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Royalty Rates Analysis:
Essential Benchmarks for Dealmaking

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  • 1. BiopharmaceuticalRoyalty Rates Analysis:Essential Benchmarks for Dealmaking
  • 2. BioWorld Data Biopharmaceutical Royalty Rates Analysis: Essential Benchmarks for DealmakingExecutives involved in any aspect of dealmaking know it’s hard to find real-world data on dealterms such as royalty rates, milestones and up-fronts. A new tool from BioWorld solves thisproblem. Biopharmaceutical Royalty Rates Analysis: Essential Benchmarks for Dealmakinganalyzes 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 ratesand 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 theanalyses are profiles of more than 320 deals including not only the royalty rates, but all dealterms and key background information on the drug or drug technology in focus – invaluabledetails 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 theopportunity 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’tuncommon.* An increase in dealmaking also results in an increase in deal terminations when big pharmasrestructure pipelines or when trials don’t produce expected results. Ironclad contracts protectboth parties.* The dealmaking trend is likely to continue because big pharma has reached the dreaded patentcliffs.* Life science attorneys need these data points, too, as part of patent valuation and to establishinfringement 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
  • 3. Table of Contents Table of ContentsBird’s-Eye View............................................................................................................................... 13A Tangible Starting Point for Smart Dealmaking ............................................................................14A Deep Dive..................................................................................................................................... 16Vital Statistics...................................................................................................................................17Make a Big Deal of Taking the Royalty Road..................................................................................18Alzheimer’s Royalty Rates...............................................................................................................26Cancer Royalty Rates. ......................................................................................................................27 .Cardiovascular Royalty Rates...........................................................................................................30Diabetes Royalty Rates.....................................................................................................................32Hepatitis Royalty Rates....................................................................................................................33 .Pain Royalty Rates............................................................................................................................34Royalty Rates for Biopharmaceutical Companies............................................................................35The Deal Details.............................................................................................................................. 46Autoimmune.................................................................................................................................... 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. ..............................................................................................................65 .Acadesine - B-cell Chronic Lymphocytic Leukemia........................................................................67AGT 203 - Cancer, Age-Related Degeneration, Diabetes, Obesity..................................................68AL6082 - Cancer..............................................................................................................................69 .Anticancer Immunity Treatment - Cancer........................................................................................70Atiprimod - Cancer...........................................................................................................................71Avicine - Multiple Cancer Indications..............................................................................................72Bisanthracyclines - Tumors..............................................................................................................74 .Cancer Drug......................................................................................................................................75Cancer Drug......................................................................................................................................76Cancer Drug......................................................................................................................................77Cancer Drug......................................................................................................................................78Cancer Therapy - Delivery...............................................................................................................79 .Cancer Therapy - Metastatic Melanoma...........................................................................................80Ceplene - Leukemia..........................................................................................................................81Cintredekin Besudotox - Cancer.......................................................................................................83Essential Benchmarks for Dealmaking 5
  • 4. Table of ContentsClolar - Hematological Malignancies...............................................................................................84CRx-026 - Multiple Tumor Types. ...................................................................................................86 .Combined Immunogene Therapy - Cancer.......................................................................................88CTCE-9908, CTCE-0214 - Cancer, Transplant................................................................................89Dacogen - Cancer. ............................................................................................................................90 .Dibromodulcitol (DBD) - Cancer.....................................................................................................93Disodium Clodronate - Cancer-Associated Bone Diseases..............................................................94Electrostatic Liposome - Cancer Drug Delivery. .............................................................................96 .Erbitux - Colorectal Cancer..............................................................................................................98Erivedge (GDC-0449) - Cancer......................................................................................................100Eylea - Cancer.................................................................................................................................103GCS-100 - Colorectal and Pancreatic Cancers...............................................................................106Genasense - Cancer.........................................................................................................................107Hematology Controls Using Reticulocytes. ...................................................................................108 .Histone 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................................................................................................. 117 .MP-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. ..............................................................................................130 .Oncaspar - Cancer...........................................................................................................................131Oncolym - Hodgkin’s B-cell Lymphoma. ......................................................................................132 .Oncolysin 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. ....................................................................................................................143 .Phosphatases - Glioblastomas.........................................................................................................145Picoplatin - Small-Cell Lung Cancer..............................................................................................146Picoplatin - Small-Cell Lung Cancer..............................................................................................148Platinate HPMA Copolymer - Cancer............................................................................................152 .Radinyl - Cancer.............................................................................................................................153RAS Human Protein/Rational Drug Design - Malignant Tumors..................................................154Recombinant Human Interleukin-12..............................................................................................155 .Retinoids - Kidney Cancer, Leukemia............................................................................................156Rhenium Radiotherapy and Monoclonal Antibodies - Colon Cancer............................................158RSR13 - Cancer..............................................................................................................................1606 BioWorld Data: Biopharmaceutical Royalty Rates Analysis
  • 5. Table of ContentsSatraplatin - Prostate Cancer. .........................................................................................................161 .Satraplatin - Cancer........................................................................................................................162 .Specific Drug Undisclosed - Various Cancer Therapies.................................................................163Stem Cell Proliferation Factor - Cancer.........................................................................................164 .TAP Technology - Cancer...............................................................................................................165Tarceva - Cancer.............................................................................................................................167Tarceva - Various Cancer Indications.............................................................................................169Thalidomide Analogues - Cancer...................................................................................................171 .Thalomid - Multiple Myeloma.......................................................................................................173 .Theragyn - Ovarian Cancer. ...........................................................................................................175 .Tissue Malignancy Treatments - Cancer. .......................................................................................176 .Vectibix - Colorectal Cancer...........................................................................................................177Xerecept - Brain Tumors................................................................................................................181 .Zaltrap - Cancer..............................................................................................................................183Cardiovascular.............................................................................................................................. 185Adenocard - Paroxysmal Supraventricular Tachycardia. ...............................................................186 .Aggrastat (tirofiban hydrochloride) - Acute Coronary Syndrome..................................................187Angiogenix - Cardiovascular..........................................................................................................191Angiomax - Cardiovascular............................................................................................................192Anti-hypertension Therapy.............................................................................................................193Autologous Gene Therapy - Hypertension.....................................................................................194BAY 59-7939 - Cardiovascular. .....................................................................................................195 .Bextra - 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..............................................................................................209 .Gel Lock Invention and Taurolidine Treatments - Cardiorenal Disease. .......................................210 .Gencaro - Cardiovascular............................................................................................................... 211Gencaro - Chronic Heart Failure....................................................................................................212 .HepArrest - Cardiovascular............................................................................................................213Integrilin - Cardiovascular Disease. ...............................................................................................214 .M-Enoxaparin - Cardiovascular. ....................................................................................................215 .MyoCell - Cardiovascular...............................................................................................................217Naked DNA Technology - Cardiovascular Disease........................................................................219Non-PESDA Microbubbles - Cardiovascular.................................................................................221Paclitaxel.........................................................................................................................................222Paclitaxel Technology - Cardiovascular.........................................................................................222Portable Ultrasonic Nebulizer - Cardiovascular Disease................................................................223Pro-Apolipoprotein A-I - Cardiovascular.......................................................................................224Essential Benchmarks for Dealmaking 7
  • 6. Table of ContentsRanexa - Angina.............................................................................................................................225 .Relovair - Chronic Obstructive Pulmonary Disease and Asthma...................................................228RNAi Technologies - Respiratory Syncytial Virus.........................................................................230Tadalafil - Hypertension. ................................................................................................................232 .Teveten - Hypertension...................................................................................................................236ThromboClear - Cardiovascular.....................................................................................................237Tiazac - To Reduce the Risk of Heart Attacks................................................................................238Central Nervous System...............................................................................................................239Acurox - Abuse-Resistant Painkiller. .............................................................................................240 .ALKS 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...........................................................................................255 .AZ-004 - Schizophrenia or Bipolar Disorder.................................................................................256Bicifadine - Dental Pain..................................................................................................................258Brain-Derived Neurotrophic Factor................................................................................................261Chronogesic - Pain..........................................................................................................................264Dexfenfluramine - Obesity. ............................................................................................................265 .Doxylamine Succinate Nasal Spray - Sleep Therapy.....................................................................267Entereg - Pain.................................................................................................................................269 .Estradot - 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.....................................................................................................293 .Memryte - Alzheimer’s Disease.....................................................................................................295 .Naked DNA Technology.................................................................................................................297Neotrofin - Neuroimunologic Disorders.........................................................................................299Nervous System Therapeutics........................................................................................................302 .8 BioWorld Data: Biopharmaceutical Royalty Rates Analysis
  • 7. Table of ContentsNeuroCell - Parkinson’s and Huntington’s diseases.......................................................................304Neuroimmunophilins - Nerve Repair.............................................................................................307 .Neurological Peptide Therapy........................................................................................................309Neurological Therapeutics.............................................................................................................. 311NGD 94-1 - Schizophrenia.............................................................................................................312NicVAX - Smoking Cessation........................................................................................................313Novantrone - Multiple Sclerosis.....................................................................................................316NRP104 - Attention Deficit Hyperactivity Disorder. .....................................................................320 .Opana - Pain...................................................................................................................................323 .Oral Flupirtine - Fibromyalgia........................................................................................................325Oruvail - Pain..................................................................................................................................326Pain Management...........................................................................................................................327 .Phospholipids - Central Nervous System Conditions.....................................................................328Posidur - Postsurgical Pain.............................................................................................................329PQ-1002 - Anesthesia.....................................................................................................................331Remoxy - Pain................................................................................................................................332 .Risperdal Consta - Schizophrenia and Bipolar Disorder................................................................333Ryzolt - Pain...................................................................................................................................335 .Sarafem - Premenstrual Syndrome.................................................................................................336Transgenic Mouse Model - Alzheimer’s Disease...........................................................................340Treximet - Migraine........................................................................................................................341Vivitrol - Alcohol & Opioid Dependency.......................................................................................343Zolpimist - Insomnia.......................................................................................................................345Diabetes.......................................................................................................................................... 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. ......................................................................................................................360 .Luteolin - Diabetes. ........................................................................................................................361 .SF-1019 - Diabetes.........................................................................................................................362Infection......................................................................................................................................... 363Alpha Interferon-Natural - Infection. .............................................................................................364 .Alferon 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 .Essential Benchmarks for Dealmaking 9
  • 8. Table of ContentsErythromycin Antibiotic - Bacterial Infections..............................................................................383 .Fuzeon - HIV..................................................................................................................................384Gene Therapy Products - Hepatitis B and C...................................................................................386HE317 - Immunodeficiencies.........................................................................................................387Hepatitis and Retrovirus Technologies - Hepatitis G.....................................................................388 .Hepatitis A Vaccine.........................................................................................................................389Hepatitis B Drug - Infection...........................................................................................................390Hepatitis B Drug.............................................................................................................................391Hepatitis C Vaccine.........................................................................................................................392Hepatitis E Vaccine.........................................................................................................................393HepeX-B - Hepatitis B....................................................................................................................394Heplisav - Infection........................................................................................................................395 .HIV and Hepatitis Vaccines............................................................................................................396HIV/AIDS Vaccine.........................................................................................................................398HIV Drug........................................................................................................................................402HIV Drugs. .....................................................................................................................................403 .Iminosugars - Potential Antiviral....................................................................................................405Incivek - Hepatitis C.......................................................................................................................406Infergen - Hepatitis C.....................................................................................................................408 .Interferon-g - HIV...........................................................................................................................412Method for Interferon - Hepatitis B and C infection......................................................................414Monoclonal Antibodies - Gram-Negative Sepsis-Related Bacteria...............................................416 .Naked DNA Technology.................................................................................................................419Nanocrystalline Particles................................................................................................................421NCX 1000 - Hepatitis C and Hypertension....................................................................................422Novasome Lipid Vesicles Encapsulation Technology - Vaccines...................................................424Omniferon - Hepatitis C.................................................................................................................425 .Oragen - 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..............................................................................................................458 .Virus-like Particle Vaccines - Human Papillomavirus....................................................................462Zadaxin - Hepatitis C......................................................................................................................46410 BioWorld Data: Biopharmaceutical Royalty Rates Analysis
  • 9. Table of ContentsMiscellaneous................................................................................................................................ 466 .A1PI - 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..........................................................................................................488 .Dermagran II Ointment and Spray - Wound Healing.....................................................................490Estrasorb - Estrogen Therapy.........................................................................................................491 .Gattex - Gastrointestinal Disorders. ...............................................................................................494 .Gene Therapy Partnership Network...............................................................................................496 .Gene 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. ..........................................................................................522 .Kuvan, PEG-PAL, 6R-BH4 - Phenylketonuria and Cardiovascular. .............................................524 .Living 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..........................................................................................................554 .Solaraze and Others - Dermatology................................................................................................555Systemic Evolution of Ligands through EXponential Enrichment (SELEX) - OligonucleotidesScreening Process...........................................................................................................................557TGF-beta - Ophthalmological, Wounds, Autoimmune...................................................................560Essential Benchmarks for Dealmaking 11
  • 10. Table of ContentsThymosin Beta 4 - Various Indications. .........................................................................................565 .Vaniqa - Excessive Facial Hair on Women.....................................................................................567Technology..................................................................................................................................... 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. .................................................................................................................607 .NTP Testing Technology - Technology..........................................................................................608 .Nucleoside Technology - Hepatitis B.............................................................................................609Optison - Contrast Agent................................................................................................................610PharmaPrint Process - Drug Development, Botanicals..................................................................612ppGpp Degradase and Peptide Deformylase Technology..............................................................613 .Stem 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...................................................................................632 .Diseases, Indications and Targets Index.........................................................................................63612 BioWorld Data: Biopharmaceutical Royalty Rates Analysis
  • 11. Cancer Picoplatin - Small-Cell Lung Cancer Licensor Genzyme Corp. Licensee Poniard Pharmaceuticals Inc. Royalty/Deal Value $11 million cash plus $1 million of common stock plus 9% of sales Drug/Product Name Picoplatin Type/Product Area License agreement for worldwide rights Terms/Details $11 million cash plus $1 million of common stock plus 9% of sales Date 2004 Deal SummaryPoniard holds an exclusive worldwide license granted from Genzyme Corp. for the development and commercialsale 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 sueany 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 excludedJapan 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 salesafter regulatory approval. The parties amended the license agreement on Sept. 18, 2006, modifying several keyfinancial 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 Genzymean 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 uponthe attainment of certain levels of annual net sales of picoplatin after regulatory approval. The amendment alsoreduced the royalty payable to Genzyme to a maximum of 9% of annual net product sales and eliminated sharingof sublicense revenues with Genzyme. The license agreement may be terminated by either party for breach, orif the other party files a petition in bankruptcy or insolvency or for reorganization or is dissolved, liquidated ormakes assignment for the benefit of creditors. Poniard can terminate the license at any time upon prior writtennotice to Genzyme. If not earlier terminated, the license agreement will continue in effect, in each country in theterritory in which the licensed product is sold or manufactured, until the earlier of (i) expiration of the last validclaim of a pending or issued patent covering the licensed product in that country or (ii) a specified number of yearsafter 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, whichcover 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 in2016 covering picoplatin in the European Union and other countries.148 BioWorld Data: Biopharmaceutical Royalty Rates Analysis
  • 12. CancerPicoplatinDrug Description/ Picoplatin is an intravenous platinum-based chemotherapeutic designed to treat sol-Mechanism 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 Founded in June 1981 by Henry Blair and Sherry SnyderHistory Began operations by acquiring Whatman Biochemicals Ltd., UK Member--Biotechnology Industry Organization Founded 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)Essential Benchmarks for Dealmaking 149
  • 13. 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- partnership 4/11 form and Genzymes tumor-targeting antibodyAngiotech Pharmaceu- identification, development and commercializa- strategic collab- 5/06ticals Inc. tion of therapies for cancer patients undergoing oration agree- surgical removal of tumors mentArecor Ltd. development of stable, high-strength formula- collaboration 4/10 tions of labile biomoleculesDe Novo Pharmaceuti- De Novo to apply its molecular structure gen- drug discovery 1/06cals Ltd. erating technology to focus on a disease target c o l l a b o r a t i o n that is of interest to Genzyme agreementERYtech Pharma therapeutic enzyme formulation for Genzyme d e v e l o p m e n t 10/10 disease indications using technology developed agreement by ERYtech150 BioWorld Data: Biopharmaceutical Royalty Rates Analysis
  • 14. CancerHospira Worldwide Inc. to perform fill and finish manufacturing services material defini- 1/10 for Genzymes Cerezyme, Fabrazyme, Myozyme tive agreement and ThyrogenIsis Pharmaceuticals mipomersen licensing and 6/08 collaboration agreementMoffitt Cancer Center diagnostic testing rights for two proteins for licensing agree- 1/08 NSCLC mentOswaldo Cruz Founda- focus on neglected diseases, initially Chagas dis- research collabo- 7/07tion ease rationPTC Therapeutics Inc. PTC124 global develop- 7/08 ment and com- mercialization agreement, rights returned to PTC (9/11)To-BBB Technologies BV evaluation of G-Technology research collabo- 11/09 rationVeracyte Inc. Veracytes Afirma Thyroid FNA Analysis diagnos- global promo- 1/12 tic for thyroid cancer tion agreementEssential Benchmarks for Dealmaking 151
  • 15. Infection HepeX-B - Hepatitis BLicensor 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 Deal SummaryIn 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-infectionby the hepatitis B virus in liver transplant patients. The companies agreed to continue the ongoing study and, ifsuccessful, move into late-stage development. Cubist agreed to fund HepeX-B’s development costs and wouldbe responsible for worldwide registration and commercialization. It agreed to pay XTL collaboration support andup-front payments totaling $3 million over the first two years and would owe an additional $3 million upon theachievement of certain regulatory milestones. Cubist also committed to pay XTL a tiered royalty, ranging from10% to 17% of net sales. HepeX-B Drug Description/ The drug is an antibody product designed to prevent re-infection by the hepatitis B Mechanism 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. XTL Biopharmaceuticals Ltd.Company Founded in 1993HistoryBusiness Development, in-licensing, acquisition and commercialization of proprietary products andStrategy late-stage pharmaceutical product candidates for the treatment of unmet medical needs394 BioWorld Data: Biopharmaceutical Royalty Rates Analysis

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