Cardiovascular drugs fuelling Phase IV trials
cardiovascular marketing teams who are increasingly using them to
rejuvenate ageing medications and improve marketing campaigns.
Cardiovascular disease is the number one killer in the US, responsible for nearly one million deaths each year, and is one of the hottest contested therapeutic areas of the pharma industry.
The cardiovascular market continues to expand through novel development innovations and poses the greatest area of growth opportunity for drug companies.
However, as patents of the current blockbuster drugs are beginning to end, big drug companies are facing significant loss to revenue through generic competition.
Pfizer's Lipitor, the world's best selling drug, with revenues close to $8 bn each year, will lose patent in four years time.
Therefore companies are increasingly using Phase IV clinical trials to develop new formulations and indications of existing compounds as they approach patent expiration in the hope of receiving a new patent and maximizing a product's sales.
In particular, several new combination therapies are emerging from this process.
Companies are also using these comparator trials to directly compare their own product against other market leaders to try and show superiority in key areas and boost their sales pitch.
"Pharmaceutical companies find it advantageous to use Phase IV clinical trials as avenues for promoting their medications," said Elio Evangelista, senior analyst at Cutting Edge Information.
"Good results can often reignite sales for ageing brands by making the public aware of superiority over other marketed products or developing new indications," he said.
Phase IV studies investigate already-approved drug products used in line with their approval labels to address questions about comparative efficacy, tolerability and cost effectiveness and explore different treatment approaches.
Pharma companies are now spending on average over $31 m (€26 m) on a cardiovascular drug's Phase IV activities, with a significant portion allocated to Phase IV clinical research, compared to only $2 m spent in oncology, according to a research report by business intelligence firm Cutting Edge Information.
In addition, the costs of running cardiovascular clinical trials are greater than for other therapeutic products, sometimes up to 25 per cent higher, according to Eli Lilly.
As a result cardiovascular compounds may increasingly provide new areas of opportunity for contract research organisations looking to offer pharma companies these clinical trial services at a lower cost than keeping them in-house.
A copy of the report "Cardiovascular Marketing: Budgets, Staffing and Strategy," can be purchased here.
