In an effort to diffuse the impact of generic competition, revitalize established brands, and enhance patient convenience
for long-term drug therapy, pharma companies are offering an increasing number of combination drugs. These products can expand
disease markets and increase patient compliance, while reducing consumer copayments, thereby benefiting pharma companies and
Getting It Approved
One example is Pfizer's new product Caduet (amlodipine and atorvastatin), which is designed to help people lower their blood
pressure and cholesterol by taking just one pill daily. This new tablet is the first to combine medicines that address two
different disorders simultaneously. The company estimates that 30 million Americans suffer from both high cholesterol and
elevated blood pressure—the two leading risk factors for heart disease. Analysts forecast that Pfizer will generate $200 million
in Caduet sales this year and $400 million in 2005.
Another example is Vytorin, a cardiovascular therapy comprising Schering-Plough's Zetia (ezetimibe) and Merck's Zocor (simvastatin)
that reduces cholesterol in different ways. Ezetimibe is a cholesterol-absorption inhibitor, whereas simvastatin decreases
endogenous liver production of cholesterol by inhibiting HMG-CoA reductase. The combination of these two different mechanisms
could achieve additive or synergistic cholesterol-lowering effects.
Low Risk, High Reward
The financial risk of developing combination products is generally low. Although they must still undergo clinical testing,
these trials generally are smaller and less demanding. As a result, they are less expensive than the type required for other
drugs. (See "Getting It Approved".)
Indeed, the financial reward for pharma can be lucrative because the new combinations often come with fresh patents that protect
the medicines from similar generic combinations for years after the individual ingredients have lost their legal protection.
Some new drugs may become available only as part of a combination pill. A Pfizer mixture in development combines Lipitor (atorvastatin),
which works primarily to reduce bad cholesterol (low-density lipoprotein), with an experimental drug, torcetrapib, which raises
good cholesterol (high-density lipoprotein). This combination, which has not yet been named, could be marketed in two or three
years, and torcetrapib will be sold only in combination with atorvastatin. Lehman Brothers estimates global peak sales will
be $1.5 billion.
Filling the Gap
As pressures mount to build up their pipelines, most major pharma companies are mixing current or past blockbusters to help
fill the product void. Because of a high percentage of failures during trials, the amount companies must spend to bring a
single drug to market in the United States has grown to approximately $1.7 billion, according to Bain & Co.
Bain points out that pharma companies are earning only a 5 percent return on their investment in finding new drugs, below
levels typically demanded by equities investors. The Bain report also notes that licensing products from other companies,
which was a profitable strategy until recently, now brings only a 6 percent return on investment. The trend has been for large
pharma companies to design strategies around blockbuster products for widespread ailments such as heartburn, high cholesterol,
and depression. But many of these products are losing patent protection and are being replaced by lower priced generics.
Although pharma companies will not likely abandon the blockbuster model, it is inevitable that they will aggressively deal
with increased pressure on R&D, aging facilities, and expensive work forces by identifying alternative strategies to support
their growth. The focus on combination products, although not a strategy that will single-handedly solve these challenges,
can ameliorate them by effectively blunting competition from generics, thus increasing the market presence of mature brands
as well as enhancing patient compliance.
Winning Over Doctors
Despite the move toward combo products, some physicians prefer to prescribe separate drugs to customize patients' medical
regimens. These doctors often avoid prescribing combination drugs because they are offered in a limited number of dosages,
which makes it difficult to tailor drug regimens or solve patients' problems with a single pill. Specifically, some physicians
are concerned that they may not be able to isolate the cause if a patient experiences side effects from a combo product.