Erwinase®

Erwinase Development

Porton Biopharma is the sole manufacturer of Erwinase® .

Erwinase® manufactured and licensed in the UK (PL44403/0002) is available for UK Orders via Clinigen via

Email: MedicineAccess@clinigengroup.com

Telephone: +44 (0) 1283 494 340

 

Porton Biopharma, via its distributer Clinigen Inc, in conjunction with the FDA has initiated a temporary importation to the US market to address drug shortage. Click here for more information

 

The product is manufactured in Porton Biopharma’s licensed pharmaceutical manufacturing facilities. Since its first registration in the UK in 1985 Erwinase® has been registered in 19 countries and commercialised in more than 75 countries world-wide, including approval in the US by the FDA in November 2011.

In April 2018 PBL announced the opening of its new fermentation facility, which following qualification and validation, should then enable PBL to meet the growing demand for the product.

In April 2020 PBL announced that it had signed an exclusive worldwide licensing agreement with Clinigen for Erwinase that will begin on January 1st 2021.

 

About Erwinase®:  Erwinase® is indicated for the treatment of Acute Lymphoblastic Leukaemia (ALL), a type of cancer that particularly affects children. Erwinase® is an asparaginase enzyme derived from the bacterium Erwinia chrysanthemi that is used as part of the treatment protocols in conjunction with radiotherapy or chemotherapy.

Asparagine is an amino acid that is essential for cell growth; it is produced by most but not all cells. Mutated cancer cells in ALL rely on asparagine circulating in the blood for growth. L-asparaginases are a group of enzymes that lower circulating asparagine levels in the blood, thereby depriving the mutated cells of asparagine and inhibiting their growth.

There are several different types of L-asparaginase available on the market, each derived from a different bacterium. Patients receiving treatment with L-asparaginase derived from Escherichia coli (E. coli), who develop hypersensitivity to that form of the enzyme, may be able to continue treatment with Erwinase® as the enzymes are immunologically distinct. Antibodies targeting E. coli derived L-Asparaginase have been shown not to cross-react with Erwinase®.

For detailed product information, please see the MHRA Medicines Information site.