Anemia Drugs Come Under Fire - Amgen runs into regulatory problems over safety of drugs

[Guest guest]

Aranesp is a drug similar to procrit--they are growth factors to

stimulate red blood cell production. " " Aranesp, Amgen's biggest drugs

that stimulate red blood cell production whose global sales are expected

to exceed $7bn this year. " "

" " Amgen yesterday said the FDA was seeking to add a " black box warning "

- the strongest possible - over using the anti-anaemia drugs for kidney

and cancer patients " "

" " The FDA has also called an experts' panel in May to review the drugs

and their potential dangerous side-effects when used in cancer patients

- such as enhancing tumours or accelerating the disease and death. " "

http://www.msnbc.msn.com/id/17390331/

Amgen runs into regulatory problems over safety of drugs

Amgen faces increased regulatory scrutiny over its blockbuster drugs

after recent studies raised concerns that the anti-anaemia products

might feed tumours in cancer patients.

The Food and Drug Administration and the Securities and Exchange

Commission are informally investigating the safety record of Epogen and

Aranesp, Amgen's biggest drugs that stimulate red blood cell production

whose global sales are expected to exceed $7bn this year.

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Amgen yesterday said the FDA was seeking to add a " black box warning " -

the strongest possible - over using the anti-anaemia drugs for kidney

and cancer patients.

The FDA has also called an experts' panel in May to review the drugs and

their potential dangerous side-effects when used in cancer patients -

such as enhancing tumours or accelerating the disease and death.

Amgen said that it was co-operating " fully " with the SEC and " looked

forward to " providing new data to the FDA.

Amgen has sought to broaden the use of its anti-anaemia drugs, which

were initially used to treat anaemia in chronic kidney patients, to

treating anaemia in cancer patients or patients with heart illness. But

questions have dogged its push over whether boosting red-blood cells

might feed tumours and cancer.

Roche, the Swiss drugmaker, is planning to sell a similar drug in the

US, while & already sells a similar treatment called

Procrit.

Results from several negative trials have recently appeared, including

data from Roche's drug in lung cancer patients. But a study by the

Danish Head and Neck Cancer group raised concern to a fever pitch and

also led some investors to ask why Amgen had not revealed its own

results earlier.

Amgen put a stop to a study last year after finding Aranesp-taking

cancer patients had fared suffered worse than those on alternative

medications.

In addition, two landmark studies late last year raised concerns that

aggressive treatment of anaemia in kidney patients could increase,

rather than lower, heart risks.