Generic assault lurks for branded heart-health meds
At the beginning of last year, the heart disease market was expected to see large capital gains and new drug arrivals that would further the growth in the market. Now, as the retail pharmacy market edges closer and closer to the years when patents will begin to expire on the top-selling drugs in this category, the danger is that the pipeline is drying up and the sales figures will be negatively impacted by the impending patent expirations.
The cardiovascular market has been one of the mainstays of the pharmaceutical industry over the last 20 years. But as the market matures, sales growth is expected to be negligible as leading brands lose patent protection and companies are unable to develop new products to replace revenue streams.
The loss of patent life on big-selling pioneer medicines affects the whole branded pharmaceuticals industry, but it is particularly pronounced within the arena of cardiovascular medications. Six of the current top 10 brands, totaling $30.9 billion in sales in the United States, Japan and major European Union countries, are slated to lose patent protection between 2010 and 2013, according to Datamonitor.
Last year, the heart market saw the introduction of two drugs by Novartis: Tekturna and Exforge. Tekturna became the first new treatment for high blood pressure in more than a decade when it was approved. The drug acts within the renin system, which is central to blood pressure regulation. Exforge is a combination of two drugs, Diovan and Norvasc, and is used to treat hypertension.
Top cholesterol products by U.S. sales dollars*| HMG-COA Reductase Inhib | Rank | Total dollar* $ 6,397,057 | % market share 100.0% | % growth -26% | 2006 dollar total*$16,510,453 |
| Lipitor | 1 | 4,162,145 | 65.1 | -6 | 8,674,944 |
| Crestor | 2 | 830,301 | 13.0 | 42 | 1,320,364 |
| Simvastatin | 3 | 743,022 | 11.6 | 382 | 1,502,049 |
| Lovastatin | 4 | 166,797 | 2.6 | 19 | 278,156 |
| Zocor | 5 | 157,016 | 2.5 | -94 | 3,188,076 |
| Total others | 337,775 | 5.3 | -64 | 1,546,866 | |
| Cholesterol Red Comb | 1,277,351 | 100.0 | 38 | 2,023,898 | |
| Vytorin | 1 | 1,197,102 | 93.7 | 42 | 1,861,372 |
| Advicor | 2 | 80,249 | 6.3 | 1 | 162,507 |
| Pravigard Pac | 3 | 0 | 0.0 | -98 | 19 |
| Cholesterol absorption | 897,130 | 100.0 | 25 | 1,539,231 | |
| Zetia | 1 | 897,130 | 100.0 | 25 | 1,539,231 |
For the heart-health therapeutic class in general, however, the future may be a different story. Generic competition is expected to wipe $67 billion from top companies’ annual U.S. sales between 2007 and 2012 as more than three dozen drugs lose patent protection. That is roughly half of the companies’ combined 2007 U.S. sales.
“The volume of sales will continue to increase for these drugs, but revenues will drop because we will see more generics on the market,” noted a report from Datamonitor. Result: The heart-health market will take a significant hit over the next couple of years as more patents expire, researchers predicted.
Pfizer will be particularly hard-hit when its patent on Lipitor, the cholesterol-lowering blockbuster that ranks as the most successful drug ever, expires as early as 2010. Pharmacists and managed care companies are likely to aggressively fill prescriptions with generics, reducing annual Lipitor sales to a fraction of last year’s $13 billion.
Torcetrapib was supposed to help Pfizer offset its Lipitor patent loss, but the drug was withdrawn from consideration by the FDA due to the number of deaths that occurred during clinical trials. It was expected that since Torcetrapib raised HDL, or good cholesterol, and Lipitor lowered LDL, or bad cholesterol, that Pfizer would have eventually combined the two into one drug.
Pfizer reportedly spent more than $800 million on the drug’s development before pulling the plug.
Another cholesterol drug facing scrutiny—this time by Congress—is Zetia. The House Committee on Energy and Commerce recently asked the makers of the drug, Merck and Schering-Plough, for more information as to what is taking the two companies so long in releasing the information from a drug trial in April 2006.
The trial, named Enhance, covered 720 patients with very high cholesterol, and was intended to prove that the combination of Zetia and an older cholesterol medicine would reduce the growth of plaque in the arteries more than the older medicine alone.
Schering and Merck originally were expected to release the results of the trial at a conference in spring 2007. That release date was pushed back to fall 2007, and two months ago, after being criticized by cardiologists, the companies said they would release the results in March 2008.
Zetia is one of the newer cholesterol medicines. It works by limiting the body’s absorption of cholesterol, unlike such statin drugs as Lipitor, which slow the liver’s ability to produce cholesterol.
Zetia racked up sales of almost $900 million for the first half of 2007, though this paled in comparison to the more than $4 billion brought in by Lipitor during the same period.
The biggest drug in the heart-health category to be affected by a generic introduction has to be Zocor.
In 2005—the last full year of market exclusivity for Zocor before the onset of generic competition—the big-selling statin drug brought in almost $4.5 billion. In 2006, that total fell to a little more than $3 billion in the face of the launch of the first me-too version of the product, simvastatin, which generated more than $1.5 billion in sales between the time of its rollout in mid-2006 to the end of the year.
Nevertheless, while Merck took a big hit with Zocor’s loss of patent protection, the company hopes to bounce back in 2008 with a few new drugs for the heart-health category.
Among them: Merck’s experimental drug anacetrapib, which is aimed at both raising levels of good cholesterol and lowering bad cholesterol. Anacetrapib will enter final-stage testing in 2008.
Merck also plans to market the drug Cordaptive, a niacin drug used to raise good cholesterol. Cordaptive