Lundbeck to Halt Sale of Leukemia Drug, Citing Supply Problems

   By Peter Loftus 
 

H. Lundbeck A/S (LUN.KO) plans to stop selling a leukemia treatment because of manufacturing and supply difficulties.

Denmark-based Lundbeck "is no longer in a position to guarantee a future supply" of the drug Elspar, Roger Keding, vice president of supply chain management, said in an Aug. 3 letter to U.S. health-care providers. "Lundbeck has concluded that continuing to manufacture and distribute Elspar is not a sustainable business going forward."

The company plans to discontinue Elspar sales globally, and to stop selling Elspar in the U.S. effective Dec. 31; the date could change depending on remaining inventory.

The Elspar discontinuation is the latest in a series of supply interruptions for pharmaceuticals--particularly among cancer drugs--caused by manufacturing problems and other issues in recent years. Doctors and hospital pharmacies have said drug shortages, recalls and product discontinuations have hampered their ability to deliver appropriate care.

In the case of Elspar, patients will continue to have alternatives because there are other drugs that contain the active ingredient in Elspar, known as asparaginase, said Lundbeck spokesman Matt Flesch.

The decision didn't result from any safety or efficacy issues with Elspar, the company said.

A decades-old drug, Elspar is used as part of a multi-drug chemotherapy regimen to treat acute lymphoblastic leukemia, a cancer of the blood and bone marrow. It is the most common form of leukemia in children, but it can also strike adults.

Elspar generates about 1% of Lundbeck's U.S. net sales, said Mr. Flesch. The company does not report specific sales figures for the drug, he said.

Lundbeck inherited Elspar with its 2009 acquisition of Ovation Pharmaceuticals, which had acquired Elspar from Merck & Co. (MRK) several years ago.

Lundbeck said it has been challenging to find a "new supply chain" for Elspar since the company acquired the product. Despite efforts to upgrade the manufacturing process, there have been periodic supply interruptions, according to Mr. Keding's letter.

Lundbeck has used a contract manufacturer to supply the drug, which it declined to identify.

"Elspar is difficult to manufacture because it is a very old biological product," said Mr. Flesch.

Lundbeck recently concluded that it would have to make "additional investment" and changes to certain processes to ensure long-term sourcing for the drug, and it was "highly uncertain" that health regulators would accept the changes, according to Mr. Keding's letter.

Lundbeck has asked wholesale customers and health-care providers to allocate remaining product inventory so current patients can conclude treatment. Patients are advised to consult with their doctors for treatment options.

Other drugs that could be alternatives to Elspar include Erwinaze, sold by a unit of Jazz Pharmaceuticals PLC (JAZZ), and Oncaspar, marketed by Sigma-Tau Pharmaceuticals Inc.

The availability of other drugs should limit the clinical impact of the discontinuation of Elspar, said Ching-Hon Pui, chairman of the Department of Oncology at St. Jude Children's Research Hospital in Memphis. For many pediatric patients, doctors already prefer Oncaspar over Elspar because of more convenient dosing, he said.

However, Dr. Pui said the absence of Elspar could affect ongoing cancer studies that incorporate the drug, including those in adult patients, requiring researchers to substitute in another drug. He also said Oncaspar is more expensive than Elspar.

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