Regado-RADAR-summary-v6292011
Regado-RADAR-summary-v6292011
Regado-RADAR-summary-v6292011
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Taking Science to Heart<br />
REG1: A ground breaking<br />
anticoagulant system<br />
Opportunity <strong>summary</strong> including top line results<br />
from the phase 2b <strong>RADAR</strong> trial<br />
June 2011
REG1 overview<br />
‣ An acute care specialty IV product designed to<br />
complement a portfolio with a chronic oral therapy<br />
‣ The only anticoagulant system that is truly reversible in<br />
real time with its specific control agent<br />
‣ Straightforward, cost-efficient path to clinical success and<br />
regulatory approval<br />
‣ Blockbuster commercial potential backed by robust<br />
independent market research<br />
‣ Positive data from <strong>RADAR</strong> (phase 2b) trial provide a sound<br />
prediction of phase 3 success<br />
2
REG1 is the optimal anticoagulant<br />
‣ Novel FIXa inhibiting anticoagulant aptamer system<br />
providing real time active control<br />
‣ Unique and advantageous target upstream in the clotting<br />
cascade (Factor IXa – proximal driver of propagation)<br />
‣ Only product shown to reduce ischemia and bleeding in<br />
ACS patients undergoing cardiac catheterization<br />
‣ Strong IP position providing protection through 2025 and<br />
beyond<br />
‣ Unencumbered worldwide rights<br />
3
<strong>RADAR</strong> (phase 2b) produces<br />
unprecedented results<br />
‣ First clinical study to demonstrate benefits in both bleeding and<br />
ischemia in ACS<br />
‣ FIXa inhibition validated as an advantageous target for<br />
anticoagulation<br />
‣ Phase 3 to be a classic, cost-minimized mortality/morbidity<br />
study powered for superiority with traditional ischemic (efficacy)<br />
and bleeding (safety) endpoints<br />
‣ <strong>RADAR</strong> portends a high probability of success<br />
‣ REG1 will provide major medical and pharmacoeconomic<br />
benefits in ACS-PCI<br />
4
REG1 is unique in offering<br />
benefits in bleeding & ischemia<br />
High risk of<br />
ischemic events<br />
“Sweet spot”<br />
High risk of<br />
bleeding events<br />
REG1<br />
Ischemia<br />
Bleeding<br />
Anticoagulation<br />
Adapted from: Ferreiro & Angiolillo. Thromb Haemost 2010 (in press)<br />
5
REG1 is a two component actively<br />
controllable aptamer anticoagulant system<br />
‣ Synthetic, single-strand oligonucleotides with low cost of goods (COGs)<br />
‣ Convenient administration (IV bolus) with no dose adjustment in the<br />
renally or hepatically impaired<br />
‣ Metabolized by blood nucleases with no active metabolites, protein binding<br />
or tissue accumulation<br />
pegnivacogin<br />
Anticoagulant aptamer<br />
‣ Specific affinity<br />
for Factor IXa<br />
‣ 31 nucleotides<br />
+ 40 kDa PEG<br />
‣ t 1/2 > 24hr<br />
‣ t max < 5 min<br />
+<br />
anivamersen<br />
Active control agent<br />
‣ Specific affinity<br />
for pegnivacogin with<br />
no other activity<br />
‣ 15 nucleotides<br />
‣ t 1/2 < 5 min<br />
‣ t max ~ immediate<br />
6
REG1 has a simple and well<br />
characterized mechanism of action<br />
Activated Inactivated Re-activated<br />
pegnivacogin<br />
anivamersen<br />
Factor IX<br />
Coagulating<br />
Coagulation proceeds<br />
unimpeded and<br />
clots form<br />
Anticoagulated<br />
Pegnivacogin selectively<br />
inhibits Factor IXa and<br />
clotting cannot proceed<br />
Coagulating<br />
Anivamersen binds to<br />
pegnivacogin; the<br />
resulting complex is inert<br />
and the clotting cascade<br />
resumes<br />
7
Factor IXa is an advantageous<br />
target uniquely suited to REG1<br />
Clotting Cascade<br />
Tissue Factor<br />
Factor VIIa<br />
Factor VIIIa<br />
Factor IXa<br />
fondaparinux<br />
apixaban<br />
rivaroxaban<br />
lepirudin<br />
desirudin<br />
dabigatran<br />
bivalirudin<br />
Factor Va<br />
Factor Xa Thrombin Fibrin<br />
pegnivacogin<br />
unfractionated heparin<br />
low molecular weight heparin<br />
‣ Total anticoagulation - Complete Factor IXa inhibition results<br />
in Factor X and thrombin “knock-out”<br />
‣ More sensitive target - Factor IXa is 7x and 60x more<br />
thrombogenic than Factor X and thrombin, respectively<br />
‣ Reduced drug exposure - Lower intrinsic FIXa concentrations<br />
allow high inhibition with less drug<br />
‣ Congruous inhibition - Aptamers perfectly suited to blocking<br />
the protein-protein interaction of the Factor VIIIa – Factor<br />
IXa enzyme complex with Factor X<br />
8
REG1 phase 1 demonstrated<br />
well tolerated active control<br />
3 studies, 174 patients, placebo controlled, randomized, double-blinded<br />
RB006=pegnivacogin<br />
RB007=anivamersen<br />
ULN = Upper Limit of Normal<br />
LLN = Lower Limit of Normal<br />
Inject<br />
RB006<br />
Chan MY, et al. J Thromb Haemost 2008; 6:789–96<br />
9
Activated Clotting Time (seconds)<br />
Elective PCI was safely and effectively<br />
performed with REG1 in phase 2a<br />
Safe immediate sheath removal post-reversal was demonstrated<br />
350<br />
300<br />
Arm 1<br />
50% then<br />
100% reversal<br />
N=10<br />
250<br />
200<br />
ACT=200: (Average<br />
value above which most<br />
catheter labs will<br />
initiate PCI in<br />
heparinized patients)<br />
ACT=170: (Average<br />
value below which<br />
most catheter labs will<br />
pull the arterial sheath<br />
in heparinized<br />
patients)<br />
Arm 2<br />
100% reversal<br />
N=10<br />
150<br />
Control<br />
heparin<br />
N=4<br />
Cohen et al., Eur Heart J 2009;30:101 (Abstract Supplement)<br />
Baseline<br />
5 min Post<br />
Study Drug<br />
15 min Post<br />
Study Drug<br />
End of PCI<br />
15 min Post<br />
1 st anivamersen<br />
Dose<br />
15 min post<br />
2 nd anivamersen<br />
Dose<br />
10
<strong>RADAR</strong> (phase 2b) protocol<br />
<strong>summary</strong><br />
‣ Adaptive design dose<br />
ranging study for anivamersen<br />
‣ Heparin or low molecular<br />
weight heparin comparator<br />
‣ ACUITY bleeding and<br />
standard ischemic composite<br />
endpoints<br />
‣ Pharmacoeconomic<br />
indicator endpoints included<br />
‣ ACS patient population<br />
‣ ACS - NSTEMI/UA patients<br />
intended for cardiac<br />
catheterization within 24 hours<br />
‣ Multinational Study<br />
‣ 69 enrolling sites in USA,<br />
Canada, Poland, France,<br />
Germany, Netherlands<br />
11
<strong>RADAR</strong> patient flow and<br />
final enrollment<br />
25% reversal<br />
n = 41<br />
Eliminated by<br />
DSMB as part of<br />
adaptive design<br />
NSTEMI-ACS<br />
n = 640<br />
Planned<br />
catheterization<br />
<strong>RADAR</strong> used traditional and prospective<br />
endpoints predictive of phase 3 success<br />
‣ Composite of major and minor (non-CABG) ACUITY<br />
bleeding through day 30<br />
[anivamersen dose selection]<br />
‣ Proportion of subjects with a composite of death,<br />
nonfatal MI, recurring ischemia or urgent target vessel<br />
revascularization (TVR) through day 30<br />
[estimate of anticoagulant efficacy]<br />
‣ Incidence of major and minor (non-CABG) ACUITY<br />
bleeding and ischemic events through hospital discharge<br />
[phase 3 endpoint]<br />
13
<strong>RADAR</strong> objectives<br />
‣ Verify 1 mg/kg dose of pegnivacogin yields<br />
rapid, precise, reproducible and complete<br />
Factor IX inhibition<br />
‣ Determine the dose range of anivamersen<br />
that allows safe immediate sheath removal<br />
‣ Assess the efficacy of REG1 in comparison<br />
to heparin based on ischemic event rates<br />
14
<strong>RADAR</strong> enrolled a typical ACS<br />
(phase 3 target) population<br />
Median age, yrs<br />
Age ≥ 70<br />
REG1<br />
n = 479<br />
63.5<br />
34.0<br />
Heparin<br />
n = 161<br />
62.2<br />
27.3<br />
Male, % 67.6 70.8<br />
BMI, mean 28.6 28.5<br />
Diabetes Mellitus, % 32.3 26.1<br />
Tobacco use, % 56.8 59.6<br />
Prior MI, % 48.4 46.6<br />
Prior PCI, % 43.1 42.9<br />
Prior CABG, % 14.2 14.3<br />
Enrollment Criteria<br />
Elevated biomarkers, % 52.6 54.7<br />
ST changes, % 24.6 28.6<br />
History of CAD, % 50.9 48.4<br />
15
<strong>RADAR</strong> subject treatment comprised current<br />
standard of background medications and care<br />
REG1<br />
n = 473<br />
Heparin<br />
n = 161<br />
Study Drug, % 98.3 95.0<br />
Anivamersen (of patients treated w/REG1, %) 99.4 -<br />
Aspirin, % 99.6 95.7<br />
Thienopyridine, % 79.9 82.6<br />
Glycoprotein 2b/3a Inhibitor, % 9.7 16.6<br />
Vascular Closure Device, % 12.9 16.8<br />
Median Time to Sheath Removal (min) 24 180<br />
Management Strategy<br />
Catheterization, % 99.4 99.4<br />
Medical Therapy, % 30.9 25.5<br />
PCI, % 58.4 68.9<br />
CABG, % 9.1 6.2<br />
16
1 mg/kg of pegnivacogin completely<br />
inhibits Factor IXa accurately and precisely<br />
<strong>RADAR</strong> PK/PD Sub-study<br />
‣ PK/PD in ACS<br />
patients is<br />
consistent<br />
with that in<br />
stable CAD<br />
patients and<br />
healthy<br />
volunteers<br />
RB006=pegnivacogin<br />
Povsic et al., abstract presented at AHA, 2010<br />
17
REG1 is measurable using standard<br />
tests but measurement is not required<br />
Procedure initiates sooner using REG1 due to faster<br />
onset of action<br />
‣ Standard and readily available ACT and aPTT tests can be<br />
employed to determine REG1 anticoagulation<br />
5.6<br />
‣ Level of anticoagulation (pegnivacogin effect) and level of<br />
reversal (anivamersen effect) can be easily determined<br />
‣ Reliability of REG1 effects (as evidenced by minimal<br />
pegnivacogin redosing in <strong>RADAR</strong> and reproducibility across<br />
all clinical 3.2 studies) precludes the requirement for<br />
measurement<br />
‣ More subjects reached ACT >200 faster with pegnivacogin than<br />
with heparin in <strong>RADAR</strong><br />
18
REG1 control is<br />
predictable and reproducible<br />
Target Reversal Dose<br />
Target reversal accurately achieved across entire study<br />
population over 69 sites in 6 countries<br />
100%<br />
92.6<br />
75%<br />
75.6<br />
50%<br />
52.5<br />
25%<br />
20.0<br />
8 (20.0)<br />
0<br />
66.1<br />
20.0<br />
40.0<br />
60.0 80.0 100.0<br />
Mean Actual Percentage Reversal Achieved<br />
19
Bleeding (%)<br />
REG1 reversal doses ≥ 50% achieve<br />
hemostasis with immediate sheath removal<br />
REG1 demonstrates a dose response in major bleeding with<br />
a 30% reduction at highest reversal dose<br />
70.0<br />
60.0<br />
50.0<br />
40.0<br />
30.0<br />
20.0<br />
10.0<br />
0<br />
N<br />
Events<br />
65.0<br />
20.0<br />
REG1-25%<br />
reversal<br />
40<br />
26 / 8<br />
REG1-25% v. REG1-100%<br />
Total bleeding<br />
OR 0.2 (0.1 – 0.5); p < 0.0001<br />
Through day 30<br />
32.7 34.5<br />
REG1-50%<br />
reversal<br />
10.3 8.4 7.1<br />
113<br />
38 / 12<br />
REG1-75%<br />
reversal<br />
119<br />
41 / 10<br />
REG-100% v. heparin<br />
Total bleeding<br />
OR 0.9 (0.6 – 1.5)<br />
Major bleeding<br />
OR 0.7 (0.3 – 1.5)<br />
29.8 31.1<br />
REG1-100%<br />
reversal<br />
194<br />
59 / 14<br />
Total Bleeding<br />
Major Bleeding<br />
9.9<br />
Heparin<br />
160<br />
50 / 16<br />
25% reversal dose eliminated by DSMB early in the study as anticipated in the adaptive design 20
Bleeding (%)<br />
REG1 exhibits a dose response and a<br />
reduction in total and major bleeding<br />
Based on FDA interaction, this is the likely<br />
phase 3 safety endpoint<br />
70.0<br />
60.0<br />
62.5<br />
Through discharge<br />
Total Bleeding<br />
Major Bleeding<br />
50.0<br />
40.0<br />
30.0<br />
20.0<br />
10.0<br />
0<br />
20.0<br />
REG1-25%<br />
reversal<br />
32.8<br />
REG1-50%<br />
reversal<br />
29.7<br />
10.3 8.5<br />
REG1-75%<br />
reversal<br />
2<br />
23.4<br />
1<br />
OR=0.4 (0.1-1.0); p=0.045<br />
2<br />
OR=0.6 (0.4-1.0); p=0.07<br />
1<br />
5.1<br />
REG1-100%<br />
reversal<br />
2<br />
30.6<br />
1<br />
10.0<br />
Heparin<br />
N<br />
Events<br />
40<br />
25 / 8<br />
116<br />
38 / 12<br />
118<br />
35 / 10<br />
197<br />
46 / 10<br />
160<br />
49 / 16<br />
25% reversal dose eliminated by DSMB early in the study as anticipated in the adaptive design 21
REG1 reduces ischemia<br />
(through day 30)<br />
Death, MI, Recurrent Ischemia,<br />
Urgent TVR (%)<br />
50% fewer ischemic events with REG1<br />
6.0<br />
5.7<br />
OR=0.5 (0.2-1.38)<br />
5.6<br />
4.0<br />
3.0<br />
2.0<br />
3.0<br />
0<br />
REG1<br />
Heparin<br />
22
REG1 reduces periprocedural<br />
myocardial infarctions<br />
Urgent TVR rates show no evidence of stent thrombosis at high reversal doses<br />
5.7<br />
REG1<br />
25%<br />
reversal<br />
n = 40<br />
REG1<br />
50%<br />
reversal<br />
n = 116<br />
REG1<br />
75%<br />
reversal<br />
n = 119<br />
REG1<br />
100%<br />
reversal<br />
n = 198<br />
REG1<br />
Overall<br />
n = 473<br />
Heparin<br />
n = 161<br />
n (%) n (%) n (%) n (%) n (%) n (%)<br />
Composite* 3 (7.5) 1 (0.9) 5 (4.2) 5 (2.6) 14 (3.0) 9 (5.7)<br />
3.0<br />
Death 0 - 0 - 1 (0.8) 0 - 1 (0.2) 1 (0.6)<br />
*No<br />
recurrent<br />
ischemia was<br />
observed in<br />
any REG1<br />
reversal<br />
group<br />
MI 3 (7.5) 1 (0.9) 4 (3.4) 4 (2.1) 12 (2.6) 7 (4.3)<br />
Urg TVR 1 (2.5) 0 - 1 (0.8) 1 (0.5) 3 (0.6) 1 (0.6)<br />
23
Death, MI, Recurrent<br />
Ischemia, Urgent TVR,%<br />
REG1 reduces ischemic events<br />
by 66% (through discharge)<br />
Based on FDA interaction, this is the likely<br />
phase 3 efficacy endpoint<br />
6.0<br />
OR=0.34 (0.21-1.13)<br />
5.7<br />
7.9<br />
4.0<br />
1.9<br />
2.0<br />
1.9<br />
4.2<br />
0<br />
REG1<br />
REG1<br />
Heparin<br />
Heparin<br />
24
<strong>RADAR</strong> Serious Adverse Events<br />
were similar to heparin<br />
Most events were endpoint related with more events in the REG1<br />
25% group<br />
Adverse<br />
Event<br />
REG1<br />
100%<br />
REG1<br />
75%<br />
REG1<br />
50%<br />
REG1<br />
25%<br />
REG1<br />
total<br />
All AEs 57% 62% 58% 82% 61% 56%<br />
All SAES 14% 21% 12% 23% 16% 11%<br />
SAEs by organ system<br />
Cardiac 5% 7% 3% 3% 5% 4%<br />
Vascular/<br />
bleeding<br />
4% 5% 7% 15% 6% 2%<br />
Respiratory 0 3% 1% 3% 1% 2%<br />
Heparin<br />
Immune<br />
system<br />
Noncardiac<br />
chest pain<br />
<strong>RADAR</strong> Adverse Events<br />
were similar to heparin<br />
Most events were endpoint related with more events in the REG1<br />
25% group<br />
Adverse<br />
Event<br />
REG1<br />
100%<br />
REG1<br />
75%<br />
REG1<br />
50%<br />
REG1<br />
25%<br />
REG1<br />
total<br />
All AEs 57% 62% 58% 82% 61% 56%<br />
All SAES 14% 21% 12% 23% 16% 11%<br />
AEs by organ system<br />
Cardiac 12% 15% 17% 21% 15% 15%<br />
Vascular/<br />
bleeding<br />
39% 41% 38% 74% 42% 33%<br />
Respiratory 7% 5% 8% 5% 6% 5%<br />
Heparin<br />
Immune<br />
system<br />
2% 3% 0 0 1% 1%<br />
GI 8% 6% 2% 15% 6% 7%<br />
Skin 4% 3% 0 0 2% 4%<br />
Neurologic 9% 5% 4% 15% 7% 6%<br />
26
The REG1 safety database<br />
supports a well tolerated drug profile<br />
No safety signals in preclinical or phase 1/2a studies<br />
‣ Preclinical safety package deemed acceptable and complete by<br />
FDA at end-of-phase 2a meeting<br />
5.6<br />
‣ <strong>RADAR</strong> AEs and SAEs other than bleeding and ischemic events<br />
were rare and evenly distributed among arms<br />
‣ 3 female patients had allergic-like SAEs shortly after receiving<br />
pegnivacogin clustered near the end of the <strong>RADAR</strong> trial and in<br />
Europe3.2<br />
‣ No other signals for allergic-like reactions seen in overall<br />
<strong>RADAR</strong> AEs<br />
‣ Reactions are linked to a pre-existing patient condition which<br />
is not REG1 specific and is expected to be rare<br />
27
REG1 earlier sheath removal<br />
contributes to increased hospital efficiency<br />
REG1 enables safe sheath removal 4-6 times sooner than heparin<br />
Time from Catheterization<br />
to Sheath Removal (median)<br />
Time from End of Procedure<br />
to Sheath Removal (median)<br />
100% Group<br />
1.0<br />
100% Group<br />
0.4<br />
75% Group<br />
1.0<br />
75% Group<br />
0.4<br />
50% Group<br />
1.0<br />
50% Group<br />
0.4<br />
25% Group<br />
1.1<br />
25% Group<br />
0.6<br />
REG1 Combined<br />
1.0<br />
REG1 Combined<br />
0.5<br />
Heparin<br />
3.8<br />
Heparin<br />
3.0<br />
2.2<br />
0<br />
2<br />
4<br />
0<br />
2<br />
4<br />
Hours<br />
Hours 28
<strong>RADAR</strong> successfully<br />
achieved all objectives<br />
Confirmed 1 mg/kg dose of pegnivacogin<br />
resulted in complete factor IX inhibition<br />
Determined that ≥ 50% reversal doses of<br />
anivamersen allowed immediate safe<br />
sheath removal post procedure<br />
Demonstrated that REG1 reduces ischemic<br />
event rates (vs. heparin) in the ACS<br />
population<br />
29
<strong>RADAR</strong> confirms the<br />
ground breaking profile of REG1<br />
‣ REG1 is the first and only anticoagulant to reduce<br />
bleeding and ischemia simultaneously in ACS patients<br />
undergoing cardiac catheterization<br />
‣ Factor IXa inhibition is validated as an advantageous<br />
anticoagulation target<br />
‣ REG1 pharmacologic and pharmacodynamic behavior is<br />
predictable, reproducible and controllable in real time in<br />
the relevant patient populations<br />
‣ REG1 delivers pharmacoeconomic benefits such as<br />
improved administration convenience, faster onset of<br />
action, virtually instantaneous reversal, immediate<br />
sheath pull and better outcomes<br />
30
<strong>RADAR</strong> results support a standard<br />
phase 3 study design and regulatory path<br />
‣ Phase 3 to be a classic, cost-minimized<br />
mortality/morbidity study powered for superiority with<br />
traditional ischemic (efficacy) and bleeding (safety)<br />
endpoints<br />
‣ <strong>RADAR</strong> data portend a high probability of phase 3<br />
success<br />
‣ Phase 3 designed in close active collaboration with<br />
leading international KOLs<br />
‣ Phase 3 protocol provides multiple opportunities for<br />
clinical success and commercially viable labelling<br />
31
REG1 offers<br />
many marketing advantages<br />
Highly profitable commercial opportunity<br />
‣ Cost-effective and uncomplicated commercialization due<br />
to low COGs, small targeted (acute care) sales force<br />
and a marketing budget focused on medical education<br />
‣ Innovative, highly differentiated profile will drive early<br />
acceptance and rapid adoption<br />
‣ Complementary to an oral, chronic anticoagulant yet<br />
can stand alone in an acute care specialty business<br />
‣ Vast life cycle opportunity due to myriad additional<br />
indications<br />
32
Rigorous third party market research<br />
confirms large REG1 commercial opportunity<br />
Eight market studies with >400 physicians and key stakeholders<br />
employed industry standard methodology<br />
‣ Premium pricing is supported by a thorough pricing and<br />
reimbursement analysis (private and government payers)<br />
‣ Substantial cost savings to healthcare systems expected<br />
based on favorable pharmacoeconomic profile<br />
‣ Results from proposed phase 3 design will drive adoption<br />
as confirmed by >130 interviewed interventional<br />
cardiologists<br />
‣ Considerable commercial upside emerged as REG1 profile<br />
from <strong>RADAR</strong> is superior to profile tested in market<br />
research<br />
33
Market research confirms REG1 multibillion<br />
dollar worldwide PCI opportunity<br />
“All Comers” PCI<br />
excluding STEMI<br />
‣ Non-ST elevation acute<br />
coronary syndrome undergoing<br />
percutaneous coronary intervention<br />
‣ Patients choosing elective PCI<br />
for coronary artery disease<br />
><br />
1.<br />
5B $peak revenues:<br />
(U.S., top five EU markets)<br />
34
<strong>Regado</strong> patent estate provides<br />
exclusivity for reversible aptamers<br />
Composition of matter protection to 2025+<br />
20<br />
Issued or allowed<br />
U.S. and foreign<br />
patents<br />
‣ Composition of matter for<br />
pegnivacogin and anivamersen<br />
‣ Anti-Factor IXa aptamers<br />
‣ Oligonucleotide modulators of<br />
aptamers<br />
‣ REG1 and REG2 product claims<br />
Other U.S. and foreign<br />
applications pending:<br />
‣ Methods of use for Anti-Factor IXa<br />
aptamers and their modulators<br />
‣ REG1 and REG2 product<br />
administration<br />
‣ Aptamers and modulators thereof for<br />
antiplatelet targets (REG3)<br />
‣ Additional molecular classes of<br />
modulators<br />
‣ Anti-FX/Xa, VII/VIIa, thrombin and<br />
ANG2 aptamers and methods<br />
35
REG1 is the optimal anticoagulant<br />
‣ Novel FIXa inhibiting anticoagulant aptamer system<br />
providing real time active control<br />
‣ Unique and advantageous target upstream in the clotting<br />
cascade (Factor IXa – proximal driver of propagation)<br />
‣ Only product shown to reduce ischemia and bleeding in<br />
ACS patients undergoing cardiac catheterization<br />
‣ Strong IP position providing protection through 2025 and<br />
beyond<br />
‣ Unencumbered worldwide rights<br />
36
<strong>Regado</strong> led by an experienced<br />
management team<br />
David J. Mazzo, Ph.D., President and Chief Executive Officer<br />
(CEO of Aeterna Zentaris; CEO of Chugai Pharma USA; Sr. VP, Dev Ops, Schering-Plough)*<br />
Chris Rusconi, Ph.D., Sr. VP and Chief Scientific Officer (Co-Founder)<br />
(Director of Research, Combinatorial Therapeutics, Duke University)*<br />
Steven Zelenkofske, D.O., F.A.C.C., Sr. VP and Chief Medical Officer<br />
(VP Cardiovascular/Thrombosis Medical Unit-US, Sanofi-Aventis)*<br />
Ellen McDonald, M.B.A., Sr. VP and Chief Business Officer<br />
(Sr. VP Cardiovascular Marketing & Medical, Bristol-Myers Squibb; VP Oncology Franchise, J&J)*<br />
Alexander R. Giaquinto, Ph.D., Sr. VP Reg. Affairs/Quality Assurance<br />
(Sr. VP Worldwide Regulatory Affairs, Schering-Plough)* and Chief Compliance Officer<br />
Chris Courts, C.P.A., M.B.A., VP Finance<br />
(Director, Finance, ITC Deltacom)*<br />
*Select Relevant Experience<br />
37
Contact:<br />
Ellen McDonald, Chief Business Officer<br />
emcdonald@regadobio.com<br />
908 580 2113