Assistant Managing Editor

The words "product recall" are never music to investors' ears (just ask Toyota), but Amgen Inc.'s voluntary recall of about 200 lots of anemia drug Epogen (epoetin alfa) following the discovery of glass flakes in vials during a visual inspection seemed a nonevent for the Thousand Oaks, Calif.-based firm

Shares of the firm (NASDAQ:AMGN) actually gained 60 cents to close Friday at $56.32.

The discovery of the thin, glass flakes (lamellae) came during part of manual inspection, said Amgen spokeswoman Emma Hurley, who added that it will "not affect the availability of the drug for patients."

Nor will the recall have "any material impact" on the company's financials, she told BioWorld Today.

While the firm acknowledged a "low potential" for adverse effects in patients who use any of the contaminated products, such as vascular events and increased immunogenicity, there had been no actual patient complaints prior to the recall that could be tied to the lamellae.

The recall also involves about 150 lots of Amgen-manufactured Procrit, the version of epoetin alfa sold by Johnson & Johnson unit Centocor Ortho Biotech LP. It's the second Procrit recall for Ortho Biotech, which pulled a batch of the drug in 2008 after identifying cracks in the vials of a single lot.

Hurley confirmed that Amgen's contamination was attributed to an interaction between the drug and the glass vials that occurred over the products' shelf life. Since it's "more common for the issue to appear" in older vials, she said Amgen is reducing expiration dates going forward. The previously 36-month expiration period will be trimmed to 12 months for single-dose vials and to 15 months for multidose vials.

"We are in the process of evaluating other drugs, but we have not found" any similar problems, Hurley added.

Epogen, approved for treating anemia in patients with chronic renal failure on dialysis, recorded 2009 sales of $2.57 billion. The drug is part of Amgen's top-selling erythropoiesis-stimulating agent franchise, which has taken some hits over the past few years on safety, reimbursement and competitive issues.

But the firm saw some good news earlier this year, when the Centers for Medicare & Medicaid Services proposed a bundling rule with no changes to the target hemoglobin levels for ESAs, and the biggest threat to Epogen – Affymax Inc.'s and Takeda Pharmaceutical Co. Ltd.'s Hematide (peginesatide) – showed troubling cardiovascular safety data in a Phase III program. (See BioWorld Today, June 22, 2010, and July 28, 2010.)

Amgen's other ESA Aranesp (darbepoetin alfa) has had a tougher time.

The company blamed last year's 15 percent sales decline on labeling changes and is waiting to assess the potential impact of the Phase III TREAT study, which not only failed to improve mortality and cardiovascular outcomes, but also showed an imbalance of cancer deaths. The FDA's Cardiovascular and Renal Drugs Advisory Committee is set to review those data Oct. 18. (See BioWorld Today, Aug. 27, 2009.)

But investors of Amgen continue to focus their attention on RANK ligand inhibitor denosumab, which was launched earlier this year as Prolia in the potential $1 billion osteoporosis market. Though the firm still is working through reimbursement issues, denosumab expectations have more than offset other pipeline disappointments, most recently the failure of EGFR-targeting Vectibix (panitumumab) in head and neck cancer. (See BioWorld Today, Aug. 12, 2010.)

Denosumab also is under FDA review for preventing skeletal-related events in cancer, a market that analysts have projected to reach $2 billion. A decision is expected by Nov. 18.

Additional trials are testing the drug in the prevention of bone metastases in prostate cancer patients.