Partnership brings together decades of pancreatin experience at Nordmark and Essential Pharma

Norzyme^® (pancreas powder) 25,000 gastro-resistant capsules, a Nordmark medicine, has received its UK marketing authorisation and is now available for treatment of pancreatic exocrine insufficiency

Essential Pharma Limited ("Essential Pharma"), a UK-headquartered specialty pharmaceutical company focused on specialty care and rare disease, and Nordmark Pharma GmbH ("Nordmark"), a German-headquartered pharmaceutical company focused on developing and manufacturing active ingredients and medicines of biological and biotechnological origin, today announce that, through a partnership between the two companies, Essential Pharma will commercialise Nordmark’s pancreas powder 25,000 gastro-resistant capsules in the UK.

The partnership brings together two companies with long experience in pancreatic enzymes. Nordmark has worked with pancreatic extract for more than 50 years and manufactures and markets the medicine in Germany. The Essential Pharma group has been providing treatments, including for speciality care and rare disease, in the UK for over 40 years and, with its UK medical, quality and pharmacovigilance teams, now makes pancreas powder 25,000 gastro-resistant capsules available to eligible UK patients.

Pancreas powder 25,000 gastro-resistant capsules is indicated for the treatment of pancreatic exocrine insufficiency.¹ Through this partnership, it is now available as a pancreatic enzyme replacement therapy (PERT) option for patients with this condition. Pancreatic exocrine insufficiency occurs when the pancreas does not produce enough of the enzymes needed to digest food, and can be associated with conditions including cystic fibrosis, chronic pancreatitis and pancreatic cancer. Patients with questions about their treatment should speak to their healthcare team.

Becki Morison, Chief Executive Officer of Essential Pharma, commented: "People living with complex conditions such as pancreatic exocrine insufficiency, and their healthcare teams, need confidence in the company behind their medicine. Our partnership with Nordmark brings together its long experience in manufacturing pancreatic enzymes with our own experience of cystic fibrosis care and pancreatic enzyme replacement therapy in the UK. It reflects how Essential Pharma works: choosing our partners carefully and committing to the patients we serve for the long term."

Dr. Jörn Tonne, Chief Executive Officer of Nordmark, commented "Pancreatic enzymes have been at the heart of Nordmark for more than five decades. Receiving marketing authorisation for our pancreas powder gastro-resistant capsules, and reaching patients in the UK, marks an important milestone for our company. In Essential Pharma we have found a partner that shares this experience and understands the UK healthcare system, and we look forward to working together for patients in the UK."

Important safety information

Pancreas powder 25,000 gastro-resistant capsules is contraindicated in patients with hypersensitivity to pancreas powder (pancreatic extract) of porcine origin or to any of the excipients. Fibrosing colonopathy has been reported in patients with cystic fibrosis taking high doses of pancreatic extract preparations, particularly above 10,000 lipase units/kg/day; unusual or changing abdominal symptoms should be medically assessed. As the product is of porcine origin, transmission of hepatitis E virus cannot be excluded.

Very common side effects (≥1/10): abdominal pain. Common (≥1/100 to <1/10): nausea, vomiting, constipation, diarrhoea, abdominal distension. Uncommon: rash. Not known: pruritus, urticaria, hypersensitivity including anaphylaxis, fibrosing colonopathy.