cardiovascular therapeutic area: trends, developments & clinical data management opportunities

Cardiovascular Therapeutic Area :Trends, Developments &Clinical Data Management Opportunities

Vinayak Thorat

Background

Cardiovascular Diseases are the number one cause of death globally representing 30% of all global deaths.

Nearly 17.3 million people died from CVDs in 2008, will increase

to reach 23.3 million by 2030.

Out of CVD deaths; (45%) deaths are due to heart disease and stroke represents (51%).

Low- and middle-income countries are disproportionally affected: over 80% of CVD deaths take place in low- and middle-income countries and occur almost equally in men and women.

Recent Patent Expirations for Cardiovascular Drugs:

Brand name in United States (US)

Patent expiration in US (month, year)

US sales ($US billion) in year patent expires

Cozaar/Hyzaar February 2010 0.8

Lipitor November 2011 4.5

Avapro March 2012 0.65

Plavix May 2012 6.2

Atacand June 2012 0.3

Diovan September 2012 2

Telmisartan Dec 2013 2.5.5.2

Sildenafil Jun 2013 2.5.

Tirofiban HCl May 2013 2.9

Irbesartan +hydrochlorothiazide Oct 2013 2.5.5.2

Clopidogrel hydrogen sulphate Aug 2013 2.9

New Drug Approved by FDA in year 2013-2014

Product Name Sponser Indication Year of Approval

Epanova (Omega-3-carboxylic acids)

AstraZeneca hypertriglyceridemia May 2014

Zontivity (Vorapaxar) Merck thrombotic cardiovascular events May 2014

Adempas (Riociguat) Bayer Healthcare Pharmaceuticals

Chronic Thromboembolic Pulmonary Hypertension and Pulmonary Arterial Hypertension

Oct 2013

Kynamro (mipomersen sodium)

Genzyme homozygous familial hypercholesterolemia

Jan 2013

Liptruzet (ezemitibe and atorvastatin)

Merck hyoerlipidemia May 2013

Opsumit (Mecitentan) Actelion Pharmaceuticals

pulmonary arterial hypertension October 2013

Varithena (Polidocanal injectable foam)

BTG plc varicose veins Nov 2013

Cardiovascular Drug in Pipeline: 2013

Pharmaceutical Research and Manufacturers of America (PhRMA), 215 Drugs are under development for treating CVDs.

That includes, 30 drugs for heart

failure, 29 for lipid disorders, 19 for stroke, 17 for hypertension and 17 for ischemic disorders.

Product Name Sponsor Indication Development Phase

Xarelto®rivaroxaban

Bayer HealthCare PharmaceuticalsWayne, NJ &Janssen Research & Development Raritan, NJ

acute coronary syndrome(Fast Track)

application submittedwww.bayerpharma.comwww.janssenrnd.com

azimilide Forest LaboratoriesNew York, NY

ventricular arrhythmia Phase

Phase IIIwww.frx.com

anacetrapib(MK-0859)

MerckWhitehouse Station, NJ

atherosclerosis Phase IIIwww.merck.com

Tekturna®aliskiren

Novartis PharmaceuticalsEast Hanover, NJ

atherosclerosis in coronaryartery disease

Phase IIIwww.novartis.com

MyoCell®stem cell therapy

BioheartSunrise, FL

heart failure Phase II/IIIwww.bioheartinc.com

LCZ696(ARB/NEP inhibitor)

Novartis PharmaceuticalsEast Hanover, NJ

heart failure Phase IIIwww.novartis.com

serelaxin(RLX030)

Novartis PharmaceuticalsEast Hanover, NJ

acute heart failure(Fast Track)

Phase IIIwww.novartis.com

Tekturna®aliskiren

Novartis PharmaceuticalsEast Hanover, NJ

acute decompensated heart failure

Phase III completedwww.novartis.com

ularitide CardiorentisZug, Switzerland

acute heart failure Phase IIIwww.cardiorentis.ch

Product Name Sponsor Indication Development Phasecandesartan cilexetil/nifedipine

Bayer HealthCare Pharmaceuticals Wayne, NJ

essential hypertension

Phase IIIwww.bayerpharma.com

nebivolol/valsartanfixed-dose combination

Forest LaboratoriesNew York, NY

essential hypertension

Phase IIIwww.frx.com

perindopril/amlodipinefixed-dose combination

XOMABerkeley, CA

hypertension Phase IIIwww.xoma.com

Collategene®beperminogene perplasmid

AnGes Bethesda, MDMitsubishi Tanabe Pharma America Jersey City, NJ

critical limb ischemia(Fast Track)

Phase IIIwww.anges-mg.comwww.mt-pharma-america.com

Generx®alferminogene tadenovec(Ad5FGF-4)

Cardium TherapeuticsSan Diego, CA

myocardial ischemia(Fast Track)

Phase IIIwww.cardiumthx.com

Epanova™eicosapentaenoic acid/docosahexaenoic acid

Omthera PharmaceuticalsPrinceton, NJ

hypertriglyceridemia

Phase IIIwww.omthera.com

fenofibrate/simvastatinfixed-dose combination

AbbVieNorth Chicago, IL

hyperlipidemia Phase IIIwww.abbvie.com

Kynamro®mipomersen

GenzymeCambridge, MA

hypercholesterolemia

Phase IIIwww.genzyme.com

pradigastat(LCQ908)

Novartis PharmaceuticalsEast Hanover, NJ

chylomicronemiasyndrome

Phase IIIwww.novartis.com

SAR236553(anti-PCSK-9 mAb)

Regeneron PharmaceuticalsTarrytown, NY Sanofi US Bridgewater, NJ

hypercholesterolemia,

Phase IIIwww.regeneron.comwww.sanofi.com

desmoteplase LundbeckDeerfield, IL

ischemic stroke(Fast Track)

Phase IIIwww.lundbeck.com

There are more than 2,000 clinical trials listed in the National Institutes of Health database – www.clinicaltrials.gov

Of those trials, more than 400 are in start up phase, either recruiting patients or have not

yet started recruiting patients.

Cardiovascular Trials Publications Increased Steadily

Fig: No of Oncology, Diabetes and Cardiovascular disease clinical trial publications by year

Conclusion

This information is potentially valuable to patients still seeking effective treatment for heart disease or stoke, as well as for CDM professional. There will be more requirement to understand complexity, manage and clean of such huge volumes of data.

By looking at these trends/development in clinical research industry, we can surely hope for 'ACCHE DIN' (HAPPY DAYS) in the field of Clinical Data Management too.