Biotech In Review: Amgen Must Post Black Box Warning

Amgen (AMGN) hit another 52-week low following news the FDA will require boxed warnings on their bread-and-butter anemia drugs, Aranesp and Epogen.

The warnings will advise physicians to prescribe the lowest possible doses that prevent blood transfusions. Previously, in dialysis patients, doctor would aim for a near-normal level of hemoglobin. That required greater amounts of drugs, but it has now been shown to also cause a greater incidence of side effects. The black box will also be placed on Procrit, Johnson & Johnson’s (JNJ) version of Epogen. The news took Amgen down to almost $60 a share. Amgen ended the day with a 2% loss, slipping $1.31 to $60.80.

A Canadian company, Liponex [LPX.TO] lost almost 80% of its value after its treatment for HDL cholesterol (or “good” cholesterol) failed a trial. The company said that CRD5 failed to provide a statistically significant increase in HDL levels. In January, Liponex suspended treatment of the highest dose of CRD5 because it caused gastrointestinal problems in patients. Liponex will perform a second Phase I/II trial on the drug, which it has the resources to complete. After the announcement, Liponex fell C$1.88 to C$.58.

Jazz Pharma (JAZZ) registered with the SEC to make its IPO. The company proposes to raise a far-larger-than-average $172.5 million in the offering. Jazz focuses on drugs for neurology and psychiatry. In 2006, Jazz had a net loss of $59.4 million on $44.9 million of revenue. The 2006 revenue figure was more than twice the $21.4 million that Jazz produced in 2005.

Encysive (ENCY) reported a larger than expected loss for 2006, and its auditors placed a “going concern” warning on their report for Encysive. Without new cash, Encysive does not have enough money to continue operations through 2007. Encysive received a severe blow when the FDA awarded Thelin, its drug for Pulmonary Arterial Hypertension, an Approvable letter.

Although Encysive says the FDA will not require another clinical trial before approving Thelin, Encysive has not won full approval for the drug. The FDA must act on Thelin by June 15, 2007. Encysive was down 22 cents at $3.14.

Biotech was off slightly on Friday, but ended the week unchanged. The Centient Biotech 200™ slipped 4 points lower to 3822, a loss of .10%. Broad market indices were similarly little changed: the S&P 500 was up .07% and Nasdaq off by .01%.

Disclosure: none.