By Kevin E. Noonan —

The fastest-growing part of the biotech/pharma
industry is anticancer drugs, according to an article in The New York Times
today ("For Profit, Industry Seeks Cancer Drugs").  Written by Andrew
Pollack, one of the paper's senior business and technology writers, the article
highlights the interplay between scientific interest and business opportunity
driving this phenomenon.

The article supports its thesis on the recent rise
in anticancer drugs with some telling statistics:  there are "more than twice the number of experimental drugs for heart disease and stroke combined, nearly twice
as many as for AIDS and all other infectious diseases combined, and nearly twice as many as for Alzheimer's and all other neurological diseases combined."  This corresponds to 860 anticancer
drugs currently in clinical trials.

The scientific reasons
for these efforts stem from the nature of cancer as a disease.  Robert Weinberg (at left) from the Whitehead
Institute at MIT is quoted in the article as saying "Cancer is not a
single disease.  It's really
dozens, arguable hundreds of diseases."  Bert Vogelstein (below right) from Johns Hopkins is quoted as saying that
a typical tumor may have 50-100 genetic mutations, with any two patients having
the same type of cancer having as few as five mutations in common.  Accordingly, there are many approaches
and molecular targets for small molecule, immunological, and other avenues for
attacking cancer cells in an effort to find a cure.  In addition, the situation is ripe for "personalized
medicine," or efforts to tailor the treatment to the tumor based on the
unique signature of genetic mutations and the corresponding phenotype of an
individual's cancer and the targets for therapeutic intervention expressed by
each individual's tumor.

But this very
complexity is the main reason why cancer remains so daunting after 40 years of
concerted efforts to find a cure.  On the one hand, individual cancers even of the same type or in the same
tissue vary dramatically in changes in gene expression, chromosomal
abnormalities, and cancer-associated phenotypes, so that treatments that are
effective for some cancer patients are completely ineffective for others.  This has caused the "war on cancer"
to resemble a "grinding war of the trenches," according to an
uncredited quote by a cancer researcher.  And intractable clinical situations provide a correspondingly broader
scope of opportunities for new drugs effective against cancer in some portion
of the patient population.

However, on the other
hand, the efficacy of many anticancer drugs is limited at best.  The article cites the instance of drugs
like Erbitux® used as a "last ditch treatment for colorectal cancer"
providing on average about 90 days of additional life to patients.  And Taceva®, used for treating
pancreatic cancer (a cancer having a 3% 5-year survival rate that hasn't
changed in the past 100 years), extends life for pancreatic cancer patients on
average only 12 days (the basis for its approval by the FDA for this
indication).

Since 1998, when there
were twelve anticancer drugs in the world's 200 medicines having the greatest
sales, the number of anticancer drugs has almost doubled (to 23), and 20 of the
126 drugs having revenues of $1 billion are anticancer drugs.  Despite these efforts, however, only a
handful of new anticancer drugs are approved each year (two in 2008, one so far
in 2009).  Nevertheless, the article cites studies by IMS Health, a
pharmaceutical market research company, for evidence that "[c]ancer drugs
have been the biggest category of drugs in terms of sales worldwide since 2006
and in the U.S. since 2008."

One factor driving
anticancer drug development is the revenues that can be generated from their
sales, which carry a hefty price tag.  Taceva® treatments cost about $3,500 a month, according to the article,
and Erbitux® costs $10,000 per month (with an "extra" cost per
patient averaging $50,000, based on the average length of treatment course).  These costs have resulted in ImClone
having revenues of $1.6 billion in 2008 for Erbitux®, revenues that the article
asserts motivated "Eli Lilly & Co. to outbid Bristol-Myers Squibb to
acquire ImClone for $6.5 billion."

While these costs are
exorbitantly high, the article notes that "[p]atients are often desperate,
and insurers risk outrage by denying payments for a[n anti]cancer drug,"
even when there is little chance of benefit from the treatment.  "Cancer is such an emotional issue
that the free market doesn't work like it does for bicycle wheels and
umbrellas," according to Robert Erwin, head of the Marti Nelson Cancer
Foundation.  Money will flow to
anticancer drugs "[a]s long as the health care system will pay the price."  This situation raises special
concerns for the healthcare system as a whole, particularly under the current
economic climate, the pressures to reduce drug costs, and the amount of
investment required to determine whether an anticancer drug lead compound will
come to market.  These
circumstances are characterized as "the biggest bubble you've ever seen,"
according to Dr. Mark Ratain (at right), a University of Chicago oncologist.

The confluence of the exponential increase in
genetic information over the past decade and the technical ability to identify
genetic polymorphism and outright mutation with different cancer phenotypes
presents an unprecedented opportunity for developing new anticancer
therapeutics.  Mr. Pollack's
article is a reminder that the science is only part of the equation, and that
the economic realities of drug development and the healthcare marketplace will
also have a role in determining how many, and which, of these drugs will be
available for the next generation of cancer patients.