BioWorld® Arthritis Report 2009: Drug and Med-Tech Innovation and Economics

Published by: Bioworld Online/AHC Media

Published: Jan. 1, 2009 - 150 Pages

Table of Contents

Introduction and Analysis

Disease Primer

Denosumab: A Future Standard-Bearer for Rheumatoid Arthritis and Osteoporosis

Amgen’s Denosumab Meets High Expectations in FREEDOM Study

Amgen Sheds Three Products to Focus on ‘Bigger Picture’ and Denosumab

Amgen Issues Positive Results for Denosumab in Increasing Bone Mineral Density

Amgen’s Denosumab Meets All Endpoints in Long Awaited Trial

Amgen Reports on Denosumab

Denosumab Trumps Fosamax in Phase III Bone Density Study

Preliminary Results Show Denosumab Beats Fosamax in Bone Density

Denosumab Builds Bone Density, but Infection Concerns Emerge

Amgen Gains Japanese Partner for Denosumab

Approved Therapies Set the Standards for the Future

Rituxan

History of Rituxan

New Approvals and Current Trials

Rituxan Faces Competition, Even from Its Developers

RA Patient Dies from PML in Rituxan Safety Study

Phase III Results of Rituxan in RA Released

Enbrel

Amgen’s Enbrel Approved for Numerous Indications

Indications, Competition and Trials

Enbrel Findings Published in The Lancet

Amgen’s Third Quarter Beats Wall Street Estimates

Humira

Approvals and Indications

History of Humira

FDA Approves Humira in Juvenile Idiopathic Arthritis

Abbott Reports on Use of Humira in AS

Abbott Presents Humira Data in RA

Humira Approved for Psoriatic Arthritis

Humira Approved for AS in Canada and U.S

FDA Orders Histoplasmosis Warnings for TNF Blockers, Including Humira

Remicade

An Array of Indications

History of Remicade and Its Approvals

New Approvals

About Centocor and J&J

Lodotra

Nitec Pharma Gets $22M for Lodotra Launch, TruNoc Development

Orthokine

Orthogen Publishes Study on Orthokine in Osteoarthritis

Upcoming Arthritis Treatments

Actemra

Actemra Receives FDA Nod

FDA Panel Backs Approval of Roche IL-6 Arthritis Drug

Roche Reports on Actemra RADIATE Study

Actemra Receives Approvals in Japan

Golimumab

BLA Submitted for Golimumab for RA, PA and AS

Golimumab Succeeds in Three Phase III Trials

MAA Submitted for Golimumab for RA, PA and AS

Centocor Reports Positive Phase III Golimumab Data

Cimzia

Cimzia Results in RA Released

FDA Accepts BLA for UCB’s Cimzia in RA

MAA Accepted for UCB’s Cimzia

UCB Licenses Keppra, Cimzia Rights in Japan in €113M Deal

FDA Orders Histoplasmosis Warnings for TNF Blockers, Including Cimzia

Arthritis Treatments in Phase III Development

MM-093

Enrollment Completed in MM-093 Phase III for RA

Merrimack Pipeline Gets $60M Series F Boost

Ofatumumab

Ofatumumab in Phase III for RA

Ofatumumab (HuMax-CD20) Meets Milestone

Subcutaneous Ofatumumab Enters Phase I/II

Ofatumumab Reaches Development Milestones

Genmab, GSK Move into Phase III with Ofatumumab in Europe

GSK, Genmab Deal Tops All: $2.1B For Phase III Antibody

dnaJP1

Pipex Adds Late-Stage RA Drug, dnaJP1, to Bolster Autoimmune Pipeline

PN 400

Pozen, AstraZeneca Starting Phase III Trial of PN 400 in Arthritis

Pozen Slides on FDA Endpoint Review, Generic Treximet Filing

Embeda

Embeda Phase III Osteoarthritis Pain Trial Data Released

Naproxcinod

NicOx Phase III Arthritis Drug Also Holds Down Blood Pressure

Naproxcinod Meets Endpoints in Third Phase III Arthritis Trial

Commercial Manufacturing and Supply Agreements Signed

NicOx Announces Results with Naproxcinod

PMI-001

Series B to Help Phytomedics Advance PMI-001 in RA

Arthritis Treatments in Phase I/II Development

R788

Rigel Seeks to Dampen ‘Rumors’ About Arthritis Drug Candidate R788

Rigel’s R788 Shows Success

Rigel Celebrates Recent Stock Climb with $135M Offering

TRU-015

TRU-015 Enters Phase IIb RA Trial

Trubion Reports Data for TRU-015 Phase I/II RA Trial

Trubion and Wyeth in Potential $840M Deal

Trubion Prices $52M IPO; Wyeth Buying $10M More

Trubion’s Series B Brings in $32M for SMIPs

Orencia

Orencia Phase II Shows Promise in RA

BMS, Repligen Reach Orencia Settlement

Orencia-Like RA Drug MAXY-4 Is in Preclinicals

MDX-1100

Medarex MAb for RA and UC, MDX-1100, Enters Phase II

Sale of Genmab Shares Garners Medarex $151.8M

Compugen Targets at Center of MAb Deal with Medarex

Tranilast

Nuon Hits the Ground Running with Tranilast Deal

Nuon Raises $27M to Move Tranilast Through Phase II

ADL5859

Adolor’s ADL5859 Enters Phase II for RA Pain

Adolor Inks $265M Deal with Pfizer for Opioid

INCB18424

Incyte Reports on INCB18424 in RA

Incyte Slips on INCB18424 Myelofibrosis Data

Incyte Prices $94.5M in Public Offering

CH-1504

Chelsea Reports on CH-1504 in RA

Chelsea Acquires I-3D Autoimmune Disease Portfolio

Chelsea Pads Cash Position

Veltuzumab

Immunomedics Inks Potential $620M Deal with Nycomed for Veltuzumab

SC12267

4SC Reports on SC12267 Phase II in RA

4SC Reports Positive Results from Phase II Study of RA Drug

VX-702

Vertex’s VX-702 in Phase II for RA

Vertex Raises $300M in Year’s Public Offering

HE3286

Hollis-Eden’s HE3286 in Phase II for RA

CF101

Can-Fite Details Phase II CF101 Trial in RA

CF101 Begins Phase I in Japan

Semapimod

Cytokine PharmaSciences Develops Semapimod for Autoimmune Diseases

KB001

KaloBios Gets $20M Series D for Humaneered Antibodies

Triolex

Triolex Enters Phase I/II for RA

Preclinical Data Shows Triolex Inflammation Benefits

Triolex Data in Arthritis Released

Chondrogen

Osiris Developing Chondrogen for Arthritis

Genzyme, Osiris Ink Deal that Includes Chondrogen

Osiris Sells Osteocel Business, Shifts Focus to Chondrogen and Prochymal

PIPE Adds $20M for Osiris’ Late-Stage Stem Cell Work

tgAAC94

tgAAC94 for Inflammatory Arthritis in Phase I/II

Targeted Genetics Permitted to Resume tgAAC94 Trial After Death

Targeted Genetics Announces More tgAAC94 Test Results

Gene Therapy Death Likely Due to Age, Weak Immunity

Targeted Genetics Adds $19.5M to Bank in Private Placement

CAM-3001

CAM-3001 MAB for RA Starts Phase I Clinicals

MedImmune Offer Comes in High: AstraZeneca To Pay $15.2 Billion

AstraZeneca Folds Cambridge Antibody into MedImmune

KB001

KaloBios Gets $20M Series D for Humaneered Antibodies

ARRY-162

Array Reports Positive Results from ARRY-162 Phase I

Array Raises $91M Publicly for Inflammation, Cancer Programs

LX2931

Lexicon Reports on LX2931 Phase I in RA and Autoimmune Conditions

LX2931 for RA Gets Positive Phase I Results

R348

Rigel’s R348 Enters Phase I for RA and Other Immune Disorders

Rigel Celebrates Recent Stock Climb with $135M Offering

Rigel Raises $48.8M for Kinase Inhibitor Trials

VGX-1027

VGX Announces Phase I Results for VGX-1027

VGX Plans a Strategic Reverse Merger with Inovio

MOR103

HuCAL Antibody Directed Against GM-CSF in Phase I

Preclinical Data Presented on MOR103

MorphoSys Provides Details on its HuCAL-Derived Antibody for RA

PG102

PG102 Starts Phase I in Psoriatic Arthritis

PanGenetics Raises $34M for Antibody Pipeline, Including PG102 Trial

CCX354

CCX354 for Inflammatory Disease Enters Phase I

CCR1 Program Progress Earns Milestone for ChemoCentryx

ChemoCentryx Partners with GSK’s CEEDD in $1.5B Deal

ISIS 353512

Isis Phase I Antisense Drug May have RA Applications

SBI-087

SBI-087 Starts Phase I for RA

ARG098

Argenes Starts Phase I of Anti-Rheumatoid Arthritis Agent

MDAM

BioNumerik’s MDAM in Phase I for RA

Arthritis Treatments in Early-Stage Development

RhuDex

MediGene’s RhuDex RA Laboratory Tests

Connection Between Death and RhuDex ‘Unlikely’

MediGene’s RhuDex on Hold After Death of Trial Volunteer

MediGene mTCR Platform Becomes Immunocore

Panzem

FDA Accepts IND for EntreMed’s Panzem in RA

EntreMed Shelving Panzem in Cancer, Reprioritizing Pipeline

VAP-1

BioTie’s VAP-1 Antibody Program for RA Will Proceed to Clinicals

Biotie, Elbion Combining CNS, Inflammatory Drugs in Stock Deal

PR-957

Proteolix Preclinical Candidate Shows RA Promise

Proteolix Bucks Downward VC Trend, Adds $79M in Series C

PS031291

Pharmacopeia’s PS031291 in Preclinicals

Ligand Buying Pharmacopeia in Deal Worth up to $70M

Pharmacopeia Announces Staff Cuts

Mesoblast Stem Cells

Mesoblast’s Stem Cells Granted Orphan Drug Status

Mesoblast Reports on Long-Bone Fracture Repair Trial

Mesoblast Reports on Stem Cell Preclinicals for Osteoarthritis

Mesoblast Announces Successful Results in Osteoarthritis Preclinicals

Mesoblast Reports on Stem Cell Use in Long-Bone Leg Fractures

PCI-32765

Animal Model Results Released for Btk Inhibitor

Pharmacyclics Receives Nasdaq Delisting Warning

Pharmacyclics Cuts Staff, Shifts Focus to Early Stage Candidates

XOMA 052

XOMA Reports on XOMA 052 for Arthritis

XOMA Gets $60M CEFF ‘Security Blanket’ for Antibody Pipeline

CD-RAP

Scil, Pfizer Enter $250M Deal for CD-RAP Osteo Drug

CT-112

Cytomedix Enters Anti-Inflammatory Market with Peptides

Cytomedix Raises $1.5M in Direct Financing

MAXY-4

Maxygen Lands $170M Preclinical Deal with Astellas

Maxygen Reduces Staff, Delays MAXY-G34 Work Pending Deal

MT203

Micromet’s MT203 Enters Preclinicals

Micromet, Nycomed GM-CSF Deal Could Be Worth €125M

Micromet Takes in $40M for Antibody Pipeline

CEL-2000

Data Presented on CEL-2000, Peptide for RA

CEL-2000 Shows Positive Preclinical Results

ARX828

AlphaRx ARX828 in Development for RA and IBD

VEL-0230

Velcura Completes First-in-Man for VEL-0230 in RA

CYT013-IL1bQb

Cytos Preclinical CYT013-IL1bQb to Start RA Trials

ARRY-614

Array Files IND for Arthritis Candidate

CH-4051

Chelsea Reports Positive Preclinical Results for RA Drug

CellArthrix

TxCell Financing Funds to Go Toward CellArthrix Development in RA

GT418

Galapagos Selects Preclinical RA and Bone Metastasis Programs

DXLr120

InNexus Adds DXLr120 (CD20) Product to Pipeline

OP-R003

GSK Licenses EUSA Antibody for RA and Other Indications

MDX-1342

Medarex Submits IND for MDX-1342 for RA

vOX2:Fc

Eden Biodesign to Develop vOX2:Fc for Autoimmune Disease

Cx601 and Cx611

Cellerix Evaluating Preclinical RA Drugs

Cellerix Raises $40M for Stem Cell Trials

BLX-301

Biolex’s BLX-301 RA Antibody Completes Humanization

MIF Inhibitors

Cytokine to Move MIF Inhibitors into Preclinicals

FAIM Program

Novogen Anti-Inflammatory Drug Shows Promise in Animal Studies

Baminercept

Failed Studies Prompts Biogen to Drop Baminercept in Arthritis

Synavive

Synavive Knee Osteoarthritis Study Misses Mark

Discontinued Phase II RA Drug Would Have Provided Funds for Synavive

CombinatoRx Had Dropped CRx-150 in RA in Favor of Synavive

CombinatoRx Stock Offering Nets $33M

Upcoming Osteoporosis Treatments

Preos/Preotact

NPS Needs Partner for Preos for Osteoporosis in U.S

FDA Proposes Another Trial To Bolster Preos Results

Partnership Breakup Nets More Money for Preos and Gattex

Fablyn

FDA Experts Like Fablyn, But Can’t Decide for Whom

Osteoporosis Treatments in Clinical Development

Oral Salmon Calcitonin

Emisphere Reports on Oral Salmon Calcitonin

Emisphere Reevaluates Emisphere Eligen Technology

VP Explains Emisphere’s Eligen Technology

Oral Calcitonin

Unigene Clarifies Phase III Oral Calcitonin Trial

Unigene Completes Phase I/II of Oral Calcitonin

Unigene Closes Financing at End of 2008

NB S101

Osteologix IND for NB S101 Is Approved

Osteologix Reports on Phase II NB S101 Study

Osteologix Completes Private Placement

ZT-031

Zelos and Aegis Collaborate on ZT-031 for Osteoporosis

Zelos to Begin Phase III of ZT-031

ViaDerm-PTH

TransPharma Gets $35M in ViaDerm-PTH Deal with Lilly

Parathyroid Hormone (PTH)

End of PTH Deal Sends Shares Tumbling

MDRNA Receives Nasdaq Notification

Disappointing Obesity Results Lead to MDRNA Layoffs

BA058

Radius Completes Enrollment in Phase II of BA058 in Osteoporosis

Second-Tranche Financing Brings Radius $28M

Radius Grants Novartis Option to BA058 in Potential $500M Deal

CaPTHymone

Bone Medical Reports on PTH CaPTHymone to Treat Osteoporosis

Bone Medical’s CaPTHymone for Osteoporosis To Be Sold in South Korea

Oral Human Parathyroid Hormone (PTH)

Oral PTH Enters Phase I in Osteoporosis

Ronacaleret

GSK Stops Phase II Study of Ronacaleret, NPS Osteoporosis Drug

Other Products in Development

Arcalyst Approved for CAPS

Regeneron IL-1 Blocker Arcalyst Receives FDA Approval

Arcalyst Data from Three Studies Published

ARRY-797 for Ankylosing Spondylitis

Array Hits Pain Endpoints with Lead Drug ARRY-797

ACE-011 for Bone Loss

Acceleron Moves Forward with ACE-011 for Bone Loss

Acceleron Publishes Preclinical Data on ACE-011

Acceleron, Celgene in Potential $1.8B Bone Loss Collaboration for ACE-011

Acceleron to Receive Award for ACE-011 R&D

Acceleron Series C Gets $31M for Bone, Muscle Growth Bids

KUR113 for Tibial Shaft Fractures

Kuros Starts Phase IIb of Product for Tibial Shaft Fractures

ENB-0040 for Metabolic Disorder

Enobia Reports on Status of ENB-0040 for Hypophosphatasia

Enobia Starts Clinicals with ENB-0040

NeoCart Implant for Joint Repair

Histogenics Developing NeoCart Neocartilage Implant

Histogenics Series B to Support NeoCart Neocartilage Implant

ALSE-100 for Bone Healing

Alseres Presents Data on Regenerative Therapy Candidate

AC-100 for Cartilage Regeneration

Acologix Reports Positive Results for AC-100 for Cartilage Regeneration

Tracker Project for RA

RA Theranostics Project ‘Tracker’ Receives Funding

Adenuric Approved for Hyperuricaemia in Gout

Ipsen’s Adenuric Approved in Europe for Hyperuricaemia in Gout

Febuxostat for Hyperuricaemia in Gout

Takeda’s Febuxostat Recommended for Approval in U.S

RDEA119 for Gout and Arthritis

Ardea Releases ERK Kinase Inhibitor Data in Arthritis

Carticel for Cartilage Repair

Genzyme Reports on Long-Term Durability of Carticel

Arthritis, Osteoporosis and Inflammation Deals: 2007-2008

Galapagos, MorphoSys Partner to Tackle Bone/Joint Diseases

Maxygen Lands $170M Preclinical Deal with Astellas

Cellzome in $1.5B Deal with GSK for Kinase Inhibitors

Novosom In-Licenses Antisense CD40 Inhibitors from Isis Pharma

TransPharma Gets $35M in Osteo Deal with Lilly

Bionomics Signs Merck Serono in MS, Autoimmune Partnership

Start-up TFT Adds NF-Kappa B Decoy Program from Anesiva

Regulus, GSK Ink $600M Deal for Drugs Targeting MicroRNA

Debiopharm and Airmid Sign Agreement for Peptide for Autoimmune Diseases

Pacific Biometrics Signs Contracts for RA Immunological Markers

Pfizer Acquires Serenex for Undisclosed Amount

Acceleron, Celgene in Potential $1.8B Bone Loss Collaboration

Early-Stage Antibody Nets EUSA $44M from GSK

Cypress Buys into Personalized Medicine with $75M Proprius Deal

Karo Bio and Zylus Cadila Collaboration for Inflammatory Diseases

Scil, Pfizer Enter $250M Deal for Preclinical Osteo Drug

Catalyst Partners with Centocor for Engineered Protease Drugs

Alder Gets $40M Series C for Yeast-Based Antibodies

Stryker Picks Up Curis’ BMP-7 Program Where Ortho Left Off

Galapagos Inks $395M Deal with Lilly for Osteo Drugs

Source MDx Signs Pfizer to RNA-Based Biomarker Deal

BioMimetic Scoring Again: $40M for Dental Business

Regeneron Signs Sanofi to Potential $1B Collaboration

Galapagos Gets €17M Up Front From Janssen in RA Partnership

Aastrom Raises $13.5M for Regenerative Products

Radius Grants Novartis Option To BA058 in Potential $500M Deal

BDSI, Meda Partner on $90M+ Licensing Deal for Opioid Disc

Nuon Hits the Ground Running with Funding License Deal

Amgen Gains Japanese Partner for Bone-Loss Drug Denosumab

Micromet, Nycomed GM-CSF Deal Could Be Worth €125M

FivePrime Signs Discovery Deal with Centocor; $15M Up Front

Galapagos Secures Deal with GSK on Osteoarthritis Program

List of Collaborations Related to Arthritis and Bone Disease

Analysis

Index

LIST OF TABLES

Denosumab Pipeline

Collaborations Related to Arthritis and Bone Disease

Rheumatoid Arthritis Drugs in Development

Osteoarthritis/Arthritis Drugs in Development

Osteoporosis Drugs in Development

Drugs in Development for Bone Loss and Bone Repair

Drugs in Development for Inflammation and Autoimmune Diseases

Clinical Trials Update

Most Common Musculoskeletal Procedures: Large Joint Replacements and Spinal Fusions

Postoperative Problems

Typical Age at Procedure

Typical Sex Distribution for Procedures and Revisions

Typical Breakdown of Spinal Fusions Performed in 2006 (Percent of each type, by location)

Market for Musculoskeletal Procedures in 2006

Cost to Payers for Musculoskeletal Procedures in 2004 and 2006

Spinal Revenue and Global Market Share by Company, 2008

Patients with Osteoarthritis of the Knee

Synovial Injection Market 2007

Total Revenue from Knee and Hip Reconstructions, in US$

Hip and Knee Revenue and Global Market Share by Company, 2008

Reasons for Spinal Procedures in Those Under 65

Prevalence of Osteoporosis and Low Bone Mass in People Aged 50 and Over

Osteoarthritis vs. Rheumatoid Arthritis

Ranking of Spinal Procedures by Number Performed in 2006-2007

Percent of Spinal Fusions Performed in 2006, by Type

Location of Osteoporosis Related Fragility Fractures

Global Market Share for Vertebral Compression Fractures

Revenue of the Top Drugs for Bone and Joint Diseases

Diagnosis Requiring Synovial Injection

Spine Companies: Top Three Market Shares in 2008

Spine Companies: Top Three Market Shares in 2005 and 2008

Statistics for U.S. Community Hospital Stays, 2006

Trends in Knee Arthroplasty, Hip Replacement and Spinal Fusion Procedures in U.S., 1997-2006

Acceptable Rheumatic Disease Medications During Pregnancy and Lactation

Major Types of Arthritis

Abstract

• Identify the top-selling arthritis drugs, medical technologies and devices
• Understand the prevalence/incidence dynamics
• Learn about the major players
• Get insight on the challenges of market participation
• Analyze the potential of the market through 2030.

• Global Arthritis Expenditures
• Global Arthritis Revenue
• Arthritis Risk Factors
• Prevalence of Arthritis in the U.S., 2000-2020
• Cost to Treat Arthritis in the U.S., 1997-2015
• Prevalence of RA, OA and Gout
• Prevalence of Arthritis by Age
• Market Share Breakdowns
• Top Arthritis Drugs
• Arthritis Investment
• Arthritis Clinical Trials

• Most common Musculoskeletal Procedures
• Musculoskeletal Procedures Revenue Market
• Spinal Revenue and Global Market Share by Company
• Patients with Osteoarthritis of the Knee
• Synovial Injection Market 2007
• Total Revenue from Knee and Hip Reconstructions
• Hip and Knee Revenue and Global Market Share by Company
• Osteoporosis-Related Fragility Fractures
• Global Market Share for Vertebral Compression Fractures

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