API issue leads Lundbeck to stop making Elspar for ALL

Undermined by supply-chain issues, Danish drugmaker Lundbeck will discontinue supplying its leukemia drug Elspar beginning in December.

Roger Keding, Lundbeck's vice president for supply-chain management, notified physicians of the decision in a letter last month. He said the company has already invested heavily updating the drug but has had difficulty getting a constant supply of the API to manufacture it. 

In an email to FiercePharmaManufacturing, Lundbeck Senior Manager of Communications Matt Flesch said, "As noted in the letter, our decision to discontinue Elspar was based on two main factors. First and most importantly, other forms of asparaginase are currently available, which means that patients in need of this therapy will continue to have alternatives. Secondly, there are numerous challenges associated with securing a reliable global and long-term product supply chain."

Flesch said the drug is a very old biological product and difficult to manufacture. The company has used a contractor to make Elspar. Flesch said that when Lundbeck acquired the product in 2006, the company had to update underlying process technology and analytical methods to meet new guidelines for biologics. Still he said, "Authorities in some markets outside the U.S. have been reluctant to accept many of these improvements, due to evolving and often tighter controls linked to biologics." Even with all of the investments, the company has had difficulty getting a guaranteed supply of the API and to do that would require additional process and specification changes that might not be approved by regulators.

Lundbeck is facing the same price pressures that other drugmakers are, after the patent expired on Lexapro, the antidepressant it developed and sells in Europe as Cipralex. In June, it said it would cut 600 jobs, mostly in Europe.

- see the Lundbeck letter (PDF)