API supply issues lead Lundbeck to drop cancer drug
pharmafile | September 18, 2012 | News story | Manufacturing and Production |Â Â Elspar, Lundbeck, OvationÂ
Danish firm Lundbeck has decided to discontinue supplies of its leukaemia drug Elspar from December after struggling to find a reliable source for the active pharmaceutical ingredient (API) used in the product.
Elspar (asparaginase) is used as a component of a standard chemotherapy regimen for patients with acute lymphoblastic leukaemia (ALL), and has been sold by Lundbeck since 2006 when it acquired the product along with Ovation Pharmaceuticals in 2009.
In a letter to healthcare providers, Lundbeck’s vice president for supply chain management, Roger Keding, noted that the company had invested ‘significant resources’ transferring the formulation to a new drug product source and developing analytical tests to meet international quality standards.
Despite this “we have continued to experience periodic supply chain interruptions which have often required short-term product allocations”, according to Keding, who notes that Elspar does not represent a ‘sustainable business going forward’.
At the moment Elspar is made by a contract manufacturing organisation (CMO) and ensuring an uninterrupted supply of the API would require additional investment and a major change in existing processes, according to the letter.
The company said it is reluctant to undertake that effort because it cannot guarantee that regulators would accept the changes.
Asparaginase is not on the list of current drug shortages in the US, according to the FDA website, and Lundbeck stressed that “other asparaginase products are available in the US and most other markets”.
Last year the agency approved a new version of the drug called Erwinaze from EUSA Pharma which is made in the bacteria Erwinia chrysanthemi rather than the usual Escherichia coli and avoids problems of hypersensitivity which have been seen with the latter version.
Meanwhile, in 2009 Enzon Pharmaceuticals won US approval for broader use of its Oncaspar (pegaspargase) version of asparaginase (now sold by Sigma Tau), which had previously been registered only for use in patients who had developed hypersensitivity to regular asparaginase.
“Patients and customers in the US should continue to have access to other forms of asparaginase, and such are encouraged to consult with healthcare providers … to discuss other available treatment options”, said Keding.
Phil Taylor
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