UPDATE:Whistleblower Suit Filed Vs Amgen Over Drug Marketing
27 Fevereiro 2009 - 3:49PM
Dow Jones News
An unidentified whistleblower has filed a lawsuit against Amgen
Inc. (AMGN) accusing the biotechnology company of illegal marketing
of its blockbuster drugs Enbrel and Aranesp.
Wyeth (WYE), which co-markets Enbrel with Amgen, also was named
as a defendant, along with wholesale drug distributor
AmerisourceBergen Corp. (ABC), online health-information provider
WebMD Health Corp. (WBMD) and other defendants.
An amended version of the lawsuit was filed in 2007 in the U.S.
District Court for the District of Massachusetts in Boston, but had
been under seal in accordance with a federal whistleblower law that
protects the identify of the plaintiff. In the drug industry, such
suits are often filed by former employees including sales
representatives. A plaintiff's lawyer listed in the suit couldn't
immediately be reached.
A U.S. judge decided earlier this month to unseal portions of
the lawsuit, and Wyeth disclosed the development in a regulatory
filing on Friday.
The suit was filed on behalf of the U.S. and several states,
though Wyeth said in its filing Friday that the U.S. Justice
Department hasn't decided whether to intervene, and the department
hasn't sought any information from Wyeth. A Justice Department
spokesperson couldn't immediately be reached.
"Amgen believes the allegations made in the complaint are
without merit and will vigorously defend against the litigation,"
said David Polk, spokesman for the Thousand Oaks, Calif,
company.
Amgen shares declined $1.38, or 2.7%, to $59.84 Friday
afternoon. Shares of Wyeth, which has agreed to be acquired by
Pfizer Inc. (PFE), fell 23 cents to $40.91.
According to the lawsuit, the defendants violated federal and
state false-claim laws, Medicare and Medicaid anti-kickback laws
and the U.S. Food, Drug and Cosmetic Act "by engaging in numerous
unlawful activities in their marketing of Aranesp and/or
Enbrel."
Aranesp is an anti-anemia treatment that raked in $3.1 billion
in sales in 2008. Aranesp and other anemia drugs are among the
biggest drug expenses for Medicare, the federal health program for
seniors. Medicare has tightened its reimbursement policies over the
past couple years because clinical studies have shown the drugs can
increase risk for heart problems and other conditions when used in
certain ways. This has hurt sales.
Enbrel, a treatment for rheumatoid arthritis and psoriasis,
generated $3.6 billion in 2008 sales for Amgen. Amgen co-markets
Enbrel with Wyeth in the U.S. and Canada. Wyeth has exclusive
rights to the drug outside these countries, and it recorded $2.6
billion in Enbrel sales for 2008 outside the U.S. and Canada.
Doug Petkus, spokesman for Madison, N.J.-based Wyeth, said "we
believe the allegations as regard to Wyeth are without merit and we
will defend ourselves vigorously."
According to the lawsuit, Amgen improperly marketed the
attractive economics of Aranesp to customers - essentially that
they could profit more from prescribing Aranesp than competing
drugs. The lawsuit also alleges Amgen offered improper price
discounts for Aranesp to customers and hid these prices from
government health programs.
The suit also alleges that both Aranesp and Enbrel were marketed
for uses not approved by the Food and Drug Administration. The suit
alleges that part of this so-called "off-label" marketing was
conducted on the online physician-education site Medscape, which is
owned by WebMD.
New York-based WebMD spokeswoman Kate Hahn said "after a
preliminary review of the WebMD programs that may be relevant,
WebMD believes we complied with the rules and regulations
applicable to our services."
The lawsuit alleges Amgen took these steps to gain an edge over
rival anemia drug Procrit, which is marketed by Johnson &
Johnson (JNJ), New Brunswick, N.J. Procrit is identical to Amgen's
own Epogen, and J&J markets Procrit under a license deal with
Amgen.
Last year, Amgen agreed to pay $200 million to J&J to settle
J&J's allegations that Amgen violated antitrust laws by
offering discounts to cancer clinics on Aranesp and certain other
Amgen drugs. Amgen admitted to no wrongdoing under the settlement.
Amgen has previously disclosed federal prosecutors have filed
requests for documents related to its products.
J&J's own marketing practices for Procrit also have come
under a cloud. A separate whistleblower suit against J&J,
brought in 2003 by former sales representatives, alleged J&J
offered kickbacks to health-care providers and encouraged off-label
use of Procrit in an effort to counter Aranesp. The Justice
Department declined to intervene, and the suit was later dismissed
at J&J's request. The whistleblowers have appealed the
action.
J&J also has previously disclosed that the U.S. Office of
Inspector General's field office in Denver and the New York State
Attorney General have sent subpoenas seeking documents related to
Procrit.
Michael Kilpatric, spokesman for Chesterbrook, Pa.-based
AmerisourceBergen, said the company couldn't comment on the
allegations because the unsealed lawsuit has redacted portions and
the government hasn't contacted the company.
-Peter Loftus; Dow Jones Newswires; 215-656-8289;
peter.loftus@dowjones.com