Santhera's DMD drug poised for wider rollout in Germany

Santhera has reached an agreement with health insurance funds in Germany on reimbursement of its Agamree treatment for Duchenne muscular dystrophy (DMD) that should support broad use of the drug.

The Swiss biopharma company said the deal with the German National Association of Statutory Health Insurance Funds (GKV-SV) makes Agamree (vamorolone) the first product to receive an agreed federal price in Germany for the treatment of all DMD patients four years and older, and independent of the underlying genetic mutation.

The agreed ex-factory price is €3,612.50 per 100ml bottle, which Santhera said translates into approximately €52,000 ($54,000) per year for an average patient "when considering required rebates, patient weight, and dosing."

Germany became the first market where Agamree was launched last year following its approval in the EU in December 2023, and it has since also been launched in Austria, as well as in the US under license by Catalyst Pharma. A launch in the UK – where it has also been backed for NHS use in all four nations – is also imminent.

Santhera has indicated that it intends to focus its commercial efforts on six key markets – Germany, France, Italy, Spain, the Benelux countries, and the UK – and rely on partners elsewhere. The drug also has approval in China and Hong Kong, where it is licensed to Sperogenix.

"We are pleased to have reached an agreement on the reimbursement for Agamree with the GKV-SV, which provides health insurance coverage for approximately 90% of the German population," said Santhera's chief executive, Dario Eklund.

Vamorolone is a novel and fully synthetic glucocorticoid that has been shown in trials to slow down muscle degeneration and prolong the ability of DMD patients to walk without causing the weight gain, bone weakness, and mood changes associated with the use of regular corticosteroids like prednisone – a standard therapy for DMD.

The company has said that more than 300 DMD patients in Germany have started treatment with Agamree since its launch, which represents almost 30% of those currently on steroid treatment for the disease. It estimates that Germany has 2,300 individuals living with DMD, of whom approximately 1,100 to 1,200 are treated with steroids at any one time.

Santhera has previously suggested that peak sales of Agamree could be in the region of $500 million a year in the US and the five largest European markets. It is currently the company's only commercial product.