drug
`W
`
`Use: (Submit indication or method a!useInformation asidenfifled 'speditcaily in theproposed labeling.)
`Treatment of partial-onset seizures as adiunclive therapy in patients with epilepsy aged 16 years and older in
`accordance with proposed labeling. including for example the indications and Usage. Dosage and Administration,
`and Clinical Thais sections.
`Management of neuropethlc pain associated with diabetic peripheral neuropathy and/on
`m in accordance with proposed labeling, including for example the Indications and Usage, Dosage
`and Administrative, and Clinical Trials sections.
`
`For thispending NDA, amendment, or supplement, there are no relevant patents that claim the drug substance (active ingredient), _
`drug product (ionnulation or composition) or methodts) of use, tor which the applicant is seeking approval and with respect to
`which a claim of patent infringement could reasonably be asserted it a person not flcensed by the owner oi the patent engaged in
`the manufacture, use. or sale oi the drug product.
`
`FORM FDA 3542a (7103)
`
`.
`
`'
`
`.
`
`Page 2
`
`

`

`
`
`6.t . The undersigneddeclaresthatthis is an seamen-1a complete submissionofpatent intonnatlon for the NDA,'
`amendment, or supplement pending under section 505 of the Federal Food, Drug, and Cosmetic Act. This time-
`sensltlve patent information is submitted pursuant to 21 CFR 314.53. I attest that l am familiar with 21 OFF? 314.53 and
`this submission complies with the requirements of the regulation. I verify under penalty ofperjury that the foregoing
`is true and correct.
`
`‘
`
`Wamlng: A willfully and knowingly false statement is a criminal offense under 18 u.s.c. 1001.
`
`6.2 Authorized Signature of NDA Applicant/Holder or Patent Owner (Attomey, Agent, Representative or
`olherAuthorized Official) (Provide Information below --<'
`
`Date Signed
`
`a,
`
`,
`
`We’ll/o7
`
`NOTE: Only an NDA applicant/holder may submit this declaration directly to the FDA. A patent owner who is not the NDA applicant!
`holder Is authorized to sign the declaration but may not submit it directly to FDA. 21 CPR 314.53(c)(-‘l) and (d)(4).
`
`box and provide information below.D—NDAApplidnnt/l-toldor___Checka—pileable| ENDAApplicant's/Holder'sAttorney.Agent(Representative)orother
`
`
`
`
`a Patent Owner
`
`Name
`
`4
`.
`_Atnhorlzed Official
`[3 Patent Owner‘s Attomey, Agent (Representative) or Other Authorized
`Official
`
`’
`
`Alan Blumberg,Sr. Director,RegulatoryAtlalre,Schwerz Blosciences, inc.(wholly-owned subeldlery ofSchwarzPharmaAG)
`Address
`‘
`'
`City/State
`_
`'
`P.0. Box 110167
`Research Triangle Park, NC
`
`-
`
`'
`
`Maturation unless it displays a currently valid OMB control number.
`
`ZIP Code
`
`TelephoneNumber
`
`FAX Number fitIavailable)
`
`E-Mail Address (if available)
`
`_—_———————————————_—___—__.____—__—
`
`including the time for reviewing
`The public reporting burden for this collection of information has been estimmd to average 9 hours per mpomc.
`instructions, searching existing data some. gathering and nointaining the data needed. and completing and reviewing the collection of information Send
`commts regarding this burden estimate or any other aspeCt ofthis collection of intonation, including suggestion for reducing this burden to:
`
`Food and Drug Administration
`CDER (HFD-OO‘I)
`56m Fishers Lane
`RochilimMD 20857
`
`An agency may not conduct or sponsor; and a person is not required to respond to, a collection of
`
`FORM FDA 35423 (7’03)
`
`Page 3
`
`-
`
`

`

`
`
`
`
`Form Approved: OMB No. 0910—0513
`Expiration Date: 7/31/06 ~
`
`'
`See OMB Statement on Page 3.
`
`NDA NUMBER '
`'
`
`22-254
`
`
`
`
`
`NAME OF APPLICANTI NDA HOLDER
`
`Sohwerz Blosciences. inc.
`
`(wholly-owned subsidiary of Schwarz Pharma AG)
`
`
`
`
`
`
`Departmentof‘Heaith and Human Services
`-
`-
`
`
`V
`Food and Drug'Administration’ ="
`'
`
`
`g
`
`_
`
`'
`
`'
`
`’
`
`'
`
`PATENT INFORMATION SUBMITTED WITH THE
`FILING OF'AN NDA, AMENDMENT, OR SUPPLEMENT
`For Each Patent That Claims a Drug Substance
`(Active Ingredient), Drug Product (Formulation and
`Composition) and/or Method of Use
`
`.
`
`
`
`
`
`
`
`
`STRENGTHS)
`ACTIVE iNGREDlENT(S)
`10 mg/mL injection
`LACOSAMIDE
`
`
`_ The followingIs provided In accordance with Section 505(b) and (c) _Of. the Federal Food, Drug, and Cosmetic Act. ‘
`TRADE NAME (OR PROPOSED TRADE NAME)
`
`
`
`This patent declaration form is required to be submittedto the Foodand Drug Administration ,(FDA) with an NDA application;
`amendment. or supplement 5's required b'y'21' CFR 314.53 at 'the address-provided in 21 CFR 314.53(d)(4).
`‘
`
`
`Wrthin thirty (30) days after approval of an NDA or supplement, or within thirty (30) days of issuance of a new patent, a new patent-
`
`
`declaration must .bersuhmifiedpursuam 19.21. QEB.31.4.5§(¢)(2)(iii with. all eitherequrred lnionnafienbasedm the approved NDA
`
`
`or Supplement. The information, Submitted [nine declaration form submitted upon or alter ,approvalwill. bethe- only information relied
`
`upon by FDA torlis'tinga patent in the Orange Book.
`..
`
`
`For handwnrren‘ot ‘tyoéWritér'iiérsrén's‘ (duly) stints ,‘rép'o’rrz. ll additional space is'jr'equiréufrdr: any-narrows answer (re; one
`
`
`
`
`thalidoes not require a ”Yes" or-No' response), please attach‘an‘additionél page rereren'e'ing the question number. "~-
`'
`'
`
`
`
`"For each patent submitted for the pending NDA, amendment, or supplement referenced above, you must submit all the
`infonrratlon described below. If you are .not submitting any patents for this pending AIDA, amendment, or supplement,
`complete above section and sections 5 and 6.
`-
`
`
`
`D
`a. United States Patent Number
`b. issue Date oi Patent
`
`
`g.
`om
`03/171201?
`
`
`
`d. Name of Patent Owner
`Address . (of Patent Owner)
`Research Corporation Tecimologles, Inc.
`101 North Wiimot Road 5 Suite 600
`
`
`
`
`City/State
`Tucson. AZ
`
`ZIP Code
`FAX Number (iiavallable)
`
`8571 1
`
`Telephone Number
`E-Mail Address (Ifavailable)
`(520) 748-4400
`
`
`
`9. Name of a out or
`resentative who resides or maintains
`
`
`Address (of agent or representative named In 1.9.)
`
`a place at business within the United States authorized to
`
`
`receive notice of patent certification under section 505(b)(3)
`
`
`and (i)(2)(B) otthe Federal Food, Drug, and Cosmetic Act
`City/State
`
`and 21 (FR-314.52 and 314.95 (It patent owner or NDA
`
`
`
`applimntihoiderdoes not reside or have a place of
`
`business within the United States)
`
`
`ZIP Code
`‘
`FAX Number (if available)
`
`
`W
`
`
`
`Telephone Number
`E-Mail Address (ifavailahle)
` t.
`
`
`is the patent referenced above a patent that has been submitted previously for the
`approved NDA or supplement referenced above?
`a Yes
`No
`
`
`9. if the patent referenced above has been submitted previously tor listing, is the expiration
`date a new expiration date?
`.
`FORM FDA 3542a (7103)
`
`‘
`
`Q Yes
`
`g No
`
`Page 1
`mud-“(sorrmmo a!
`
`

`

`For the patent referenced above, provide the followinginformation on thedrug substance, drug product and/ormethod of
`use that is the su iect'of the.pendingNDA, amendment; or supplemen
`'-
`
`2.1 Does the patentclaim the drug substance that is the active ingredient in the drug product
`described in the pending NDA, amendment,or supplement?
`
`2.2 Does the patent claim a drug substance that is a different polymorph oi the active
`ingredient described in the pending NDA, amendment, or supplement?
`
`2.3 lithe answer to question 2.2 is 'Yes,’ do you certify that. as of the date of this declaration, you have test
`data demonstrating that a drug product containing the poiymorph will perform the same as the dmg
`product described inhthe NBA? The type of test data required ls described at 21 CFR 314.53(b).
`
`2.}1 Specify the polymorphic tonn(s) claimed by the patent lot which you have the test results described in 2.3.
`The patent claims the term of the dmg substance described in the pending application, among others. and is submitted for listing on that basis.
`Aooordngly. no further testing is required.
`
`.. ' " "
`'the'p'eteiit'daiinoiily a'mé't‘aho’lit‘e‘oi tiieaciive... haemanieeaa‘narntne NBA'or'supplement?’" ‘
`
`2.5‘ Does‘" ‘
`
`(Complete the information in section4 below it the[patentclaimsapendingmethod atusing the pending
`drug product to administer the metabolite.)
`‘
`
`' ‘
`
`A
`
`' U 'I '
`
`H J " U"
`
`'
`
`'
`
`2.6 Does the patent claim only an' intermediate?
`
`2.7 time patent-'ier'eianeéd in 2.119 a'brb’ctiicrpyprooess"' ' pérbnr,‘ is tir'e‘productciaimed it me‘ *
`
`patent novel? (An answer is. required only it the patent is a product-by-procees patent.)
`
`‘
`
`"
`
`ed.
`
`3.1 Does the patent claim the drug product. as defined in 21 CFR 314.3, in the pending NDA,
`amendment. or supplement?
`
`3.2 Does the patent claim only an intermediate?
`
`3.3 lithe patent relerenced in 3.1 is a product-by-process patent, is the product claimed in the
`patent novel? (An answer Is required only if the patent is a product-by-process patent.)
`
`
`
`Sponsors must submit the lnlonnetion In section 4 separately for each patent claim claiming a method of using the pending drug
`product for which approval is being sought. For each method of use claim referenced, provide the lollowlng lnfonnatlon:
`4.1 Does the patent claim one or more methods oi use tor which approval is being sought in
`the pending NDA, amendment. orsupplement?
`
`D No
`
`4.2 Claim Number (as Ir’siedin the patent) Does the patent claim referenced in 5.2 claim a pending method
`oi use for which approval is being sought in the pending NDA,
`emenmient, or supplement?
`
`Claims 1 1'13 ‘
`
`Yes
`
`a No
`
`4.2a It the answer to 4.2 is
`'Yes,‘ Identity with speci-
`ticity the use with reier-
`once to the proposed
`labeling for the drug
`product.
`
`Use: (Submit indication or method of use information asidenfilied specifically in theproposed labeling.)
`.
`‘
`.
`.
`Treatment of partial-onset seizures as adjunctlva therapy in patients wrth epilepsy aged 16 years and older rn
`accordance with proposed labeling. Including for example the indications and Usage, Dosage and Administration.
`and Clinical Trials sections.
`
`5."11’ Relevant Patents
`Forthis pending NDA, amendment,orsupplement, there are norelevant patentsthat claim the dmg substance (active ingredient),
`drug product (formulation or oomposlflon) or methodis) of use. for which the applicantIS seeking approval and with respect to
`which a claim of patent infringement could reasonably be asserted it a person not licensed by the owner of the patent engaged in
`the manufacture. use. or sale of the drug product.
`
`FORM FDA 3542a (7103)
`
`Page 2
`
`«we—W...
`
`

`

`
`
`6-1 The undersigned declares that! this ‘Is an accurate and corhpiete submission'ofpatent infonnstlon.tor the NBA” "
`amendment, or supplement pending under section 505 of the Federal Food, Drug, and Cosmetic Act. This time-
`sensitive patent inforrhation is submmed pursuant to 21 CFR 314.53. Iattes't that Iam familiar with 21 CFR 31453 and
`this submission compiles with the requirements of the regulation. I verify under penalty of perjury that the foregoing
`Is true and correct.
`
`Warning: A willfully and knowingly false statement is a criminal offense under 18 0.5.c. 1001. '
`
`6.2 Authorized Signature of NBA Applicanm-lolder or Patent Owner (Attorney, Agent, Representative or
`other Authorized Official) (Provide information below)
`
`Date Signed
`
`a '
`
`9AM”
`
`NOTE: Only an NBA applicant/holder may submit this declaration directly to the FDA. A patent owner who is not the NDA applicant!
`holder is authorized to sign the declaration but may not submit it directly to FDA. 21 CFR 314553(c)(4) and (d)(4).
`
`Check applicable box and provide lntormatlon below.
`
`‘
`
`END/swimmer
`
`..
`
`a PatentOwner
`
`Narne'
`
`INQAAPP'ieamislflQldfifISAtiomey.Agent(Rénresmhfive)oromer
`Authorized Official- ~
`-
`E Patent Owner‘s Attorney, Agent (Representative) or OtherAuthorized
`Official
`.
`
`V
`
`Nan Numbers. Sr. Qirprtormesulatew Affairs. sewer; Entrances. Inc. (whoilyovvned swears! “mil. FiremaAG).
`Address
`..
`.
`t
`..
`.
`,
`.
`.
`.
`.
`"'CityIState
`P.O.Box110167
`ResearchTrianglePatk, NC
`
`-
`
`...
`
`r‘ry‘bnnation unless it displays a currently valid OMB control number.
`
`zrpoode
`27709
`
`’
`
`'
`
`.
`
`FAX Number (If available)
`(919) 767-3139
`
`I
`
`Telephom'neNumber-
`(919) 767-2513
`
`,
`
`II
`
`,
`
`.
`
`E-Mall Address (If available)
`alan.blumberg@ucbvgroup.oom
`
`‘
`
`I
`
`'
`
`.
`
`V
`
`'
`
`including the time for reviewing
`The public reporting burden for this collection of information has been estimated to average 9 hours per mpome,
`instructiom, searching existing data sources, gathering and maintaining the data needed, and countleting and reviewing the collection of information. Send
`comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to:
`
`Food and Drug Administration
`CDER (RFD-007)
`5600 Fishers Lane
`Rockville. MD 10857
`
`An agency may not conductor sponsor. and aperson is not required to respond to. a collection of
`
`FORM FDA 35423 (7]03)
`
`-
`
`Page 3
`
`

`

`EXCLUSIVITY SUMMARY
`
`NDA # 22-253 & 22-254
`
`SUPPL #
`
`7
`
`HFD # 120
`
`Trade Name Vimpat Tablets & Injection
`
`Generic Name lacosamide
`
`Applicant Name. Schwarz Biosciences, Inc.
`
`Approval Date, If Known 10/28/08
`
`PART I
`
`IS AN EXCLUSIVITY DETERMINATION NEEDED?
`
`1. An exclusivity determination will be made for all original applications, and all efficacy
`supplements Complete PARTS II and III of this Exclusivity Summary only ifyou answer "yes" to
`one‘or more of the following questions about the submission
`
`a) Is it a 505(b)(l), 505(b)(2) or efficacy supplement?
`
`YES
`
`NO El
`
`Ifyes, what type? Specify 505(b)(1), 505(b)(2), SE1, SE2, SE3,SE4,_ SE5, SE6, SE7, SE8
`
`505(b)(l) original NDAs
`
`c) Did it require the review ofclinical data other than to support a safety claim or change1n
`labeling related to safety? (If it required review only of bioavailability or bioequivalence
`data, answer "no ")
`
`YES E]
`
`NO [I
`
`Ifyour answer is "no" because you believe the Study is a bioavailability study and, therefore,
`not eligible for exclusivity, EXPLAIN why it is a bioavailability study, including your
`reasons for disagreeing with any arguments made by the applicant that the study was not
`simply a bioavailability study.
`
`If it is a supplement requiring the review of clinical data but it is not an effectiveness
`supplement, describe the change orclaim that is supported by the clinical data:
`
`Page 1
`
`

`

`d) Did the applicant request exclusivity?
`
`YES
`
`NO D
`
`If the answer to (d) is "yes," how many years of exclusivity did the applicant request?
`
`5 years
`
`e) Has pediatric exclusivity been granted for this Active Moiety?
`YES E]
`
`NO
`
`If the answer to the above question in YESa is this approval a result of the studies submitted in
`response to the Pediatric Written Request?
`
`IF YOU HAVE ANSWERED "NO" TO ALL OF THE ABOVE QUESTIONS, GO DIRECTLY TO
`THE SIGNATURE BLOCKS AT THE END OF THIS DOCUMENT.
`
`2. Is this drug product or indication a DESI upgrade?
`
`YES |:|
`
`NO X]
`
`IF THE ANSWER TO QUESTION 2 IS "YES," GO DIRECTLY TO THE SIGNATURE BLOCKS
`ON PAGE 8 (even if a study was required for the upgrade).
`
`PART II
`FIVE-YEAR EXCLUSIVITY FOR NEW CHEMICAL ENTITIES
`(Answer either #1 or #2 as appropriate)
`
`1. Single active ingredient product.
`
`Has FDA previously approved under section 505 of the Act any drugrproduct containing the same
`active moiety as the drug under consideration? Answer "yes" if the active moiety (including other
`esterified forms, salts, complexes; chelates or clathrates) has been previously approved, but this
`particular form ofthe active moiety, e.g., this particular ester or salt (including salts with hydrogen or
`coordination bonding) or other non-covalent derivative (such as a complex, chelate, or clathrate) has
`not been approved. Answer "no" if the compound requires metabolic conversion (other than
`deesterification of an esterified form of the drug) to produce an already approved active moiety.
`
`YES [:|
`
`NO IX}
`
`If "yes," identify the approved drug product(s) containing the active moiety, and, ifknown, the NDA
`#(s).
`
`Page 2
`
`

`

`NDA#
`
`NDA#
`
`NDA#
`
`2. Combination product.
`
`If the product contains more than one active moiety(as defined in Part II, #1), has FDA previously
`approved an application under section 505 containing a_ny % of the active moieties in the drug
`product? If, for example, the combination contains one never-before-approved active moiety and
`one previously approved active moiety, answer "yes." (An active moiety that is marketed under an
`OTC monograph, but that was never approved under an NDA, is considered not previously
`approved.)
`E]
`[Z
`
`YES
`
`NO
`
`If "yes," identify the approved drug product(s) containing the active moiety, and, ifknown, the NDA
`#(s).
`
`NDA#
`
`NDA#
`
`NDA#
`
`IF THE ANSWER TO QUESTION 1 OR 2 UNDER PART 11 IS "NO," GO DIRECTLY TO THE
`SIGNATURE BLOCKS ON PAGE 8.
`(Caution: The questions in part II of the summary should
`only be answered “NO? for original approvals of new molecular entities.)
`IF “YES,” GO TO PART III.
`
`PART III
`
`THREE-YEAR EXCLUSIVITY FOR NDAs AND SUPPLEMENTS
`
`To qualify for three years of exclusivity, an application or supplement must contain "reports ofnew
`clinical investigations (other than bioavailability studies) essential to the approval ofthe application
`and conducted or sponsored by the applicant." This section should be completed only ifthe answer
`to PART H, Question 1 or 2 was "yes."
`
`1. Does the application contain reports of clinical investigations? (The Agency interprets "clinical
`investigations" to mean investigations conducted on humans other than bioavailability studies.) If
`the application contains clinical investigations only by virtue of a right of reference to clinical
`investigations in another application, answer "yes," then skip to question 3(a). If the answer to 3(a)
`is "yes" for any investigation referred to in another application, do not complete remainder of
`
`Page 3
`
`

`

`summary for that investigation.
`
`YES
`
`[I
`
`NO [:1
`
`IF "NO," GO DIRECTLY TO THE SIGNATURE BLOCKS 0N, PAGE 8.
`
`2. A clinical investigation is "essential to the approval" if the Agency could not have approved the
`application or supplement without relying on that investigation. Thus, the investigation is not
`essential to the approval if 1) no clinical investigation is necessary to support the supplement or
`application in light of previously approved applications (i.e., information other than clinical trials,
`such as bioavailability data, would be sufficient to provide a basis for approval as an ANDA or
`505(b)(2) application because ofwhat is already known about a previously approved product), or 2)
`there are published reports of studies (other than those conducted or sponsored by the applicant) or
`other publicly available data that independently would have been sufficient to support approval of
`the application, without reference to the clinical investigation submitted in the application.
`
`(a) In light ofpreviously approved applications, is a clinical investigation (either conducted
`by the applicant or available from some other source, including the published literature)
`necessary to support approval of the application or supplement?
`YES |:|
`
`NO [:1
`
`If "no," state the basis for your conclusion that a clinical trial is not necessary for approval
`AND GO DIRECTLY TO SIGNATURE BLOCK ON PAGE 8:
`
`(b) Did the applicant submit a list ofpublished studies relevant to the safety and effectiveness
`ofthis drug product and a statement that the publicly available data would not independently
`support approval of the application?
`
`YES [I
`
`NO [:1
`
`(1) If the answer to 2(b) is "yes," do you personally know of any reason to disagree
`with the applicant's conclusion? If not applicable, answer NO.
`
`YES [:1
`
`NO |:|
`
`If yes, explain:
`
`(2) Ifthe answer to 2(b) is "no," are you aware ofpublished studies not conducted or
`sponsored by the applicant or other publicly available data that could independently
`demonstrate the safety and effectiveness of this drug product?
`
`YES [I
`
`NO [:1
`
`Page 4
`
`

`

`If yes, explain:
`
`(c)
`
`Ifthe answers to (b)(1) and (b)(2) were both "no," identify the clinical investigations
`submitted in the application that are essential to the approval:
`
`Studies comparing two products with the same ingredient(s) are considered to be bioavailability
`studies for the purpose of this section.
`’
`
`3. In addition to being essential, investigations must be "new" to support exclusivity. The agency
`interprets "new clinical investigation" to mean an investigation that 1) has not been relied on by the
`agency to demonstrate the effectiveness ofa previously approved drug for any indication and 2) does
`not duplicate the results of another investigation that was relied on by the agency to demonstrate the
`effectiveness of a previously approved drug product, i.e., does not redemonstrate something the
`agency considers to have been demonstrated in an already approved application.
`
`a) For each investigation identified as "essential to the approval," has the investigation been
`relied on by the agency to demonstrate the effectiveness of a previously approved drug
`product? (If the investigation was relied on only to support the safety of a previously
`approved drug, answer "no.")
`
`Investigation #1
`
`Investigation #2
`
`YES |:|
`
`NO Ij
`
`YES E]
`
`NO [:1
`
`Ifyou have answered "yes" for one or more investigations, identify each such investigation
`and the NDA in which each was relied upon:
`
`b) For each investigation identified as "essential to the approva ", does the investigation
`duplicate the results of another investigation that was relied on by the agency to support the
`effectiveness of a previously approved drug product?
`
`Investigation #1
`
`Investigation #2
`
`YES D
`
`NO D
`
`YES [3
`
`NO El
`
`Page 5
`
`

`

`If you have answered "-yes" for one or more investigation, identify the NDA in which a
`similar investigation was relied on:
`
`. c) If the answers to 3(a) and 3(b) are no, identify each "new" investigation in the application
`or supplement that is essential to the approval (i.e., the investigations listed in #2(c), less any
`that are not "new" :
`'
`
`4. To be eligible for exclusivity, a new investigation that is essential to approval must also have
`been conducted or sponsored by the applicant. An investigation was "conducted or sponsored by"
`the applicant if, before or during the conduct ofthe investigation, 1) the applicant was the sponsor of
`the IND named in the form FDA 1571 filed with the Agency, or 2) the applicant (or its predecessor
`in interest) provided substantial support for the study. Ordinarily, substantial support will mean
`providing 50 percent or more of the cost of the study.
`
`a) For each investigation identified in response to question 3(0): if the investigation was
`carried out under an 1ND, was the applicant identified on the FDA 1571 as the sponsor?
`
`! !
`
`! NO [I
`! Explain:
`
`!
`!
`
`1 NO D
`! Explain:
`
`Investigation #1
`
`V
`
`IND #
`
`YES [3
`
`Investigation #2
`
`IND#
`
`-
`
`YES El
`
`(b) For each investigation not carried out under an IND or for whiCh the applicant was not
`identified as the sponsor, did the applicant certify that it or the applicant's predecessor in
`interest provided substantial support for the study?
`'
`
`Page 6
`
`

`

`l !
`
`!NO|:I
`! Explain:
`
`l!
`
`1 NO El
`!
`Explain:
`
`Investigation #1
`
`YEslj
`Explain:
`
`Investigation #2
`
`YES [I
`Explain:
`
`(c) Notwithstanding an answer of "yes" to (a) or (b), are there other reasons to believe that
`the applicant should not be credited with having "conducted or sponsored" the study?
`(Purchased studies may not be used as the basis for exclusivity. However, if all rights to the
`drug are purchased (not jiIst studies on the drug), the applicant may be considered to have
`sponsored or conducted the studies sponsored or conducted by its predecessor in interest.)
`
`YES [I
`
`NO El
`
`If yes, explain:
`
`Name of person completing form: Jacqueline H. Ware, PharmD
`Title: Supervisory Regulatory Health Project Manager
`Date: 11/18/08
`
`Name of Office/Division Director signing form: Russell Katz, M.D.
`Title: Director, Division of Neurology Products, ODEl, CDER
`
`Form OGD-Ol 1347; Revised 05/10/2004; formatted 2/15/05
`
`Page 7
`
`

`

`-----n--_-------------------—--------—---___—---------—--------------------------------—--_-_------—----------------
`
`This is a representation of an electronic record that was signed electronically and
`this page is the manifestation of the electronic signature.
`---------------------------------------------------------------------------------------------------------------------
`
`Russell Katz
`
`11/21/2008 07:53 :34 AM
`
`

`

`
`Module 1
`
`Lacosamide
`
`Exclusivity Reguest ‘
`
`CONFIDENTIAL
`
`31 August 2007
`
`1
`
`EXCLUSIVITY REQUEST
`
`In accordance with 21 CPR § 314.500), Schwarz claims five years of new chemical entity
`exclusivity under 21 CPR § 314.108(b)(2) for lacosamide, the active moiety that is the subject
`of NDAs 22,253; 22,254; and 22,255.
`
`Schwarz requests five years of marketing exclusivity for lacosamide, and, pursuant to 21 CPR
`§ 314.500)(3), certifies that, to the best of the company’s knowledge, no drug product containing
`lacosamide has previously been approved under section 505(b) of the Federal Food, Drug and
`Cosmetic Act.
`
`Page 1
`
`

`

`PEDIATRIC PAGE
`(Complete for all filed original applications and efficacy supplements)
`
`NDA/BLA#: 22-253' 22-254
`
`Supplement Number:
`
`NDA Supplement Type (e.g. SE5):
`
`
`Division NamezDivision of
`Neurology Products
`
`Proprietary Name:
`
`Vim at
`
`PDUFA Goal Date: 10/28/08
`
`Stamp Date: 9/25/07
`
`Established/Generic Name: Lacosamide
`
`Dosage Form:
`
`Tablets & lniection
`
`Applicant/Sponsor:
`
`Schwarz Bioscience
`
`lndication(s) previously approved (please complete this question for supplements and Type 6 NDAs only):
`
`(.1)
`(2) _
`(3) __
`
`
`(4)
`
`Pediatric use for each pediatric subpopuiation must be addressed for each indication covered by current
`application under review. A Pediatric Page must be completed for each indication.
`
`Number of indications for this pending application(s):1
`(Attach a completed Pediatric Page for each indication in current application.)
`
`Indication: Adiunctive treatment of partial onset seizures
`
`l
`Q1: Is this application in response to a PREA PMC/PMR? Yes I:I Continue
`
`If Yes, NDA/BLA#: _
`
`Supplement #:
`
`.
`
`No (X Please proceed to Question 2.
`
`
`PMC/PMR #:__
`
`Does the division agree that this is a complete response to the PMC/PMR?
`I:I Yes. Please proceed to Section D.
`I] No. Please proceed to Question 2 and complete the Pediatric Page, as applicable.
`
`02: Does this application provide for (If yes, please check all categories that apply and proceed to the next
`question):
`
`(a) NEW [XI active ingredient(s) (includes new combination); [I indication(s); 1:] dosage form; I] dosing
`regimen; or [:1 route of administration?