TRENDS AND CONSIDERATIONS IN GLOBAL CARDIOVASCULAR DRUG DEVELOPMENT | Page 4

Inflammation has also gained significant attention, based on trials that have
shown increased cardiac morbidity and mortality in association with elevated
inflammatory markers.
Cardiovascular medical devices, a vital component of the CV therapeutic landscape,
include pacemakers, automated external defibrillators, implantable cardioverter
defibrillators, artificial heart valves, and treatments for both acute coronary
syndrome and angina, including stents. Devices are also being used for
atherosclerotic disease in the vascular vessels outside the heart. Cardiac surgery
continues to evolve with robotic and on-pump procedures. Cardiovascular devices
account for 18 percent of the U.S.-dominated devices industry, which had sales
over $60 billion in 2011.

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Recently approved devices include resynchronizing

pacemakers, improved homeograft cardiac valves, a compact heart assist device to
extend life for patients awaiting heart transplant, and a totally implanted,
permanent artificial heart for patients not eligible for heart transplant.

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The 2011

approval of transcatheter delivered aortic valves provided a life-saving option for
patients who otherwise are not candidates for aortic valve replacement surgery.

CV Clinical Development Profile: Increasing Cost and Complexity
Despite the rich pipeline, cardiovascular product innovation is declining. The U.S
Food and Drug Administration approved only 49 novel chemical entities and
biologics indicated for CVDs between 2000 and 2009, compared to 74 between 1990
and 1999.

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In 2011, five cardiovascular therapies were approved; in 2012, only one

new CV therapy has been approved by October.
Since the three-phase clinical development process was initiated 50 years ago, both
cost and development time required to bring drugs and devices to market have
increased. Expanding regulatory requirements are driving trends toward larger,
longer and more complex clinical trials. Escalating development costs pose evergreater barriers to CV therapy innovation.

Cardiovascular development posts the

longest timelines and the lowest success rates.