Embed Size (px)
Citation preview
Diabetes Pipeline: Intense Activity to Meet Unmet NeedPeter Norman, MBA, PhD
InsightPharmaReports.com
• www.InsightPharmaReports.com • Reproduction prohibited i
Diabetes Pipeline:
Intense Activity to Meet Unmet Need
Peter Norman, MBA, PhD
Published in August 2010 by Cambridge Healthtech Institute
ii • www.InsightPharmaReports.com • Reproduction prohibited
Insight Pharma Reports is a division of Cambridge Healthtech Institute, a world leader in life science information and analysis through conferences, research reports, and targeted publications. Insight Pharma Reports focus on pharmaceutical R&D—the technologies, the companies, the markets, and the strategic business impacts. They regularly feature interviews with key opinion leaders; surveys of the activities, views, and plans of individuals in industry and nonprofit research; and substantive assessments of technologies and markets. Managers at the top 50 pharma companies, the top 100 biopharma companies, and the top 50 vendors of tools and services rely on Insight Pharma Reports as a trusted source of balanced and timely information.
Related Report
Obesity Drug Pipeline: Developing Therapies for a Complex DiseaseAllan B. Haberman, PhD
General Manager: Alfred R. Doig, Jr. 781-972-1348, [email protected]
Editorial Operations Director: Laurie Sullivan 781-972-1353, [email protected]
Design Director: Tom Norton 781-972-5440, [email protected]
Production Director: Ann Handy 781-972-5493, [email protected]
Marketing Manager: James Prudhomme 781-972-5486, [email protected]
Customer Service: Rose LaRaia 781-972-5444, [email protected]
Corporate Subscriptions: David Cunningham 781-972-5472, [email protected]
Global Report Sales: Jack Valeri 781-972-1355, [email protected]
Insight Pharma Reports, 250 First Ave., Suite 300, Needham, MA 02494
www.InsightPharmaReports.com
• www.InsightPharmaReports.com • Reproduction prohibited iii
Diabetes Pipeline:
Intense Activity to Meet Unmet Need
Peter Norman, MBA, PhD
A Cambridge Healthtech Institute publication © 2010 by Cambridge Healthtech Institute (CHI). This report cannot be duplicated without prior written permission from CHI.
Every effort is made to ensure the accuracy of the information presented in Insight Pharma Reports. Much of this information comes from public sources or directly from company representatives. We do not assume any liability for the accuracy or completeness of this information or for the opinions presented.
Cambridge Healthtech Institute, 250 First Ave., Suite 300, Needham, MA 02494 Phone: 781-972-5444 • Fax: 781-972-5425 • www.InsightPharmaReports.com
About the Author
Peter Norman, MBA, PhD, is a pharmaceutical consultant and analyst based in Burnham Beeches, near Windsor, England. He has written and presented widely on various aspects of respiratory disease, drug development, and the analysis of diverse therapeutic markets. Dr. Norman has over 20 years of experience of the pharmaceutical industry in both R&D and competitive intelligence. His publications include many reviews, 16 original scientific papers, and 11 patents, together with a number of management reports. The latter have been published by a number of companies including Business Insights, FT Pharmaceuticals, Urch Publications, SMi, Decision Resources, Informa, and Insight Pharma (CHI). Dr. Norman holds science degrees from Cambridge University and Brunel University and an MBA degree from the Open University.
For more information about published Insight Pharma Reports, visit www.InsightPharmaReports.com or call Rose
LaRaia at 781-972-5444.
iv • www.InsightPharmaReports.com • Reproduction prohibited
• www.InsightPharmaReports.com • Reproduction prohibited xi
Table of Contents
CHAPTER 1
INTRODUCTION ................................................................................................................................................1
1.1. What is Diabetes? ............................................................................................................................................1Type I Diabetes ................................................................................................................................................1Type II Diabetes ...............................................................................................................................................2
1.2. Diabetic Complications ...................................................................................................................................2
1.3. The Need for Improved Disease Control ......................................................................................................3
CHAPTER 2
DIABETES ..............................................................................................................................................................5
2.1. Pathophysiology ...............................................................................................................................................5
2.2. Diagnosis ..........................................................................................................................................................6
2.3. Incidence and Prevalence ................................................................................................................................6Gestational Diabetes .......................................................................................................................................7Early Onset Diabetes .......................................................................................................................................7Metabolic Syndrome .......................................................................................................................................7Other Causes of Diabetes ................................................................................................................................8
2.4. Current Treatment Options ............................................................................................................................8
CHAPTER 3
CURRENTLY MARKETED THERAPIES ........................................................................................................9
3.1. Introduction .....................................................................................................................................................9
3.2. Insulin ..............................................................................................................................................................9Recombinant Insulins ...................................................................................................................................10Insulin Analogs .............................................................................................................................................10
3.3. Metformin ......................................................................................................................................................11
3.4. KATP Blockers ..............................................................................................................................................12Sulfonylureas .................................................................................................................................................12Non-Sulfonylureas .........................................................................................................................................13
3.5. PPAR Agonists ..............................................................................................................................................14
Table of Contents
xii • www.InsightPharmaReports.com • Reproduction prohibited
3.6. Alpha−Glucosidase Inhibitors ......................................................................................................................14
3.7. Incretin Modulators ......................................................................................................................................15Peptide Agonists ............................................................................................................................................15DPP IV Inhibitors ..........................................................................................................................................15
3.8. Combination Products ..................................................................................................................................16
3.9. Market Breakdown ........................................................................................................................................17
CHAPTER 4
DEVELOPMENT PIPELINES ...........................................................................................................................19
4.1. Introduction ...................................................................................................................................................19
4.2. Established Approaches ................................................................................................................................19Insulin, Analogs, and Formulations ..............................................................................................................20Pharmacodynamic Approaches for Improved Control of Plasma Insulin ....................................................22
Fast Release ............................................................................................................................................22VIAject ...................................................................................................................................................22Long Acting ...........................................................................................................................................22Degludec .................................................................................................................................................22FT-105 ....................................................................................................................................................24Sustained Control ..................................................................................................................................24Degludec Plus .........................................................................................................................................24LY-2605541 ............................................................................................................................................25
Alternative Delivery Routes for Insulin ........................................................................................................25Inhaled ...................................................................................................................................................25Afrezza ....................................................................................................................................................26Intranasal ................................................................................................................................................27Oral .........................................................................................................................................................28Oral-lyn ..................................................................................................................................................29IN-105 ...................................................................................................................................................29AI-401 ....................................................................................................................................................29Transdermal ............................................................................................................................................30Absorption Enhancing ...........................................................................................................................30
PPAR Agonists ..............................................................................................................................................31PPARγ Agonists .....................................................................................................................................32PPARδ Agonists .....................................................................................................................................33Dual PPARα /γ Agonists ........................................................................................................................34Indeglitazar: A Pan-PPAR Agonist ........................................................................................................35
Other, Non-Incretin, Approaches ................................................................................................................35Mitiglinide ..............................................................................................................................................36Avandastat ..............................................................................................................................................36Imeglimin ...............................................................................................................................................36
GLP-1 Analogs ..............................................................................................................................................37Exenatide Formulations .........................................................................................................................38Bydureon ................................................................................................................................................38Novel GLP-1 Analogs ............................................................................................................................39Taspoglutide ...........................................................................................................................................41Lixisenatide ............................................................................................................................................43
Diabetes Pipeline: Intense Activity to Meet Unmet Need
• www.InsightPharmaReports.com • Reproduction prohibited xiii
Albiglutide ............................................................................................................................................43Dulaglutide ............................................................................................................................................43Other GLP-1 Agonists in Clinical Development .................................................................................44GLP-1 Modulator ...................................................................................................................................45
DPP IV Inhibitors ..........................................................................................................................................45Phase III DPP IV Inhibitors ...................................................................................................................48Linagliptin .............................................................................................................................................48Dutogliptin ............................................................................................................................................50SK-0403 ..................................................................................................................................................51Teneligliptin ..........................................................................................................................................51Gemigliptin ...........................................................................................................................................51Phase II DPP IV Inhibitors ....................................................................................................................51
4.3. New Approaches ...........................................................................................................................................52SGLT2 Inhibition ..........................................................................................................................................52
Dapagliflozin ..........................................................................................................................................54Canagliflozin ...........................................................................................................................................55 ASP-1941 ..............................................................................................................................................56BI-10773 and BI-44847 ..........................................................................................................................56RG-7201 .................................................................................................................................................56LX-4211 .................................................................................................................................................56TS-071 ....................................................................................................................................................57ISIS-388626 ...........................................................................................................................................57Kissei, GlaxoSmithKline SGLT Inhibitors ............................................................................................57
Glucokinase Activators .................................................................................................................................58AZD-1656 and AZD-6370 .....................................................................................................................59LY-2599506 ............................................................................................................................................60AMG-151 ..............................................................................................................................................60TTP-355 and TTP-399 ..........................................................................................................................60Phase I Compounds ................................................................................................................................61
11β-Hydroxysteroid Dehydrogenase 1 Inhibitors .........................................................................................61INCB-13739 ..........................................................................................................................................63Roche .....................................................................................................................................................63JTT-654 .................................................................................................................................................63AstraZeneca............................................................................................................................................64HSD-016 ................................................................................................................................................64Amgen ....................................................................................................................................................64
PTP1B Inhibitors ...........................................................................................................................................64ISIS-113715 ...........................................................................................................................................65TransTech Pharma’s TTP-814 ................................................................................................................65
GPR119 Agonists ..........................................................................................................................................66FFA1 Agonists ...............................................................................................................................................68DGAT-1 Inhibitors ........................................................................................................................................68SCD1 Inhibitors ............................................................................................................................................69GPBA Agonists .............................................................................................................................................70Fructose Bisphosphatase Inhibitors ...............................................................................................................71Glycogen Phosphorylase Inhibitors ..............................................................................................................72AMPKa Modulators .....................................................................................................................................73SIRT1 Activators ..........................................................................................................................................74Other Oral Agents ........................................................................................................................................75
Table of Contents
xiv • www.InsightPharmaReports.com • Reproduction prohibited
D-Tagatose ..............................................................................................................................................76Phase II Agents ......................................................................................................................................77Phase I Agents ........................................................................................................................................78
Biological Agents ..........................................................................................................................................78Anti-CD3 Antibodies ............................................................................................................................80Teplizumab .............................................................................................................................................80Otelixizumab ..........................................................................................................................................80DiaPep277 ..............................................................................................................................................81Diamyd’s Vaccines ..................................................................................................................................81IL-1 Antagonists.....................................................................................................................................81Bayhill Therapeutics/Genentech’s RG-7426 .........................................................................................82
CHAPTER 5
COMPANY PROFILES .......................................................................................................................................83
5.1. Introduction ...................................................................................................................................................83
5.2. Major Players .................................................................................................................................................83Eli Lilly ..........................................................................................................................................................83GlaxoSmithKline ..........................................................................................................................................85Merck .............................................................................................................................................................86Novo Nordisk ................................................................................................................................................87sanofi-aventis .................................................................................................................................................88Takeda ............................................................................................................................................................89
5.3. Emerging Players ...........................................................................................................................................90Amgen ...........................................................................................................................................................90Astellas ..........................................................................................................................................................91AstraZeneca ...................................................................................................................................................91Boehringer Ingelheim ....................................................................................................................................92Bristol-Myers Squibb .....................................................................................................................................93Novartis .........................................................................................................................................................95Pfizer ..............................................................................................................................................................95Roche .............................................................................................................................................................96
5.4. Specialist Companies .....................................................................................................................................97Amylin ...........................................................................................................................................................97Arisaph Pharmaceuticals ...............................................................................................................................98Biodel .............................................................................................................................................................99DARA BioSciences .......................................................................................................................................99Diabetology ..................................................................................................................................................100DiaMedica ...................................................................................................................................................101Diasome Pharmaceuticals ............................................................................................................................102Ipsen ............................................................................................................................................................102Lexicon Therapeutics ..................................................................................................................................103Metabolex ....................................................................................................................................................103Phenomix ....................................................................................................................................................104Piramal Life Sciences ..................................................................................................................................104Poxel ............................................................................................................................................................105Syndexa Pharmaceuticals ............................................................................................................................106Theracos ......................................................................................................................................................106TransTech Pharma .......................................................................................................................................106
Diabetes Pipeline: Intense Activity to Meet Unmet Need
• www.InsightPharmaReports.com • Reproduction prohibited xv
CHAPTER 6
MARKET OUTLOOK ......................................................................................................................................109
6.1. Introduction .................................................................................................................................................109
6.2. The Impact of Generics ..............................................................................................................................110
6.3. The Impact of New Therapies ...................................................................................................................110Injectable Agents ........................................................................................................................................112Oral Agents .................................................................................................................................................113
6.4. Market Development ...................................................................................................................................114
CHAPTER 7
EXPERT INTERVIEWS ...................................................................................................................................115
Peter Kurtzhals, PhD Senior Vice President and Head of Diabetes Research Novo Nordisk ............................................................................................................................................115
Pascale Malgouyres, PharmD Business Development and Marketing Director Poxel ...........................................................................................................................................................115
Harold E. Van Wart, PhD President and Chief Executive Officer Metabolex ...................................................................................................................................................115
Type I Diabetes ..................................................................................................................................................115
Type II Diabetes ..................................................................................................................................................116
REFERENCES............................................................................................................................................................123
GLOSSARY ..............................................................................................................................................................131
COMPANY INDEX ................................................................................................................................................133
TABLES
Table 1.1. Advantages and Disadvantages of Classes of Drugs Used To Treat Type II Diabetes .........................................................................................................................................................................4
Table 3.1. Global Sales in 2009 of Modified Insulins ..................................................................................................11
Table 3.2. Significant KATP Channel Modulators and 2009 Sales ...............................................................................13
Table 3.3. 2009 Global Sales of Approved DPP IV Inhibitors ...................................................................................16
Table 3.4. 2009 Global Sales of Leading Branded Combination Products .................................................................17
Table 4.1. Insulin Formulations in Development ........................................................................................................20
Table 4.2. PPAR Agonists in Development ................................................................................................................31
Table 4.3. Other Development Products Acting on Established Targets....................................................................36
Table of Contents
xvi • www.InsightPharmaReports.com • Reproduction prohibited
Table 4.4. Exenatide Formulations in Development ...................................................................................................37
Table 4.5. Novel GLP-1 Analogs in Development .....................................................................................................40
Table 4.6. DPP IV Inhibitors in Development ............................................................................................................45
Table 4.7. SGLT2 Inhibitors in Development.............................................................................................................53
Table 4.8. Glucokinase Activators in Development ...................................................................................................59
Table 4.9. 11Beta-HSD1 Inhibitors in Development .................................................................................................62
Table 4.10. PTP1B Inhibitors in Development ...........................................................................................................65
Table 4.11. GPR119 Agonists in Development ..........................................................................................................66
Table 4.12. DGAT-1 Inhibitors in Development ........................................................................................................69
Table 4.13. SCD1 Inhibitors in Development ............................................................................................................70
Table 4.14. TGR5 Agonists in Development ..............................................................................................................71
Table 4.15. FBP Inhibitors in Development ................................................................................................................72
Table 4.16. Glycogen Phosphorylase Inhibitors in Development ...............................................................................73
Table 4.17. AMPKa Modulators in Development.......................................................................................................74
Table 4.18. SIRT1 Activators in Development ...........................................................................................................74
Table 4.19. Other Orally Active Antidiabetic Drugs in Development ......................................................................75
Table 4.20. Other Biological Agents in Development for the Treatment of Diabetes ...............................................79
Table 5.1. Eli Lilly’s Development Pipeline of Diabetes Products ..............................................................................84
Table 5.2. GlaxoSmithKline’s Development Pipeline of Diabetes Products ..............................................................85
Table 5.3. Merck’s Development Pipeline of Diabetes Products .................................................................................87
Table 5.4. Novo Nordisk’s Development Pipeline of Diabetes Products ....................................................................88
Table 5.5. sanofi-aventis’ Development Pipeline of Diabetes Products ......................................................................89
Table 5.6. Takeda’s Development Pipeline of Diabetes Products ................................................................................90
Table 5.7. Amgen’s Development Pipeline of Diabetes Products ...............................................................................90
Table 5.8. Astellas’ Development Pipeline of Diabetes Products ...............................................................................91
Table 5.9. AstraZeneca’s Development Pipeline of Diabetes Products .......................................................................92
Table 5.10. Boehringer Ingelheim’s Development Pipeline of Diabetes Products ......................................................93
Table 5.11. Bristol-Myers Squibb’s Development Pipeline of Diabetes Products .......................................................94
Table 5.12. Novartis’ Development Pipeline of Diabetes Products ............................................................................95
Table 5.13. Pfizer’s Development Pipeline of Diabetes Products.................................................................................96
Table 5.14. Roche’s Development Pipeline of Diabetes Products ...............................................................................97
Table 5.15. Amylin’s Development Pipeline of Diabetes Products .............................................................................98
Table 5.16. Arisaph’s Development Pipeline of Diabetes Products ............................................................................98
Table 5.17. Biodel’s Development Pipeline of Diabetes Products ...............................................................................99
Diabetes Pipeline: Intense Activity to Meet Unmet Need
• www.InsightPharmaReports.com • Reproduction prohibited xvii
FIGURES
Figure 1.1. Schematic of Treatment Regimen for Diagnosed Type II Diabetics ..........................................................3
Figure 3.1. 2009 Global Diabetes Market, Market Share by Therapeutic Class .........................................................18
Figure 3.2. 2009 Global Diabetes Market, Market Share by Company ......................................................................18
Figure 6.1. Anticipated FDA Filing Dates For Significant New Products ................................................................111
Figure 6.2. Forecast of Global Diabetes Market in 2014, Share By Therapeutic Class ............................................114
Table 5.18. DARA BioSciences’ Development Pipeline of Diabetes Products ........................................................100
Table 5.19. Diabetology’s Development Pipeline of Diabetes Products ....................................................................101
Table 5.20. DiaMedica’s Development Pipeline of Diabetes Products .....................................................................101
Table 5.21. Diasome’s Development Pipeline of Diabetes Products .........................................................................102
Table 5.22. Ipsen’s Development Pipeline of Diabetes Products...............................................................................102
Table 5.23. Metabolex’ Development Pipeline of Diabetes Products .......................................................................103
Table 5.24. Piramal’s Development Pipeline of Diabetes Products ...........................................................................105
Table 5.25. Poxel’s Development Pipeline of Diabetes Products ..............................................................................105
Table 5.26. Theracos’ Development Pipeline of Diabetes Products .........................................................................106
Table 5.27. TransTech Pharma’s Development Pipeline of Diabetes Products .........................................................107
Introduction
4 • www.InsightPharmaReports.com • Reproduction prohibited
ties. These provide considerable incentives for pharmaceutical companies to seek to develop new therapies for the treatment of diabetes. The level of their interest is demonstrated by the large number of new chemi-cal entities (NCEs) in development, which are discussed in detail in Chapter 4.
Table 1.1. Advantages and Disadvantages of Classes of Drugs Used To Treat Type II Diabetes
Drug Class Advantages Disadvantages
Metformin
• Widely used
• Low cost
• Effective
• Effective in combination
• No effect on weight
• Not suitable for renally insufficient patients
• Significant (10–15%) incidence of gastrointes-tinal side effects
• Some increase in LDL cholesterol
Insulin secretagogues
Sulfonylureas
• Potent
• Low cost
• Widely used
• Problems of weight gain
• Inadequate hypoglycemic control
Glinides• Fast acting
• Effective post-prandially
• Modest potency, frequent dosing (t.i.d.)
• Modest hypoglycemic control
Glitazones
• High potency
• No hypoglycemia
• Beneficial effects on triglycerides
• Weight gain
• Edema
• Increased cholesterol levels
• Increased risk of congestive heart failure
α-Glucosidase inhibitors• No effect on weight
• No risk of hypoglycemia
• Modest efficacy
• Substantial gastrointestinal issues
DPP IV inhibitors
• Well tolerated
• Weight neutral
• Positive effects on beta cells (?)
• Moderate efficacy
• High cost
GLP-1 agonists
• Some weight loss
• Positive effects on beta cells
• Good hypoglycemic control with metformin
• Frequent (q.d. or b.i.d.) subcutaneous injec-tions
• Nausea
• Safety concerns
Source: Norman Consulting
Currently Marketed Therapies
16 • www.InsightPharmaReports.com • Reproduction prohibited
Table 3.3. 2009 Global Sales of Approved DPP IV Inhibitors
Drug Brand Supplier ApprovedGlobal 2009 Sales ($ millions)
US 2009 Sales ($ millions)
Sitagliptin Januvia Merck October 2006 $1,922 $1,404
Vildagliptin Galvus, Equa Novartis July 2007 $181 N/A
Saxagliptin Onglyza Bristol-Myers Squibb July 2009 $24 $24
Alogliptin Nesina Takeda April 2010 N/A N/A
Source: Norman Consulting
Novartis’ vildagliptin had been expected to be the first agent in this class to reach the market. However, Mer-ck’s accelerated development of sitagliptin and the FDA’s response to vildagliptin’s NDA resulted in Januvia becoming firmly established as a first-in-class agent, with no competition until the mid-2009 approval of saxagliptin. Bristol-Myers Squibb signed a co-development and marketing deal with AstraZeneca for saxa-gliptin in January 2007 just after licensing the Japanese rights to Otsuka. Both sitagliptin (since November 2007) and saxagliptin (since June 2009) are approved for use in Europe; sitagliptin was launched in Japan in December 2009.
Vildagliptin has been available in Europe, as Galvus, since 2008. In April 2010, it was launched in Japan as Equa. But the FDA’s concerns about the renal safety of the drug led to rejection of the NDA that was filed in March 2006. In 2009, Novartis announced that it had abandoned plans to resubmit the NDA. Takeda’s alogliptin has also encountered problems with the FDA. Assessment of a January 2008 filing was first de-layed and then led to a request for an additional clinical study. This two-year study began in October 2009 and will also be used when filing for European approval. However, Japanese approval was granted in April 2010.
3.8. Combination Products
The majority of type II diabetics find that their disease is not well controlled with a single oral agent, thus leading to the use of two or three oral hypoglycemic agents. Because of this, there is significant incentive for companies to develop combination products to facilitate patient compliance. Many such combinations with metformin and certain of the sulfonylureas are now available. A few other combinations are also available, with many more in development.
• www.InsightPharmaReports.com • Reproduction prohibited 29
Diabetes Pipeline: Intense Activity to Meet Unmet Need
Three orally delivered insulin formulations are in Phase III studies: Generex’ Oral-lyn, Biocon and Nobex’ IN-105, and AutoImmune’s AI-401. These represent three contrasting approaches to the oral delivery of insulin.
Oral-lyn
Oral-lyn is a spray mist formulation that is orally delivered via a RapidMist device and is already available in a number of markets including India. A 26-week, open-label study began in April 2008 comparing the efficacy of Oral-lyn to human insulin in 314 type I diabetics.
Generex describes Oral-lyn as a simple, fast, and effective method of orally delivering insulin using a simple inhaler device similar to those used for inhaled beta agonists. The company’s own data suggest that this in-halation is highly reproducible, but others have suggested that the product’s need for ten puffs to deliver the desired dose renders reproducibility questionable. Limited data have been published on the clinical efficacy of Oral-lyn, despite the fact that it has progressed to Phase III studies. A ten-patient study in type I diabetics showed Oral-lyn to have comparable efficacy to insulin glargine (Guevara-Aguirre et al. 2007).
IN-105
The strategy taken by Nobex, initially in partnership with Biocon prior to being acquired by the latter in 2006, to develop IN-105 is very different. IN-105 is a PEGylated insulin analog designed to have reduced immunogenicity as well as better stability and absorption than insulin. Phase II and dose-ranging studies have been completed with IN-105, and in December 2009 Biocon indicated that it was in the middle of a long-term efficacy and safety study, with results due around the end of 2010.
Phase IIa studies showed IN-105 to be absorbed in a dose-proportional manner, with Cmax
concentrations achieved 30–45 minutes after dosing. Further data from an open-label, ascending-dose study in 20 type II diabetics were presented at the 2009 ADA meeting. These showed dose-related effects on C-reactive peptide, insulin and glucose concentrations and provided no evidence of hypoglycemia. But no clinical data have been published to date.
AI-401
AutoImmune’s AI-401 is an encapsulated form of human insulin that AutoImmune was developing, originally in partnership with Eli Lilly. A Phase III study began in 2007 in 400 type I diabetics, which is not scheduled for completion until February 2014. However, in March 2010, AutoImmune went into liquida-tion, so the future of the drug is unclear. AI-401 is a long-acting formulation that was being delivered once daily. An earlier study, the DPT-1 study, was designed to examine the prophylactic ability of parenteral insu-lin in type I diabetes, and the Phase III study with AI-401 was a follow-on study using an oral product.
Development Pipelines
78 • www.InsightPharmaReports.com • Reproduction prohibited
Lisofylline is a methylxanthine derivative that was originally being developed for the treatment of septic shock, but in 2005 it was suggested that it could have beneficial effects in the treatment of diabetes (Yang et al. 2005). This led to the establishment of DiaKine to develop such compounds; it has progressed lisofylline to Phase II studies, while DT-22669 and DT-23552 are improved-profile compounds in early development. However, the two studies underway are both small-scale studies on its use to improve islet survival in type I diabetics.
Phase I Agents
The nine agents in Phase I studies comprise a highly heterogeneous group, with the mode of action of sev-eral of the compounds uncertain. Napo’s NP-500 is described as having a broad spectrum and novel mode of action but is only known to be a natural product. Gilead’s decision to develop GS-9667 for the treatment of diabetes represents an unusual use of an adenosine A
1 receptor ligand, while both the targets of RG-7089
and AP-1030 are more commonly viewed as of interest in the treatment of obesity.
Phenex’ Px-101 and Elixir’s EX-1350 represent the most interesting agents of this group, both represent-ing first-in-class approaches to the treatment of diabetes. Px-101 acts on the nuclear receptor FXR but is described as lacking the liabilities associated with agents that act on PPARγ or PPARα and PPARγ. Px-101 entered clinical development in early 2010.
In May 2009, Elixir signed an agreement with Novartis giving it the option to acquire Elixir should Elixir’s EX-1350, which was then in preclinical IND studies, successfully complete a Phase IIa study. EX-1350 pro-gressed to Phase I studies at the end of 2009.
Biological Agents
In addition to the many small-molecule agents that target the treatment of diabetes, there is a significant diversity of biological agents, with diverse mechanisms of action, in differing stages of development, as shown in Table 4.20. Many of these are being developed for the treatment of type I diabetes rather than type II diabetes. The following discussion focuses on the four agents in Phase III and the four in Phase II studies. These eight agents span five different mechanisms of action.
• www.InsightPharmaReports.com • Reproduction prohibited 83
Chapter 5COMPANY PROFILES
5.1. Introduction
This chapter considers the portfolios of companies that are significantly interested in the development of new therapies for the treatment of diabetes, in order to provide an overview of each company’s current inter-ests. Just six companies are currently major players in the diabetes market; three (Eli Lilly, Novo Nordisk, and sanofi-aventis) dominate the insulin market segment, while another three (GlaxoSmithKline, Merck, and Takeda) are the major providers of branded oral antidiabetic products. Those grouped as emerging play-ers are major companies with an extensive number of pipeline products (few of which currently market any commercially significant antidiabetic products), while the specialist companies are the biotechnology firms with a significant focus on developing novel treatments for metabolic disorders, especially diabetes.
5.2. Major Players
Eli Lilly
Eli Lilly’s diabetes portfolio currently accounts for 17% of the company’s total revenues, with the bulk of these revenues derived from its recombinant human insulin products Humalog and Humulin. These are augmented by revenues generated by Byetta, through its agreement with Amylin, and some minor diabetes products such as Glucagon. In addition, it includes its human growth hormone product Humatrope in its diabetes portfolio. All of the company’s significant diabetes treatments are injectable products and, with the exception of Byetta, are mature products, having been available for a long period of time following the emergence of recombinant human insulin as preferable to animal insulin.
In 2009, these products (excluding Humatrope) collectively generated revenues of $3.7 billion. Sales of Humalog (insulin lispro) accounted for 52% of these ($1.95 billion), the Humulin range (recombinant insu-lins) 27% ($1.0 billion), and Byetta 11% (Lilly’s revenue share $396 million). Lilly is focused on developing sales of Byetta and Humalog and on increasing its presence in emerging markets, having established itself as the number 2 player in China’s insulin market segment.
• www.InsightPharmaReports.com • Reproduction prohibited 91
Diabetes Pipeline: Intense Activity to Meet Unmet Need
Astellas
Astellas currently only markets one product for the treatment of diabetes, the potassium channel blocker Starsis (nateglinide), and that is only available in Japan. But it now has a significant, mostly early stage, pipeline (Table 5.8). Metabolic diseases now constitute one of the company’s more significant research areas, and Astellas anticipates entering the market by 2014 with the launch of the SGLT2 inhibitor ASP-1941 in Japan. European and US launch is expected later than 2014. ASP-1941 is being co-developed with Kotobuki Pharmaceutical, but no details of the arrangement between the companies have been made public. Astellas (potentially) further enhanced its diabetes pipeline with its 2010 acquisition of OSI, but since the focus of the deal is the enhancement of Astellas’ oncology pipeline it is unclear whether it will continue the ongoing research efforts.
Table 5.8. Astellas’ Development Pipeline of Diabetes Products
Drug Action Status
ASP-1941 SGLT2 inhibitor Phase III
ASP-4178 Phase I
ASP-5034 Phase I
ASP-4000 DPP IV inhibitor Discovery
ASP-8497 DPP IV inhibitor Discovery
AS-1535907 GPR119 agonist Discovery
PSN-IV/119-1 DPP IV inhibitor Discovery
Source: Norman Consulting
AstraZeneca
AstraZeneca made a determined effort to enter the diabetes market by establishing a partnership with Bris-tol-Myers Squibb to co-develop the latter’s DPP IV and SGLT2 inhibitors in the United States and Europe; the deal was subsequently extended to cover the development of the SGLT2 inhibitors in Japan. The two companies signed a co-development and marketing deal for saxagliptin in January 2007 and saw the drug launched, as Onglyza, in both the United States and Europe in 2009. The SGLT2 inhibitor dapagliflozin is part of the same collaborative agreement and is currently in Phase III studies, with regulatory submissions planned for late 2010. Metformin combinations of both products are also in late-stage development: Filings for the dapagliflozin combination are scheduled for 2011, while the NDA for the saxagliptin combination was filed in 2009 with the MAA scheduled for the third quarter of 2010. AstraZeneca’s earlier-stage pipeline contains multiple development candidates directed at certain targets (Table 5.9). Of the earlier-stage com-pounds, a filing date has been suggested only for AZD-1656 (2015).
• www.InsightPharmaReports.com • Reproduction prohibited 109
Chapter 6MARKET OUTLOOK
6.1. Introduction
Recent years have seen a marked change in the therapeutic areas targeted by major companies. There has been a general shift away from pursuing new therapeutics for cardiovascular diseases and a strong shift to-ward developing new therapies, especially kinase inhibitors, for the treatment of cancer. However, there has also been a resurgence of interest in the development of new therapies for the treatment of diabetes despite the many problems encountered by companies trying to develop novel PPAR agonists.
Several factors have influenced this strategic decision, and it has not been adversely impacted by the FDA’s recent demands for more extensive late-stage trials to assess the cardiovascular safety of new therapeutics. Although the size and nature of these trials do increase development costs, the potential returns are viewed as sufficient justification. Another stimulus to efforts in this field has been the emergence of an increasing number of novel (but apparently valid) targets for regulating insulin secretion or glucose metabolism. These increase the opportunities for companies, large and small, to obtain a competitive advantage and help to explain why so many companies are actively seeking to develop new treatments for diabetes, especially type II diabetes. Although the treatment of type I diabetes doesn’t appear to offer many novel drug targets, the size of the insulin market does highlight the potential scope for developing innovative delivery methods for insulin.
The previous two chapters highlighted the number of companies interested in developing new products for the treatment of diabetes and especially the large number of new products in development for the treatment of both type I and type II diabetes. The additional opportunities in developing agents for the treatment of diabetic complications have not been considered in this report, although some of the agents discussed in this report may also be of value in the treatment of obesity and/or metabolic syndrome.
Chapter 3 examined the current major products available for the treatment of diabetes and highlighted the segmentation of this large market between oral and injectable treatments. It also highlighted how a few companies currently dominate these market segments. This chapter considers how near-term developments may impact upon the value of each of these market segments, and how new products may result in the emer-gence of significant new players in each of these market segments.
• www.InsightPharmaReports.com • Reproduction prohibited 133
Company Index
A
Abbott (www.abbott.com) ...............................................................................................................47, 69-70, 72
Action Pharma (www.actionpharma.com) ......................................................................................................75
ActiveX Biosciences (www.activx.com) ............................................................................................................52
Addex (www.addexpharma.com) .....................................................................................................................40
Ajinomoto (www.ajinomoto.com) .................................................................................................13, 53, 56, 93
Alantos (www.alantos.com) ..............................................................................................................................52
Alkermes (www.alkermes.com) ..................................................................................................................38, 98
Allostera (www.allostera.com) ..........................................................................................................................79
Altea Therapeutics (www.alteatherapeutics.com) ......................................................................................20, 30
Alza (www.jnj.com) ..........................................................................................................................................38
Ambrx (www.ambrx.com) ................................................................................................................................79
Amgen (www.amgen.com) ................................................................................................. 46, 52, 59-64, 68, 90
Amylin (www.amylin.com) .......................................................................................15, 37-39, 76, 83, 85, 97-98
Andromeda Biotech (www.andromedabio.com) .......................................................................................79, 81
Arena (www.arenapharm.com) ........................................................................................................... 66-67, 113
Arisaph (www.arisaph.com) ............................................................................................................40, 46, 98-99
Array (www.arraybiopharma.com) ........................................................................................................59-60, 90
Astellas (www.astellas.com) ................................................................................. 13, 46-47, 53-54, 56, 66-67, 91
AstraZeneca (www.astrazeneca.com) ..................................16, 34, 53, 55, 58-60, 62, 64, 69, 73, 91-92, 94, 114
Aus Bio (www.ausbio.com.au) .........................................................................................................................65
AutoImmune (www.autoimmune.com)............................................................1, 7, 20, 29, 77, 80-82, 116, 126
Index
134 • www.InsightPharmaReports.com • Reproduction prohibited
B
Banyu (www.banyu.co.jp) ........................................................................................................................... 61, 70
Bayer (www.bayer.com) .....................................................................................................14, 33, 68-69, 96, 100
Bayhill (www.bayhilltherapeutics.com) ................................................................................................79, 82, 97
Bentley Pharmaceuticals (www.tevapharm.com) (Merge with Teva Pharmaceuticals) .................................... 27
Beta Pharma (www.betapharma.com) .................................................................................................. 40, 46-47
Biocompatibles (www.biocompatibles.com) ....................................................................................................40
Biocon (www.biocon.com) ...........................................................................................................20, 29, 98, 111
Biodel (www.biodel.com) ...............................................................................................20-22, 24, 27-28, 79, 99
Biospherics (www.biospherics.org) .................................................................................................................. 76
Biovitrum (www.biovitrum.com) ..............................................................................................61, 63-64, 66, 90
Boehringer Ingelheim (www.boehringer-ingelheim.com) ............................................... 13, 45, 48, 53, 56, 66, 68, 73, 92-93, 111-113
Bristol-Myers Squibb (www.bms.com) ....................................................11, 16-17, 34, 47, 53, 55, 58-59, 61-62, 66, 69, 75, 91, 93-94, 96, 114
BTG (www.btgplc.com) ..............................................................................................................................80, 85
C
Calyx Therapeutics (www.calyxti.com) ..........................................................................................................106
Camurus (www.camurus.com) .........................................................................................................................40
Chiesi (www.chiesigroup.com) ...........................................................................................................45, 50, 104
Chong Kun Dang (www.chongkundang.en.ec21.com) ............................................................................. 31, 34
Chugai (www.chugai-pharm.com) ........................................................................................................53, 56, 97
ConjuChem (http://conjuchem.hyphenhealth.com) ....................................................................21-22, 40, 44
Connexios (www.connexios.com) ....................................................................................................................62
CovX (www.covx.com) ...............................................................................................................................45, 95
CPEX (www.cpexpharm.com) ...................................................................................................................20, 27
Cytos (www.cytos.com) ..............................................................................................................................79, 82
D
Daiichi Sankyo (www.daiichisankyo.com) ............................................................................................32, 70-72
Dainippon Sumitomo (www.ds-pharma.com) ............................................................................... 31, 35, 46, 57
DARA BioSciences (www.darabiosciences.com) ..................................................................... 31-33, 46, 99-100
DeveloGen (www.develogen.com) .................................................................................................. 75-76, 81, 93
Diabetology (www.diabetology.co.uk) ......................................................................................... 20, 28, 100-101
DiaKine (www.diakine.com) .................................................................................................................75-76, 78
• www.InsightPharmaReports.com • Reproduction prohibited 135
Diabetes Pipeline: Intense Activity to Meet Unmet Need
DiaMedica (www.diamedica.com) ................................................................................................................. 101
Diamyd (www.diamyd.com) .......................................................................................................................79, 81
Diasome (www.diasome.com) ............................................................................................................20, 28, 102
Dong-A (www.donga-pharm.com) ........................................................................................................ 37-38, 46
Double Crane (www.dcpc.com) ....................................................................................................................... 51
Dr. Reddy’s (www.drreddys.com) ...........................................................................................................31-32, 74
E
Egret (www.egretpharma.com) ...........................................................................................................33, 76, 106
Elixir (www.elixirpharm.com) .........................................................................................36, 74, 76, 78, 111, 113
Emisphere (www.emisphere.com) .............................................................................................................. 21, 28
enGene (www.engeneinc.com) ........................................................................................................................79
Ensemble (www.ensemblediscovery.com) ........................................................................................................65
F
Ferring (www.ferring.com) ............................................................................................................................... 47
Flamel (www.flamel.com) ..................................................................................................................... 21-22, 24
Forest (www.forestpharm.com) ..................................................................................... 50, 59-60, 104, 107, 113
G
Galmed (www.galmedgroup.com) ...................................................................................................................70
Genentech (www.gene.com) ........................................................................................................................2, 97
Generex (www.generex.com) ......................................................................................................................20, 29
Genfit (www.genfit.com) .................................................................................................................31-32, 35, 88
Gilead (www.gilead.com) ................................................................................................................70, 75-76, 78
GlaxoSmithKline (www.gsk.com) ..................................................... 14, 17, 33, 35-36, 39-40, 43, 47-48, 53-54, 57-58, 66-68, 71, 73-74, 79-80, 83, 85-86, 112, 114
Glenmark (www.glenmarkpharma.com) .............................................................................................46, 52, 70
Graceway (www.gracewaypharma.com) ...........................................................................................................70
Green Cross (www.mt-pharma.co.jp) ...............................................................................................................54
H
Halozyme (www.halozyme.com)................................................................................................................. 21, 30
Hanmi (www.hanmi.com)..........................................................................................................................40, 45
Harbor BioSciences (www.harborbiosciences.com) ..................................................................................75, 77
Heptahelix ........................................................................................................................................................68
Hoechst (www.hoechst.com) ............................................................................................................................13
Index
136 • www.InsightPharmaReports.com • Reproduction prohibited
Hollis-Eden (www.harborbiosciences.com) ..................................................................................................... 77
Human Genome Sciences (www.hgsi.com) ...............................................................................................43, 86
I
Incyte (www.incyte.com) ................................................................................................................viii, 62-63, 65
iNovacia (www.inovacia.se) ..............................................................................................................................70
Intarcia (www.intarcia.com) ........................................................................................................................ 37-38
Intercept (www.interceptpharma.com) ..................................................................................................... viii, 71
Ipsen (www.ipsen.com) ......................................................................................... 40-41, 62-63, 79, 97, 102-103
Isis (www.isispharm.com) ....................................................................................................45, 53-54, 57, 65, 79
J
Japan Tobacco (www.jti.co.jp) ....................................................................................................62-64, 68-69, 73
Johnson & Johnson (www.jnj.com) ........................................ 31, 33, 40-41, 45-46, 53-55, 66-69, 104, 111, 121
Joslin Diabetes Center (www.joslin.org) ..........................................................................................................79
K
Kainos Medicine (www.kainosmedicine.com) ................................................................................................46
Kalypsys (www.kalypsys.com) ......................................................................................................... 31, 33, 66, 71
Kissei (www.kissei.co.jp) ...........................................................................................................13, 36, 54, 57, 86
Kotobuki Pharmaceutical (www.kotobuki-pharm.co.jp) .....................................................................53, 56, 91
Kowa (www.kowa.com) ................................................................................................................... vii, 45-46, 51
Kyorin (www.kyorin-pharm.co.jp) ..............................................................................................................46, 52
Kyowa Hakko (www.kyowa-usa.com) ............................................................................................................... 47
L
Lexicon (www.lexicon.com) ...............................................................................................................53, 56, 103
LG Life Sciences (www.lgls.com) ...................................................................................................45, 51, 59, 66
Ligand (www.ligand.com) ............................................................................... 41, 66, 69-72, 74, 76, 78, 87, 106
Lilly (www.lilly.com) ........................................................... 9-11, 15, 20, 24-25, 29, 37-40, 43-44, 59-60, 75, 77, 79-80, 82-85, 97-98, 104, 112, 116, 121
Lipoxen (www.lipoxen.com) ....................................................................................................................... 20-21
Lupin (www.lupinpharmaceuticals.com) ........................................................................................31-32, 46, 65
M
MacroGenics (www.macrogenics.com) ......................................................................................................80, 85
Makoto Life Sciences (www.makotolife.com) .................................................................................................. 74
• www.InsightPharmaReports.com • Reproduction prohibited 137
Diabetes Pipeline: Intense Activity to Meet Unmet Need
MannKind (www.mannkindcorp.com) ....................................................................................20, 26-27, 40, 45
MAP Pharmaceuticals (www.mappharma.com) ........................................................................................ 21, 26
Marcadia (www.marcadiabiotech.com) ............................................................................................................45
MDRNA (www.marinabio.com) ................................................................................................................ 21, 27
Merck (www.merck.com) ............................................... 16-17, 36, 52, 54, 57, 59, 61, 67-68, 70, 72, 74-75, 83, 86-87, 95, 105, 111, 113-114, 118
Merck KGaA (www.merck.de) .........................................................................................................................36
Merck Serono (www.merckserono.net) ........................................................................................52, 54, 57, 105
Metabasis (www.ligand.com) ........................................................................................................... 69-72, 74, 87
Metabolex (www.metabolex.com) ............................................... 31, 33-34, 66-67, 75-76, 89, 103-104, 115, 121
Metabolic Solutions (www.metsol.com) .................................................................................................... 31, 33
Mitsubishi Tanabe (www.mt-pharma.co.jp) .............................................................................45, 47, 51, 53, 55
Mochida (www.mochida.co.jp) ........................................................................................................................63
N
Napo (www.napopharma.com) ..................................................................................................................75, 78
Nastech (www.marinabio.com) .................................................................................................................. 21, 27
Neurocrine (www.neurocrine.com) ...........................................................................................................66, 68
Nobex (www.biocon.com) ..........................................................................................................................20, 29
NOD (www.nodpharm.com) ...................................................................................................................... 37-38
Novartis (www.novartis.com) ............................................................................13, 16, 48, 59, 68-70, 76, 78, 95
Novo Nordisk (www.novonordisk.com) ........................... 9-11, 13, 15, 17, 20-22, 24-25, 28, 32, 34, 39-40, 44, 59-60, 83, 87-88, 107, 111-112, 114-116
Nuada ............................................................................................................................................................... 47
O
Ontogen ...........................................................................................................................................................72
Oramed (www.oramed.com) .....................................................................................................20-21, 28, 40, 45
Orchid (www.orchidpharma.com) ...................................................................................................................62
OSI (www.osip.com) ................................................................................................47, 59-60, 66-67, 73, 85, 91
Otsuka (www.otsuka-global.com) ............................................................................................................... 16, 94
P
Peptron (www.peptron.com) ....................................................................................................................... 37-38
Pfizer (www.pfizer.com) ..............................9, 13-14, 25-26, 40, 45, 47-48, 52, 62-64, 68-70, 72, 76, 94-96, 104
Phenex (www.phenex-pharma.com) ...........................................................................................................76, 78
Index
138 • www.InsightPharmaReports.com • Reproduction prohibited
Phenomix (www.phenomix.com) .......................................................................................45, 50, 104, 111, 113
Phosphagenics (www.phosphagenics.com) ................................................................................................ 21, 30
Piramal (www.piramalhealthcare.com) .................................................................................. 68-69, 75, 104-105
Plexxikon (www.plexxikon.com) ................................................................................................................ 31, 35
Poxel (www.poxel.com)...................................................................................36, 41, 57, 59, 62, 74-76, 105, 115
Pozen (www.pozen.com) ...................................................................................................................................63
Probiodrug (www.probiodrug.de) .................................................................................................................... 47
Prolor Biotech (www.prolor-biotech.com) .......................................................................................................40
Prosidion (www.prosidion.com) ................................................................................................................59, 66
R
Ranbaxy (www.ranbaxy.com) ...........................................................................................................................46
Rheoscience (www.rheoscience.com) ..............................................................................................................32
Roche (www.roche.com) ..............................................................31, 34-35, 39-42, 47-48, 53, 56, 58-59, 62-64, 66-67, 69-70, 72, 75, 79, 82, 96-97, 103, 112-113, 120-121
S
Sankyo (www.daiichisankyo.com) ...................................................................................................14, 32, 70-72
sanofi-aventis (www.sanofi-aventis.us) .............................. 10-11, 13-14, 17, 21, 32, 39-40, 43, 47, 54, 57-58, 68,
71, 73, 75, 77, 83, 88-89, 99, 104, 112, 116, 121
Santhera (www.santhera.com) .........................................................................................................................46
Sanwa (www.skk-net.com) ............................................................................................................... 45-46, 51, 79
Schering-Plough (www.merck.com) ................................................................................................................. 67
Scottish Biomedical (www.scottish-biomedical.com) ......................................................................................62
SemBioSys Genetics (www.sembiosys.com) ................................................................................................ 20-21
Senexis (www.senexis.com) .............................................................................................................................. 76
Servier (www.servier.com) ..............................................................................................................13, 36, 46, 52
Shanghai Hengrui (www.bio-pharma.com.cn) ................................................................................................46
Shenzhen Chipscreen Biosciences (www.chipscreen.com) ....................................................................... 31, 34
Silicos (www.silicos.be) .....................................................................................................................................65
Sirona Biochem (www.sironabiochem.com) ....................................................................................................54
Sirtris (www.sirtrispharma.com) ................................................................................................................ 74, 86
SmartCells (www.smartinsulin.com) ......................................................................................................... 21, 24
Spherix (www.spherix.com) .................................................................................................................75-77, 111
Sterix (www.ipsen.com) ..................................................................................................................................102
Surface Logix (www.surfacelogix.com) ............................................................................................................69
• www.InsightPharmaReports.com • Reproduction prohibited 139
Diabetes Pipeline: Intense Activity to Meet Unmet Need
Swedish Orphan Biovitrum (www.swedishorphan.com) ................................................................................66
Syndexa (www.syndexa.com) .........................................................................................................................106
Syrrx (www.tpna.com) ......................................................................................................................................52
T
Taisho (www.taisho.co.jp) .....................................................................................................................53-54, 57
Takeda (www.tpna.com) ..............14, 16-17, 45-46, 48, 52, 59, 61, 68-71, 83, 89-90, 104, 110-111, 113-114, 121
Tanabe (www.mt-pharma.co.jp) ................................................................................................ 45, 47, 51, 53-55
Teijin (www.teijin.co.jp) .................................................................................................................................103
Teva (www.tevapharm.com) ................................................................................................................. 21, 79, 81
Theracos (www.theracos.com) ..................................................................................................... 31, 33, 76, 106
Tolerx (www.tolerx.com) ............................................................................................................................80, 85
Toray (www.toray.com) .....................................................................................................................................46
Torrent (www.torrentpharma.com) ...........................................................................................................46, 65
Transition Therapeutics (www.transitiontherapeutics.com) .....................................................................75, 77
TransTech Pharma (www.ttpharma.com) ............................................................32, 40, 44, 59-60, 65, 106-107
V
Versartis (www.versartis.com) .........................................................................................................37-38, 79, 82
Verva (www.vervapharma.com) .................................................................................................................75, 77
VIA Pharmaceuticals (www.viapharmaceuticals.com) ...............................................................................69, 76
Vitae (www.vitaepharma.com) ...................................................................................................................62, 93
W
Warner-Lambert (www.pfizer.com) .................................................................................................................. 14
Wellstat (www.wellstat.com) ...........................................................................................................75, 77, 88-89
Wockhardt (www.wockhardtin.com) ............................................................................................................... 10
Wyeth (www.wyeth.com) ................................................................................................................35, 62, 64, 95
X
Xenon (www.xenon-pharma.com) ...................................................................................................................70
Xention (www.xention.com) ............................................................................................................................95
XOMA (www.xoma.com) .................................................................................................................................79
Z
Zealand (www.zealandpharma.com) ..................................................................................................... 40-41, 43
Zydus Cadila (www.zyduscadila.com) .................................................................................................. 31, 40, 45
Index
140 • www.InsightPharmaReports.com • Reproduction prohibited
About Cambridge Healthtech Institute
Founded in 1992, Cambridge Healthtech Institute (CHI) strives to develop quality information resources that provide valuable new insights and competing points of view while offering balanced coverage of the latest developments in the life
sciences industry. Basic research related to commercial implications is covered, with heavy emphasis placed on end-user insights into new products and technology as well as coverage of the strategy behind the business.
Cambridge Healthtech Institute (CHI)—www.chicorporate.com—is the preeminent life science network for leading researchers and business experts from top pharmaceutical, biotech, CROs, academia, and niche service providers. CHI offers a fully integrated life sciences portfolio of products, services, educational programs, analytical research reports, management consulting services, multi-media solutions, and publications including Bio-IT World magazine.
For a comprehensive listing and detailed information about our products and services, please continue reading below or visit our web site at www.chicorporate.com.
Cambridge Healthtech Institute Conferences (www.healthtech.com)
For the past 15 years, Cambridge Healthtech Institute (CHI) has developed more than 700 conferences, which have attracted over 60,000 attendees from around the world. CHI is the industry leader in offering quality programs that provide valuable new insights and competing points of view while offering balanced coverage of the latest developments in the life science industry. Leading researchers and business experts from top pharmaceutical, biotech, and academic organizations present their most current findings in a forum that features panel discussions and audience participation.
CHI’s Marketing Services (http://proservices.healthtech.com)
The Marketing Services group is an ideal solution for companies seeking assistance in all aspects of life sciences direct marketing. CHI’s Marketing Services continues to be chosen #1 over our competitors for one reason – We deliver results that impact the bottom-line with many services to choose from. Services include list rentals, direct marketing, product and service alerts, and mail piece designs.
Cambridge Meeting Planners (http://proservices.healthtech.com)
Cambridge Meeting Planners (CMP) has a highly professional, experienced team dedicated to providing you with the finest services to match any budget. With five meeting planners who combined have over 50 years of experience in the field, CMP has extensive working relationships with hotels and vendors guaranteeing you superior service with all of your contract negotiation needs.
CMP is available to manage all of your preplanning and onsite meeting needs, including site selection, contracting, audio visual/food and beverage selection, hiring/managing security and temps, etc. CMP is there for you whether you need help planning a reception for 1000 or a working dinner meeting for 20 professionals. CMP can manage your entire event from soup to nuts and make your vision a reality. Types of events include:
• Conferences• Tradeshows• User-group meetings• Product launches• Focus groups• Client appreciation events• Team building excursions• Recreational and hospitality programs• And many more. Please visit the web site for a more detailed list.
Cambridge Healthtech Associates (CHA) (www.chacorporate.com)
Cambridge Healthtech Associates (CHA) is the leading organizer and facilitator of biopharmaceutical collaboration. CHA reduces the costs of R&D by bringing together different companies to work cooperatively to evaluate novel technologies, assess vendors in emerging global markets and address other areas of shared concern. This is accomplished through short, six-month collaborative projects, market research surveys, roundtable summits, virtual meetings (via tele/web conference) and the Drug Safety Executive Council (an exclusive online community of industry leaders).
Cambridge Healthtech Media Group (www.chimediagroup.com)
Cambridge Healthtech Media Group delivers content to decision makers through its print, online, and electronic products designed to serve the life sciences community. The Media Group’s editors are at the pulse of the market and disseminate ground-breaking news, analysis, trends, and insights that shape the life science industry through a suite of published resources – Bio-IT World magazine—CHI’s flagship publication, topic-specific eNewsletters, and web sites.
Bio-IT World (www.bio-itworld.com)
Bio-IT World magazine—CHI’s flagship publication—publishes critical insights, analysis, and opinion on the enabling technologies propelling the spread of information and the passage of drug candidates through the drug discovery process. Bio-IT World’s focus is increasingly one that explores the tools and results of predictive biology, drug discovery, informatics, and personalized medicine as well as the strategic decisions made by companies in this area and the impact on the company’s performance.
A few key areas covered in-depth include: recent advances in whole genome analysis and next-generation sequencing, data handling technologies, the vast potential of adaptive clinical trials, in silico modeling, cheminformatics, electronic data capture, and much more. Please visit www.bio-itworld.com to view more feature articles on the life sciences industry and to subscribe.
Bio-IT World Weekly Update (www.bio-itworld.com)
Published weekly, Bio-IT World Weekly Update is a summary of the week’s latest news, industry highlights and trends, product reviews, upcoming events, and key stories from Bio-IT World magazine and its companion web site, www.bio-itworld.com
Lead Generation Programs & Custom Solution Packages (www.chimediagroup.com)
A variety of custom publishing, multi-media solutions, and lead-generation programs can be used to convey your company’s message to a core life science audience of qualified scientists, technology professionals, executive managers, clinical professionals in pharma, biotech, academia, and niche service provider companies. The media group team can help you create a comprehensive media package—targeting specific demographics—and incorporating your message within the published resources that our audiences trust. Programs may include Microsites, white papers, webcasts, podcasts, custom surveys, special mailings, and other solution packages to meet your business needs.
To request information on the Lead Generation Programs, Custom Solution Packages, or to develop a comprehensive multi-media package to reach a target audience, contact Marketing [email protected]
Contact Us:
Cambridge Healthtech Institute
250 First Avenue, Suite 300 Needham, MA 02494
Phone: 781-972-5400 Toll-Free: 888-999-6288 Fax: 781-972-5425 Email: [email protected]
Web: www.chicorporate.com
Your Life Science Network
Timely, Authoritative, Concise
Your one-stop source for analysis of the technologies, markets, and strategic
issues driving R&D productivity
Insight Pharma Reports is a division of Cambridge Healthtech Institute
© 2010 Cambridge Healthtech Institute
