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