Download - 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.