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Future Pharmaceutical Trends - PowerPoint Presentation

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Future Pharmaceutical Trends - PPT Presentation

Future Pharmaceutical Trends Patent amp Pipeline Chris Peterson PharmD Aimee Tharaldson PharmD Patent Expiration Overview 20112013 Traditional Pipeline Highlights Specialty Pipeline Overview ID: 765310

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Future Pharmaceutical Trends- Patent & Pipeline – Chris Peterson, PharmD Aimee Tharaldson, PharmD

Patent Expiration Overview: 2011-2013Traditional Pipeline HighlightsSpecialty Pipeline Overview Objectives 2

Patent Expiration Overview: 2011-2013Traditional Pipeline HighlightsSpecialty Pipeline Overview Objectives 3

Patent Expiration Landscape $ Billion 4

Patent Expiration LandscapeNext 5 Years $ Billion 5

Patent Expiration LandscapeNext 5 Years $ Billion Cymbalta OxyContin Niaspan Nexium Celebrex Actonel Abilify Gleevec Namenda 6

Patent Expirations: 2011 7 Drug Manufacturer Patent Sales (US) Taxotere Sanofi Mar 1 5 $1,200 Xalatan Pfizer Mar 22 $711 Concerta * J&J May 01$1,437 Femara Novartis Jun 03 $682 Nasacort AQ*SanofiJun 15$244 LevaquinJ&JJun 20$1,523 ArixtraGSKExpired$340UroxatralSanofiJul 18$248 Combivir*ViiV4Q2011$328 ZyprexaLillyOct 23$2,958 Solodyn (45, 90, 135)*MedicisNov 01$667 Lipitor*PfizerNov 30$7,245 * Settlement Agreement

Patent Expirations: 2011 8 Drug Manufacturer Patent Sales (US) Taxotere Sanofi Mar 1 5 $1,200 Xalatan Pfizer Mar 22 $711 Concerta * J&J May 01$1,437 Femara Novartis Jun 03 $682 Nasacort AQ*SanofiJun 15$244 LevaquinJ&JJun 20$1,523 ArixtraGSKExpired$340UroxatralSanofiJul 18$248 Combivir*ViiV4Q2011$328 ZyprexaLillyOct 23$2,958 Solodyn (45, 90, 135)*MedicisNov 01$667 Lipitor*PfizerNov 30$7,245 * Settlement Agreement

Patent Expirations: 2012 9 Drug Manufacturer Patent Sales (US) Avandia * GSK 1Q2012 $342 Lexapro* Forest Mar-14 $2,812 Seroquel AstraZeneca Mar-26 $5,172 Avapro BMS Mar-30 $486 Provigil* Cephalon Apr-01 $1,133 PlavixBMSMay-17$6,130 Clarinex*MerckJul-01$248 Tricor*AbbottJul-01$1,345 SingulairMerckAug-03$4,073 Actos*TakedaAug-17$3,535 Xopenex neb*SunovionAug-20$545 GeodonPfizerSep-01$1,281 DiovanNovartisSep-21$3,533 Detrol Pfizer Sep-25 $790 Atacand AstraZeneca Dec-04 $199 * Settlement Agreements

Patent Expirations: 2012 10 Drug Manufacturer Patent Sales (US) Avandia * GSK 1Q2012 $342 Lexapro* Forest Mar-14 $2,812 Seroquel AstraZeneca Mar-26 $5,172 Avapro BMS Mar-30 $486 Provigil* Cephalon Apr-01 $1,133 PlavixBMSMay-17$6,130 Clarinex*MerckJul-01$248 Tricor*AbbottJul-01$1,345 SingulairMerckAug-03$4,073 Actos*TakedaAug-17$3,535 Xopenex neb*SunovionAug-20$545 GeodonPfizerSep-01$1,281 DiovanNovartisSep-21$3,533 Detrol Pfizer Sep-25 $790 Atacand AstraZeneca Dec-04 $199 * Settlement Agreements

Patent Expirations: 2012 11 Drug Manufacturer Patent Sales (US) Avandia * GSK 1Q2012 $342 Lexapro* Forest Mar-14 $2,812 Seroquel AstraZeneca Mar-26 $5,172 Avapro BMS Mar-30 $486 Provigil* Cephalon Apr-01 $1,133 PlavixBMSMay-17$6,130 Clarinex*MerckJul-01$248 Tricor*AbbottJul-01$1,345 SingulairMerckAug-03$4,073 Actos*TakedaAug-17$3,535 Xopenex neb*SunovionAug-20$545 GeodonPfizerSep-01$1,281 DiovanNovartisSep-21$3,533 Detrol Pfizer Sep-25 $790 Atacand AstraZeneca Dec-04 $199 * Settlement Agreements

Patent Expirations: 2012 12 Drug Manufacturer Patent Sales (US) Avandia * GSK 1Q2012 $342 Lexapro* Forest Mar-14 $2,812 Seroquel AstraZeneca Mar-26 $5,172 Avapro BMS Mar-30 $486 Provigil* Cephalon Apr-01 $1,133 PlavixBMSMay-17$6,130 Clarinex*MerckJul-01$248 Tricor*AbbottJul-01$1,345 SingulairMerckAug-03$4,073 Actos*TakedaAug-17$3,535 Xopenex neb*SunovionAug-20$545 GeodonPfizerSep-01$1,281 DiovanNovartisSep-21$3,533 Detrol Pfizer Sep-25 $790 Atacand AstraZeneca Dec-04 $199 * Settlement Agreements

Patent Expirations: 2012 13 Drug Manufacturer Patent Sales (US) Avandia * GSK 1Q2012 $342 Lexapro* Forest Mar-14 $2,812 Seroquel AstraZeneca Mar-26 $5,172 Avapro BMS Mar-30 $486 Provigil* Cephalon Apr-01 $1,133 PlavixBMSMay-17$6,130 Clarinex*MerckJul-01$248 Tricor*AbbottJul-01$1,345 SingulairMerckAug-03$4,073 Actos*TakedaAug-17$3,535 Xopenex neb*SunovionAug-20$545 GeodonPfizerSep-01$1,281 DiovanNovartisSep-21$3,533 Detrol Pfizer Sep-25 $790 Atacand AstraZeneca Dec-04 $199 * Settlement Agreements

Patent Expirations: 2013 14 Drug Manufacturer Patent Sales (US) Propecia * Merck Jan-01 $154 Opana ER* Endo Jan-01 $369 Reclast Novartis Mar-02 $405 Zometa Novartis Mar-02$768 Valcyte Genentech Mar-15 $289 OxyContinPurdueApr-16$3,085 ZomigAstraZenecaMay-14$200 AcipHexEisaiMay-18$1,055 TemodarMerckAug-11$389 Advicor*AbbottSep-20$111 Niaspan*AbbottSep-20$1,129 CymbaltaLillyDec-11$3,153 * Settlement Agreement

Patent Expirations: 2013 Drug Manufacturer Patent Sales (US) Propecia * Merck Jan-01 $154 Opana ER* Endo Jan-01 $369 Reclast Novartis Mar-02 $405 Zometa Novartis Mar-02 $768 Valcyte Genentech Mar-15 $289 OxyContinPurdueApr-16$3,085 ZomigAstraZenecaMay-14$200 AcipHexEisaiMay-18$1,055 TemodarMerckAug-11$389 Advicor*AbbottSep-20$111 Niaspan*AbbottSep-20$1,129 CymbaltaLillyDec-11$3,153 * Settlement Agreement15

Patent Expiration Overview: 2011-2013Traditional Pipeline HighlightsSpecialty Pipeline Overview Objectives 16

Cardiovascular Pipeline Xarelto ( rivaroxaban – Bayer/J&J) Indication: Stroke/systemic embolism in a-fib. Route: Oral (once daily) Comments: Approved July 1, 2011. Also under FDA Review for a-fib indication (Nov. 5, 2011). Eliquis ( apixaban – BMS/Pfizer) Indication: Stroke/systemic embolism in a-fib. Route: Oral (twice daily)Comments: Submission of NDA by the end of 2011 with FDA approval in 2012. 17

FDA Action Dates: Cardiovascular Drug Manufacturer Use Action Date Simvastatin / sitagliptin Merck DM/Lipids Oct 17 Xarelto ( rivaroxaban ) Bayer/J&J A-Fib (new indication) Nov 5Azilsartan/chlorthalidoneTakedaHypertensionDec 23Eliquis (apixaban)BMS/PfizerA-Fib 2012ethyl icosapentate (AMR101)Amarinhypertriglyceridemia2012Kynamro (mipomersen) Genzyme/ISISHyperlipidemia2012 18

Diabetes Pipeline Dapagliflozin (AstraZeneca/BMS) Indication: Type 2 diabetes Route: Oral (two times daily) Comments: FDA Ad Board held on July 19. FDA action date is October 28, 2011. Bydureon ( exenatide LAR – Amylin /Lilly) Indication: Type 2 diabetes Route: subcutaneous injection (once weekly)Comments: “Complete response” received in March 2011. FDA action date is January 28, 2012. 19

Diabetes Pipeline Insulin Degludec (Novo-Nordisk) Indication: Diabetes Route: Subcutaneous injection (three times weekly) Comments: Long-acting basil insulin. Submission planned by the end of 2011. 20

FDA Action Dates: Diabetes Drug Manufacturer Use Action Date Simvastatin / sitagliptin Merck T2DM/Lipids Oct 17 Dapagliflozin BMS/AZ Diabetes Oct 28 Janumet XR Merck Type 2 diabetes Nov 11 AlogliptinTakeda Type 2 diabetesJan 26Alogliptin/pioglitazoneTakedaType 2 diabetesJan 26Bydureon Lilly/ Amylin Type 2 diabetesJan 28Insulin decludecNovo NordiskDiabetes2012Pioglitazone/sitagliptinMerckType 2 diabetes201221

Respiratory Pipeline Eklira ( aclidinium – Forest) Indication: COPD Route: Inhalation (twice daily) Comments: FDA Action date is Apr 30, 2012. Glycopyrronium (NVA237 – Novartis) Indication: COPD Route: Inhalation (once daily) Comments: NDA submission planned by the end of 2011. 22

FDA Action Dates: Respiratory Drug Manufacturer Use Action Date Dymista Meda Allergic Rhinitis Feb 4 Omnaris HFA Nasal Sunovion Allergic rhinitis Apr 06 Eklira Forest COPD Apr 30 QNaze TevaAllergic RhinitisMay 24glycopyrronium (NVA237)NovartisCOPD2012 23

CNS Pipeline Opana ER ( oxymorphone e.r . – Endo) Indication: Chronic pain Route: Oral (Twice daily) Comments: “Tamper resistant” formulation. FDA Action date is Dec 13, 2011. Remoxy ( oxycodone e.r . – Pfizer) Indication: Chronic painRoute: Oral (Twice daily)Comments: “Tamper resistant” formulation. Complete response issued in in June. 24

CNS Pipeline Levomilnacipran (Forest) Indication: Depression Route: Oral (once daily) Comments: Isomer of milnacipran ( Savella ). NDA by expected “early 2012”. 25

CNS Pipeline Levadex ( dihydroergotamine - MAP) Indication: Acute migraine Route: Inhalation Comments: Asthma-sized inhaler device. F DA Action date is Mar 26, 2012. 26

FDA Action Dates: CNS Drug Manufacturer Use Action Date Onfi Lundbeck Seizures 4 th Quarter CPI-300 IntelGenx Depression Nov 13 Opana E.R. (TR) Endo Pain Dec 13 Fentanyl SL SprayInsysPainJan 4 AdasuveAlexzaAgitationFeb 4LevadexMAPMigraineMar 26MoxDuoQRxPharmaPainMay 11IPX066 Impax Parkinson’s disease 2012 LevomilnacipranForestDepression2012TelcagepantMerckMigraine201227

FDA Action Dates: Other Drug Manufacturer Use Action Date Saflutan Merck Glaucoma 4Q2011 Alendronate, effervescent EffRx Osteoporosis Nov 11 Bio-T Gel Teva HRT Nov 14 Plan B One Step (OTC) Teva Contraceptive Dec 7AnturolAntarex Overactive Bladder Dec 8CivanexWinstonOsteoarthritisDec 31Ivermectin CreamTopazHead LiceFeb 7Prochieve WatsonPreterm Birth Feb 26 Avanafil Vivus Erectile dysfunctionApr 30LinaclotideForestChronic ConstipationJun 928

Patent Expiration Overview: 2011-2013Traditional Pipeline HighlightsSpecialty Pipeline Overview Objectives 29

FDA New Drug Approvals 30 Traditional Specialty Source : U.S. Food and Drug Administration

Specialty Trend Continues to Dwarf TraditionalPMPY Annual Trend 31 Source: Express Scripts ’ Drug Trend Report data and Forecasting Specialty Traditional

Top Specialty Therapy Classes PMPY 2010 PMPY $22 $30 $37 Source : Express Scripts’ Drug Trend Report data

Therapy Class ReviewInflammatory Conditions Multiple Sclerosis Cancer Hepatitis C Cystic Fibrosis Other Drugs to Watch 33

Inflammatory ConditionsPipeline TrendsOral biologics will compete with injectables More therapies for gout? “ Biobetters ” on the horizon 34

Inflammatory ConditionsPipeline 35 Drug (Manufacturer) Indication Route Approval Orencia * (BMS) RA (new SQ) SQ Approved Humira * (Abbott) Ulcerative Colitis SQ Feb 2012 Apremilast ( Celgene ) Psoriasis, PAOral2012Tofacitinib (Pfizer)RA, PsoriasisOral2012Arcalyst* (Regeneron)GoutSQ2012Ilaris* (Novartis)Gout SQ2012Benlysta* (HGS / GSK)Lupus (new SQ)SQ2013Fostamatinib (Rigel / AZ)RAOral2013INCB-28050 (Incyte / Lilly)RAOral 2013 RA = Rheumatoid Arthritis; PA = Psoriatic Arthritis *Already on the market for another indication or different route

Oral Biologics Apremilast ( Celgene ) Indication: Psoriasis, Psoriatic Arthritis Route: Oral (twice daily) Comments: Inhibits inflammatory cytokines; Approval in 2012 for psoriasis Tofacitinib (Pfizer) Indication: Rheumatoid Arthritis, Psoriasis Route: Oral (twice daily) Comments: Inhibits JAK; Approval in 2012 for RA 36RA = Rheumatoid ArthritisJAK = Janus Kinase

Gout Ilaris ( canakinumab - Novartis) Indication: Treatment and prevention of acute gout Route: SQ Injection Comments: Negative Ad Board, CRL in August Arcalyst ( rilonacept - Regeneron ) Indication: Treatment and prevention of acute gout Route: SQ InjectionComments: Approval in 2012?- Both already on market for CAPS - 37 CRL = Complete Response Letter; CAPS = Cryopyrin-Associated Periodic Syndromes

Multiple Sclerosis Pipeline Trends More oral disease-modifying drugs May see combination use of MS drugs Expanded MS use for currently marketed drugs 38

Multiple Sclerosis Pipeline 39 Drug Manufacturer Route Approval BG-12 Biogen Idec Oral 2012 Laquinimod Teva / Active Biotech Oral 2012 Lemtrada * Genzyme IV 2012 TeriflunomideSanofiOral2012Zenapax*Biogen Idec / AbbottSQ2012TovaxinOpexaSQ2013Peg-Avonex Biogen IdecIM2014*Already on the market for another indication

Oral Disease-Modifying Drugs for MS Dimethyl Fumarate (BG-12 – Biogen Idec) Indication: Relapsing Remitting Multiple Sclerosis Route: Oral (two times daily) Comments: Approval in 2012; G.I./flushing issues Laquinimod ( Teva / Active Biotech) Indication: Relapsing Remitting Multiple SclerosisRoute: Oral (once daily)Comments: Approval in 2012; May liver enzymes40

Currently Marketed Drugs Expand into MS Lemtrada ( alemtuzumab - Genzyme ) Indication: Relapsing Remitting Multiple Sclerosis Route: IV Infusion (5 then 3 days per year) Comments: Approved for CLL; ITP and infection risk Zenapax ( daclizumab – Biogen Idec/Abbott) Indication: Relapsing Remitting Multiple SclerosisRoute: SQ Injection (once monthly)Comments: Approved for transplant; Infection and liver toxicity risk41 CLL = Chronic Lymphocytic Leukemia; ITP = Immune Thrombocytopenic Purpura

Cancer Pipeline TrendsCancer treated as a chronic conditionOral drugs Targeted therapies Niche or orphan cancer types Pharmacogenomics plays a role 42

2011 Cancer Drug Approvals 43 Drug (Manufacturer) Indication Route Approval Yervoy (Bristol Myers Squibb) Malignant Melanoma IV March 25 th Sylatron (Merck) Melanoma SQ March 29 th Caprelsa (AstraZeneca) Thyroid Cancer Oral April 6thZytiga (Centocor)Prostate CancerOralApril 28th Zelboraf (Genentech) Malignant Melanoma OralAugust 17thAdcetris (Seattle Genetics)HL and ALCLIVAugust 19thXalkori (Pfizer)Lung Cancer (NSCLC)OralAugust 26thHL = Hodgkin’s Lymphoma; ALCL = Anaplastic Large Cell Lymphoma;NSCLC = Non-Small Cell Lung Cancer

Pharmacogenomics Zalboraf ( vemurafenib – Genentech) Indication: Malignant Melanoma Route: Oral (twice daily) Comments: For patients with BRAF mutation; Approved Aug. 17 th Xalkori ( crizotinib - Pfizer) Indication: Non-Small Cell Lung Cancer Route: Oral (twice daily)Comments: For patients with ALK mutation; Approved Aug. 26th44

Cancer Pipeline- 2011 – Erwinaze ( crisantaspase – EUSA) Indication: Acute Lymphoblastic Leukemia Route: IM (every other day) Comments: Cell growth inhibitor; Approval in 2011 Ruxolitinib ( Incyte ) Indication: Myelofibrosis Route: Oral (twice daily) Comments: JAK inhibitor; FDA action: Dec 3rd 45JAK = Janus Kinase

Cancer Pipeline- 2012 - Drug Use Route Axitinib (Pfizer) Kidney Cancer Oral Biovax ID ( Biovest ) Lymphoma (NHL) SQ Bositinib (Pfizer) Leukemia (CML) Oral Brivanib (Bristol-Myers) Liver Cancer OralCabozantinib (Exelixis)Thyroid CancerOralCarfilzomib (Onyx)Multiple MyelomaIVHerceptin (Genentech)Breast Cancer (SQ)SQLucanix (NovaRx )Lung Cancer (NSCLC)Inj.DrugUse RouteNeuVax Vaccine (Apthera)Breast CancerInj.Omapro ( Cephalon ) Leukemia (CML)SQPerifosine (Keryx)Multiple MyelomaOralRegorafenib (Bayer)Kidney CancerOralRidaforolimus (Merck)Bone SarcomasOralTalacteroferrin alfa (Agennix)Lung Cancer (NSCLC)OralTivozanib (Aveo)Kidney CancerOralVismodegib (Genentech)Basal Cell CarcinomaOral46NHL = Non-Hodgkin’s Lymphoma; CML = Chronic Myeloid Leukemia; NSCLC = Non-Small Cell Lung Cancer

Cancer Pipeline- 2012 - Drug Use Route Axitinib (Pfizer) Kidney Cancer Oral Biovax ID ( Biovest ) Lymphoma (NHL) SQ Bositinib (Pfizer) Leukemia (CML) Oral Brivanib (Bristol-Myers) Liver Cancer OralCabozantinib (Exelixis)Thyroid CancerOralCarfilzomib (Onyx)Multiple MyelomaIVHerceptin (Genentech)Breast Cancer (SQ)SQLucanix (NovaRx)Lung Cancer (NSCLC)Inj.DrugUse RouteNeuVax Vaccine (Apthera)Breast Cancer Inj. Omapro ( Cephalon)Leukemia (CML)SQPerifosine (Keryx)Multiple MyelomaOralRegorafenib (Bayer)Kidney CancerOralRidaforolimus (Merck)Bone SarcomasOralTalacteroferrin alfa (Agennix)Lung Cancer (NSCLC)OralTivozanib (Aveo)Kidney CancerOralVismodegib (Genentech)Basal Cell CarcinomaOral47NHL = Non-Hodgkin’s Lymphoma; CML = Chronic Myeloid Leukemia; NSCLC = Non-Small Cell Lung Cancer

Cancer Pipeline- 2012 - Drug Use Route Axitinib (Pfizer) Kidney Cancer Oral Biovax ID ( Biovest ) Lymphoma (NHL) SQ Bositinib (Pfizer) Leukemia (CML) Oral Brivanib (Bristol-Myers) Liver Cancer OralCabozantinib (Exelixis)Thyroid CancerOralCarfilzomib (Onyx)Multiple MyelomaIVHerceptin (Genentech) Breast Cancer (SQ)SQLucanix (NovaRx)Lung Cancer (NSCLC)Inj.DrugUse RouteNeuVax Vaccine (Apthera ) Breast Cancer Inj. Omapro (Cephalon)Leukemia (CML)SQPerifosine (Keryx)Multiple MyelomaOralRegorafenib (Bayer)Kidney CancerOralRidaforolimus (Merck)Bone SarcomasOralTalacteroferrin alfa (Agennix)Lung Cancer (NSCLC)OralTivozanib (Aveo)Kidney CancerOralVismodegib (Genentech)Basal Cell CarcinomaOral48NHL = Non-Hodgkin’s Lymphoma; CML = Chronic Myeloid Leukemia; NSCLC = Non-Small Cell Lung Cancer

Oral Drugs for Cancer Axitinib (Pfizer) Indication: Renal Cell Carcinoma Route: Oral (twice daily) Comments: Angiogenesis inhibitor; FDA approval expected in April 2012 Ridaforolimus (Merck) Indication: Soft-Tissue and Bone Sarcomas Route: Oral (once daily x 5 days each week) Comments: mTOR inhibitor; Approval in April 2012 49

Hepatitis C Pipeline TrendsOral protease inhibitors hit the market Watch for more direct acting antivirals Novel interferons in 2-3 years 50

Hepatitis C Pipeline- Protease Inhibitors - 51 Drug Manufacturer Dosing* Approval Victrelis ( boceprevir ) Merck TID May 13 th Incivek ( telaprevir ) Vertex TID May 23 rd ABT-450AbbottQD2013TMC-435Tibotec (J&J) / MedivirQD2013ACH-1652AchillionQD 2014BI-201335Boehringer IngelheimQD2014VaniprivirMerckBID / QD2014BMS-650032Bristol-Myers SquibbBID / QD2015Danoprevir InterMune / Genentech TID / BID 2015* TID = Three Times Daily; BID = Twice Daily; QD = Once DailyApproved

Hepatitis C Pipeline- Polymerase Inhibitors - 52 Drug Manufacturer Dosing* Approval IDX-184 Idenix QD 2013 mericitabine Roche BID 2014 ANA-598 Anadys BID 2014 Filibuvir Pfizer TID / BID 2014PSI-7997PharmassetQD2014VX-222VertexBID2014 * QD = Once Daily; BID = Twice Daily; TID = Three Times Daily

Hepatitis C Pipeline- Novel Interferons - 53 Drug Manufacturer Route Approval Locteron Biolex SQ 2013 Peg-Interferon Lambda Bristol-Myers Squibb SQ 2013 IFN-Alpha-2b XL Flamel Technologies SQ 2014 Interferon Omega Boehringer IngelheimImplant2014

Cystic Fibrosis Pipeline TrendsNew drugs to:Increase mucus clearance Treat underlying disease Fight lung infections 54

Cystic Fibrosis Pipeline 55 Drug Manufacturer Route Approval Ataluren PTC Therapeutics Oral 2012 Aeroquin Mpex Inhaled 2012 Arikase Transave Inhaled 2012 Bronchitol Pharmaxis Inhaled 2012VX-770VertexOral2012

Cystic Fibrosis Pipeline 56 Drug Manufacturer Route Approval Ataluren PTC Therapeutics Oral 2012 Aeroquin Mpex Inhaled 2012 Arikase Transave Inhaled 2012 Bronchitol Pharmaxis Inhaled 2012VX-770VertexOral2012 - Increase Mucus Clearance -

Cystic Fibrosis Pipeline 57 Drug Manufacturer Route Approval Ataluren PTC Therapeutics Oral 2012 Aeroquin Mpex Inhaled 2012 Arikase Transave Inhaled 2012 Bronchitol Pharmaxis Inhaled 2012VX-770VertexOral2012 - Treat Underlying Disease -

Cystic Fibrosis Pipeline 58 Drug Manufacturer Route Approval Ataluren PTC Therapeutics Oral 2012 Aeroquin Mpex Inhaled 2012 Arikase Transave Inhaled 2012 Bronchitol Pharmaxis Inhaled 2012VX-770VertexOral2012 - Fight Infections -

Other Drugs to Watch 59 Drug (Manufacturer) Indication Route Approval Soliris ( Alexion ) aHUS IV 10/07/11 Iluvien ( Alimera ) DME Intra- vitreal 11/12/11Eyela ( Regeneron)AMDIntra-vitreal11/18/11rFactor XIII (Novo N.)FXIII Deficiency IV12/23/11Velcade (Millenium)Multiple MyelomaSQ01/23/12Corlux (Corcept)Cushing DiseaseOral02/17/12Peginesatide (Affymax)AnemiaIV/SQ03/27/12aHUS = Atypical Hemolytic Uremic Syndrome; DME = Diabetic Macular Edema; AMD = Age-related Macular Degeneration

Other Drugs to Watch 60 Drug (Manufacturer) Indication Route Approval Soliris ( Alexion ) aHUS IV 10/07/11 Iluvien ( Alimera ) DME Intra- vitreal 11/12/11 Eyela (Regeneron)AMDIntra-vitreal11/18/11rFactor XIII (Novo N.)FXIII Deficiency IV12/23/11Velcade (Millenium)Multiple MyelomaSQ01/23/12 Corlux (Corcept)Cushing DiseaseOral02/17/12Peginesatide (Affymax)AnemiaIV/SQ03/27/12aHUS = Atypical Hemolytic Uremic Syndrome; DME = Diabetic Macular Edema; AMD = Age-related Macular Degeneration

Other Drugs to Watch 61 Drug (Manufacturer) Indication Route Approval Soliris ( Alexion ) aHUS IV 10/07/11 Iluvien ( Alimera ) DME Intra- vitreal 11/12/11 Eyela (Regeneron)AMDIntra-vitreal11/18/11rFactor XIII (Novo N.)FXIII Deficiency IV12/23/11Velcade (Millenium)Multiple MyelomaSQ01/23/12 Corlux (Corcept)Cushing DiseaseOral02/17/12Peginesatide (Affymax)AnemiaIV/SQ03/27/12aHUS = Atypical Hemolytic Uremic Syndrome; DME = Diabetic Macular Edema; AMD = Age-related Macular Degeneration

Other Drugs to Watch 62 Drug (Manufacturer) Indication Route Approval Soliris ( Alexion ) aHUS IV 10/07/11 Iluvien ( Alimera ) DME Intra- vitreal 11/12/11Eyela ( Regeneron)AMDIntra-vitreal11/18/11rFactor XIII (Novo N.)FXIII Deficiency IV12/23/11Velcade (Millenium)Multiple MyelomaSQ01/23/12 Corlux (Corcept)Cushing DiseaseOral02/17/12Peginesatide (Affymax)AnemiaIV/SQ03/27/12aHUS = Atypical Hemolytic Uremic Syndrome; DME = Diabetic Macular Edema; AMD = Age-related Macular Degeneration

Other Drugs to Watch 63 Drug (Manufacturer) Indication Route Approval Soliris ( Alexion ) aHUS IV 10/07/11 Iluvien ( Alimera ) DME Intra- vitreal 11/12/11Eyela ( Regeneron)AMDIntra-vitreal11/18/11rFactor XIII (Novo N.)FXIII Deficiency IV12/23/11Velcade (Millenium)Multiple MyelomaSQ01/23/12 Corlux (Corcept)Cushing DiseaseOral02/17/12Peginesatide (Affymax)AnemiaIV/SQ03/27/12aHUS = Atypical Hemolytic Uremic Syndrome; DME = Diabetic Macular Edema; AMD = Age-related Macular Degeneration

Other Drugs to Watch 64 Drug (Manufacturer) Indication Route Approval Soliris ( Alexion ) aHUS IV 10/07/11 Iluvien ( Alimera ) DME Intra- vitreal 11/12/11Eyela ( Regeneron)AMDIntra-vitreal11/18/11rFactor XIII (Novo N.)FXIII Deficiency IV12/23/11Velcade (Millenium)Multiple MyelomaSQ01/23/12 Corlux (Corcept)Cushing DiseaseOral02/17/12Peginesatide (Affymax)AnemiaIV/SQ03/27/12aHUS = Atypical Hemolytic Uremic Syndrome; DME = Diabetic Macular Edema; AMD = Age-related Macular Degeneration

Other Drugs to Watch 65 Drug (Manufacturer) Indication Route Approval Soliris ( Alexion ) aHUS IV 10/07/11 Iluvien ( Alimera ) DME Intra- vitreal 11/12/11Eyela ( Regeneron)AMDIntra-vitreal11/18/11rFactor XIII (Novo N.)FXIII Deficiency IV12/23/11Velcade (Millenium)Multiple MyelomaSQ01/23/12Corlux (Corcept)Cushing DiseaseOral02/17/12Peginesatide (Affymax)AnemiaIV/SQ03/27/12aHUS = Atypical Hemolytic Uremic Syndrome; DME = Diabetic Macular Edema; AMD = Age-related Macular Degeneration

Other Drugs to Watch 66 Drug (Manufacturer) Indication Route Approval Soliris ( Alexion ) aHUS IV 10/07/11 Iluvien ( Alimera ) DME Intra- vitreal 11/12/11Eyela ( Regeneron)AMDIntra-vitreal11/18/11rFactor XIII (Novo N.)FXIII Deficiency IV12/23/11Velcade (Millenium)Multiple MyelomaSQ01/23/12Corlux (Corcept)Cushing DiseaseOral02/17/12Peginesatide (Affymax)AnemiaIV/SQ03/27/12aHUS = Atypical Hemolytic Uremic Syndrome; DME = Diabetic Macular Edema; AMD = Age-related Macular Degeneration

Questions? 67