[Ip-health] FDA Approves Amgen Cancer Drug

[julie.patel@cptech.org]

http://online.wsj.com/services/article/SB115939162944475897-search.html?KEYWORDS=amgen+colon+cancer&COLLECTION=wsjie/6month




FDA Approves Amgen Cancer Drug
By. DAVID P. HAMILTON

September 28, 2006; Page D6


Wall Street Journal

(copied as fair use)



The drug hasdemonstrated the ability to slow the growth of cancer but
hasn't yet been proven to help cancer patients live longer.


To jump-start competition with Erbitux, Amgen said it
will price Vectibix approximately 20% lower than its rival, at roughly
$8,000 a month. Such price-cutting is rare in the market for
biotechnology drugs, even if it leaves the treatments extremely
expensive by conventional measures. A year of Vectibix treatment could
run almost $100,000.


The Food and Drug Administration approved Amgen
Inc.'s new colon-cancer drug Vectibix, giving the biotechnology giant
its first cancer treatment and setting the stage for an unusual and
aggressive price war with Erbitux, a rival drug from ImClone Systems Inc.
Amgen said the FDA approved Vectibix, which also goes by the generic name
panitumumab, for use in colon-cancer patients who have failed all forms of
traditional chemotherapy. The drug has demonstrated the ability to slow
the growth of cancer but hasn't yet been proven to help cancer patients
live longer. Amgen, based in Thousand Oaks, Calif., said it will launch
Vectibix in early-to-mid-October.

The company, whose main products to date include drugs that treat
arthritis and that help support chemotherapy and kidney-disease patients,
has big plans for Vectibix. Last year, Amgen Chief Executive Kevin Sharer
said the drug should generate as much as $2 billion in annual sales, an
estimate that some analysts say is plausible and others consider
aggressive. Amgen obtained Vectibix in April when it acquired its maker,
small biotech Abgenix Inc., for $2.2 billion.

Many analysts expect much of Vectibix's growth to come at the expense of
Erbitux. Both drugs are antibodies genetically engineered to attack cancer
cells by latching onto a growth-related protein called epidermal
growth-factor receptor, or EGFR. Erbitux, which was approved for use
against colon cancer more than two years ago, racked up U.S. sales of $413
million in 2005. It is sold by Bristol-Myers Squibb Co. in the U.S. and by
Merck KGaA outside the U.S.

To jump-start competition with Erbitux, Amgen said it will price Vectibix
approximately 20% lower than its rival, at roughly $8,000 a month. Such
price-cutting is rare in the market for biotechnology drugs, even if it
leaves the treatments extremely expensive by conventional measures. A year
of Vectibix treatment could run almost $100,000.

"They're taking an aggressive stance from the pricing perspective," said
Joel Sendek, an analyst with Lazard Capital Markets LLC. Biotechnology
companies often price new drugs the same as or higher than rival drugs,
typically to justify their claims that the new treatments are superior to
the old. Because the move is unusual, it isn't clear to analysts how the
discount will affect Vectibix sales.

That discount may also reflect a growing resistance among some insurers to
the sky-high prices of biotechnology drugs. In addition to the lower
Vectibix price, Amgen said it will also cap out-of-pocket costs for the
drug at a level equal to 5% of patients' adjusted gross incomes. Amgen
said that program is the first of its kind in the industry.

Write to David P. Hamilton at david.hamilton@wsj.com