diosyn (sacubitril/valsartan)

Diosyn

Group 7Sandeepkumar Balabbigari, Vaibhavi Bhavsar, Jessica Garzon, Raj Kalaria, Kimberly Reustle

(sacubitril/valsartan)

“Many of my heart failure patients have been

on the standard therapy of treatment;

but their blood pressure is not fully

controlled, putting them at risk for serious

cardiac complications.”

Positioning Statement

Diosyn

Is the first Angiotensin Receptor Blocker and Neprilysin

Inhibitor combination

That is better than the current standard of care

Because it is more effective in lowering blood pressure

So your patients can reach their blood pressure goals

and improve their health-related quality of life

Overview

Brand Vision

Strategies

Brand Wheel

Brand Hallmarks & Creative Concepts

Brand Vision

Where We Are

New drug class in Phase III clinical trials that will

compete against the gold standard, enalapril, in

treating chronic heart failure.

Where We Are Going

FDA approved gold standard for treating chronic heart

failure to improve health-related quality of life,

decrease cardiovascular deaths, and decrease

hospitalizations.

SWOT Analysis

Strengths● Dual mechanism of action

● Well tolerated at all dosing

● No angioedema reported

● PARADIGM-HF is the largest ever trial of a heart failure

treatment

● Reduced morbidity and mortality in patients with heart

failure with reduced ejection fraction1

Weaknesses● Has not been approved yet

● Contraindicated in pregnancy and bilateral renal artery

stenosis

● Lack of clinical information due to class novelty

● Difficulty of new drugs to successfully enter saturated

market

Opportunities● Contains first in class Angiotensin receptor neprilysin

inhibitor (ARNI)

● Possible future indication for heart failure with

preserved ejection fraction

● Over 20 million people across the US and EU live with

chronic heart failure2

● Diovan is going generic3

Threats● Potential adverse events are possible in sub populations

that have not been studied yet

● Unexpected regulatory actions, delays, or government

intervention

● The company's ability to obtain or maintain proprietary

intellectual property protection

● Global trends toward health care cost containment

Key Issues

Contraindicated in renal failure● Heart failure and renal disease are common comorbidities

● The prevalence of congestive heart failure increases greatly as the patient's renal function

approaches end-stage renal disease (65%-70%).1

Possibility of additional adverse events may occur with further studies● Lack of available clinical information

● Sub populations not studied in clinical trials

● Phase IV post marketing observations

Saturated market● Patients may already be stable on available drugs

● Doctors may be hesitant to switch therapy

Strategies

Strategy 1

Obtain FDA approval● Allow patients to receive the benefits of an ARNi

● Conduct Phase IV studies in larger population

● Become aware of drug interactions and adverse events

Strategy 2

Market to cardiologists● Raising awareness to cardiologists will increase interest in Diosyn

● Benefits will compel cardiologists to prescribe Diosyn for their

patients

● Will ease the transition to becoming the current gold standard

Strategy 3

New indications● Increase market penetration

● Extend life cycle and patent life

● More benefits for patients

Brand Wheel

Axle

“Many of my heart failure patients have been

on the standard therapy of treatment;

but their blood pressure is not fully

controlled, putting them at risk for serious

cardiac complications.”

Hub

Go above and beyond the standard

Spoke 1

1st ARNi to market

Spoke 2

Combination drug: two complementary drugs

for an additional effect

Spoke 3

Patients in PARADIGM trial lived longer

without being hospitalized for heart failure

than those who received standard care

with ACE-inhibitor enalapril.

Spoke 4

A trial funded by Novartis found that LCZ696

had more significant reduction in blood

pressure compared to valsartan alone.

Spoke 5

Valsartan provides lower risk of angioedema

in patients presently taking an ACE-

inhibitor, which is the current standard of

care.

Tread

Fortifying

Remodeling

Surpassing the standard

Brand Hallmarks & Creative Concepts

Name

Diosyn

Type Style

Bauhaus 93 Eras Medium ITC

Color Palette

#f6b300#547da9

Tag Line

Go above and beyond the standard

Logo Lockup

Symbol

Summary

“Many of my heart failure patients have been on the standard therapy of treatment;

but their blood pressure is not fully controlled, putting them at risk for serious cardiac complications.”

VisionNew drug class → replace current gold standard How To Reach The Vision

● Obtain FDA approval

● Market to cardiologists

● Become approved for new indications

Benefits & Features

● 1st in class

● Combination drug

● PARADIGM: longer life without HF

hospitalizations

● Novartis trial: greater reduction in BP

● Lower Risk of angioedema

Positioning

Diosyn

Is the first Angiotensin Receptor Blocker and Neprilysin

Inhibitor combination

That is better than the current standard of care

Because it is more effective in lowering blood pressure

So your patients can reach their blood pressure goals and

increase their health-related quality of life

ReferencesGu, J., A. Noe, P. Chandra, S. Al-Fayoumi, M. Ligueros-Saylan, R. Sarangapani, S. Maahs, G.

Ksander, D. F. Rigel, A. Y. Jeng, T.-H. Lin, W. Zheng, and W. P. Dole. "Pharmacokinetics and Pharmacodynamics of LCZ696, a Novel Dual-Acting Angiotensin

Receptor-Neprilysin Inhibitor (ARNi)." The Journal of Clinical Pharmacology 50.4 (2010): 401-14. Print.

Novartis Pharmaceuticals. This Study Will Evaluate the Efficacy and Safety of LCZ696 \

Compared to Enalapril on Morbidity and Mortality of Patients With Chronic Heart Failure (PARADIGM-HF). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National

Library of Medicine (US). 2000- [cited 2014 Apr 22]. Available from: http://www.clinicaltrials.gov/show/NCT01035255 NLM Identifier: NCT01035255.

Ruilope, Luis Miguel, Andrej Dukat, Michael Böhm, Yves Lacourcière, Jianjian Gong, and

Martin P. Lefkowitz. "Blood-pressure Reduction with LCZ696, a Novel Dual-acting Inhibitor of the Angiotensin II Receptor and Neprilysin: A Randomised, Double-blind,

Placebo-controlled, Active Comparator Study." The Lancet375.9722 (2010): 1255-266. Print.

Silverberg, D., D. Wexler, M. Blum, D. Schwartz, and A. Iaina. "The Association between

Congestive Heart Failure and Chronic Renal Disease."PubMed. N.p., 13 Mar. 2004. Web. 13 May 2014. <http://www.ncbi.nlm.nih.gov/pubmed/15202610>.

Solomon, Scott, and Piotr Ponikowski. PARAMOUNT: Efficacy and Safety of LCZ696, a First-in-Class Angiotensin Receptor Neprilysin Inhibitor, in Patients with Heart Failure

and Preserved Ejection Fraction: Primary Results from the PARAMOUNT Study. Rep. Munich: European Society of Cardiology, 2012. Print.

Sun, Ningling, Fu-Tien Chiang, Kazuomi Kario, Tatsuo Shimosawa, Ouppatham Supasyndh,

Linda Staikos-Byrne, Zhaohui Liu, Martin Lefkowitz, and Jack Zhang. "G-008 Efficacy And Safety Of Three Doses Of Lcz696 In Asian Hypertensive Patients."Journal of

Hypertension 29 (2011): E18. Print.