Theory & Application – A Case Study Bill Rote

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Peptide Therapeutics:
Theory & Application – A Case Study
Bill Rote
VP, Clinical Development
Ardea Biosciences
A wholly owned subsidiary of AstraZeneca
November 11, 2014
Disclosure/Disclaimer
The slides in this deck have been prepared for medical and
scientific purposes. They may contain information on a use
that is not approved by the FDA and therefore may only be
utilized in response to an unsolicited question from a
healthcare provider. This information should not be
construed as an inducement to use exenatide for
unapproved indications. Neither Ardea Biosciences nor
AstraZeneca recommend the use of exenatide in any
manner inconsistent with that described in the full
Prescribing Information.
©2012 Bristol-Myers Squibb Company. All text and design are copyrighted works of Bristol-Myers Squibb unless noted otherwise. Any
referenced figures, tables and graphs are copyrighted works of their respective owners. All Rights Reserved. Any redistribution or
reproduction of any materials herein is strictly prohibited.
2
• Founded in 1987
• 2005 – SYMLIN and BYETTA, two firstin-class medicines approved by the FDA
• 2012 – BYDUREON approved by FDA
• 2012 – Purchased by Bristol-Myers
Squibb
Amylin Pharmaceuticals Timeline
– A Synopsis of Key Events (1)
3
• 2013 – Bristol-Myers Squibb sold their half of the diabetes collaboration,
including Amylin Pharmaceuticals, to their partner AstraZeneca.
• 2014 – MYALEPT (metreleptin) approved by the FDA for the treatment
of lipodystrophy, sold to Aegerion Pharmaceuticals.
• 2014 – BYDUREON dual chambered pen
approved by FDA
Amylin Pharmaceuticals Timeline
– A Synopsis of Key Events (2)
4
3
5
Peptide Therapeutics
Peptide Therapeutics – one more tool
6
http://www.gene.com/about-us/views-on-public-policy/biosimilars
Small Molecule
24 atoms
Peptide
~3000 atoms
Monoclonal Antibody
~25,000 atoms
4
The genetic codes of all organisms encode the
same 20 amino acid building blocks
Amino Acids are the
building blocks of
peptides and proteins
(Amino)
(Acid)
But what if we expand that universe to include
unnatural amino acids?
Borrowed from Dr. Peter Schultz:
http://schultz.scripps.edu/research.php
5
9
Target Based Approach Activity Based Approach
Small Molecule Library Bioactive Peptide Library
A Different Approach to Drug Discovery
10
• Sights of high charge or polarity
• Blue = nitrogen
• Red = oxygen
• High polarity causes water
association and very low lipid
solubility
• Unstable in acid (or base)
• Unstable to enzymes
• Short half life
• Unlikely to be orally bioavailable
Properties of peptides and proteins make them
challenging molecules for drug development
6
11
Defining Pharmaceutical Properties
Can the potency or efficacy be improved?
Are there any pharmaceutical properties to improve?
> Solubility, stability, aggregation potential
> Metabolic stability
> Clearance, half-life
> Immunogenicity
What is the desired pharmacokinetic profile?
> Sustained
> Pulsatile
What is the desired route of delivery?
Given the challenges, why entertain peptide based
drug discovery?
• Peptide and protein hormones make ideal drugs as they integrate
physiological systems
7
Increasing number of peptides entering clinical
development
13
Number of peptides entering the clinic
Given the challenges, why entertain peptide based
drug discovery?
• Peptide and protein hormones make ideal drugs as they integrate
physiological systems
• Most diseases potentially treatable with peptide therapeutics
8
Peptide Candidates sorted by Disease Area
15 Drug Discovery Today, Vol 00, Number 00, July 2013
Peptide Candidates sorted by Disease Area
16 Drug Discovery Today, Vol 00, Number 00, July 2013
9
Given the challenges, why entertain peptide based
drug discovery?
• Peptide and protein hormones make ideal drugs as they integrate
physiological systems
• Most diseases potentially treatable with peptide therapeutics
• Peptide hormone therapeutics generally potent and largely devoid of
idiosyncratic toxicities
• Adverse events are most often dose-dependent and manageable
Target Site of Action is Most Often Extracellular
18
10
Extracellular Target Breakdown – Primarily GPCRs
19
Much Greater Percentage of Agonists Among the
Peptide Therapeutics Relative to Other Classes
20
GPCR-A GPCR-B
Agonists
Antagonists
11
Given the challenges, why entertain peptide based
drug discovery?
• Peptide and protein hormones make ideal drugs as they integrate
physiological systems
• Most diseases potentially treatable with peptide therapeutics
• Peptide hormone therapeutics generally potent and largely devoid of
idiosyncratic toxicities
• Adverse events are most often dose-dependent and manageable
• After proof-of-concept is established, risk of failure in phase 3 is lower
than with small molecules
Approval Probabilities by Stage
22
9
15
44
80
Red dotted lines indicate probability of success for non-peptide drug candidates
http://biostrategics.wordpress.com/2011/06/27/clinical-trial-probability-of-success-just-how-probable-is-a-great-outcome/
12
Given the challenges, why entertain peptide based
drug discovery?
• Peptide and protein hormones make ideal drugs as they integrate
physiological systems
• Most diseases potentially treatable with peptide therapeutics
• Peptide hormone therapeutics generally potent and largely devoid of
idiosyncratic toxicities
• Adverse events are most often dose-dependent and manageable
• After proof-of-concept is established, risk of failure in phase 3 is lower
than with small molecules
• If highly effective and safe, and patients know the drug is working,
injectables can compete in “oral agent space”
Given the challenges, why entertain peptide based
drug discovery?
• Peptide and protein hormones make ideal drugs as they integrate
physiological systems
• Most diseases potentially treatable with peptide therapeutics
• Peptide hormone therapeutics generally potent and largely devoid of
idiosyncratic toxicities
• Adverse events are most often dose-dependent and manageable
• After proof-of-concept is established, risk of failure in phase 3 is lower
than with small molecules
• If highly effective and safe, and patients know the drug is working,
injectables can compete in “oral agent space”
13
Manufacturing Paradox
25
• Recombinant manufacture of peptides can reduce the final cost of the active
pharmaceutical ingredient (API) by up to 80% or more versus synthetic methods
Manufacturing Paradox
26
• Recombinant manufacture of peptides can reduce the final cost of the active
pharmaceutical ingredient (API) by up to 80% or more versus synthetic methods
14
Manufacturing Paradox
27
• Recombinant manufacture of peptides can reduce the final cost of the active
pharmaceutical ingredient (API) by up to 80% or more versus synthetic methods
• However, the lead time to develop recombinant processes, and up front
investment required come before proof-of-concept
Target
Validation Lead
Optimization
Translational
Medicine Phase 1 Phase 2 Phase 3
Recombinant Process
Development
Significant Investment Proof-of-Activity Proof-of-Concept
28
GI system designed to break down
nutrients for absorption (acidic pH,
enzymes)
Nutrient absorption occurs mostly
in the small intestine (orange)
Absorption requires transport
across a lipid bilayer membrane
Gastro-intestinal tract is a challenging
environment for peptides and proteins
Stomach
Distal
ileum
Ascending
colon
Proximal
jejunum
pH
2-4
6-7
7
6-7
Several factors work against oral:
Instability to acidic pH and enzymatic systems
Low absorption due to poor membrane permeation
15
Drug Delivery Product Options
Non-Invasive Systems Once Daily Systems
Once Weekly or Less Implantable Systems
30
Exenatide Case Study
16
31
32
17
Exendin-4 – a Hormone in Gila Monsters?
Young AA. Chapter 14 Glucagon-like peptide-1, exendin and insulin sensitivity. In Hansen B, Shafrir E, Editors. Insulin Resistance
and Insulin Resistance Syndrome. 1st ed. Harwood Academic Press; (2002) p235-262.
Plasma
exendin-4
concentration
(ng/mL)
0 3 6 9 12
0
100
200
300
400 4 mice
1 rat
Hours
> Exenatide is a synthetic version of exendin-4
> Shares >50% of its amino acid identity with human GLP-1 (green)
> Exenatide and GLP-1 have equivalent binding affinities for the GLP-1
receptor
> Exenatide is not inactivated by DPP-4
DPP-4, dipeptidyl peptidase-4; Nielsen LL, et al. Regul Pept. 2004;117:77-88; Raufman JP. Regul Pept. 1996;61:1-18; Fehmann HC, et al. Peptides. 1994;15:453-
456; Thorens B, et al. Diabetes. 1993;42:1678-1682; Baggio LL, et al. Gastroenterology. 2007;132:2131-2157; Parkes D, et al. Drug Dev Res. 2001;53:260-267; Göke
R, et al. J Biol Chem. 1993;268:19650-19655; Data on file, Amylin Pharmaceuticals, LLC; Blase E, et al. J Clin Pharmacol. 2005;45:570-577; Deacon CF, et al.
Diabetes. 1995;44:1126-1131
Exenatide
39
1
Asn
His Gly Glu Gly Thr Phe Thr Ser Asp
Leu
Ser
Arg Val Ala Glu Glu Glu Met Gln Lys
Phe
Leu
Ile Glu Trp Leu Lys Gly Gly Pro
Ser
Ser
Ser Pro Pro Pro Ala Gly
Exendin-4 Isolated from the Gila monster
(Heloderma suspectum)
18
First Evidence – Exendin-4 Lowers Glucose in
Diabetic Mice
Eng J. Diabetes (Suppl 1) – ADA Annual Scientific Sessions. 1996.
John Eng, MD
Bronx VA
Salivary protein – Exocrine gland product with endocrine function
Structure similar to GLP-1 – binds GLP-1 receptor, t ½ = 7-8 hours
1
GLP-1 Activity Addresses the Core Defects
of Type 2 Diabetes
Fasting state
> Stimulates glucose-dependent insulin
secretion1
> Suppresses glucagon secretion, which
decreases hepatic glucose production2
Fed state
> Stimulates glucose-dependent insulin
secretion1
> Suppresses postprandial glucagon
secretion, which decreases hepatic
glucose production2
> Improves first-phase insulin response3
> Slows gastric emptying1
> Reduces food intake4
1. Drucker DJ. Diabetes. 1998;47(2):159-169.
2. Larsson H, et al. Acta Physiol Scand. 1997;160(4):413-422.
3. Quddusi S, et al. Diabetes Care. 2003;26:719-798.
4. Flint A, et al. J Clin Invest. 1998;101(3):515-520.
5
4
3
1
2
1
2
2
5
4
3
36
19
Exenatide Franchise: Built Around Lifecycle
Planning with Continuous Improvement
37
EQW AI Exenatide Once Weekly
Autoinjector
EQM Exenatide Once Monthly
Form
Frequency
SR Tech.
Diluent
Recon.
—
BID Weekly Weekly Weekly &
Monthly
Aqueous Aqueous Aqueous Non-Aqueous
(MCT)
No Yes Yes No
Exenatide Franchise: Built Around Lifecycle
Planning with Continuous Improvement
38
EQW AI Exenatide Once Weekly
Autoinjector
EQM Exenatide Once Monthly
Form
Frequency
SR Tech.
Diluent
Recon.
—
BID Weekly Weekly Weekly &
Monthly
Aqueous Aqueous Aqueous Non-Aqueous
(MCT)
No Yes Yes No
20
100
150
200
250 Exenatide 10 mcg BID
Placebo
6P 8P 12A 4A 8A 12P 4P
Serum glucose (mg/dL)
BYETTA: Pharmacodynamic Effects
Completer population, N = 30; patients with T2D receiving MET ± TZD; least squares (LS) mean values
Schwartz SL, et al. Clin Ther. 2008;30:858-867.
Dinner Breakfast Lunch
Significant effects on PPG
Modest effect on FPG
39
Newest Indication: BYETTA in Combination With
Insulin Glargine – Robust Glycemic Control
> Superior A1C lowering primarily the result of prandial effects of BYETTA
> No increased risk of hypoglycemia with BYETTA plus titrated insulin (24.8%) compared to titrated
insulin alone (28.7%); no exenatide subject experienced major hypoglycemia.
*P <0.001 or †P <0.010 for between group comparisons.
Buse et al. Annals of Internal Medicine. 2011;154(2):103-112.
-2.0
-1.5
-1.0
-0.5
0.0
100
125
150
175
200
-2.0
-1.5
-1.0
-0.5
0.5
1.0
1.5
Final A1C 6.7% 7.4%
∆ A1C (%) Blood Glucose (mg/dL)
Breakfast Lunch Dinner
* * * * * † -1.7%
-1.0%
-1.8%
+1.0%
Weight (kg)
* * Placebo + insulin glargine
BYETTA 10 mcg + insulin glargine
40
21
Exenatide Franchise: Built Around Lifecycle
Planning with Continuous Improvement
41
EQW AI Exenatide Once Weekly
Autoinjector
EQM Exenatide Once Monthly
Form
Frequency
SR Tech.
Diluent
Recon.
—
BID Weekly Weekly Weekly &
Monthly
Aqueous Aqueous Aqueous Non-Aqueous
(MCT)
No Yes Yes No
The Microsphere Delivery System Provides
Continuous Therapeutic Levels of Exenatide
Each dose of BYDUREON is made up of PLGA microspheres that encapsulate the
active ingredient. Over a 60-70 day window, the microspheres slowly dissolve,
continuously releasing the medicine into the body.
42
22
Sustained Therapeutic Concentrations of Exenatide
with BYDUREON vs. BYETTA
‡
Time (h)
4A 8A noon 4P 8P 12A 4A
*Arithmetic mean ± SD; †Geometric mean ± SD; ‡Minimum effective concentration.
Exenatide BID 10 mcg*
Exenatide QW 2 mg†
Plasma Exenatide
Concentration (pg/mL)
400
300
200
100
0
43
Summary of DURATION Study Results
BYDUREON Delivers Superior A1C Reduction Across all
DURATION Studies
* BYDUREON results from phase 2 exenatide monthly suspension study completed in Q2 2011.
All Data from ITT Analyses
-2.0
-1.5
-1.0
-0.5
0.0
∆ A1C (%)
-1.9% -1.5% -1.5% -1.5% -1.6%
6.7% 7.2% 6.9% 6.9% 7.2% Ending
A1C 7.1%
-1.3% -1.5%
*
7.1%
DURATION-1
DURATION-2
DURATION-3
DURATION-4
DURATION-5
DURATION-6
BYDUREON arm in Phase 2
monthly suspension study
Reduced glucose monitoring
Once weekly dosing
Potential weight loss
Straightforward delivery system
No dose adjustments
Leverages BYETTA experience
Key Drivers of Prescribing BYDUREON
Low risk of severe hypoglycemia
Improved GI tolerability vs. BYETTA
Durable and consistent A1C reductions
Utilizing Microsphere Technology to Give Patients the Power of Continuous Glucose Control
with Just One Weekly Dose
44
23
Sustained Improvements in Broader
Cardiometabolic Measures in BYDUREON Patients
Treated for 4 Years
45
MacConell, et al., ADA Scientific Sessions 2012; June 9th 11:30am – 12:30pm, Poster Session #1156-P.
A1C and Weight Results Cardiometabolic Measures
Improved CV-risk markers are consistent with reduced rate of MACE events in clinical trial
meta-analyses and reduced hazard ratio of CV events in claims-database analyses
-6 -4 -2 0 2 4
-40
-20
0
20 23%
61% 10%
6%
 A1C (%)
 Body Weight (kg)
-15
-10
-5
0
DBP
Baseline
(mmHg):
SBP
abnormal (130mmHg)
All completer
-2.7
-8.7
-5.3
-1.6
129 78 140 82
 Blood Pressure (mmHg)
-15
-10
-5
0
-15
-10
-5
0
Total
Chol. LDL HDL
Baseline
(mg/dL):
Triglycerides
173 93
46
154
+2
– 11
– 8
– 13%
 Lipids (mg/dL)
 Triglycerides (%)
EXSCEL Cardiovascular Outcomes
Study
Exenatide Study of Cardiovascular Event Lowering
> Pragmatic design to parallel usual clinical practice and monitor patient safety
> Randomized, double-blind, placebo-controlled
~9500 patients with:
Type 2 diabetes (A1C 7%-10%)
Broad spectrum of CV risk
Both arms: Usual care for glycemic control
~60 month follow-up
PLACEBO
EXENATIDE ONCE WEEKLY
46
24
Exenatide Franchise: Built Around Lifecycle
Planning with Continuous Improvement
47
EQW AI Exenatide Once Weekly
Autoinjector
EQM Exenatide Once Monthly
Form
Frequency
SR Tech.
Diluent
Recon.
—
BID Weekly Weekly Weekly &
Monthly
Aqueous Aqueous Aqueous Non-Aqueous
(MCT)
No Yes Yes No
BYDUREON Dual Chamber Pen
Transition from the single dose tray to a more convenient and easier to use device.
Single Dose Tray BYDUREON Pen
25
Background
Manually operated,
single-use device
Dual-chamber cartridge
with bypass
Delivers same product,
concentration & dose
as BYDUREON vial &
syringe
Regulated as drugdevice combination
product
49 COMPANY CONFIDENTIAL INFORMATION
Exenatide Franchise: Built Around Lifecycle
Planning with Continuous Improvement
50
EQW AI Exenatide Once Weekly
Autoinjector
EQM Exenatide Once Monthly
Form
Frequency
SR Tech.
Diluent
Recon.
—
BID Weekly Weekly Weekly &
Monthly
Aqueous Aqueous Aqueous Non-Aqueous
(MCT)
No Yes Yes No
26
Background – Suspension Technology
A new formulation, exenatide suspension, utilizes the extended-release microsphere
technology of BYDUREON with a triglyceride diluent (miglyol, or MCT)
> Same drug substance and drug load in the same extended-release microspheres
> The MCT diluent is rated GRAS and approved for use in a variety of marketed
applications
Suspension formulation provides greater ease of use for patients
> Fewer steps for patient instruction; does not require suspension of the
microspheres by the patient before use
> Intended commercial device is a prefilled auto-injector
> Enables delivery of higher doses (to support less frequent dosing)
– Improved tolerability due to reduced initial release of exenatide
51
Exenatide Suspension: POC Data Paves the Way for
Phase 3 Studies and the First Monthly Diabetes Therapy
MacConell et al., ADA Scientific Sessions 2011; Late-breaking abstract
Suspension Program Change in A1C (%) at 20 weeks
Profile
˃ Weekly and monthly dosing with no need for
re-suspension
˃ Anticipated similar profiles to BYDUREON in
terms of efficacy, safety and tolerability
Phase 3 Program
˃ Weekly Phase 3 program underway
˃ Monthly development also in progress
-1.5 -1.3 -1.3 -1.5
-2.0
-1.5
-1.0
-0.5
0.0
BYDUREON
2 mg 5 mg 11 mg 8 mg
Weekly Monthly
% A1c <7% 48% 50% 57% 70%
52
27
State of the Biotech Industry
A Brief Snapshot
53
State of the Biotech Industry Today?
Healthy and Dynamic
Money is flowing into the sector
> Biotech companies in the US and Europe raised $54.3B in 2014, a 72%
increase over a healthy 2013
> Venture funding represented $7.6B, a 28% increase over the prior year
and just shy of the all time record ($7.9B in 2007)
> A record number of companies went public in 2014 (94) shattering the
previous record of 79 in 2000.
> Pharma acquisitions reached a 10 year high with 68 M&A deals.
> Pharma alliances – strongest in the last 8 yrs with $5.1B in up front cash
Those funds are being deployed in R&D
> R&D spending, a key indicator of the health of the sector, increased
20% from the prior year
54
Increased R&D spending = more opportunity for Drexel grads
28
State of the Biotech Industry Today?
Hiring and salary growth remains strong
55
US Life Science Cluster Rankings
56
29
57
AstraZeneca Gets FDA Advisory Panel
Nod for Gout Drug Lesinurad
AstraZeneca Plc said a U.S.
Food and Drug Administration
advisory panel recommended
approval of Lesinurad, a gout
drug gained with the acquisition
of Ardea Biosciences Inc. three
years ago.
The FDA’s Arthritis Advisory
Committee voted 10 to 4 to
clear the treatment in
combination with traditional
options such as allopurinol.
Contact Info
William E. Rote, Ph.D.
Vice President, Clinical Development
Ardea Biosciences, A Wholly Owned Subsidiary of AstraZeneca PLC
9390 Towne Centre Drive
San Diego, CA 92121
858-652-6527
[email protected]
Bill Rote on LinkedIn
58

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