Biopharmaceutical Royalty Rates Analysis: Essential Benchmarks for Dealmaking (Preview)

Biopharmaceutical Royalty Rates Analysis: Essential Benchmarks for Dealmaking

BioWorld Data Biopharmaceutical Royalty Rates Analysis:

Essential Benchmarks for Dealmaking

Executives involved in any aspect of dealmaking know it’s hard to find real-world data on deal terms such as royalty rates, milestones and up-fronts. A new tool from BioWorld solves this problem. Biopharmaceutical Royalty Rates Analysis: Essential Benchmarks for Dealmaking analyzes hundreds of licensing deals to provide a tangible starting point for smart dealmaking. In addition to sector-wide analyses, which provide an array of average and median royalty rates and up-front licensing fees, the report takes a deeper dive into these hot disease areas: Alzheimer’s, cancer, cardiovascular, diabetes, hepatitis and pain management. Backing up the analyses are profiles of more than 320 deals including not only the royalty rates, but all deal terms and key background information on the drug or drug technology in focus – invaluable details to be used as benchmarks and comparators when crafting new licensing deals.

IP Asset Payout Information is Critical: * The tough economy has forced drug makers to sharpen dealmaking skills. Without the opportunity for investors to cash out in normal cycles, deals are more important than ever. * There’s a trend now to do bigger deals earlier in the game. Preclinical pacts aren’t uncommon. * An increase in dealmaking also results in an increase in deal terminations when big pharmas restructure pipelines or when trials don’t produce expected results. Ironclad contracts protect both parties. * The dealmaking trend is likely to continue because big pharma has reached the dreaded patent cliffs. * Life science attorneys need these data points, too, as part of patent valuation and to establish infringement litigation damages.

Don’t get caught at the negotiating table without critical deal terms to justify proposals.

Available in digital reader edition available with interactive point & click features. For Special Introductory Rates Call 1-800-888-3912

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Table of Contents

Bird’s-Eye View............................................................................................................................... 13A.Tangible.Starting.Point.for.Smart.Dealmaking.............................................................................14

A Deep Dive..................................................................................................................................... 16Vital.Statistics...................................................................................................................................17Make.a.Big.Deal.of.Taking.the.Royalty.Road..................................................................................18Alzheimer’s.Royalty.Rates...............................................................................................................26Cancer.Royalty.Rates........................................................................................................................27Cardiovascular.Royalty.Rates...........................................................................................................30Diabetes.Royalty.Rates.....................................................................................................................32Hepatitis.Royalty.Rates.....................................................................................................................33Pain.Royalty.Rates............................................................................................................................34Royalty.Rates.for.Biopharmaceutical.Companies............................................................................35

The Deal Details.............................................................................................................................. 46

Autoimmune.................................................................................................................................... 47BB-882.-.Asthma..............................................................................................................................48Copaxone.-.Multiple.Sclerosis..........................................................................................................49Drugs.for.Arthritis.and.Pneumocystis.carinii.pneumonia.................................................................51Humanized.Monoclonal.Antibody....................................................................................................52Humira.-.Rheumatoid.Arthritis.........................................................................................................54Indaflex.-.Arthritis.............................................................................................................................56Primatized.Anti-CD4.Antibodies.-.Rheumatoid.Arthritis.................................................................58Primatized.Anti-CD4.Antibodies.-.Allergies....................................................................................59R788.-.Rheumatoid.Arthritis.............................................................................................................60

Cancer.............................................................................................................................................. 622-deoxy-d-glucose.-.Cancer..............................................................................................................63AastromReplicell.-.Cancer................................................................................................................65Acadesine.-.B-cell.Chronic.Lymphocytic.Leukemia........................................................................67AGT.203.-.Cancer,.Age-Related.Degeneration,.Diabetes,.Obesity..................................................68AL6082.-.Cancer...............................................................................................................................69Anticancer.Immunity.Treatment.-.Cancer........................................................................................70Atiprimod.-.Cancer...........................................................................................................................71Avicine.-.Multiple.Cancer.Indications..............................................................................................72Bisanthracyclines.-.Tumors...............................................................................................................74Cancer.Drug......................................................................................................................................75Cancer.Drug......................................................................................................................................76Cancer.Drug......................................................................................................................................77Cancer.Drug......................................................................................................................................78Cancer.Therapy.-.Delivery................................................................................................................79Cancer.Therapy.-.Metastatic.Melanoma...........................................................................................80Ceplene.-.Leukemia..........................................................................................................................81Cintredekin.Besudotox.-.Cancer.......................................................................................................83

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Clolar.-.Hematological.Malignancies...............................................................................................84CRx-026.-.Multiple.Tumor.Types.....................................................................................................86Combined.Immunogene.Therapy.-.Cancer.......................................................................................88CTCE-9908,.CTCE-0214.-.Cancer,.Transplant................................................................................89Dacogen.-.Cancer..............................................................................................................................90Dibromodulcitol.(DBD).-.Cancer.....................................................................................................93Disodium.Clodronate.-.Cancer-Associated.Bone.Diseases..............................................................94Electrostatic.Liposome.-.Cancer.Drug.Delivery...............................................................................96Erbitux.-.Colorectal.Cancer..............................................................................................................98Erivedge.(GDC-0449).-.Cancer......................................................................................................100Eylea.-.Cancer.................................................................................................................................103GCS-100.-.Colorectal.and.Pancreatic.Cancers...............................................................................106Genasense.-.Cancer.........................................................................................................................107Hematology.Controls.Using.Reticulocytes.....................................................................................108Histone.Deacetylase.(HDAC).Inhibitors.-.Multiple.Cancer.Indications........................................109huN901-DM1.(IMGN901).Tumor-Activated................................................................................. 111Prodrug.-.Small-Cell.Lung.Cancer................................................................................................. 111Intron.A.-.Cancer,.Infection............................................................................................................ 113Listeria.Monocytogenes-Based.Vaccine.-.Various.Cancer.Indications.......................................... 114Mammary.Cell.Growth.Inhibitor.Protein....................................................................................... 116Monoclonal.Antibody.Technology.................................................................................................. 117MP-470.-.Small.Cell.Lung.Cancer................................................................................................. 119MuGard.-.Cancer............................................................................................................................120Multikine.-.Cancer..........................................................................................................................122Naked.DNA.Technology.-.Cancer..................................................................................................123Nano.Curcumin...............................................................................................................................125Nexavar.-.Cancer............................................................................................................................127NOV-002/NOV-205.-.Cancer,.Infection.........................................................................................128NV-128.-.Cancer.............................................................................................................................129Nuclear.Matrix.Protein.Technology................................................................................................130Oncaspar.-.Cancer...........................................................................................................................131Oncolym.-.Hodgkin’s.B-cell.Lymphoma........................................................................................132Oncolysin.B.-.B-cell.Lymphoma....................................................................................................134Optisome.Nanoparticle.Technology.-.Drug.Delivery.Technology.................................................136Optisome.Nanoparticle.Technology.-.Drug.Delivery.Technology.................................................139Oxygen.Enhancement.Technology.for.Chemotherapeutics.-.Various.Cancers..............................141Phenoxodiol.-.Cancer......................................................................................................................143Phosphatases.-.Glioblastomas.........................................................................................................145Picoplatin.-.Small-Cell.Lung.Cancer..............................................................................................146Picoplatin.-.Small-Cell.Lung.Cancer..............................................................................................148Platinate.HPMA.Copolymer.-.Cancer.............................................................................................152Radinyl.-.Cancer.............................................................................................................................153RAS.Human.Protein/Rational.Drug.Design.-.Malignant.Tumors..................................................154Recombinant.Human.Interleukin-12...............................................................................................155Retinoids.-.Kidney.Cancer,.Leukemia............................................................................................156Rhenium.Radiotherapy.and.Monoclonal.Antibodies.-.Colon.Cancer............................................158RSR13.-.Cancer..............................................................................................................................160


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Satraplatin.-.Prostate.Cancer...........................................................................................................161Satraplatin.-.Cancer.........................................................................................................................162Specific.Drug.Undisclosed.-.Various.Cancer.Therapies.................................................................163Stem.Cell.Proliferation.Factor.-.Cancer..........................................................................................164TAP.Technology.-.Cancer...............................................................................................................165Tarceva.-.Cancer.............................................................................................................................167Tarceva.-.Various.Cancer.Indications.............................................................................................169Thalidomide.Analogues.-.Cancer....................................................................................................171Thalomid.-.Multiple.Myeloma........................................................................................................173Theragyn.-.Ovarian.Cancer.............................................................................................................175Tissue.Malignancy.Treatments.-.Cancer.........................................................................................176Vectibix.-.Colorectal.Cancer...........................................................................................................177Xerecept.-.Brain.Tumors.................................................................................................................181Zaltrap.-.Cancer..............................................................................................................................183

Cardiovascular.............................................................................................................................. 185Adenocard.-.Paroxysmal.Supraventricular.Tachycardia.................................................................186Aggrastat.(tirofiban.hydrochloride).-.Acute.Coronary.Syndrome..................................................187Angiogenix.-.Cardiovascular..........................................................................................................191Angiomax.-.Cardiovascular............................................................................................................192Anti-hypertension.Therapy.............................................................................................................193Autologous.Gene.Therapy.-.Hypertension.....................................................................................194BAY.59-7939.-.Cardiovascular.......................................................................................................195Bextra.-.Congestive.Heart.Failure..................................................................................................196Bystolic.-.Hypertension..................................................................................................................197Cardio.Vascu-Grow.-.Cardiovascular.............................................................................................199Cardiovascular.Drug.......................................................................................................................200Cardiovascular.Drug.......................................................................................................................201Cardiovascular.Drug.......................................................................................................................202CMI-121.-.Cardiovascular..............................................................................................................204Elafin.-.Cardiovascular...................................................................................................................205Esbriet.-.Fibrotic.Disease................................................................................................................206Fenoglide.-.Cardiovascular.............................................................................................................208Fortamet,.Altoprev.-.Cardiovascular...............................................................................................209Gel.Lock.Invention.and.Taurolidine.Treatments.-.Cardiorenal.Disease.........................................210Gencaro.-.Cardiovascular............................................................................................................... 211Gencaro.-.Chronic.Heart.Failure.....................................................................................................212HepArrest.-.Cardiovascular............................................................................................................213Integrilin.-.Cardiovascular.Disease.................................................................................................214M-Enoxaparin.-.Cardiovascular......................................................................................................215MyoCell.-.Cardiovascular...............................................................................................................217Naked.DNA.Technology.-.Cardiovascular.Disease........................................................................219Non-PESDA.Microbubbles.-.Cardiovascular.................................................................................221Paclitaxel.........................................................................................................................................222Paclitaxel.Technology.-.Cardiovascular.........................................................................................222Portable.Ultrasonic.Nebulizer.-.Cardiovascular.Disease................................................................223Pro-Apolipoprotein.A-I.-.Cardiovascular.......................................................................................224


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Ranexa.-.Angina..............................................................................................................................225Relovair.-.Chronic.Obstructive.Pulmonary.Disease.and.Asthma...................................................228RNAi.Technologies.-.Respiratory.Syncytial.Virus.........................................................................230Tadalafil.-.Hypertension..................................................................................................................232Teveten.-.Hypertension...................................................................................................................236ThromboClear.-.Cardiovascular.....................................................................................................237Tiazac.-.To.Reduce.the.Risk.of.Heart.Attacks................................................................................238

Central Nervous System...............................................................................................................239Acurox.-.Abuse-Resistant.Painkiller...............................................................................................240ALKS.33.-.Alcohol.Dependence....................................................................................................241Alzheimer’s.Drug.-.Alzheimer’s.Disease.......................................................................................243Alzheimer’s.Drug.-.Alzheimer’s.Disease.......................................................................................244Alzheimer’s.Drug.-.Alzheimer’s.Disease.......................................................................................246Alzheimer’s.Drug.-.Alzheimer’s.Disease.......................................................................................247Ampligen.-.Chronic.Fatigue.Syndrome..........................................................................................248Attention.Deficit.Hyperactivity.Disorder.Therapy.........................................................................250Avinza.-.Pain...................................................................................................................................251Avinza.-.Pain...................................................................................................................................253Axokine/Pegylated.Axokine.-.Obesity............................................................................................255AZ-004.-.Schizophrenia.or.Bipolar.Disorder.................................................................................256Bicifadine.-.Dental.Pain..................................................................................................................258Brain-Derived.Neurotrophic.Factor................................................................................................261Chronogesic.-.Pain..........................................................................................................................264Dexfenfluramine.-.Obesity..............................................................................................................265Doxylamine.Succinate.Nasal.Spray.-.Sleep.Therapy.....................................................................267Entereg.-.Pain..................................................................................................................................269Estradot.-.Menopausal.Symptoms..................................................................................................270Fanapt.-.Schizophrenia...................................................................................................................272Fanapt.-.Schizophrenia...................................................................................................................273Fanapt.-.Schizophrenia...................................................................................................................274Flexogan.-.Pain.Management.........................................................................................................276Frova.-.Menstrual.Migraines..........................................................................................................277Frova.-.Migraine.Relief..................................................................................................................279Gralise.-.Postherpetic.Neuralgia.....................................................................................................281Horizant.-.Pain................................................................................................................................282Indiplon.-.Insomnia.........................................................................................................................284Indiplon.-.Insomnia.........................................................................................................................287Inflammation.Antibody-based.Therapeutics...................................................................................289Ion.Channel.Modulators.-.Pain.......................................................................................................291Ketoprofen.-.Inflammation.............................................................................................................292Memryte.-.Alzheimer’s.Disease......................................................................................................293Memryte.-.Alzheimer’s.Disease......................................................................................................295Naked.DNA.Technology.................................................................................................................297Neotrofin.-.Neuroimunologic.Disorders.........................................................................................299Nervous.System.Therapeutics.........................................................................................................302


NeuroCell.-.Parkinson’s.and.Huntington’s.diseases.......................................................................304Neuroimmunophilins.-.Nerve.Repair..............................................................................................307Neurological.Peptide.Therapy........................................................................................................309Neurological.Therapeutics.............................................................................................................. 311NGD.94-1.-.Schizophrenia.............................................................................................................312NicVAX.-.Smoking.Cessation........................................................................................................313Novantrone.-.Multiple.Sclerosis.....................................................................................................316NRP104.-.Attention.Deficit.Hyperactivity.Disorder.......................................................................320Opana.-.Pain....................................................................................................................................323Oral.Flupirtine.-.Fibromyalgia........................................................................................................325Oruvail.-.Pain..................................................................................................................................326Pain.Management............................................................................................................................327Phospholipids.-.Central.Nervous.System.Conditions.....................................................................328Posidur.-.Postsurgical.Pain.............................................................................................................329PQ-1002.-.Anesthesia.....................................................................................................................331Remoxy.-.Pain.................................................................................................................................332Risperdal.Consta.-.Schizophrenia.and.Bipolar.Disorder................................................................333Ryzolt.-.Pain....................................................................................................................................335Sarafem.-.Premenstrual.Syndrome.................................................................................................336Transgenic.Mouse.Model.-.Alzheimer’s.Disease...........................................................................340Treximet.-.Migraine........................................................................................................................341Vivitrol.-.Alcohol.&.Opioid.Dependency.......................................................................................343Zolpimist.-.Insomnia.......................................................................................................................345

Diabetes.......................................................................................................................................... 347A-4166.-.Diabetes...........................................................................................................................348AERx.-.Diabetes.............................................................................................................................349AGT.203.-.Cancer,.Age-Related.Degeneration,.Diabetes,.Obesity................................................350Bydureon.-.Diabetes.......................................................................................................................351Bydureon.-.Type.II.Diabetes...........................................................................................................353Development.of.Drugs.-.Type.II.Diabetes......................................................................................355Diabetes.Therapy............................................................................................................................356Diabetes.Therapy............................................................................................................................358Fortamet.-.Type.II.Diabetes............................................................................................................359Glumetza.-.Diabetes........................................................................................................................360Luteolin.-.Diabetes..........................................................................................................................361SF-1019.-.Diabetes.........................................................................................................................362

Infection......................................................................................................................................... 363Alpha.Interferon-Natural.-.Infection...............................................................................................364Alferon.N.Injection.-.Viral.Diseases...............................................................................................367AmBisome.-.Fungal.Infections.......................................................................................................371Antibody.IFT.-.HIV........................................................................................................................372BioNasal.-.Chronic.Rhinosinusitis.................................................................................................373BPI.-.Sepsis.....................................................................................................................................375CY.1787.and.CY.1503.-.Septic.Shock.and.Adult.Respiratory.Distress.Syndrome........................379Danoprevir.(RG7227).-.Hepatitis.C................................................................................................380

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Erythromycin.Antibiotic.-.Bacterial.Infections...............................................................................383Fuzeon.-.HIV..................................................................................................................................384Gene.Therapy.Products.-.Hepatitis.B.and.C...................................................................................386HE317.-.Immunodeficiencies.........................................................................................................387Hepatitis.and.Retrovirus.Technologies.-.Hepatitis.G......................................................................388Hepatitis.A.Vaccine.........................................................................................................................389Hepatitis.B.Drug.-.Infection...........................................................................................................390Hepatitis.B.Drug.............................................................................................................................391Hepatitis.C.Vaccine.........................................................................................................................392Hepatitis.E.Vaccine.........................................................................................................................393HepeX-B.-.Hepatitis.B....................................................................................................................394Heplisav.-.Infection.........................................................................................................................395HIV.and.Hepatitis.Vaccines............................................................................................................396HIV/AIDS.Vaccine.........................................................................................................................398HIV.Drug........................................................................................................................................402HIV.Drugs.......................................................................................................................................403Iminosugars.-.Potential.Antiviral....................................................................................................405Incivek.-.Hepatitis.C.......................................................................................................................406Infergen.-.Hepatitis.C......................................................................................................................408Interferon-g.-.HIV...........................................................................................................................412Method.for.Interferon.-.Hepatitis.B.and.C.infection......................................................................414Monoclonal.Antibodies.-.Gram-Negative.Sepsis-Related.Bacteria................................................416Naked.DNA.Technology.................................................................................................................419Nanocrystalline.Particles................................................................................................................421NCX.1000.-.Hepatitis.C.and.Hypertension....................................................................................422Novasome.Lipid.Vesicles.Encapsulation.Technology.-.Vaccines...................................................424Omniferon.-.Hepatitis.C..................................................................................................................425Oragen.-.HIV..................................................................................................................................428Protease.Inhibitors.-.HIV.and.AIDS...............................................................................................430Questcor.Patents.–.Hepatitis.C.......................................................................................................432Relenza.-.Influenza.........................................................................................................................434Ribozymes.-.HIV............................................................................................................................436S-1153.-.HIV...................................................................................................................................438Small.Molecules.-.Hepatitis.C........................................................................................................440Tamiflu.-.Influenza..........................................................................................................................442Taribavirin.-.Hepatitis.C.................................................................................................................445Technologies.and.Product.Candidates.-.Hepatitis.C.......................................................................448Tyzeka/Sebivo.-.Hepatitis.B...........................................................................................................449Vaccines,.Gene-Based.-.HIV,.Hepatitis.B.&.C.Viruses,.Herpes,....................................................451Papilloma,.Measles,.Tuberculosis.and.Influenza............................................................................451Vaccine.Research.-.HIV,.Hepatitis,.Influenza.................................................................................453Vibativ.-.Gram-Positive.Infections.................................................................................................454Viread.-.HIV...................................................................................................................................455Viread.and.Preveon.-.HIV...............................................................................................................458Virus-like.Particle.Vaccines.-.Human.Papillomavirus....................................................................462Zadaxin.-.Hepatitis.C......................................................................................................................464

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Miscellaneous................................................................................................................................. 466A1PI.-.Alpha-1.antitrypsin.deficiency............................................................................................467Actimmune.-.Infections,.Pulmonary.Fibrosis.and.Cancer..............................................................469Aldurazyme.-.Mucopolysaccharidosis.I.........................................................................................471Alpha.Interferon..............................................................................................................................473Auriculin.Anaritide.-.Acute.Renal.Failure......................................................................................475Bio-Equivalent.Cardizem.CD.........................................................................................................477Cochleates,.Liposomes.and.Proteoliposomes.................................................................................478Collagenase.Ointment.-.Dermal.Ulcers.and.Burns.........................................................................484Combinatorial.Chemistry.Services.-.Drug.Discovery....................................................................485CY.1787.and.CY.1503.-.Septic.Shock.and.Adult.Respiratory.Distress.Syndrome........................486Cytofectins.-.Cystic.Fibrosis...........................................................................................................488Dermagran.II.Ointment.and.Spray.-.Wound.Healing.....................................................................490Estrasorb.-.Estrogen.Therapy..........................................................................................................491Gattex.-.Gastrointestinal.Disorders.................................................................................................494Gene.Therapy.Partnership.Network................................................................................................496Gene.Therapy.Treatments...............................................................................................................497Genentech.Products........................................................................................................................499Hectorol.-.Osteoporosis..................................................................................................................504Hextend.and.PentaLyte.-.Hypovolemia..........................................................................................507Hextend.and.PentaLyte.-.Hypovolemia..........................................................................................509Hextend.-.Hypovolemia.................................................................................................................. 511Hextend.-.Hypovolemia..................................................................................................................513Human.Growth.Hormone...............................................................................................................515Humanized.Antibody......................................................................................................................516IgA.Nephropathy.Treatment...........................................................................................................518IMOs.-.Allergy................................................................................................................................520Indaflex.and.Flexogan.-.Inflammatory............................................................................................522Kuvan,.PEG-PAL,.6R-BH4.-.Phenylketonuria.and.Cardiovascular...............................................524Living.Cells.Connective.Tissue......................................................................................................526Loteprednol.Etabonate.-.Ophthalmic..............................................................................................527Lubrin.-.Vaginal.Dryness................................................................................................................528M-Enoxaparin.................................................................................................................................529MDX-RA.-.Secondary.Cataracts....................................................................................................530Monoclonal.Antibodies.Binding.to.TGF-B....................................................................................534Neupogen.-.Anemia........................................................................................................................536Oral.Contraceptives........................................................................................................................539Prochieve.-.Preterm.Birth...............................................................................................................540Procrit.-.Anemia..............................................................................................................................541Receptor-Mediated.Permeabilizers.................................................................................................545RNA.Interference.Technology........................................................................................................547RNA.Interference.Technology........................................................................................................550Sexual.Dysfunction.Therapy...........................................................................................................554Solaraze.and.Others.-.Dermatology................................................................................................555Systemic. Evolution. of. Ligands. through. EXponential. Enrichment. (SELEX). -. Oligonucleotides.Screening.Process...........................................................................................................................557TGF-beta.-.Ophthalmological,.Wounds,.Autoimmune...................................................................560

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Thymosin.Beta.4.-.Various.Indications...........................................................................................565Vaniqa.-.Excessive.Facial.Hair.on.Women.....................................................................................567

Technology..................................................................................................................................... 570ACTCellerate.-.Embryonic.Stem.Cell.Technology........................................................................571Bioadhesive.Delivery.System.-.Drug.Delivery..............................................................................573Cell.Culture.Flask.Patent................................................................................................................574Cochleate.Technology.....................................................................................................................576Cypress.Stem.Cells.........................................................................................................................580DNA.Nanocircles.-.Research..........................................................................................................581Duros.Drug.Delivery.Technology...................................................................................................582Gene.Alteration.Technology...........................................................................................................585Gene.Sequencing.Technology.-.Infectious.Diseases......................................................................586Genetically.Engineered.Listeria.Immune.Therapy.........................................................................588Heat-Activated.Gene.Therapy.Technology.-.Cancer......................................................................591hESC.Technology.-.Technology.....................................................................................................593HuMAb-Mouse.Technology...........................................................................................................595Mammalian.Embryonic.Stem.Cells.Technology............................................................................599Method.for.Binding.DNA.and.RNA...............................................................................................601Naked.DNA.Technology.................................................................................................................602NASA.Technology..........................................................................................................................604Natural.Cell.Signaling.Technologies..............................................................................................605Nebulizer.-.Technology...................................................................................................................607NTP.Testing.Technology.-.Technology...........................................................................................608Nucleoside.Technology.-.Hepatitis.B.............................................................................................609Optison.-.Contrast.Agent................................................................................................................610PharmaPrint.Process.-.Drug.Development,.Botanicals..................................................................612ppGpp.Degradase.and.Peptide.Deformylase.Technology...............................................................613Stem.Cell.Lines...............................................................................................................................614Stem.Cell.Technology.....................................................................................................................615Stem-Loop.Vector.Technology.......................................................................................................616Thrombus.Ligands.-.Diagnostic.Imaging.......................................................................................617Thymidine.Kinase.Isoenzyme.Diagnostics.and.Thymidine.Kinase.Hybridomas..........................619UMASS.Patents.-.Cartilage.Regenerative.Technology..................................................................620VelocImmune.Technology..............................................................................................................621XenoMouse.Technology.-.Cancer...................................................................................................623

Indices............................................................................................................................................ 624Companies.and.Other.Organizations.Index....................................................................................625Inventors.Index...............................................................................................................................631Drugs.and.Therapeutic.Technologies.Index....................................................................................632Diseases,.Indications.and.Targets.Index.........................................................................................636


cancer

Licensor Genzyme Corp.Licensee Poniard Pharmaceuticals Inc.Royalty/Deal Value $11 million cash plus $1 million of common stock plus 9% of salesDrug/Product Name PicoplatinType/Product Area License agreement for worldwide rightsTerms/Details $11 million cash plus $1 million of common stock plus 9% of sales

Date 2004

Picoplatin - Small-Cell Lung Cancer

Deal Summary

Poniard.holds.an.exclusive.worldwide.license.granted.from.Genzyme.Corp..for.the.development.and.commercial.sale.of.picoplatin..Under.the.license.agreement,.as.amended,.Genzyme.retains.the.right.to.prosecute.its.patent.ap-plications.and.maintain.all.licensed.patents,.with.Poniard.reimbursing.such.expenses..Poniard.has.the.right.to.sue.any.third.party.infringers.of.the.picoplatin.patents..If.Poniard.does.not.file.suit,.Genzyme,.in.its.sole.discretion,.has.the.right.to.sue.the.infringer.at.its.expense..

The.parties.executed.the.license.agreement.in.April.2004,.at.which.time.Poniard.paid.a.one-time.upfront.mile-stone.payment.of.$1.million.in.common.stock.and.$1.million.in.cash..The.original.license.agreement.excluded.Japan.from.the.licensed.territory.and.provided.for.$13.million.in.development.and.commercialization.milestones,.payable.in.cash.or.a.combination.of.cash.and.common.stock,.and.a.royalty.rate.of.up.to.15%.of.product.net.sales.after.regulatory.approval..The.parties.amended.the.license.agreement.on.Sept..18,.2006,.modifying.several.key.financial.terms.and.expanded.the.licensed.territory.to.include.Japan,.thereby.providing.Poniard.worldwide.rights..In.consideration.of.the.amendment,.Poniard.paid.Genzyme.$5.million.in.cash.on.Oct..12,.2006.and.paid.Genzyme.an.additional.$5.million.in.cash.on.March.30,.2007..The.amendment.eliminated.all.development.milestone.pay-ments.to.Genzyme..Poniard.remains.obligated.to.pay.a.total.of.$5.million.in.commercialization.milestones.upon.the.attainment.of.certain.levels.of.annual.net.sales.of.picoplatin.after.regulatory.approval..The.amendment.also.reduced.the.royalty.payable.to.Genzyme.to.a.maximum.of.9%.of.annual.net.product.sales.and.eliminated.sharing.of.sublicense.revenues.with.Genzyme..The.license.agreement.may.be.terminated.by.either.party.for.breach,.or.if.the.other.party.files.a.petition.in.bankruptcy.or.insolvency.or.for.reorganization.or.is.dissolved,.liquidated.or.makes.assignment.for.the.benefit.of.creditors..Poniard.can.terminate.the.license.at.any.time.upon.prior.written.notice.to.Genzyme..If.not.earlier.terminated,.the.license.agreement.will.continue.in.effect,.in.each.country.in.the.territory.in.which.the.licensed.product.is.sold.or.manufactured,.until.the.earlier.of.(i).expiration.of.the.last.valid.claim.of.a.pending.or.issued.patent.covering.the.licensed.product.in.that.country.or.(ii).a.specified.number.of.years.after.first.commercial.sale.of.the.licensed.product.in.that.country..

Poniard’s.picoplatin.portfolio.includes.U.S..and.foreign.patents.and.applications.licensed.from.Genzyme,.which.cover.the.picoplatin.product..With.respect.to.picoplatin,.Poniard.expected.to.rely.primarily.on.U.S..Patent.No..5,665,771.(expiring.Feb..7,.2016),.which.is.licensed.to.it.by.Genzyme,.and.additional.licensed.patents.expiring.in.2016.covering.picoplatin.in.the.European.Union.and.other.countries..


cancer

PicoplatinDrug Description/ Mechanism

Picoplatin is an intravenous platinum-based chemotherapeutic designed to treat sol-id tumors that are resistant to existing platinum-based cancer therapies.

Drug History The FDA designated picoplatin as an orphan drug for the treatment of small cell lung cancer and the European Commission designated picoplatin as an orphan medicinal product for the treatment of small cell lung cancer in the European Union, which en-titles Poniard to exclusive marketing rights for picoplatin in the European Union for ten years following market approval. In 2010, Poniard decided to suspend efforts to obtain regulatory approval of pico-platin after a detailed analysis primary and updated data from the Phase III study of picoplatin in small-cell lung cancer (SCLC) and an evaluation of the ongoing new drug application process with the FDA. The company said it has engaged Leerink Swann LLC to conduct a comprehensive review of strategic alternatives, which could include capital raising alternatives, merger, sale or partnership. Poniard also announced a re-structuring of its work force, eliminating about 45%, to a total of 12, effective April 30. The company said it would focus its resources on developing pivotal clinical strate-gies for picoplatin in small-cell lung cancer, as well as colorectal, prostate and ovarian cancers. Poniard executives blamed the failure of the highly anticipated SPEAR (Study of Pico-platin Efficacy After Relapse) trial on an imbalance of third-line chemotherapy given to patients in the best supportive care arm vs. the picoplatin arm.

Genzyme Corp.Company History

Founded in June 1981 by Henry Blair and Sherry SnyderBegan operations by acquiring Whatman Biochemicals Ltd., UKMember--Biotechnology Industry OrganizationFounded 16 labs (1990)Formed Neozyme Corp. to fund development of programs (10/90)Formed Neozyme II to fund the research, development and clinical testing of biotherapeutic products for the treatment of cystic fibrosis (4/92)Subsidiary IG Laboratories Inc. purchased Genetic Design Inc., a privately held genetic testing company (6/92)Acquired phospholipid business of Enzymatix Ltd. (6/92)Acquired Medix Biotech Inc. (6/92)Acquired Vivigen Inc., in exchange for stock valued at $40M (11/92)Neozyme I buyback of four programs, $49M (12/92)Established Genzyme Transgenics (now GTC Biotherapeutics) for producing human biothera-peutic products in the milk of transgenic animals (2/93)Acquired diagnostic business Virotech System-Diagnostika GmbH (4/93)Acquired diagnostic business Omnia Res srl (5/93)Neozyme I buyback of two programs, $49M (12/93)Acquired Swiss pharmaceutical manufacturer, Sygena Ltd. (7/94)Subsidiary Genzyme Transgenics purchased TSI, a publicly held clinical testing and production company (10/94)


cancer

Created Genzyme Tissue Repair by acquiring BioSurface Technology Inc. and combining with several of Genzyme Corp.’s tissue repair programs (12/94)Acquired all shares of IG Laboratories Inc. (9/95)Formed Aristogen GmbH with Symbiomed (Germany) to offer genetic diagnostic services in Germany (3/96)Acquired Genetrix Inc. (4/96)Acquired Deknatel Snowden Pencer Inc., $250M (7/96)Neozyme II Corp. buyback, $109M (9/96)Formed Genzyme Molecular Oncology Division after acquisition of PharmaGenics Inc. (6/97)Acquired ABIOMED Inc. for $15M (7/97)Sold research products business to Techne Corp. for $65.5M (6/98)Acquired GelTex Pharmaceuticals Inc. (12/00)Acquired Novazyme Pharmaceuticals (9/01)Ceased trading of Genzyme Biosurgery and Genzyme Molecular Oncology stock (7/03)Acquired Sangstat Medical Corp. (12/03)Acquired ILEX Oncology Inc. (12/04)Acquired Verigen AG (2/05)Acquired Bone Care International (7/05)Acquired AAV gene therapy assets from Avigen Inc. (12/05)Acquired AnorMED Inc. (11/06)Acquired manufacturing equipment and other technology from Targeted Genetics Corp. for up to $7M (2/10)Sold Genzyme Genetics to Laboratory Corp. of America for $925M (9/10)Sold its diagnostic products business to Sekisui Chemical Co. Ltd. For $265M (11/10)Sold its enetics business unit to Laboratory Corp. of America (11/10)Sold its pharmaceutical intermediates business to International Chemical Investors Group (3/11)Acquired by Sanofi-Aventis SA (4/11)

Genzyme Corp.: Additional AgreementsPartnered Company Products Involved Agreement Type DateAlgeta ASA to study cancer targets using its Thorium plat-

form and Genzyme's tumor-targeting antibodypartnership 4/11

Angiotech Pharmaceu-ticals Inc.

identification, development and commercializa-tion of therapies for cancer patients undergoing surgical removal of tumors

strategic collab-oration agree-ment

5/06

Arecor Ltd. development of stable, high-strength formula-tions of labile biomolecules

collaboration 4/10

De Novo Pharmaceuti-cals Ltd.

De Novo to apply its molecular structure gen-erating technology to focus on a disease target that is of interest to Genzyme

drug discovery c o l l a b o ra t i o n agreement

1/06

ERYtech Pharma therapeutic enzyme formulation for Genzyme disease indications using technology developed by ERYtech

d e v e l o p m e n t agreement

10/10


cancer

Hospira Worldwide Inc. to perform fill and finish manufacturing services for Genzyme's Cerezyme, Fabrazyme, Myozyme and Thyrogen

material defini-tive agreement

1/10

Isis Pharmaceuticals mipomersen licensing and c o l l a b o ra t i o n agreement

6/08

Moffitt Cancer Center diagnostic testing rights for two proteins for NSCLC

licensing agree-ment

1/08

Oswaldo Cruz Founda-tion

focus on neglected diseases, initially Chagas dis-ease

research collabo-ration

7/07

PTC Therapeutics Inc. PTC124 global develop-ment and com-mercial izat ion a g r e e m e n t , rights returned to PTC (9/11)

7/08

To-BBB Technologies BV evaluation of G-Technology research collabo-ration

11/09

Veracyte Inc. Veracyte's Afirma Thyroid FNA Analysis diagnos-tic for thyroid cancer

global promo-tion agreement

1/12


infection

XTL Biopharmaceuticals Ltd.Company History

Founded in 1993

Business Strategy

Development, in-licensing, acquisition and commercialization of proprietary products and late-stage pharmaceutical product candidates for the treatment of unmet medical needs

Licensor XTL Biopharmaceuticals Ltd.Licensee Cubist Pharmaceuticals Inc.Royalty/Deal Value $5 million plus 10% to 17% of salesDrug/Product Name HepeX-BType/Product Area Cubist licensed worldwide rights to develop and commercialize the monoclonal anti-

body for hepatitis BTerms/Details XTL got $3 million in collaboration support and up-front payments and would be

entitled to another $3 million in milestones, plus royaltiesDate June 2004

HepeX-B - Hepatitis B

Deal Summary

In.June.2004,.XTL.granted.worldwide.rights.to.Cubist.for.the.development.and.commercialization.of.an.inves-tigational.monoclonal.antibody.known.as.HepeX-B,.then.in.Phase.IIb.testing.for.the.prevention.of.re-infection.by.the.hepatitis.B.virus.in.liver.transplant.patients..The.companies.agreed.to.continue.the.ongoing.study.and,.if.successful,.move.into.late-stage.development..Cubist.agreed.to.fund.HepeX-B’s.development.costs.and.would.be.responsible.for.worldwide.registration.and.commercialization..It.agreed.to.pay.XTL.collaboration.support.and.up-front.payments.totaling.$3.million.over.the.first.two.years.and.would.owe.an.additional.$3.million.upon.the.achievement.of.certain.regulatory.milestones..Cubist.also.committed.to.pay.XTL.a.tiered.royalty,.ranging.from.10%.to.17%.of.net.sales.

HepeX-BDrug Description/ Mechanism

The drug is an antibody product designed to prevent re-infection by the hepatitis B virus in liver transplant patients.

Drug History HepeX-B demonstrated positive results in a Phase IIb study; however, meetings with the FDA indicated that the regulatory pathway for the drug would pose operational and economic challenges, and the companies decided to stop investing in the part-nership in 2006.