Trademark Trial and Appeal Board Electronic Filing System. http://estta.uspto.gov
`ESTTA273259
`ESTTA Tracking number:
`03/19/2009
`
`Filing date:
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE TRADEMARK TRIAL AND APPEAL BOARD
`91182731
`Plaintiff
`Glaxo Group Limited
`Glenn A. Gundersen
`DECHERT LLP
`Cira Centre, 2929 Arch Street
`Philadelphia, PA 19104-2808
`UNITED STATES
`erik.bertin@dechert.com
`Opposition/Response to Motion
`Erik Bertin
`trademarks@dechert.com, glenn.gundersen@dechert.com,
`erik.bertin@dechert.com
`/erik bertin/
`03/19/2009
`TINISA Opposers Brief in Opposition to Applicants Motion to Amend Its
`Answer.pdf ( 21 pages )(2167042 bytes )
`
`Proceeding
`Party
`
`Correspondence
`Address
`
`Submission
`Filer's Name
`Filer's e-mail
`
`Signature
`Date
`Attachments
`
`

`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE TRADEMARK TRIAL AND APPEAL BOARD
`
`GLAXO GROUP LIMITED.
`
`Opposer,
`
`V.
`MERZ PHARMA GMBH & CO. KGAA
`
`:
`
`Applicant.
`
`Opposition No. 91 182731
`
`OPPOSER’S BRIEF IN OPPOSITION TO APPLICANT’S
`
`MOTION FOR LEAVE TO AMEND ITS ANSWER
`
`Opposer, Glaxo Group Limited, respectfully submits this brief in opposition to Applicant,
`
`Merz Pharma GMBH & Co. KGAA’s, motion for leave to amend its answer and to extend the
`
`discovery period. Applicant is unjustified in waiting until the last day of discovery to amend its
`
`answer and in seeking to extend discovery. Opposer respectfully requests that the Motion be
`
`rejected or, if the Motion is allowed, that Applicant’s request to further extend the discovery
`
`period be refused.
`
`I.
`
`ALLOWING APPLICANT TO PROCEED WITH ITS PROPOSED
`
`COUNTERCLAIM WOULD BE PREJUDICIAL TO THE OPPOSER
`
`In seeking to amend its answer, Applicant cites TBMP § 507.02, which states that
`
`“Amendments to pleadings should be allowed with great liberality at any stage of the proceeding
`
`where necessary to bring about a fiirtherance ofjustice unless it is shown that the entry of the
`
`amendment would violate settled law or be prejudicial to the rights of any of the opposing
`
`parties.” This very lenient standard makes it easy for the moving party to justify a request to
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`amend its pleadings, and difficult for a party in Opposer’s position to object, even if the amended
`
`pleading has no apparent merit.
`
`

`
`Opposer is concerned that Applicant is using this Motion as a pretext for increasing the
`
`expense and duration of this proceeding, which would be prejudicial to Opposer.
`
`Applicant claims that it filed this Motion “almost immediately after learning of the
`
`grounds in support of such counterclaim.” (Applicant’s Brief (“App. Br.”) at 2.) However,
`
`Applicant’s proposed counterclaim is premised on the fact that Opposer’s initial application
`
`contained a broad identification of goods and that this identification was subsequently amended.
`
`These are the only facts set forth in the proposed counterclaim, although Applicant also notes in
`
`its Motion that Opposer has used a similar identification in its registrations for other marks. (See
`
`Declaration of Sarah Robertson, Exhibit D, Counterclaim for Cancellation W 1, 2.) All of these
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`facts were obvious from the record at the time Applicant filed its original Answer. They did not
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`come to light on the last day of discovery.
`
`Applicant has been pursuing a potential cancellation claim since it first began discovery,
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`even though it did not seek to add that claim until the last day ofthe discovery period. Applicant
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`served Opposer with its discovery requests on July 7, 2008, asking questions and seeking
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`documents concerning Opposer’s bonafide intent to use the mark TYRISA, Opposer’s decision
`
`to amend the identification set forth its application, and other marks Opposer considered for use
`
`in connection with the products described in that application. (See Order dated Mar. 3, 2009 at
`
`3, 4, 1 1, 13-14.) Opposer responded that such discovery was not relevant to the issues presented
`
`in this proceeding, in part, because Applicant had not sought to cancel Opposer’s registration.
`
`Although the Board allowed Applicant to take a limited amount of discovery on the issue of
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`Opposer’s intent, the Board agreed that Opposer’s other marks would not be relevant to this issue
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`and that discovery concerning Opposer’s decision to amend its registration would not be
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`warranted. (See id. at 5, 11, 15.)
`
`

`
`Applicant could have sought to amend its answer early on, which would have saved the
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`time and expense of the dispute over its discovery requests, its subsequent Motion to Compel,
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`and this Motion. Instead, Applicant waited until the last minute, seeking to extend discovery and
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`the burden on Opposer. Applicant claims that if this latest Motion is granted it “will finally have
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`the opportunity to obtain full and fair discovery” on the issue of Opposer’s bonafide intent.
`
`(App. Br. at 7.) However, Applicant has failed to explain why additional discovery “would
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`differ from what has already been produced.” (Mar. 3"‘ Order at 15.)
`
`Applicant claims that Opposer will not suffer any prejudice if Applicant is allowed to
`
`proceed with its counterclaim, because “this proceeding is still at the discovery stage.” '(App. Br.
`
`at 7.) In fact, this is the third time Applicant has asked the Board to extend discovery and the
`
`third time Applicant has waited until the Very end of the discovery period to request an
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`extension.
`
`Applicant is unjustified in waiting until the last day of discovery to amend its answer and
`
`in seeking yet another extension. Opposer respectfully submits that this Motion should be
`
`rejected or, ifthe Motion is allowed, that Applicant’s request to further extend the discovery
`
`period should be refused.
`
`II.
`
`EVEN IF THE BOARD GRANTS THIS MOTION, APPLICANT WOULD NOT
`BE ENTITLED TO THE RELIEF IT HAS REQUESTED
`
`“Where the moving party seeks to add a new claim or defense, and the proposed pleading
`
`thereof is legally insufficient, or would serve no useful purpose, the Board normally will deny
`
`the motion for leave to amend.” See Converse Inc. v. Worldwide Kids Associates, Ltd., 2004
`
`TTAB LEXIS 247, at *7 (TTAB Apr. 29, 2004); see also TBMP § 507.02. That is the case here.
`
`In its proposed counterclaim, Applicant asserts that “[u]pon information and belief,
`
`Opposer did not have a bonafide intent to use the mark TYRISA for all of the goods identified
`
`

`
`in the Application at the time it was filed,” and on that basis Opposer’s registration “should be
`
`deemed invalid.” (See Robertson Decl., Exhibit D, Counterclaim for Cancellation W 3, 4.)
`
`Applicant fails to delineate the burden of proof it would need to satisfy in order to obtain the
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`relief it has requested. Specifically, Applicant would have to prove that Opposer lacked a bona
`
`fide intent with respect to each and evegg medical indication in Opposer’s original identification
`
`of goods.
`
`In The Wet Seal Inc. v. FD Management, Inc. the Board held that “an application will not
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`be deemed void for lack of a bona fide intention to use absent proof of fraud, or proof of a lack
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`of bona fide intention to use the mark on all of the goods identified in the application, notjust
`
`some ofthem.” 82 U.S.P.Q.2d 1629, 1633 (TTAB 2007) (emphasis added). Wet Seal is a
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`precedential decision and in its recent Order the Board ruled that this same standard applies to
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`this case:
`
`The validity of opposer’s entire registration may be challenged (1) on the ground that
`opposer lacked a bona fide intent to use the mark on all the goods listed at the time the
`underlying application was filed, or (2) on the ground of fraud with respect to such a lack
`of bona fide intent to use the mark on all of the goods listed at the time the underlying
`application was filed, i.e. not only did opposer lack bona fide intent to use the mark on all
`the goods, but it nonetheless made its statement of such intent to secure approval by the
`Office of its application} (See Mar. 3rd Order at 5-6 (citing Wet Seal; emphasis added.)
`
`Even if Applicant alleged that Opposer did not have a bonafide intent to use its mark in
`
`connection with some — but not all — of the goods, Applicant would not be entitled to the relief it
`
`has requested. When an opposer alleges that an applicant did not have a bonafide intent to use
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`Applicant has not alleged any fraud claims in this dispute. The word “fraud” is not
`1
`mentioned in the proposed counterclaim, nor does it appear anywhere in Applicant’s motion to
`amend or App1icant’s supporting declaration in support. Even if the proposed counterclaim
`could be construed as a fraud claim, the same burden of proof would apply. In order to cancel
`Opposer’s entire registration Applicant would need to prove that Opposer did not have a bona
`fide intent to use its mark in connection with all of the products listed in its application. (See
`Mar. 3”‘ Order at 6).
`
`

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`the mark “on at least some of the identified goods” the Board “will decide this issue in terms of
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`whether the items, if any, for which opposer has shown app1icant’s lack of bona fide intention to
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`use the mark should be deleted from the application.” See Wet Seal, 82 U.S.P.Q.2d at 1633.
`
`In
`
`other words, even if the opposer satisfies its burden of proof on this issue, the Board will not
`
`void the entire application. Instead, it will delete those goods and services for which no bona
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`fide intent has been shown. Because Wet Seal is a precedential decision, Opposer respectfully
`
`submits that the same rule would apply in this case.
`
`Thus, in order to void Opposer’s entire registration, Applicant would have to prove that
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`Opposer lacked a bonafide intent to use the TYRISA mark with each and every one of the
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`products listed in its identification of goods. If Applicant is unable to prove that Opposer lacked
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`the requisite intent to use the mark for all of these products, Applicant would not be entitled to
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`the relief it has requested. Conversely, Applicant would not be entitled to cancel Opposer’s
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`registration if Opposer produces evidence sufficient to show that it had a bonafide intent to use
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`the TYRlSA mark for one or more ofthe products listed in its application.
`
`Applicant would not be able to present a primafacie case for cancelling Opposer’s
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`registration and it would not be entitled to the relief it has requested, because Opposer already
`
`produced evidence which would be sufficient to rebut this claim. As Applicant admits,
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`Opposer’s annual reports demonstrate that Opposer was in the business of developing
`
`pharmaceutical products for treating a wide range of medical conditions as of Opposer’s June 24,
`
`2004 application filing date. (App. Br. at 5-6.) Likewise, the reports confirm that Opposer was
`
`developing new products in 2003 and 2004 which were being considered for use in treating
`
`cardiovascular diseases, infectious diseases, pain, inflammation, and many of the other medical
`
`

`
`conditions listed in its application. (See excerpts from Opposer’s annual reports, attached hereto
`
`as Exhibit A.)
`
`These reports demonstrate that Opposer had the capability to produce pharmaceutical
`
`products for treating the cardiovascular diseases described in Opposer’s registration for TYRISA
`
`as well as the other medical conditions which were described in its application for that mark.
`
`Applicant claims there is no legal authority that this evidence would be enough in and of itself to
`
`demonstrate Opposer’s bonafide intent.
`
`(App. Br. at 6.) However, in Wet Seal the Board held
`
`that evidence that an applicant “had the capacity to market and/or manufacture” two of the
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`products listed in its application — based on the fact that applicant had produced those products in
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`the past — “would tend to affirmatively rebut any claim by opposer regarding applicant’s intent.”
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`82 U.S.P.Q.2d at 1643 [precedential decision]. Likewise, in Lane Limited v. Jackson
`
`International Trading Company, the Board held that evidence that the applicant’s predecessor-
`
`in-interest had experience marketing and exporting one of the products listed in the application
`
`was “sufficient to establish as a matter of law that applicant possessed the requisite bona fide
`
`intention to use its mark in commerce on [such products].” 33 U.S.P.Q.2d 1351, 1356 (TTAB
`
`1994) [precedential decision].
`
`Even if the Board allowed Applicant to proceed with its proposed counterclaim,
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`Applicant would not be able to cancel Opposer’s entire registration, because Applicant would not
`
`be able to satisfy its burden of proving that Opposer did not intend to use its mark in connection
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`with each and every one of the products described in its application. Likewise, even if Applicant
`
`could prove that Opposer only intended to use its mark in connection with some — but not all — of
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`the products listed in the application, Applicant would not be entitled to the relief it has
`
`requested.
`
`

`
`CONCLUSION
`
`For the foregoing reasons, Opposer respectfully requests that the Board deny Applicant’s
`
`Motion for leave to amend its answer and deny Applicant’s request for an extension of the
`
`discovery period.
`
`Dated: March 19, 2009
`
`Attorneys for Opposer,
`GLAXO GROUP LIMITED
`
`£,z,fiwz:;
`
`Glenn A. Gundersen
`
`Erik Bertin
`
`Kristina M. Case
`
`DECHERT LLP
`
`Cira Centre, 2929 Arch Street
`Philadelphia, PA 19104-2808
`(215) 994-2183
`
`CERTIFICATE OF SERVICE
`
`I hereby certify that a true and correct copy of the foregoing Opposer’s Brief in
`Opposition to Applicant’s Motion for Leave to Amend Applicant’s Answer is being deposited
`with the U.S. Postal Service, postage prepaid, on March 19, 2009 and addressed to the following
`individuals:
`
`Sarah Robertson
`Dorsey & Whitney LLP
`250 Park Avenue
`New York, NY 10177
`
`G. Patrick Sage
`Joanna T. French
`Hueschen and Sage
`Seventh Floor, The Kalamazoo Building
`107 West Michigan Avenue
`Kalamazoo, MI 49007
`
`Z,/L651:-4
`
`Erik Bertin
`
`

`
`Exhibit A
`
`(Excerpts from Opposer’s Annual Reports for 2003 and 2004)
`
`

`
`Annual Report 2004
`
`New challenges
`New thinking
`
` GlaxoSmithl(line
`
`Do more, feel better, live longer
`
`GSK 000781
`
`

`
`14 GlaxoSmithK|ine Description of business
`
`Build the best product pipeline in the industry continued
`
`GlaxoSmithKline's pipeline
`
`The chart below shows GlaxoSmithKllne's new chemical entities (NCE), product line extensions (PLE) and vaccine pipeline evolution for
`projects in the clinic since 2001. It shows increased levels of productivity particularly in Phase ll. This is expected to lead to an increase in
`Phase ill and registrations in the coming years.
`
`Phase I NCEs with multiple indications are only counted once. NCEs in later phases are counted by each indication.
`
` *
`’ NCE Phase llvregistration
`
`i NCE Phase I
`I PLEs
`
`I Vaccines
`
`
`
`26% of pipeline
`
`39% of pipeline
`
`160
`
`120
`
`80
`
`40
`
`0
`
`Product development pipeline
`The product development pipeline, set out on the following three pages shows considerable breadth and depth. At the end of February
`2005, GlaxoSmithK|ine had 195 pharmaceutical and vaccine projects in development, of which 140 are in the clinic comprising 88 new
`chemical entities, 32 product line extensions and 20 vaccines. The content of the drug development portfolio will change over time as new
`compounds progress from discovery to development and from development to the market. Owing to the nature of the drug development
`process, many of these compounds, especially those in early stages of investigation, may be terminated as they progress through
`development. For competitive reasons, new projects in pre-clinical development have not been disclosed and some project types may not
`have been identified.
`
`Key
`(v)
`(p)
`*
`
`l
`5
`A
`
`AL
`MAA
`NDA
`
`Vaccine
`Pharmaccine
`Compounds in Shionogi-GlaxoSmithK|ine Pharmaceuticals
`LLC joint venture
`ln-license or other alliance relationship with third party
`Date of first submission
`Date of first regulatory approval (for MAA, this is the first
`EU approval letter)
`Approvable letter
`Marketing authorisation application (Europe)
`New drug application (USA)
`
`Phase I
`
`Phase II
`
`Phase Ill
`
`Evaluation of clinical pharmacology, usually conducted
`in volunteers
`Determination of dose and initial evaluation of
`efficacy, conducted in a small number of patients
`Large comparative study (compound versus placebo
`and/or established treatment) in patients to
`establish clinical benefit and safety
`
`GSK 000796
`
`

`
`Description of business GlaxoSmithKline
`
`15
`
`Estimated filing dates
`
`Indication
`Phase
`MAA
`NDA
`
`atherosclerosis
`atherosclerosis
`atherosclerosis (also rheumatoid arthritis & COPD)
`prevention of stroke in atrial fibrillation
`atherosclerosis
`dyslipidaemia
`dyslipidaemia
`prevention of thrombotic complications of
`cardiovascular disease & deep vein thrombosis (DVT)
`prophylaxis
`treatment of acute coronary syndrome
`hypertension & congestive heart failure — once daily
`acute heart failure
`prevention of DVT — abdominal surgery
`prevention of DVT — medical conditions
`treatment of DVT
`
`Compound/Product
`
`Type
`
`Cardiovascular, Metabolic & Urogenital
`6S9032i
`Lp—PLA2 inhibitor
`6771 16*
`Lp-PLA2 inhibitor
`681323
`p38 kinase inhibitor
`813893
`factor Xa inhibitor
`4808481’
`I.p-PLA2 inhibitor
`493838
`adenosine AIA agonist
`501516‘
`PPAR delta agonist
`odiparcili
`indirect thrombin inhibitor
`
`synthetic factor Xa inhibitor
`beta blocker
`recombinant B—type natriuretic peptide
`synthetic factor Xa inhibitor
`synthetic factor Xa inhibitor
`synthetic factor Xa inhibitor
`
`Arixtra
`Coreg 09*
`Norataki
`Arixtra
`Arixtra
`Arixtra
`Metabolic projects
`189075*
`
`856464
`677954
`823093
`869682T
`solabegron (427353)
`Avandamet XR
`Avandaryli
`Infectious Diseases
`
`I
`I
`I
`I
`ll
`ll
`ll
`II
`
`Ill
`Ill
`Ill
`Submitted
`Approved
`Approved
`
`2006
`2006
`2005
`N/A
`N/A
`2007
`5:Jul04
`S:lul04
`S:Feb04
`A:.Ian05
`A:NovO4 A:Jun04
`
`I
`
`I
`II
`II
`ll
`ll
`III
`Approvable 2005
`
`2005
`AL:Aug()4
`
`I
`ll
`II
`
`Ill
`III
`III
`
`I
`II
`II
`ll
`Approved
`
`I
`I
`I
`
`Ill
`III
`Ill
`III
`Submitted
`
`Submitted
`Approved
`
`2007
`
`2006
`
`TBD
`
`N/A
`
`2005
`N/A
`2007
`
`2007
`2007
`2007
`2007
`A:Dec04 A:Aug04
`
`2007
`
`2007
`
`2007
`
`2007
`
`2006
`
`2007
`
`2005
`
`2007
`
`2007
`
`2006
`
`2007
`
`S:Dec04
`
`S:Sep04
`
`S:May04
`
`2005
`N/A
`
`S:Jun04
`A:Nov04
`
`GSK 000797
`
`sodium dependent glucose transport
`(SGLT2) inhibitor
`melanin concentrating hormone antagonist
`PPAR pan agonist
`DPP IV inhibitor
`SGLT2 inhibitor
`beta3 adrenergic agonist
`PPAR gamma agonist plus metformin
`PPAR gamma agonist plus sulphonylurea
`
`type 2 diabetes
`
`obesity
`type 2 diabetes
`type 2 diabetes
`type 2 diabetes
`type 2 diabetes (also over-active bladder)
`type 2 diabetes — extended release
`type 2 diabetes — fixed dose combination
`
`topical pleuromutilin
`8-aminoquinoline
`8-aminoquinoline
`
`treatment of respiratory tract infections
`sepsis
`treatment of uncomplicated malaria
`
`bacterial skin infections
`treatment of visceral leishmaniasis
`malaria prophylaxis (adults)
`
`681323
`768975
`856553
`8760081’
`Enteregi
`solabegron (427353)
`270384
`274150
`6836991’
`talnetant
`Avandia
`‘Enteregi
`mepolizumab
`
`p38 kinase inhibitor
`parathyroid hormone agonist
`p38 kinase inhibitor (oral)
`corticotrophin releasing factor (CRFI) antagonist
`peripheral mu-opioid antagonist
`beta3 adrenergic agonist
`endothelial cell adhesion molecule inhibitor
`selective iNOS inhibitor
`dual alphati integrin antagonist (VLA4)
`NK3 antagonist
`PPAR gamma agonist
`peripheral mu—opioid antagonist
`anti-ILS monoclonal antibody
`
`Avandia
`Avodart + alpha blocker
`Avodart
`Boniva/Bonviva
`
`PPAR gamma agonist
`5-alpha reductase inhibitor plus alpha blocker
`5~a|pha reductase inhibitor
`bisphosphonate
`
`Boniva/Bonviva
`
`bisphosphonate
`
`Enteregi
`Vesicarel
`
`peripheral mu—opioid antagonist
`muscarinic antagonist
`
`oral pleuromutilin
`565154
`phospholipid anti-endotoxin emulsion
`2707731’
`chlorproguanil. dapsone + antifolate + artemisinin
`artesunate (CDA)*
`275833
`sitamaquine
`Etaquinel
`Anti-virals
`HIV infections
`DNA antiviral vaccine
`825780?
`HIV infections
`aspartyl protease inhibitor
`640385
`HIV infections
`non-nucleoside reverse transcriptase inhibitor
`695634
`HIV infections
`CCR5 antagonist
`873140?
`HIV infections - combination tablet
`reverse transcriptase inhibitor
`Epzicom/Kivexal
`Musculoskeletal, Inflammation, Gastrointestinal & Urology
`423557'i
`calcium antagonist
`osteoporosis
`4235621"
`calcium antagonist
`osteoporosis
`4627951“
`cathepsin K inhibitor
`osteoporosis & osteoarthritis
`679769
`NKI antagonist
`urinary incontinence (Ul) (also depression & anxiety,
`chemotherapy induced & postoperative nausea
`I
`& vomiting)
`I
`rheumatoid arthritis (also atherosclerosis & COPD)
`I
`osteoporosis
`I
`rheumatoid arthritis (also COPD)
`I
`irritable bowel syndrome (IBS) also depression & anxiety
`I
`IBS
`I
`over-active bladder (also type 2 diabetes)
`ll
`inflammatory bowel disease
`ll
`rheumatoid arthritis (also migraine, asthma)
`ll
`inflammatory bowel disease (also multiple sclerosis)
`II
`IBS (also schizophrenia)
`II
`rheumatoid arthritis
`chronic opiate induced bowel dysfunction & constipation II
`hypereosinophillic syndrome (also asthma & eosinophilic
`esophagitis)
`psoriasis
`benign prostatic hyperplasia — fixed dose combination
`reduction in the risk of prostate cancer
`treatment of postmenopausal osteoporosis
`— intermittent i.v. dosing
`treatment & prevention of postmenopausal osteoporosis Submitted
`— monthly oral dosing
`post operative ileus
`overactive bladder
`
`

`
`16 GlaxoSmithK|ine Description of business
`
`Build the best product pipeline in the industry continued
`
`Compound/Product
`Neurosciences
`
`Type
`
`Indication
`
`Phase
`
`Estimated filing dates
`NDA
`MAA
`
`Histamine H3 antagonist
`endothelin A antagonist
`selective iNOS inhibitor
`gap junction blocker
`dual acting COX-2 inhibitor
`
`dementia
`stroke
`migraine (also rheumatoid arthritis, asthma)
`migraine. epilepsy & neuropathic pain
`acute & chronic pain conditions including neuropathic
`pain (also schizophrenia)
`acute migraine
`vanilloid 1 antagonist
`stroke
`endothelin A antagonist
`schizophrenia 8. dementia
`SHT6 antagonist
`schizophrenia
`mixed SHT/dopaminergic antagonist
`depression 8: anxiety
`NK1 antagonist
`inflammatory pain
`non—cannabinoid CB2 agonist
`corticotrophin releasing factor (C RF1) antagonist depression & anxiety (also I85)
`noradrenaline/dopamine re-uptake inhibitor
`fibromyalgia & neuropathic pain
`non-ergot dopamine agonist
`restless legs syndrome (RLS)
`noradrenaline/dopamine re-uptake inhibitor
`depression
`noradrenaline/dopamine re-uptake inhibitor
`RLS
`triple (5HT/noradrenaline/dopamine) re-uptake
`depression
`inhibitor
`dual acting COX-2 inhibitor
`glycine antagonist
`re-uptake inhibitor
`NK1 antagonist
`
`acute & chronic pain & migraine
`smoking cessation
`
`depression & anxiety (also chemotherapy induced
`& postoperative nausea & vomiting and UI)
`multiple sclerosis (also inflammatory bowel disease)
`
`depression & anxiety
`schizophrenia (also IBS)
`Alzheimer's disease
`bipolar disorder — acute treatment
`neuropathic pain (epilepsy, NDA only) once daily
`schizophrenia
`Parkinson's disease — once daily controlled release
`formulation
`migraine — fixed dose combination
`seasonal affective disorder
`RLS
`depression
`
`189254
`234551 *
`274150
`406725
`644784
`r
`705498
`737004*
`742457
`773812
`823296
`842166
`8760081"
`radafaxine (353162)
`Requip XR
`radafaxine (353162)
`radafaxine (353162)
`372475 (NS2359)*
`
`406381
`468816
`
`679769
`
`683699;’
`vestipltant (597599)
`+ paroxetine
`talnetant
`Avandia
`Lamictal
`Lamictal XR
`Lamictal XR
`Requip CR)‘
`
`Trexima
`Wellbutrin XLf
`Requip
`Wellbutrin XLJI
`
`Oncology
`7439211’
`elacridar
`4971151’
`485232"
`679769
`
`7159921’
`786034
`
`vestipitant (597599)
`
`dual alpha4 integrin antagonist (VLA4)
`
`NK1 antagonist + selective serotonin
`NK3 antagonist
`PPAR gamma agonist
`sodium channel inhibitor
`sodium channel inhibitor
`sodium channel inhibitor
`non-ergot dopamine agonist
`
`5HT1 agonist + naproxen
`noradrenaline/dopamine re-uptake inhibitor
`non-ergot dopamine agonist
`noradrenaline/dopamine re-uptake inhibitor
`
`kinesin spindle protein (KSP) inhibitor
`oral bloenhancer
`thrombopoietin agonist
`recombinant human IL18 immunomodulator
`NK1 antagonist
`
`kinesin spindle protein (KSP) inhibitor
`vascular endothelial growth factor 2
`tyrosine kinase inhibitor
`NK1 antagonist
`
`ethynylcytidinel
`lapatinib
`
`selective RNA polymerase inhibitor
`ErbB-2 and EGFR dual kinase inhibitor
`
`Hycamtin
`Hycamtin
`
`nelarabine
`Hycamtin
`
`topo-isomerase I inhibitor
`topo-isomerase I inhibitor
`
`guanine arabinoside prodrug
`topo—isomerase I inhibitor
`
`I
`I
`I
`I
`I
`
`I
`I
`I
`I
`I
`I
`I
`I
`I
`II
`II
`II
`
`ll
`II
`
`ll
`
`ll
`
`ll
`ll
`Il
`III
`III
`Ill
`III
`
`Ill
`Submitted
`Approved
`Approved
`
`2007
`
`2007
`
`2006
`
`2006
`2007
`
`TBD
`
`TBD
`
`N/A
`2006
`
`2005
`
`N/A
`
`A:JunO4
`2006
`
`2006
`2006
`2007
`2005
`
`2005
`S:Dec04
`A:Dec03
`A:Aug03
`
`2006
`2007
`
`2006
`2007
`
`I
`cancer
`I
`cancer
`II
`thrombocytopaenia
`immunologically-sensitive cancers (melanoma & renal cell) II
`chemotherapy induced & postoperative nausea &
`ll
`vomiting (also depression & anxiety and UI)
`non small cell lung cancer 8: other tumours
`solid tumours
`
`II
`II
`
`postoperative nausea & vomiting (also chemotherapy
`induced nausea & vomiting)
`solid tumours
`breast cancer (also renal, lung, bladder, gastric,
`head & neck cancers)
`ovarian cancer first line therapy
`small cell lung cancer second line therapy
`— oral formulation
`acute lymphoblastic leukaemia & lymphomas
`small cell lung cancer second line therapy
`
`II
`
`II
`Ill
`
`III
`Ill
`
`Ill
`Approved
`
`2006
`
`2006
`
`2006
`2006
`
`2005
`2005
`
`GSK 000798
`
`

`
`Description of business GIaxoSmithKIine
`
`17
`
`Compound/Product
`
`Type
`
`Indication
`
`Phase
`
`Estimated filing dates
`MAA
`NDA
`
`1s93o2*
`642444*
`656933
`681323
`856553
`i59797*
`
`202405
`274150
`5979o1*
`
`678oo7*
`
`685698
`
`766994
`799943
`
`84247o*
`mepolizumab
`
`muscarinic antagonist
`selective INOS inhibitor (oral)
`long acting beta2 agonist
`
`long acting beta2 agonist
`
`glucocorticoid agonist
`
`chemokine 3 (CCR3) antagonist (oral)
`glucocorticoid agonist
`
`PDE IV inhibitor (inhaled)
`anti-IL5 monoclonal antibody
`
`II
`II
`II
`
`II
`
`II
`
`ll
`II
`II
`II
`
`.............................................................................................__
`asthma & chronic obstructive pulmonary disease (COPD)
`long acting beta2 agonist
`asthma & COPD
`long acting beta2 agonist
`COPD
`IL8 antagonist
`COPD (also rheumatoid arthritis & atherosclerosis)
`p38 kinase inhibitor (oral)
`COPD (also rheumatoid arthritis)
`p38 kinase inhibitor (oral)
`COPD, also COPD & asthma in combination with
`long acting beta2 agonist
`a glucocorticoid agonist
`COPD
`asthma, (also migraine & rheumatoid arthritis)
`COPD, also COPD & asthma in combination with
`a glucocorticoid agonist
`COPD, also COPD & asthma in combination with
`a glucocorticoid agonist
`asthma 8: COPD in combination with a long acting
`beta2 agonist (also allergic rhinitis)
`asthma & allergic rhinitis
`asthma & COPD in combination with a long acting
`beta2 agonist
`COPD
`asthma (also hypereosinophillic syndrome and
`eosinophiiic esophagltis)
`2006
`2006
`III
`allergic rhinitis
`2006
`2006
`III
`COPD — mortality claim
`S:AugO4 N/A
`Submitted
`asthma — initial maintenance therapy
`S:Apr04
`N/A
`Submitted
`asthma & COPD — non-CFC inhaler
`AL:Oct03
`Approvable
`COPD
`AL:OCtO 1
`A:JunOO
`Approved
`asthma — non-CFC inhaler
`& OCKOZ
`
`
`Avamys/Allemnist (685698) glucocorticoid agonist
`Seretide/Advair
`beta2 agonist/inhaled corticosteroid
`Seretide
`beta2 agonistfinhaled corticosteroid
`Serevent
`beta2 agonist
`Ariflo
`PDE N inhibitor (oral)
`Seretide/Advair
`beta2 agonistfinhaled corticosteroid
`
`Hepatitis v§EEiné§
`Hepatitis E
`Fendrix Extra Strength
`Hepatitis B
`Paediatric Vaccines
`
`Rotarix
`Streptorix
`N. meningitidis
`combinations
`Priorix—Tetra
`other Vaccines
`
`recombinant
`recombinant
`
`live attenuated — oral
`conjugated
`conjugated
`
`live attenuated
`
`recombinant
`HIV
`subunit
`flu improved
`recombinant
`S. pneumoniae elderly
`recombinant
`Va ricella Zoster
`attenuated tetravalent vaccine
`Dengue fever
`recombinant
`Epstein-Barr virus
`recombinant
`Mosquirix
`Staphylococcal antibodiesi monoclonal antibody
`Cervarix
`recombinant
`Simplirix
`recombinant
`Boostrix
`subunit
`
`Pharmaccines
`
`breast cancer therapeutic
`(Her 2 Neu)
`P501
`mage 3 (249553)
`
`recombinant
`
`recombinant
`recombinant
`
`II
`hepatitis E prophylaxis
`extra strength hepatitis B prophylaxis (pre-haemodialysis Approved
`and haemodialysis patients)
`
`A:Nov04 A:FebO5
`
`rotavirus prophylaxis
`S. pneumoniae disease prophylaxis for children
`meningitis prophylaxis
`
`Ill
`III
`Submitted
`
`2005
`2007
`S:2005
`
`2007
`
`measles, mumps, rubella and varicella prophylaxis
`
`
`
`HIV prophylaxis
`influenza prophylaxis
`S. pneumoniae disease prophylaxis
`Varicella Zoster prevention
`prophylactic use
`EBV prophylaxis
`malaria prophylaxis
`prevention of staphylococcal infections
`prophylaxis of human papillomavirus (HPV) infections
`genital herpes prophylaxis
`adolescent/adult booster for diphtheria, tetanus and
`pertussis
`
`treatment of breast cancer
`
`treatment of prostate cancer
`treatment of lung cancer/melanoma
`
`I
`I
`I
`I
`II
`II
`II
`II
`III
`III
`Approved
`
`I
`
`I
`II
`
`2006
`
`A:Oct00
`
`S:Jun04
`
`GSK 000799
`
`

`
`Description of business GIaxoSmithKIine
`
`25
`
`Products and competition
`
`Pharmaceutical products
`
`Antiwirais
`
`GlaxoSmithKline's principal pharmaceutical products are presently
`directed to nine therapeutic areas. An analysis of sales by these
`therapeutic areas, and a description of the principal products, are
`set out below:
`
`Turnover by therapeutic area
`Respiratory
`Central nervous system
`Anti-virals
`Anti-bacterials/anti-malarials
`Metabolic
`Vaccines
`Oncology and emesis
`Cardiovascular and urogenital
`Other
`
`2094
`Em
`4.415
`3,463
`2.360
`1,561
`1.253
`1,196
`934
`933
`1.031
`17,146
`
`2003
`Em
`4,417
`4,455
`2,349
`1,815
`1,079
`1,123
`1,001
`771
`1,171
`18,181
`
`2002
`£m
`3,987
`4,511
`2,299
`2,210
`960
`1,080
`977
`661
`1,310
`17,995
`
`Products and their versions may not be approved for all indications
`in all markets where they are available.
`
`Respiratory
`Seretide/Advair, a combination of Serevent and Flixotide, offers
`a long-acting bronchodilator and an anti-inflammatory in a single
`inhaler. It is approved for the treatment of asthma and COPD.
`Flixotide/Fiovent and Becotide/Beclovent are inhaled steroids for
`the treatment of inflammation associated with asthma and COPD.
`
`Serevent is a long-acting bronchodilator used to treat asthma and
`COPD, and Ventolin is a selective short-acting bronchodilator used
`to treat bronchospasm.
`
`Flixonase/Flonase and Beconase are intra-nasal preparations for
`the treatment of perennial and seasonal rhinitis.
`
`Centrai nervous system (CNS)
`$eroxat/Paxi/ is a selective serotonin re—uptake inhibitor (SSRI) for
`the treatment of depression, panic, obsessive compulsive disorder,
`post traumatic stress disorder, social anxiety disorder, premenstrual
`dysphoric disorder, and general anxiety disorder.
`
`Wel/butrin is an anti-depressant, available in the USA in normal,
`sustained-release (SR) and once daily formulations.
`
`Imigran/Imitrex is a SHT1 receptor agonist used for the treatment
`of severe or frequent migraine and cluster headache, and has
`become the reference product in this sector. Naramig/Amerge is
`a newer migraine product.
`
`Lamictal, a well established treatment for epilepsy, is now also
`indicated for bipolar disorder.
`
`Requip is a specific dopamine D2/D3 receptor agonist indicated
`for the treatment of Parkinson's disease.
`
`Combivir, a combination of Retrovir and Epivir, has consolidated
`the position of these two reverse transcriptase inhibitors as the
`cornerstone of many multiple anti-HIV product regimens.
`Physician acceptance has clearly demonstrated the value placed
`on minimising the pill burden faced by patients.
`
`Ziagen is a reverse transcriptase inhibitor. The product's potency,
`ease of use and resistance profile allow it to play a significant
`role in a variety of highly active, well tolerated and simplified HIV
`treatment regimens.
`
`Trizivir is a combination of Combivir and Ziagen, combining three
`anti-HIV therapies in one tablet, for twice daily administration.
`
`Epzicom/Kivexa, approved by the FDA in August 2004, is a
`combination of Epivir and Ziagen that is taken as one tablet with
`once-daily closing for Hlv/AIDS in combination with at least one
`other anti-HIV drug.
`
`Lexiva/Telzir is a protease inhibitor for the treatment of Hl\/, that is
`well tolerated and more convenient than Agenerase which it
`supersedes. Lexiva may be taken twice daily or once daily when
`boosted with ritonavir.
`
`Zeffix has been approved for marketing in the USA, Europe, China
`and other markets for the treatment of chronic hepatitis B.
`
`Valtrex is a treatment for episodic genital herpes as well as the
`long term suppression and reduction of transmission of genital
`herpes, zoster (shingles), cold sores and chicken pox. Va/trex
`supersedes Zovirax, which is also used to treat herpes infections.
`
`Antiwbacterials and anti~maiaria§s
`Augmentin is a broad—spectrum antibiotic suitable for the
`treatment of a wide range of common bacterial infections and
`is particularly effective against respiratory tract infections.
`Augmentin ES-600 is an extra strength suspension specifically
`designed to treat children with recurrent or persistent middle ear
`infections. Augmentin XR is an extra strength tablet form for
`adults to combat difficult to treat infections.
`
`Zinnat is an oral antibiotic used primarily for community-acquired
`infections of the lower respiratory tract.
`Malarone is an oral