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Daniel Ruppar, North American Industry Manager, Pharmaceuticals and Biotechnology Research group at Frost & Sullivan, moderated a panel on drug delivery technologies at a recent BIO International conference.
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Enabling Drug Delivery Technologies
Improving Current Therapies and Helping New Chemical Entities Reach the Market
2
Panel Discussion
Eric Tomlinson, PhD, DSc - President and CEO, Altea Therapeutics
Riccardo Panicucci, PhD Global Head of Chemical & Pharmaceutical Profiling - Novartis
Mary Gardner - Director, Technology Assessment, Hospira, Inc. Randy Johnson, PhD - Vice President and Chief of Technology
Development, KAI Pharmaceuticals Bob Baughman, PhD, PharmD - VP Experimental Pharmacology,
MannKind Corporation
Daniel Ruppar – ModeratorIndustry Manager, North AmericaPharmaceuticals & Biotechnology, Frost & Sullivan
3
Current State of BioPharma
The pharmaceutical and biotechnology industry is in a state of transition.
Reorganization, M&A, consolidation, and portfolio changes are being evaluated in order to maintain growth centers in the face of a myriad of serious challenges.
Overall, companies are looking to align with areas of growth opportunity as well as new business strategy and product development paradigms.
Biologics, biogenerics, and drug delivery technologies are some of the areas companies are seeking to provide solutions for future revenues.
4
Importance of Drug Delivery
The use of drug delivery technology applications can result in a multitude of outcomes for drug products
Enabling of Lifecycle Management scenarios
Enables use of generic compounds and NCEs in new ways
Can result in new efficacy outcomes and improved drug profile
Use with new indication development can spur new revenue opportunities
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Drug Delivery Challenges
Business Model Evolution Capturing Value and Returns Differentiation Understanding True Commercial Opportunity Technology and Reformulation Hurdles Partnerships
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0
100
200
300
400
500
600
700
800
900
2002 2003 2004 2005 2006 2007 2008
Rev
enue
s ($
Mill
ions
)
0.0%
5.0%
10.0%
15.0%
20.0%
25.0%
30.0%
35.0%
Gro
wth
Rat
e
Revenues Growth Rate
LCM Example: Exelon Franchise Revenues (Global), 2002-2008
Exelon Patch Launch
Source: Frost & Sullivan
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Improving Current Therapies
8
Presented Data
Data Collection Methods
The study utilized Frost & Sullivan’s web-based survey capability. A structured questionnaire with the appropriate metrics was set-up in web format (GMI-MR software).Appropriate screening questions and quota controls were provided to ensure that only qualified respondents participate in the survey.
Sample Structure
Doctors 206 Primary Care Physicians 50 Endocrinologists 50 Psychiatrists 27 Rheumatologists 26 Neurologists 28 Physical Medicine/ Rehab 10 Anesthesiologist / Pain Management 15
Patients 450• Diabetes 150• Chronic Pain 150• Inflammation 150
Sample
Doctors (206) and patients (450) in the U.S. participated in this survey. The structure of the sample is shown in the table.
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Factors Impacting Patient Compliance
Efficacy, adverse side effects, ease-of-use, and patient education are perceived by doctors as the most important drivers of patient compliance.
Efficacy, adverse side effects, ease-of-use, and patient education are perceived by doctors as the most important drivers of patient compliance.
2%1% 1% 2% 2% 5% 1% 1% 4% 2%9%14% 12%
18% 15%
26%25% 22%
30%28%
45%
47%59%
52% 56%
46% 50% 54%
46% 55%
31%
38%28% 28% 27% 24% 24% 22% 20%
15% 15%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Efficacy Adverse sideeffects
Ease of Use PatientEducation
Cost Comfort Convenience PersonalResponsibility
DosingFrequency
Length of timeon medication
Not Important At All Slightly Important Moderately Important Very Important Most Important
How would you categorize the importance of the following factors on patient compliance?
MD
10
Factors for Selecting Drug Delivery Type
The top 5 factors considered by a majority (over 50%) of doctors are: minimal side effects, patients’ ease of use, satisfaction, convenience, comfort.The top 5 factors considered by a majority (over 50%) of doctors are: minimal side effects, patients’ ease of use, satisfaction, convenience, comfort.
Q5. In order of importance, please select the top 5 factors that you consider when selecting a drug delivery type? (1= most important, 2=2nd most important, 3=3rd most important, etc.)
MD
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Importance of Overall Device in Final Selection to Prescribe
The device itself is an important consideration when selecting device-driven drugs.
Only 12 percent of doctors consider it as only slightly important or not important at all.
The device itself is an important consideration when selecting device-driven drugs.
Only 12 percent of doctors consider it as only slightly important or not important at all.
For Device Driven Drug Delivery (Examples: Inhaler, Autoinjector) – How important is the overall device in your final selection to prescribe that drug product?
Not Important At All3%
Moderately Important
44%
Very Important40%
Slightly Important
9%
Most Important
4%
MD
12
20%
20%
40%
60%
0% 10% 20% 30% 40% 50% 60% 70%
Reduce frequency ofdosing
Decrease or eliminatedosing
pain/discomfort
Decrease or eliminateside effects
Delivery device
Q10c) Have you used Exubera? Q10d How satisfied are you with your overall experience using Exubera? Q10e What would you like to change about your usage experience with Exubera?
20% are satisfied with the product. Improvements in the delivery device and a decrease in side effects are most desired.
PatientExubera:Satisfaction, Desired Improvements (U.S.), Q4 2007
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Byetta: Usage, Satisfaction, Desired Improvements (U.S.), Q4 2007
Q11c Have you used Byetta? Q11d How satisfied are you with your overall experience using Byetta? Q11e What would you like to change about your usage experience with Byetta?
21% have used Byetta, including 13% who are currently using it. 53% of patients are satisfied. Lowering or elimination of side effects and reduction in frequency of dosing are the most desired improvements.
Change in Byetta Desired
24%
24%
18%
18%
29%
35%
0% 10% 20% 30% 40%
Other
None (no change needed)
Delivery device
Decrease or eliminate dosingpain/discomfort
Reduce frequency of dosing
Decrease or eliminate sideeffects
Satisfaction with Byetta
Very Dissatisfied
29%
Satisfied35%
Neutral12%
Very Satisfied
18%
Dissatisfied6%
Patient
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New Opportunities
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Attitude Towards New Delivery Forms
A majority of respondent doctors are willing to prescribe new drug delivery forms. Forty-one percent adopt new delivery forms earlier than their peers. Thirty-four percent disagree that they are very cautious about prescribing new delivery forms, while an equal proportion would agree to the same statement.
A majority of respondent doctors are willing to prescribe new drug delivery forms. Forty-one percent adopt new delivery forms earlier than their peers. Thirty-four percent disagree that they are very cautious about prescribing new delivery forms, while an equal proportion would agree to the same statement.
2% 2% 5%4%
16%
29%28%
41%
32%
61%
33%
30%
6% 9%4%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
I am generally willing to prescribe productsthat require patients to try a new drug
delivery form.
I usually adopt new drug delivery formsearlier than most of my peers.
I am generally very cautious and would rathernot prescribe drug delivery forms that are just
new in the market.
Strongly Disagree Disagree Neutral Agree Strongly Agree
Q9. To what extent would you agree or disagree with the following statements, as they apply to your own beliefs and practices?
MD
16
Pulmonary Delivery – Willingness to UseDiabetes Type I
Indicate your degree of willingness to use it in the future assuming it is available, affordable, and can be prescribed by your doctor?
35%
28%
7%
24%
7%
0.0% 5.0% 10.0% 15.0% 20.0% 25.0% 30.0% 35.0% 40.0%
Pulmonary/Inhaled
Very Willing to Use ItWilling To Use ItUnwilling but will comply if prescribed by doctorWill Definitely Not Use ItIndifferent/Don't Know
31%: Willing To Use
35%Education Gap
Patient
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From 12 different possible reason statements presented, there were 4 top categories for willing to use pulmonary delivery, the leading beingNo (or Minimal) Discomfort/Pain.
From 12 different possible reason statements presented, there were 4 top categories for willing to use pulmonary delivery, the leading beingNo (or Minimal) Discomfort/Pain.
No (or Minimal) Discomfort / Pain,
44%
Easy to self administer, 33%
Very Convenient, 11%
Rapid Onset of Drug Action, 11%
Q2h What is your Top reason for your willingness to use these types of drug delivery in the future for Diabetes Type I?
Reasons for Willingness to Use Pulmonary DeliveryDiabetes Type I
.
Patient
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Q2f. For each of the following types of drug delivery, please indicate your degree of willingness to use it in the future for <Disease Type>, assuming all these are available, affordable, and can be prescribed by your doctor
Drug Delivery Method – Willingness to UseDiabetes Type II
About 41% of Diabetes Type 2 patients are willing to use a transdermal patch in the futureAbout 41% of Diabetes Type 2 patients are willing to use a transdermal patch in the future
30% 29%
19% 26%
11%
14%
30%24%
11% 7%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Transdermal Patch Pulmonary /Inhaled
Indifferent/Don't Know Will Definitely Not Use ItUnwilling but will comply if prescribed by doctor Willing To Use ItVery Willing to Use It
Education Gap
Willing To Use
Patient
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Intranasal9%
Pulmonary10%
Transdermal Patch47%
Currently Unavailable but Desirable Method – Diabetes
Transdermal Patch is the most preferred method followed by Pulmonary and Intranasal when all profiled types are considered for new delivery forms by MDs.
Transdermal Patch is the most preferred method followed by Pulmonary and Intranasal when all profiled types are considered for new delivery forms by MDs.
Q2d. Which drug delivery method (if any) that is currently unavailable, do you think should be made available for the for the treatment of <Disease Type>?
MD
20
Reasons for Drug Delivery Method to be Made Available - Diabetes
Patient convenience, ease-of-use, and satisfaction are the most appealing attributes of transdermal patches. Pulmonary and intranasal methods are both associated with rapid onset of action, though intranasal is more identified with ease of use.
Patient convenience, ease-of-use, and satisfaction are the most appealing attributes of transdermal patches. Pulmonary and intranasal methods are both associated with rapid onset of action, though intranasal is more identified with ease of use.
What are the top 3 attributes of <method chosen> that make it appealing for the treatment of Diabetes?
52%55%
9%8% 8%
25%
58% 58%
42%
27%
46%
8%
25%
9%8%
25%27%
46%
25%
8%
6%
64%
8%
25%
10%
25%
19%
10%
27%
8%4%
2%
0%
10%
20%
30%
40%
50%
60%
70%
Transdermal Patch Pulmonary/Inhaled Intranasal
Easy for patient to use Patient satisfactionLow cost Minimal adverse side effectsEasy for doctor to administer Requested by patients Patient convenience Rapid onset of actionPatient comfort BioavailabilityLow frequency of dosing Well designed deviceHigher drug absorption Dose accuracyEase of cost reimbursement Formulary tiering of product with the delivery formSpeedy recovery Close proximity of drug to target areaOthers
MD
21
Q2f. For each of the following types of drug delivery, please indicate your degree of willingness to use it in the future for <Disease Type>, assuming all these are available, affordable, and can be prescribed by your doctor
Drug Delivery Method – Willingness to Use – Chronic Pain
More than 60 percent of patients are willing/very willing to use a Transdermal patch or a Topical gel/cream for Chronic pain in the future.
More than 60 percent of patients are willing/very willing to use a Transdermal patch or a Topical gel/cream for Chronic pain in the future.
16%24%
17% 18%
36%
24%
38%
4%
18%
32%
14% 10%
23%38%
32%
2%
36%
31%
8%9%
16%20%
14%
3%
22%
11%
37% 37%
18%13% 12%
25%
8%2%
25% 26%
7% 5% 4%
66%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Injection IntravenousInfusion
TransdermalPatch
TopicalGel/Cream
Pulmonary/Inhaled
Implant Intranasal Oral
Indifferent/Don't Know Will Definitely Not Use It
Unwilling but will comply if prescribed by doctor Willing To Use It
Very Willing to Use It
Patient
22
Q2h What is your Top reason for your willingness to use these types of drug delivery in the future for <Disease Type>.
Easy to self administer is the top reason for willingness to use for most drug delivery methods. Patients are most willing to use use injection or an intravenous infusion due to its rapid onset of drug action.
Easy to self administer is the top reason for willingness to use for most drug delivery methods. Patients are most willing to use use injection or an intravenous infusion due to its rapid onset of drug action.
23%
5%
58%64%
56%
7%
60%
73%
53%
56%
4%4% 19%
16%
19%3%1%
2%7%
2%
1%
22%
0%1%
2%
5%
7% 9%3%
2%
0%1% 7% 7% 6%
2%
10%4%
2%
11% 10% 11%
20%
14%3%
1%
15%
2%1%
5%
1% 1% 1%
7%2%
4%10%
20%
1% 1% 4%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Injection IntravenousInfusion
TransdermalPatch
Topical Gel/Cream Pulmonary/Inhaled
Implant Intranasal Oral
Easy to self administer Rapid Onset of Drug Action Low frequency of dosingMinimal Side effects No (or Minimal) Discomfort / Pain Low Cost / Insurance Co-PayLikelihood of Reimbursement Very Convenient Well designed deviceMy doctor prefers it Administered by another person Other
Reasons for Willingness to Use Drug Delivery Methods - Chronic PainPatient
23
Panel Discussion
24
Panel Discussion Points
• Key Benefits to Developers
• Current Value Within Big Pharma
• Challenges with Reformulation and NCE Usage of DD Tech
• New Opportunities for Developers
• Importance of 360 Degree Draw Factors
• Partnership Benefits
• AFRESA Benefits and Challenges with Peer Failures
• Transdermal Applications in Diabetes
• Economic Environment, New Administration, Health Economics
• Importance of Continued Tech Investment
• Business Model Evolution and Sustainability
25
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Jake WengroffGlobal Director, Corporate Communications(210) 247- [email protected].
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