2. 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
3. Table of Contents
Table of Contents
Bird’s-Eye View............................................................................................................................... 13
A Tangible Starting Point for Smart Dealmaking ............................................................................14
A Deep Dive..................................................................................................................................... 16
Vital Statistics...................................................................................................................................17
Make a Big Deal of Taking the Royalty Road..................................................................................18
Alzheimer’s Royalty Rates...............................................................................................................26
Cancer Royalty Rates. ......................................................................................................................27
.
Cardiovascular Royalty Rates...........................................................................................................30
Diabetes Royalty Rates.....................................................................................................................32
Hepatitis Royalty Rates....................................................................................................................33
.
Pain Royalty Rates............................................................................................................................34
Royalty Rates for Biopharmaceutical Companies............................................................................35
The Deal Details.............................................................................................................................. 46
Autoimmune.................................................................................................................................... 47
BB-882 - Asthma..............................................................................................................................48
Copaxone - Multiple Sclerosis..........................................................................................................49
Drugs for Arthritis and Pneumocystis carinii pneumonia.................................................................51
Humanized Monoclonal Antibody....................................................................................................52
Humira - Rheumatoid Arthritis.........................................................................................................54
Indaflex - Arthritis.............................................................................................................................56
Primatized Anti-CD4 Antibodies - Rheumatoid Arthritis.................................................................58
Primatized Anti-CD4 Antibodies - Allergies....................................................................................59
R788 - Rheumatoid Arthritis............................................................................................................60
.
Cancer.............................................................................................................................................. 62
2-deoxy-d-glucose - Cancer..............................................................................................................63
AastromReplicell - Cancer. ..............................................................................................................65
.
Acadesine - B-cell Chronic Lymphocytic Leukemia........................................................................67
AGT 203 - Cancer, Age-Related Degeneration, Diabetes, Obesity..................................................68
AL6082 - Cancer..............................................................................................................................69
.
Anticancer Immunity Treatment - Cancer........................................................................................70
Atiprimod - Cancer...........................................................................................................................71
Avicine - Multiple Cancer Indications..............................................................................................72
Bisanthracyclines - Tumors..............................................................................................................74
.
Cancer Drug......................................................................................................................................75
Cancer Drug......................................................................................................................................76
Cancer Drug......................................................................................................................................77
Cancer Drug......................................................................................................................................78
Cancer Therapy - Delivery...............................................................................................................79
.
Cancer Therapy - Metastatic Melanoma...........................................................................................80
Ceplene - Leukemia..........................................................................................................................81
Cintredekin Besudotox - Cancer.......................................................................................................83
Essential Benchmarks for Dealmaking 5
8. Table of Contents
Erythromycin Antibiotic - Bacterial Infections..............................................................................383
.
Fuzeon - HIV..................................................................................................................................384
Gene Therapy Products - Hepatitis B and C...................................................................................386
HE317 - Immunodeficiencies.........................................................................................................387
Hepatitis and Retrovirus Technologies - Hepatitis G.....................................................................388
.
Hepatitis A Vaccine.........................................................................................................................389
Hepatitis B Drug - Infection...........................................................................................................390
Hepatitis B Drug.............................................................................................................................391
Hepatitis C Vaccine.........................................................................................................................392
Hepatitis E Vaccine.........................................................................................................................393
HepeX-B - Hepatitis B....................................................................................................................394
Heplisav - Infection........................................................................................................................395
.
HIV and Hepatitis Vaccines............................................................................................................396
HIV/AIDS Vaccine.........................................................................................................................398
HIV Drug........................................................................................................................................402
HIV Drugs. .....................................................................................................................................403
.
Iminosugars - Potential Antiviral....................................................................................................405
Incivek - Hepatitis C.......................................................................................................................406
Infergen - Hepatitis C.....................................................................................................................408
.
Interferon-g - HIV...........................................................................................................................412
Method for Interferon - Hepatitis B and C infection......................................................................414
Monoclonal Antibodies - Gram-Negative Sepsis-Related Bacteria...............................................416
.
Naked DNA Technology.................................................................................................................419
Nanocrystalline Particles................................................................................................................421
NCX 1000 - Hepatitis C and Hypertension....................................................................................422
Novasome Lipid Vesicles Encapsulation Technology - Vaccines...................................................424
Omniferon - Hepatitis C.................................................................................................................425
.
Oragen - HIV..................................................................................................................................428
Protease Inhibitors - HIV and AIDS...............................................................................................430
Questcor Patents – Hepatitis C.......................................................................................................432
Relenza - Influenza.........................................................................................................................434
Ribozymes - HIV............................................................................................................................436
S-1153 - HIV...................................................................................................................................438
Small Molecules - Hepatitis C........................................................................................................440
Tamiflu - Influenza..........................................................................................................................442
Taribavirin - Hepatitis C.................................................................................................................445
Technologies and Product Candidates - Hepatitis C.......................................................................448
Tyzeka/Sebivo - Hepatitis B...........................................................................................................449
Vaccines, Gene-Based - HIV, Hepatitis B & C Viruses, Herpes, . .................................................451
Papilloma, Measles, Tuberculosis and Influenza............................................................................451
Vaccine Research - HIV, Hepatitis, Influenza.................................................................................453
Vibativ - Gram-Positive Infections.................................................................................................454
Viread - HIV...................................................................................................................................455
Viread and Preveon - HIV..............................................................................................................458
.
Virus-like Particle Vaccines - Human Papillomavirus....................................................................462
Zadaxin - Hepatitis C......................................................................................................................464
10 BioWorld Data: Biopharmaceutical Royalty Rates Analysis
9. Table of Contents
Miscellaneous................................................................................................................................ 466
.
A1PI - Alpha-1 antitrypsin deficiency............................................................................................467
Actimmune - Infections, Pulmonary Fibrosis and Cancer..............................................................469
Aldurazyme - Mucopolysaccharidosis I.........................................................................................471
Alpha Interferon..............................................................................................................................473
Auriculin Anaritide - Acute Renal Failure......................................................................................475
Bio-Equivalent Cardizem CD ........................................................................................................477
Cochleates, Liposomes and Proteoliposomes.................................................................................478
Collagenase Ointment - Dermal Ulcers and Burns.........................................................................484
Combinatorial Chemistry Services - Drug Discovery....................................................................485
CY 1787 and CY 1503 - Septic Shock and Adult Respiratory Distress Syndrome........................486
Cytofectins - Cystic Fibrosis..........................................................................................................488
.
Dermagran II Ointment and Spray - Wound Healing.....................................................................490
Estrasorb - Estrogen Therapy.........................................................................................................491
.
Gattex - Gastrointestinal Disorders. ...............................................................................................494
.
Gene Therapy Partnership Network...............................................................................................496
.
Gene Therapy Treatments...............................................................................................................497
Genentech Products........................................................................................................................499
Hectorol - Osteoporosis..................................................................................................................504
Hextend and PentaLyte - Hypovolemia..........................................................................................507
Hextend and PentaLyte - Hypovolemia..........................................................................................509
Hextend - Hypovolemia.................................................................................................................. 511
Hextend - Hypovolemia..................................................................................................................513
Human Growth Hormone...............................................................................................................515
Humanized Antibody......................................................................................................................516
IgA Nephropathy Treatment...........................................................................................................518
IMOs - Allergy................................................................................................................................520
Indaflex and Flexogan - Inflammatory. ..........................................................................................522
.
Kuvan, PEG-PAL, 6R-BH4 - Phenylketonuria and Cardiovascular. .............................................524
.
Living Cells Connective Tissue......................................................................................................526
Loteprednol Etabonate - Ophthalmic..............................................................................................527
Lubrin - Vaginal Dryness................................................................................................................528
M-Enoxaparin.................................................................................................................................529
MDX-RA - Secondary Cataracts....................................................................................................530
Monoclonal Antibodies Binding to TGF-B....................................................................................534
Neupogen - Anemia........................................................................................................................536
Oral Contraceptives........................................................................................................................539
Prochieve - Preterm Birth...............................................................................................................540
Procrit - Anemia..............................................................................................................................541
Receptor-Mediated Permeabilizers.................................................................................................545
RNA Interference Technology........................................................................................................547
RNA Interference Technology........................................................................................................550
Sexual Dysfunction Therapy..........................................................................................................554
.
Solaraze and Others - Dermatology................................................................................................555
Systemic Evolution of Ligands through EXponential Enrichment (SELEX) - Oligonucleotides
Screening Process...........................................................................................................................557
TGF-beta - Ophthalmological, Wounds, Autoimmune...................................................................560
Essential Benchmarks for Dealmaking 11
10. Table of Contents
Thymosin Beta 4 - Various Indications. .........................................................................................565
.
Vaniqa - Excessive Facial Hair on Women.....................................................................................567
Technology..................................................................................................................................... 570
ACTCellerate - Embryonic Stem Cell Technology........................................................................571
Bioadhesive Delivery System - Drug Delivery..............................................................................573
Cell Culture Flask Patent................................................................................................................574
Cochleate Technology.....................................................................................................................576
Cypress Stem Cells.........................................................................................................................580
DNA Nanocircles - Research..........................................................................................................581
Duros Drug Delivery Technology...................................................................................................582
Gene Alteration Technology...........................................................................................................585
Gene Sequencing Technology - Infectious Diseases......................................................................586
Genetically Engineered Listeria Immune Therapy.........................................................................588
Heat-Activated Gene Therapy Technology - Cancer......................................................................591
hESC Technology - Technology.....................................................................................................593
HuMAb-Mouse Technology...........................................................................................................595
Mammalian Embryonic Stem Cells Technology............................................................................599
Method for Binding DNA and RNA...............................................................................................601
Naked DNA Technology.................................................................................................................602
NASA Technology..........................................................................................................................604
Natural Cell Signaling Technologies..............................................................................................605
Nebulizer - Technology. .................................................................................................................607
.
NTP Testing Technology - Technology..........................................................................................608
.
Nucleoside Technology - Hepatitis B.............................................................................................609
Optison - Contrast Agent................................................................................................................610
PharmaPrint Process - Drug Development, Botanicals..................................................................612
ppGpp Degradase and Peptide Deformylase Technology..............................................................613
.
Stem Cell Lines...............................................................................................................................614
Stem Cell Technology.....................................................................................................................615
Stem-Loop Vector Technology ......................................................................................................616
Thrombus Ligands - Diagnostic Imaging.......................................................................................617
Thymidine Kinase Isoenzyme Diagnostics and Thymidine Kinase Hybridomas..........................619
UMASS Patents - Cartilage Regenerative Technology..................................................................620
VelocImmune Technology..............................................................................................................621
XenoMouse Technology - Cancer..................................................................................................623
.
Indices............................................................................................................................................ 624
Companies and Other Organizations Index....................................................................................625
Inventors Index...............................................................................................................................631
Drugs and Therapeutic Technologies Index...................................................................................632
.
Diseases, Indications and Targets Index.........................................................................................636
12 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 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.
148 BioWorld Data: Biopharmaceutical Royalty Rates Analysis
12. Cancer
Picoplatin
Drug 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 Snyder
History 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 Agreements
Partnered Company Products Involved Agreement Type Date
Algeta ASA to study cancer targets using its Thorium plat- partnership 4/11
form and Genzyme's tumor-targeting antibody
Angiotech Pharmaceu- identification, development and commercializa- strategic collab- 5/06
ticals Inc. tion of therapies for cancer patients undergoing oration agree-
surgical removal of tumors ment
Arecor Ltd. development of stable, high-strength formula- collaboration 4/10
tions of labile biomolecules
De Novo Pharmaceuti- De Novo to apply its molecular structure gen- drug discovery 1/06
cals 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 agreement
ERYtech 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 ERYtech
150 BioWorld Data: Biopharmaceutical Royalty Rates Analysis
14. Cancer
Hospira Worldwide Inc. to perform fill and finish manufacturing services material defini- 1/10
for Genzyme's Cerezyme, Fabrazyme, Myozyme tive agreement
and Thyrogen
Isis Pharmaceuticals mipomersen licensing and 6/08
collaboration
agreement
Moffitt Cancer Center diagnostic testing rights for two proteins for licensing agree- 1/08
NSCLC ment
Oswaldo Cruz Founda- focus on neglected diseases, initially Chagas dis- research collabo- 7/07
tion ease ration
PTC 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
ration
Veracyte Inc. Veracyte's Afirma Thyroid FNA Analysis diagnos- global promo- 1/12
tic for thyroid cancer tion agreement
Essential Benchmarks for Dealmaking 151
15. Infection
HepeX-B - Hepatitis B
Licensor XTL Biopharmaceuticals Ltd.
Licensee Cubist Pharmaceuticals Inc.
Royalty/Deal Value $5 million plus 10% to 17% of sales
Drug/Product Name HepeX-B
Type/Product Area Cubist licensed worldwide rights to develop and commercialize the monoclonal anti-
body for hepatitis B
Terms/Details XTL got $3 million in collaboration support and up-front payments and would be
entitled to another $3 million in milestones, plus royalties
Date June 2004
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-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 1993
History
Business Development, in-licensing, acquisition and commercialization of proprietary products and
Strategy late-stage pharmaceutical product candidates for the treatment of unmet medical needs
394 BioWorld Data: Biopharmaceutical Royalty Rates Analysis