The drug in question is the acute lymphoblastic leukaemia (ALL) treatment Elspar, which Lundbeck gained through its acquisition of Ovation Pharmaceuticals in 2009.
In a letter sent to US physicians yesterday the Danish drugmaker said it would stop production and distribution by the end of the year, describing it as “not a sustainable business going forward.”
Company VP of supply chain management Roger Keding explained that Lundbeck has struggled to secure supplies of the Elspar active pharmaceutical ingredient (API) – asparaginase- since acquiring the product.
“We have invested significant resources transferring the formulation to a new product source and developing new analytical procedures to comply with FDA/GMP/ICH standards. Despite our diligent efforts we have continued to experience periodic supply interruptions.”
He also said that: “Recent development activities have led us to the conclusion that securing future long-term sourcing for the active substance and the drug product would require additional investment and significant changes to underlying process and specifications.”
Keding did not specify what changes but did say that regulatory acceptance of such changes would be 'highly uncertain.'
Alternative forms of asparaginase are available - Erwinaze, sold by a unit of Jazz Pharmaceuticals and Oncaspar by Sigma-Tau Pharmaceuticals - and the drug is not one of those deemed to be in short supply by the US Food and Drug Administration (FDA).
Whether the FDA will contact alternate suppliers – as it did when Sanofi Pasteur halted production of its cancer treatment TheraCys BCG Live (Intavesical) which is on the list – remains unclear.
While Elspar is a legacy product that – according to a Dow Jones report – generates only one per cent of Lundbeck revenues and is a minor part of its business, the firm’s comments about ‘highly uncertain’ regulatory acceptance are a concern because at present – according to the newswire - the drug is produced by an unnamed contract manufacturing organisation (CMO).
The relationship between pharmas and their CMOs have been under considerable scrutiny in recent years after manufacturing quality problems at a number of contractors resulted in drug shortages, garnering criticism for all involved.
Such issues – and a recent report that criticised the FDA for its role in the shortages – prompted the agency to clamp down on pharmas that only work with a limited number of suppliers.
While there is no suggestion its CMO suffered quality problems, Lundbeck's decision to stop making Elspar rather than invest may indicate that regulatory efforts to address shortages will discourage the production of important drugs if pharmas have API sourcing difficulties or only a limited number of contractors.