HSP

A unit of Fresenius SE (FRE.XE) plans to resume shipments of the leukemia drug cytarabine next week, helping to alleviate a life-threatening shortage of the chemotherapy drug, although it won't immediately fix the problem.

The shortage is so severe that major cancer and academic medical centers are rationing the drug while other hospitals have run out and are scrambling to get more. Cytarabine is a critical part of the treatment for people with acute myeloid leukemia, or AML. Doctors say that without it people will die. The drug is also used as part of a treatment regimen for another type of leukemia and some types of lymphoma.

Two of the three companies that make cytarabine have had production difficulties, and the third company can't make the drug fast enough to fill the void. Only one of the companies, Hospira Inc., (HSP) of Lake Forest, Ill., is currently shipping the drug, but in limited quantities.

In 2010, Hospira had problems getting active ingredient used to make cytarabine, which slowed production. Then the company, and another manufacturer, Fresenius SE's APP Pharmaceuticals, of Schaumburg, Ill., had more recent problems involving particles in some of the cytarabine vials, which turned out to be tiny clumps of dried active ingredient that stopped shipments from both companies. Any type of particle in a sterile injectable drug is considered a quality problem.

Hospira said in an April 11 letter to doctors that dried cytarabine on filling needles may have entered vials during manufacturing, which halted shipments for part of February. A Hospira spokesman said the problem has been resolved and that shipments resumed last month. The company is now working to increase production "ahead of other products" to address the shortage.

APP said in a March 15 letter to doctors that it hadn't determined a "root cause" for the cytarabine crystals. APP had to recall one lot of cytarabine and also had to stop shipments.

In a statement Friday, APP said it would begin releasing "newly manufactured" cytarabine starting the week of April 18. APP appears to be the smallest cytarabine manufacturer of the three firms.

The third and dominant manufacturer, Bedford Laboratories, of Bedford, Ohio, said it has been dealing with "manufacturing capacity constraints" partly because of higher demand for the drug caused by decreases in "competitors' capacity." The company has 82,000 vials of cytarabine in the manufacturing process that should be released in the coming weeks, according to a company spokesman. Bedford had more than half of the cytarabine market share in 2010.

Food and Drug Administration spokeswoman Shelly Burgess said the agency was working "nonstop" with all three manufacturers on the supply issues and was also seeking to allow the importation of cytarabine from overseas as a backup. When one company has a manufacturing problem with a sterile injectable drug like cytarabine a competing company can't immediately make enough make up a shortfall. Once a decision is made to produce more of a drug, it takes a minimum of six to eight weeks to manufacture and then release it, and that's if the needed supplies are on hand and the FDA has already approved the manufacturing line. The three companies also make several other types of hospital-based injectable drugs, so increasing production in one area can cause shortages of other products.

Even if all goes as planned, doctors are concerned it will take weeks or months for the cytarabine shortage to resolve. Some pediatric leukemia specialists who are attending their annual medical society meeting in Baltimore kept a close eye on their email for news of cytarabine shipments.

Jeffrey Hord, who directs Akron Children's Hospital's children's cancer and blood-disorders department, said the hospital had enough cytarabine for the next round of treatment for existing patients but will soon need more. "Without cytarabine, people will not be cured," he said.

Although doctors are most concerned about restoring the supply of cytarabine, they are also concerned about the long-term effects including clinical research. Cytarabine will continue to be first routed to patients with AML before being given to patients with another type of leukemia known as acute lymphoblastic leukemia, or ALL.

-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; jennifer.corbett@dowjones.com

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