INTELLIGENT COMMENT AND INSIGHT INTO THE LATEST GLOBAL INDUSTRY MARKET TRENDS

december

11th

by Jonna Dagliden

Cardiovascular Drug Blockbusters Under Pressure From Raft of Patent Expiries

jonna_dagliden.jpgA new report shows that growth in the use of cardiovascular drugs has been steady in the last five years at around three percent compound annual growth rate (CAGR) and growth is expected to continue at a similar rate, in-line with population growth.

Despite growth in the use of cardiovascular drugs, sales growth is unlikely to match this. Growth in the last five years has been moderate at eight percent CAGR but there is likely to be negligible growth between now and 2016, giving an effective fall of three percent in cardiovascular revenues.

The report shows that sales growth is being hindered by the loss of patent protection on key cardiovascular blockbusters and the uptake of generic versions of leading drugs, as cost containment measures are promoted by national healthcare providers. Some of the brands losing patent protection during the 2010 to 2013 window include; Pfizer’s Lipitor® the world’s number one selling brand, Sanofi Aventis/Bristol-Myers Squibb (BMS) Plavix, the best selling platelet aggregation inhibitor and the anti-hypertensive, Novartis’ Diovan.

The uptake of generic versions of these drugs is expected to be heavily promoted in an effort to reduce healthcare budgets and branded sales will slump accordingly. Replacement drugs currently in development are unlikely to be able to fill the void left by the loss of these blockbusters.

Many cardiovascular diseases now have an array of generic drugs that provide effective treatment without the need to resort to expensive branded products. This provides a major challenge to pharmaceutical companies as any new drug must be able to demonstrate significant clinical benefit to meet the cost effectiveness criteria determined by healthcare providers. According to the report, as a consequence, future blockbusters will not be of the same scale as the current crop. Byetta LAR is likely to be the best performing of the drugs currently in development and is predicted to have peak sales of $3 billion in the seven major markets. This compares to the sales of Lipitor® in 2006 of $11.2 billion

However, the one disease area which will continue to grow in the cardiovascular franchise is diabetes. With the majority of the western world in the grips of an obesity epidemic, the number of sufferers of type 2 diabetes will continue to increase at a rapid clip. Pharmaceutical companies have invested heavily in this area to meet unmet clinical needs and a large proportion of the top ten cardiovascular brands in 2016 will be diabetes therapies.

The ‘patent cliff’ will be most acutely felt by Pfizer as patent protection in the US for Norvasc was lost in 2007 and Lipitor® will be lost in 2010. Adding insult to injury, Pfizer’s current cardiovascular pipeline is particularly bare after the company dropped the development of the Lipitor® replacement, torcetrapib, and the withdrawal of Exubera®, an inhaled insulin which some analysts had predicted would generate $2 billion in annual sales but only generated $5 million in the US in the first half of 2007.

The report predicts revenue losses for many drug makers in the cardiovascular market once the ‘patent cliff’ takes effect. However, Pfizer will be acutely affected, with a net loss in cardiovascular revenue of $12 billion, with Sanofi-Aventis becoming the largest player in the cardiovascular market by 2009.

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