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ChangeWave Research: Trends in Diabetes September 2, 2004 ChangeWave Research Report: Trends in Diabetes - 2004 Strong Preference for Inhalable Insulin; Exanatide Seen as Promising Along With “Increased Self Monitoring” & “Earlier Detection” Products Overview This past February we surveyed Alliance healthcare members knowledgeable about Diabetes and found diabetes cases to be on the rise – mainly because of obesity. Inhalable Insulin was identified as the biggest winner for new therapies, and an increase in self-monitoring was seen as the most significant new trend. To follow-up, during the week of August 10 – 16, 2004, we surveyed Alliance Healthcare members who are knowledgeable about Diabetes. A total of 110 healthcare members participated, including 48 doctors. Here’s what we found: (A) Overall Trends in Diabetes Most Promising New Product/Service Areas. “Increase in Self Monitoring” (45%) is still seen as the most promising new product/service area in Phase II or III clinical trials, followed by “Earlier Detection” (38%) and “Type II Insulin Based Therapies” (27%). Biggest Gainers. In terms of momentum, “Earlier Detection” experienced the largest increase (24 percentage pts) since the last time we conducted an Alliance Healthcare survey on Diabetes trends (February 2004). “Increase in Self-Monitoring” also improved from the previous survey by 17 percentage pts. On the down side, “NonInsulin Based Therapies” declined the most, dropping 9 percentage pts since Feb. 2004. Drugstore/Medical Supply Stores Preferred for Purchasing. Eighty-five percent of respondents say their patients prefer to purchase self-testing and treatment products from “Drugstore/Medical Supply Stores,” up 10 percentage pts from the February 2004 survey. “Doctor’s Office” (20%) and “Via the Internet” (19%) came in second and third, respectively. Innovative Approaches to “Cure” Diabetes Need More Time. When given a list of current innovative approaches to cure diabetes, a majority of respondents (54%) says none will achieve success within the next 12-24 months. Significantly, 18% see Islet Cell Transplantation to Produce Insulin” as having the best chance of succeeding in the marketplace within 12-24 months, the only approach to reach double-digits. The Small Companies Most Likely to Succeed. Alteon (8%), CuraGen (8%), and Insmed (8%) were the small companies identified as most likely to succeed over the next 12-24 months. A percentage point behind them were Cholestech (7%) and Emisphere Technologies (7%), followed by Stemcells Inc (6%). Copyright ©2004 ChangeWave Research All rights reserved. ChangeWave Research: Trends in Diabetes (B) Inhalable Insulin Existing Patients Would Prefer Inhalable Insulin Over the Injectable Form. A majority of Alliance healthcare respondents (61%) believe “Greater than 50%” of existing diabetes patients would prefer to use an inhalable form of insulin rather than a traditional injectable form. An even higher proportion of Doctors (67%) believe this to be the case. Newly Diagnosed Patients Would Prefer Inhalable Insulin Even More. Better than three-quarters (80%) of respondents believe that “Greater than 50%” of newly diagnosed patients would prefer to use an inhalable form of insulin rather than a traditional injectable form. Again, an even higher percentage of doctors (88%) believe this to be the case. Most Patients Won’t Avoid Inhalable Insulin – Even if Pulmonary Testing and/or Supplemental Injections are Required. The majority of respondents (61%) believe patients won’t avoid Inhalable Insulin treatments even if it requires follow-up pulmonary testing or supplemental injections. However, 27% of respondents say patients would avoid Inhalable Insulin if it requires follow-up pulmonary testing or supplemental injections. (C) Exenatide Among Those Familiar With Exenatide, the Consensus is it’s Promising. Among the one-out-of-five respondents familiar with Exenatide, 43% believe that more than half of Type II diabetes patients not responding to oral medications will want to use Exenatide to prevent progression of their diabetic condition. Bottom Line: As Diabetes cases continue to rise, these survey results show promise for several new types of therapies and technologies. First, “Increase in Self Monitoring” is seen as the most promising new product/service area in Phase II or III clinical trials, along with “Earlier Detection.” Secondly, Alliance healthcare respondents also see a strong preference for Inhalable Insulin among both existing and newly diagnosed patients. Moreover, Exenatide also appears to have real market potential as an alternative to oral medications for treating Type II Diabetes, although the drug treatment is still unfamiliar to many respondents. These results notwithstanding, when given a list of current innovative approaches to “cure” Diabetes, a majority of respondents (54%) still says none will achieve success within the next 12-24 months (although 18% did see “Islet Cell Transplantation to Produce Insulin” as having the best chance). Rather, innovative approaches to “cure” diabetes that are currently being pursued, are seen by a majority of respondents as being more than two years away from success. The ChangeWave Alliance is a group of 4,600 highly qualified business, technology, and medical professionals in leading companies of select industries—credentialed professionals who spend their everyday lives working on the frontline of technological change. ChangeWave surveys its Alliance members on a range of business and investment research and intelligence topics, collects feedback from them electronically, and converts the information into proprietary quantitative and qualitative reports. Helping You Profit From A Rapidly Changing World ™ www.ChangeWave.com Copyright ©2004 ChangeWave Research All rights reserved. 2 ChangeWave Research: Trends in Diabetes Table of Contents Summary of Key Findings ............................................................................................ 4 The Findings .................................................................................................................. 5 (A) Overall Trends in Diabetes ............................................................................ 5 (B) Inhalable Insulin ............................................................................................ 15 (C) Exenatide...................................................................................................... 17 (D) Medicare and Obesity ................................................................................... 19 ChangeWave Research Methodology ....................................................................... 22 About ChangeWave Research ................................................................................... 23 Copyright ©2004 ChangeWave Research All rights reserved. 3 ChangeWave Research: Trends in Diabetes I. Summary of Key Findings Inhalable Insulin Overall Diabetes Trends Most Promising New Product/Service Areas Increase in SelfMonitoring (45%) Earlier Detection (38%) Type II Insulin Based Therapies (27%) Where Do Patients Prefer to Purchase Self-testing and Treatment Products? Drugstore/Medical Supply Stores (85%) Doctor’s Office (20%) Via the Internet (19%) Small Companies Most Likely to Succeed – Next 12-24 Months: Alteon (8%) CuraGen (8%) Insmed (8%) 61% of respondents believe the majority of “existing” diabetes patients would prefer inhalable insulin over the traditional injectable form And 80% believe the majority of “newly” diagnosed patients would prefer inhalable insulin over the injectable form Another 61% believe most patients won’t avoid Inhalable Insulin even if it required follow-up pulmonary testing and/or supplemental injections But 27% say patients would avoid the treatment if it required follow-up testing/ treatment Innovative Approaches to “Cure” Diabetes Need More Time A majority of respondents (54%) says none of the current innovative ‘cure’ approaches for diabetes will achieve success within the next 12-24 months But 18% do see “Islet Cell Transplantation to Produce Insulin” as having the best chance of succeeding within the next 12-24 months Exenatide Consensus is it’s Promising – 43% of respondents familiar with the treatment believe that more than half of Type II diabetes patients not responding to oral medications will want to use Exenatide Introduction This past February we surveyed Alliance healthcare members knowledgeable about Diabetes and found diabetes cases to be on the rise – mainly because of obesity. Inhalable Insulin was identified as the biggest winner for new therapies, and an increase in self-monitoring was seen as the most significant new trend. To follow-up, during the week of August 10 – 16, 2004, we surveyed Alliance Healthcare members who are knowledgeable about Diabetes. A total of 110 healthcare members participated, including 48 doctors. The findings focus on four key areas: (A) Overall Trends in Diabetes (B) Inhalable Insulin (C) Exenatide (D) Medicare and Obesity Copyright ©2004 ChangeWave Research All rights reserved. 4 ChangeWave Research: Trends in Diabetes II. The Findings Trends in Diabetes – 2004 Total Respondents: (n = 110) Doctors: (n = 48) Healthcare Workers: (n = 26) Other Respondents: (n = 36) (A) Overall Trends in Diabetes (1) Question Asked: There are a host of new diabetes products/ services in Phase II or Phase III clinical trials. Which of the following product/service areas would you say look the most promising? (Choose No More Than Two) Total Healthcare Other Doctors Respondents Workers Respondents Increase in Self-Monitoring 45% 44% 54% 39% Earlier Detection 38% 27% 35% 56% Type II Insulin Based Therapies 27% 29% 27% 25% Increase in Self-Treatment 24% 27% 19% 22% Non-Insulin Based Therapies 24% 40% 12% 11% Type I Insulin Based Therapies 11% 13% 12% 8% Don't Know 7% 2% 12% 11% Other 2% 0% 0% 3% Most Promising New Product/Service Areas. “Increase in Self Monitoring” (45%) is seen as the most promising new product/service area in Phase II or III clinical trials, followed by “Earlier Detection” (38%) and “Type II Insulin Based Therapies” (27%). Earlier Detection Increase in Self-Monitoring Increase in Self-Treatment Type I Insulin Based Therapies Type II Insulin Based Therapies Non-Insulin Based Therapies Current Survey Aug ‘04 38% 45% 24% 11% 27% 24% Previous Survey Feb ’04 14% 28% 21% 12% 30% 33% Net Gain +24 +17 +3 -1 -3 -9 Biggest Gainers. In terms of momentum, “Earlier Detection” experienced the largest increase (24 percentage pts) since the last time we conducted an Alliance Healthcare survey on Diabetes trends (February 2004). “Increase in Self-Monitoring” also improved from our previous survey by 17 percentage pts. On the down side, “Non-Insulin Based Therapies” declined the most, dropping 9 percentage pts since Feb. 2004. Copyright ©2004 ChangeWave Research All rights reserved. 5 ChangeWave Research: Trends in Diabetes (2) Question Asked: From the patient perspective, what is the preferred way of purchasing self-testing and treatment products? (Choose No More Than Two) Total Healthcare Other Doctors Respondents Workers Respondents Drugstore/Medical Supply Store 85% 85% 88% 83% Doctor's Office 20% 21% 15% 22% Via the Internet 19% 17% 19% 22% Catalog/Phone Service 10% 10% 15% 6% Don't Know 5% 4% 4% 8% Other 2% 0% 4% 3% Net Gain – August 2004 Drugstore/Medical Supply Store Doctor's Office Via the Internet Catalog/Phone Service Don't Know Other Current Survey Aug ‘04 85% 20% 19% 10% 5% 2% Previous Survey Feb ‘04 75% 13% 24% 15% 10% 3% Net Gain +10 +7 -5 -5 -5 -1 Drugstore/Medical Supply Stores Preferred for Purchasing. An overwhelming 85% of respondents say their patients prefer to purchase self-testing and treatment products from “Drugstore/Medical Supply Stores,” up 10 percentage pts from the February 2004 survey. “Doctor’s Office” (20%) and “Via the Internet” (19%) came in second and third, respectively. Copyright ©2004 ChangeWave Research All rights reserved. 6 ChangeWave Research: Trends in Diabetes (3) Question Asked: Several innovative approaches to "cure" diabetes are currently being pursued by medical researchers. Of the following approaches, which one do you believe has the best chance of succeeding in the marketplace within the next 12 to 24 months? Islet Cell Transplantation (to produce insulin) Genetic Manipulation (creation of "pseudo" islet cells for transplant) Pancreas Transplantation Artificial Pancreas Development None of These will Achieve Success Within the Next 12-24 Months Don't Know Total Healthcare Other Doctors Respondents Workers Respondents 18% 17% 19% 19% 5% 4% 0% 11% 3% 2% 54% 4% 2% 56% 0% 4% 46% 3% 0% 58% 17% 17% 31% 8% Innovative Approaches to “Cure” Diabetes – Need More Time. When given a list of current innovative approaches to cure diabetes, a majority of respondents (54%) says none will achieve success within the next 12-24 months. Significantly, 18% see “Islet Cell Transplantation to Produce Insulin” as having the best chance of succeeding in the marketplace within the next 12-24 months, the only category to reach double-digits. (3A) Question Asked: Why? Sample of Alliance Member Responses: a. None of These will Achieve Success Within the Next 12-24 Months (54%) Editors Note: Many of the respondents who chose this category said the 12-24 month timeframe is too short to achieve success, but were generally optimistic of the longerterm potential of these approaches. MIN9289 writes, "Some success will be obtained in the mentioned time period, but a longer time period will be required before results offer a good handle on which of these therapies appears most promising." MJW5673 writes, "Time frame too short. Further out, several of the approaches are likely to be successful." VDS1474 writes, "All these "cures" are still in the experimental phase." AGR0426 writes, "Path to Phase III approval would likely take at least twice the time stated." Copyright ©2004 ChangeWave Research All rights reserved. 7 ChangeWave Research: Trends in Diabetes KCO6695 writes, "I don't think that the technology is far enough along for wide spread usage." WRT9962 writes, "The sequella of whole-organ transplantation are still more formidable than injections and the other technologies are simply MORE than 24 months away. I like to think that pseudo islets and/or islet transplants are close, but realistically, I'm not sure they are! For me, if I were in need, I'd want a transplant that was specific to me...that would keep me from having to take immune-suppressing drugs...that's the big holdup. It's coming, but not in the next two years." SER5830 writes, "These are approaches for type 1 which is less than 10% of the diabetic market. These procedures are very costly and are invasive and of limited value. The timeline, if they go, is more like 4-5 years." KES5963 writes, "Needs prolonged testing and FDA approval." BCA3438 writes, "Long lead times and FDA approval." ELW4764 writes, "Transplants are for 'end stage' patients and, to me, just buy time at best. Islet cell could be the 'cure' but doesn't appear to be 'ready for the market' within 12-24 months ... maybe never." DRK5861 writes, "Lots of problems to still work out." WLU8236 writes, "Pancreas transplantation: major surgery, immunosuppression required, scarcity of donor organs, only applicable for selected type I diabetes patients (possibly in combination with kidney transplantation). Islet cell transplantation: results still variable though improving, shortage of donor organs, procedure still deemed experimental. Artificial pancreas: technology continues to improve but remains experimental; market success will take longer than 1-2 years. Genetic manipulation: promising in the long term, a whole range of different approaches falls under this heading, major research and clinical issues remain to be resolved. Success in marketplace is many years away." TRU7599 writes, "Time scale too short." MAD2680 writes, "R & D development timelines along with extended trials will elongate approvals." LEO7024 writes, "Too far from efficacy/approval." ZSA8198 writes, "Too soon to complete necessary research." TAC8398 writes, "Delay from clinical trials to FDA approval would most likely take longer than 2 years." BOL2762 writes, "Needs lots of time to develop." Copyright ©2004 ChangeWave Research All rights reserved. 8 ChangeWave Research: Trends in Diabetes ELS7356 writes, "It will take 4-5 years of testing and clinical trials before any of these would be ready for marketing." DRJ5952 writes, "Not there yet technologically." 8486810 writes, "More research needed." ALF1482 writes, "Too soon, maybe in 5-10 yrs." CAR8242 writes, "There is a shortage of organs for transplantation, islet cell transplantation still requires procurement and possibly culture issues which are not near completion." CEN9132 writes, "The procedures sound too complicated. They will likely gain popularity very slowly and gradually." COB6520 writes, "Patients must take responsibility for their health and change their diet, exercise and lose weight. Trying to "cure" diabetes without responsibility goes against the laws of the universe and will never work long-term." PEG8651 writes, "Inability for reimbursement from insurance." LON6196 writes, "Too complex." FOR3567 writes, "Complex biology more complex regulation." KVR1320 writes, "Pancreas and islet cell transplant are used in conjunction with renal transplants. Isolated pancreas or islet cell transplants are years away." BIN8250 writes, "There is the problem of rejection with any transplant. The injections are trivial in any event. The artificial pancreas may be expensive and cumbersome..." JAN4089 writes, "Some are already used, but achieved only small application." ALA8640 writes, "Although Pseudo Islet cells are probably less immunogenic, rejection might still be a problem and takes sometimes many months to ascertain." KUR3102 writes, "The research for these will not translate into products before 10 more years." GHM8270 writes, "There may be limited use, but not large scale commercial use within the next 2 years." WPW6938 writes, "Not sure that progress is far enough along to say that success will be achieved in that time frame." GRA1199 writes, "We are not far enough advanced." Copyright ©2004 ChangeWave Research All rights reserved. 9 ChangeWave Research: Trends in Diabetes MIK6029 writes, "Too many rejection problems with transplantations; not enough cells to be harvested for patients." GOO3505 writes, "Large scale studies need to be completed before something could be thought to be used for large amounts of people. Benefits need to outweigh risks." STE3218 writes, "To much leg work to be done. Not well enough studied to be adopted and would still rely on increase in stem cell lines." PWG2815 writes, "Regulatory pathway issues will slow down the release to the market place." GDA7384 writes, "Because in the vast majority of people the problem is insulin resistance at target cell level as well as pancreatic failure in varying degrees." WIL1338 writes, "Creating viable cells equivalent to body cells and able to produce insulin, regulate glucose level, is complicated and will require long term testing which goes over the 2 years indicated above." KEN1900 writes, "Type one diabetes is about more than insulin. Transplantation is very expensive and creates its own problems with immunosupression." SCI3493 writes, "Alogenate transplantation would not be suitable for diabetics due to lower immune responses and increased susceptibility to infection. Genetic manipulation would be promising but it still has long way to go." SNU3210 writes, "They are not far enough along for mass use or acceptance by insurers as proven therapies." b. Islet Cell Transplantation (18%) SBE5857 writes, "Most developed as of today. Cannot predict time required as progress is always slow." MAM7387 writes, "There are already methods of shielding transplanted cells from the immune system. Of course the great breakthrough will come with gene therapy but unlikely within 12-24 months. ..." DAV6135 writes, "If any of these therapies does actually achieve success and approval for use in the next 2 years, I believe that the Islet Cell Transplantation would be the one to be approved. Whether it can do that within the next 2 years is debatable however." GOP2712 writes, "Has been tried for several years." SSR9050 writes, "The technology to do this is most advanced." COA5836 writes, "Most research interest." Copyright ©2004 ChangeWave Research All rights reserved. 10 ChangeWave Research: Trends in Diabetes CLE2459 writes, "Genetic manipulation holds a better promise long term, however, Islet Cell Transplantation has a better chance within the next 12-24 months due to the positive track record and "user familiarity" with other "organ" transplants, i.e. kidney, liver, etc." ALA7205 writes, "Development is proceeding well." MAK7890 writes, "Procedure has been developing for many years." c. Genetic Manipulation (5%) AME1382 writes, "Availability in near future." d. Pancreas Transplantation (3%) WSU8151 writes, "Transplant of the pancreas is a stop gap measure for now. Islet cell, artificial, and genetic manipulation will be successful but not in 24 months...probably in 5 to 10 years." SR10005 writes, "There are better immunosuppressive drugs now so that the success of pancreatic transplantation is improving. The other therapies are still at least 4 to 5 years away from reality." e. Artificial Pancreas Development (2%) WOO7602 writes, "Patients are currently wearing the Minimed Pump with a sensor which gives them real-time blood sugar information. This is BY Far the closest technology to curing diabetes, and will likely happen Many years before islet cell transplantation becomes commonplace." JGR0393 writes, "No rejection issues." Copyright ©2004 ChangeWave Research All rights reserved. 11 ChangeWave Research: Trends in Diabetes (4) Question Asked: The small companies listed below are all involved in various aspects of the prevention, treatment and monitoring of diabetes. Of the companies that you are familiar with which - if any - do you think is most likely to succeed over the next 12 - 24 months? (Choose No More Than Two) Alteon (compounds targeting A.G.E. Pathway) CuraGen (partnering with Bayer on small molecule therapeutic) Insmed (IGF-I regulates glucose uptake) Cholestech (Diagnostics for Glucose) Emisphere Technologies (oral insulin) Stemcells Inc. (pancreatic stem cell) SpectRx (glucose monitor, insulin device) Biotech Holdings (Sucanon diabetes drug) Amylin Pharmaceuticals* Nutrition 21 (chromium picolinate/compounds) Hi-Tech Pharmacal (branded OTC products) Keryx Biopharmaceuticals (KRX-101 for diabetic nephropathy) Lexicon Genetic (small molecule drug candidates) Not familiar with any of these companies or their products/technologies Don't Know Other Total Healthcare Other Doctors Respondents Workers Respondents 8% 6% 4% 14% 8% 10% 0% 11% 8% 6% 12% 8% 7% 10% 4% 6% 7% 6% 12% 6% 6% 2% 4% 14% 5% 2% 4% 6% 4% 2% 4% 8% 3% 2% 2% 4% 0% 0% 6% 0% 1% 2% 0% 0% 1% 2% 0% 0% 1% 2% 0% 0% 25% 29% 31% 14% 40% 2% 42% 0% 46% 4% 33% 3% * Note that Amylin Pharmaceuticals was not provided in the pick list. In the “Other” category, 3% of respondents named Amylin in their response. The Small Companies Most Likely to Succeed. Alteon (8%), CuraGen (8%), and Insmed (8%) were the small companies identified as most likely to succeed over the next 12-24 months. A percentage point behind them were Cholestech (7%) and Emisphere Technologies (7%), followed by Stemcells Inc (6%). Copyright ©2004 ChangeWave Research All rights reserved. 12 ChangeWave Research: Trends in Diabetes (4A) Question Asked: Why? Sample of Alliance Member Responses: a. Alteon (8%) WRT9962 writes, "Alteon because they're the big player in that niche as far as I can tell...and it's going to be a ‘big’ niche, I think...though ‘maybe’ more then 24 months out…” HER4689 writes, "Cost and ease of use." FLO8176 writes, "Complex disease, targeting pathways may be more sensible …” b. CuraGen (8%) GHM8270 writes, "Curagen/Bayer partnering on therapy will more rapidly introduce to larger population group..." 8486810 writes, "I believe they are working on inhaled insulin." FLO8176 writes, " ... Partnering with a large pharma gives access to a progression path for following up in relevant disease models etc." c. Insmed (8%) GDA7384 writes, "… Target cell insulin resistance critical so glucose uptake modulators will become more and more important." WIL1338 writes, "Insmed is reaching phase 3 testing. The others I am not aware of reaching that phase." d. Cholestech (7%) MES5884 writes, "Easy to use in a clinic or office setting." TAC8398 writes, "Pipeline" GHM8270 writes, "… Cholestech for the diagnostic and management." e. Emisphere Technologies (7%) LEO7024 writes, "Better acceptance under current conditions, FDA or patient willingness to adapt." f. Stemcells Inc. (6%) JES5551 writes, "Best approach but will only have demonstrated it - at best." Copyright ©2004 ChangeWave Research All rights reserved. 13 ChangeWave Research: Trends in Diabetes WRT9962 writes, "Stem cells are gonna be big...but again...’maybe’ more than 24 months." h. SpectRx (5%) ELS7356 writes, "Improved diagnostics will be the most successful approach over the next year or two." g. Biotech Holdings (4%) WLU8236 writes, "Because Biotech Holdings will shortly launch Sucanon (in Mexico).” WPW6938 writes, "Sucanon will begin to be marketed in Mexico in September and apparently has been OK’d for marketing in several other countries. It augments insulin utilization in Type 2 DM.” i. Keryx Biopharmaceuticals (1%) WPW6938 writes, "Keryx KRX-101 has shown significant efficacy in phase II trials in treating diabetic nephropathy and it has been sold in Europe for over 20 years with a well-known safety profile." j. Other – Amylin Pharmaceuticals (3%) GOO3505 writes, "They are partnering with Eli Lilly to bring to market the use of Exenatide which should we widely used." WLU8236 writes, "Amylin expects FDA approval for Exenatide." Copyright ©2004 ChangeWave Research All rights reserved. 14 ChangeWave Research: Trends in Diabetes (B) Inhalable Insulin (5A) Question Asked: Focusing on inhalable insulin, what percentage of existing Diabetes patients do you think would prefer to use an inhalable form of Insulin rather than a traditional injectable form? Total Healthcare Other Doctors Respondents Workers Respondents 0-10% 4% 4% 4% 3% 11%-20% 4% 6% 0% 3% 21%-30% 11% 4% 15% 17% 31%-50% 14% 15% 12% 14% Greater than 50% 61% 67% 58% 53% Don't Know 7% 4% 8% 11% 0-10% 11%-20% 21%-30% 31%-50% Greater than 50% Current Survey Aug ‘04 4% 4% 11% 14% 61% Previous Survey Feb ‘04 7% 4% 4% 18% 63% Existing Patients Would Prefer Inhalable Insulin Over the Injectable Form. A majority of Alliance healthcare respondents (61%) believe “Greater than 50%” of existing diabetes patients would prefer to use an inhalable form of insulin rather than a traditional injectable form. An even higher proportion of Doctors (67%) believe this to be the case. (5B) Question Asked: And what percentage of newly diagnosed Diabetes patients do you think would prefer to use an inhalable form of Insulin rather than a traditional injectable form? Total Healthcare Other Doctors Respondents Workers Respondents 0-10% 2% 2% 0% 3% 11%-20% 1% 0% 4% 0% 21%-30% 5% 4% 4% 8% 31%-50% 5% 2% 4% 8% Greater than 50% 80% 88% 77% 72% Don't Know 6% 4% 8% 8% Other/No Answer 1% 0% 4% 8% Copyright ©2004 ChangeWave Research All rights reserved. 15 ChangeWave Research: Trends in Diabetes 0-10% 11%-20% 21%-30% 31%-50% Greater than 50% Current Survey Aug ‘04 2% 1% 5% 5% 80% Previous Survey Feb ‘04 6% 2% 2% 9% 78% Newly Diagnosed Patients Would Prefer Inhalable Insulin Even More. More than three-quarters (80%) of respondents believe that “Greater than 50%” of newly diagnosed patients would prefer to use an inhalable form of insulin rather than a traditional injectable form. Again, an even higher percentage of doctors (88%) believe this to be the case. (6) Question Asked: Some forms of inhalable insulin may require Diabetic patients to undergo follow-up pulmonary testing. Other forms may require patients to take supplemental (but less frequent) insulin injections. Do you think either of these inhalable forms would result in large numbers of patients avoiding the treatment and staying with the traditional injectable form? Yes, Having to Undergo Followup Pulmonary Testing would cause large numbers of patients to avoid the treatment Yes, Having to Undergo Supplemental Insulin Injections would cause large numbers of patients to avoid the treatment Both Forms would cause large numbers of patients to avoid the treatment Neither Form would cause large numbers of patients to avoid the treatment Don't Know Total Healthcare Other Doctors Respondents Workers Respondents 8% 8% 12% 6% 14% 13% 12% 17% 5% 4% 12% 3% 61% 67% 54% 58% 12% 8% 12% 17% Most Patients Won’t Avoid Inhalable Insulin – Even if More Testing and/or Supplemental Injections are Required. The majority of respondents (61%) believe patients won’t avoid Inhalable Insulin treatments even if it requires follow-up pulmonary testing or supplemental injections. A total of 27% of respondents say patients would avoid Inhalable Insulin if it requires follow-up pulmonary testing or supplemental injections. Copyright ©2004 ChangeWave Research All rights reserved. 16 ChangeWave Research: Trends in Diabetes (C) Exenatide (7) Question Asked: In your opinion, if Exenatide is approved, what percentage of Type II diabetes patients not responding to oral medications will want to use it to prevent progression of their diabetic condition?* Total Healthcare Other Doctors Respondents Workers Respondents 0-10% 13% 0% 0% 33% 11%-25% 22% 42% 0% 0% 25%-50% 22% 8% 50% 33% 50%-75% 39% 50% 50% 22% Greater than 75% 4% 0% 0% 11% Don't Know 0% 0% 0% 0% Other 0% 0% 0% 0% *Note that only 21% of the total respondents were familiar with Exenatide, and the above results present the responses of that group. Among Those Familiar With Exenatide, the Consensus is it Looks Promising. Of the 21% of respondents familiar with Exenatide, 43% believe that more than half of Type II diabetes patients not responding to oral medications will want to use Exenatide to prevent progression of their diabetic condition. (7A) Question Asked: If Exenatide is approved, do you think it will succeed or fail in the marketplace? Why? All respondents who provided an opinion as to whether Exenatide, if approved, will succeed or fail, say they think it will succeed. Some see modest or limited success for the drug therapy. Sample of Alliance Member Responses: a. Definite Success WSU8151 writes, "Preliminary data looks quite good and it should succeed in the market place...I’m also intrigued by its potential to protect beta cells. Also the various forms will have to be compared (albumin based)..." WLU8236 writes, "I expect it to succeed in large part because it has the marketing power of Eli Lilly behind it." WOO7602 writes, "It will succeed because it targets one of the earliest defects in the Type 2 Diabetes natural history (post-prandial hyperglycemia). I predict its HUGE market will be in its eventual use in prevention of Type 2 diabetes in those at risk." SSR9050 writes, "Succeed. It will prevent vast numbers from going on insulin." GOO3505 writes, "It will definitely succeed." Copyright ©2004 ChangeWave Research All rights reserved. 17 ChangeWave Research: Trends in Diabetes WPW6938 writes, "Succeed - many Type II drugs have adverse effects (e.g., GI side effects) and the drop-out rates in the Exenatide trials were fairly low due to nausea, indicating that most patients tolerated the side effects. Many Type II diabetics are also using supplemental doses of insulin anyway. Exenatide studies have shown lower A1C levels as well as a beneficial weight loss during the treatments. Researchers studying the drug think that it may also prevent further loss of pancreatic beta cells, in which case it would likely be recommended to be used as an initial treatment if beta cells are preserved." DB76584 writes, "Succeed. Evidence that Exenatide regenerates beta cells in pancreas. Also, Exenatide causes weight loss, and since obesity is a big problem with diabetics, this will be helpful." DB76584 writes, "Succeed. Evidence that Exenatide regenerates beta cells in pancreas. Also, Exenatide causes weight loss, and since obesity is a big problem with diabetics, this will be helpful." HER4689 writes, "Succeed. Benefit of weight loss will help in marketing." SNU3210 writes, "I think it will succeed because people are reluctant to go on insulin therapy for fear of becoming completely dependent on it as well as the weight gain and difficulty in adjusting dosages based on food intake." b. Modest/Limited Success SER5830 writes, "Modest success because the side effect issue will not go away" MAD2680 writes, "Succeed within limits of their total available market to penetrate. There appears to be ‘side effects’ that may be beneficial to patients regarding weight loss, etc." LON6196 writes, "Succeed for a while until something new comes along in 6-12 months." ALA7205 writes, "Limited success." SBE5857 writes, "Low uptake." STE3218 writes, "Will probably see limited success as it is tried in patients that are failing traditional therapy." ECR4086 writes, "The endocrinologists I have spoken with do not think this will be a blockbuster drug, but will just be another option." FRE9804 writes, "The type II market is so large and growing, there is a place for many of these drugs to make money in this market until a bio-artificial pancreas is developed." Copyright ©2004 ChangeWave Research All rights reserved. 18 ChangeWave Research: Trends in Diabetes (D) Medicare and Obesity (8) Question Asked: In mid-July, Health and Human Services opened the door for Medicare to begin considering obesity an illness, which would allow treatments to be covered solely for treating obesity. Based upon this change, can you think of a product(s) (e.g., dietary, surgical, pharmacological) that would likely qualify as a Medicare treatment for obesity that would also have good market acceptance? Sample of Alliance Member Responses: a. Surgery GAN3623 writes, "I think gastric stapling would qualify for treatment and be accepted in the market place." CLE2459 writes, "Gastric bypass or clip, but only in severe cases (morbid obesity)." KVR1320 writes, "Major push is towards surgery which remains the only documented successful treatment." GOP2712 writes, "Gastric bypass/banding surgery." DAV2704 writes, "Stapled stomach." WSU8151 writes, "Knowing how government works, I think that the process will be long and slow to take effect. First, doctors will be paid for office visits involving obesity counseling, and more surgical procedures will be covered. I don’t think that weight loss programs will initially be covered as their success rates vary." JAM8235 writes, "Surgery for lap-band or gastric-bypass." BCA3438 writes, "Stomach Banding, X-FAT (Vital Living-VTLV)." MIN9289 writes, "Intestinal/stomach "stapling" procedures." JRJ9829 writes, "…lap banding." ELW4764 writes, "We all want quick fixes, thus surgery will be 'in'." ZEB4159 writes, "Bariatric surgery - however, good market acceptance is debatable." ZSA8198 writes, "Gastric Banding and gastric bypass." LON6196 writes, "Liposuction." SR10005 writes, "Gastric by-pass is an obvious effective surgical modality. Other than that I don't know of anything on the horizon which is more effective without the associated side effect problems." Copyright ©2004 ChangeWave Research All rights reserved. 19 ChangeWave Research: Trends in Diabetes DRJ5952 writes, "Stomach staple surgery." POR7751 writes, "Gastric banding (minimally invasive) but not bariatric surgery." JAN4089 writes, "Surgical gastric bypass and surgical gastric bending are increasing strong." SBE5857 writes, "Only clinically proven and generally medically accepted therapies will be covered. Thus, think of banding approaches and liposuction." 8486810 writes, "...The Roux-En-Y Bypass (Surgical) Procedure." JGE3402 writes, "Surgical treatment (endoscopic), the only thing that does work." KUR3102 writes, "Staple stomach." GHM8270 writes, "Gastric banding. Widespread ‘obesity treatment centers’ on the order of dialysis centers may be in the offing." WJH7828 writes, "Gastric by-pass. Drugs when new generation is available. I can't see Medicare going for nutritional supplements/substitute because it's a minefield of unproven claims." SSR9050 writes, "Gastric banding surgery." GOO3505 writes, "Perhaps better coverage for bariatric surgery." ECR4086 writes, "Surgery appears to be increasingly the option of choice for those who are morbidly obese. Mortality rate approaching 2% has not kept people away." PWG2815 writes, "Gastric bypass." AMO7582 writes, "Bariatric surgery (gastric stapling)." GDA7384 writes, "Surgical procedures such as apronectomy/jaw wiring in highly selected patients." SNU3210 writes, "Bariatric surgery." FER6743 writes, "Gastric stapling." JGR0393 writes, "Bariatric surgery." b. Dietary / Weight Loss Programs KCO6695 writes, "The only one that I am familiar with is Medifast." WRT9962 writes, "Weight watchers? Jenni Craig? Gold's Gym?" Copyright ©2004 ChangeWave Research All rights reserved. 20 ChangeWave Research: Trends in Diabetes JRJ9829 writes, "Weight watchers..." GRA1199 writes, "Medifast." CHA0353 writes, "Low carb diets and carb substitutes such as splenda and atkinslike products have the most likelihood of being effective in weight loss." DDY0175 writes, "South Beach Diet..." FLO8176 writes, "Diet and exercise regime supervised by a physician (trained in this specifically)." STE3218 writes, "Weight loss and dietary consultant programs that focus on the entire patient and not necessarily fad diets. Efforts that focus on increasing activity/exercise will also be successful." c. Pharmaceuticals/Appetite Suppressants LEO7024 writes, "Appetite suppressants." CEN9132 writes, "Perhaps, dietary supplements to lose weight." WOO7602 writes, "Meridia." COA5836 writes, "Meridia" 8486810 writes, "Meridia (Appetite Suppressant)...” SER5830 writes, "DiaMedica, is producing a product line for new and very early diagnosis and therapeutics that treats type 2 and obesity but is not yet publicly traded." VDS1474 writes, "Rimonabant" MAD2680 writes, "Amyln's Exenitide product." WPW6938 writes, "Sanofi-Aventis’ phase III drug Acomplia, if approved. It would also be marketed as an aid to help smokers quit smoking without the associated weight gain. " GDA7384 writes, "Older products such as metformin. Newer ones such as glitazones." SCI3493 writes, "Carb and lipid blockers and proper balancing the meals to avoid hunger and craving for foods." Copyright ©2004 ChangeWave Research All rights reserved. 21 ChangeWave Research: Trends in Diabetes III. ChangeWave Research Methodology This report presents the findings of the latest ChangeWave Alliance survey on Diabetes conducted August 10 - August 16, 2004. The survey was for Alliance healthcare industry members knowledgeable about Diabetes. A total of 110 Alliance Members participated, including 48 doctors. The Alliance’s proprietary research and business intelligence gathering system is based upon the systematic gathering of valuable business and investment information directly over the Internet from accredited members. ChangeWave surveys its Alliance members on a range of business and investment research and intelligence topics, collects feedback from them electronically, interprets and reconciles the information in a cohesive manner and converts the information into valuable quantitative and qualitative reports. The Alliance has assembled its membership team from senior technology and business executives in leading companies of select industries. Nearly 3 out of every 5 members (58%) have advanced degrees (e.g., Master’s or Ph.D.) and 94% have at least a fouryear bachelor’s degree. The business and investment intelligence provided by the Alliance provides a real-time view of companies, technologies and business trends in key market sectors, along with an in-depth perspective of the macro economy – well in advance of other available sources. Copyright ©2004 ChangeWave Research All rights reserved. 22 ChangeWave Research: Trends in Diabetes IV. About ChangeWave Research ChangeWave Research, a subsidiary of Phillips Investment Resources, LLC, identifies and quantifies "change" in industries and companies through surveying a network of thousands of business executives and professionals working in more than 20 industries. ChangeWave has a very unique asset in its 4,600-member Alliance. We have assembled our membership team from a broad cross section of more than 20 vertical markets such as telecom, semiconductors, data storage, and biotechnology, along with a wide range of professional disciplines including CIOs, IT managers and programmers, executive management, scientists, engineers and sales personnel. The ChangeWave Alliance is composed of senior technology and business executives in leading companies - credentialed professionals who spend their everyday lives working on the frontline of technological change. This proprietary research and business intelligence gathering system provides a real-time view of companies, technologies and business trends in key market sectors along with an in-depth perspective of the macro economy - well in advance of other available sources. ChangeWave surveys its 4,600 Alliance members on a wide range of investment research topics and converts the findings into valuable investment and business intelligence reports. ChangeWave delivers its products and services on the Web at www.ChangeWave.com. ChangeWave Research does not make any warranties, express or implied, as to results to be obtained from using the information in this report. Investors should obtain individual financial advice based on their own particular circumstances before making any investment decisions based upon information in this report. For More Information: ChangeWave Research 9420 Key West Avenue Rockville, MD 20850 USA Telephone: 301-279-4200 Fax: 301-610-5206 www.ChangeWave.com [email protected] Helping You Profit From A Rapidly Changing World ™ www.ChangeWave.com Copyright ©2004 ChangeWave Research All rights reserved. 23