Novimmune files rare disease drug in EU, after selling rights to Sobi

Switzerland’s Novimmune has filed its rare disease drug emapalumab in Europe, days after it sealed a deal selling rights to Sweden’s Sobi.

The biotech, based in Geneva and Basel, has filed for a marketing authorisation for emapalumab as a treatment for haemophagocytic lymphohistiocytosis (HLH), teeing up a potential launch next year.

Novimmmune has already filed the drug with the FDA for HLH and a decision is expected before November 20 this year following a fast review.

The EMA has also granted emapalumab priority medicine (PRIME) status, where its CHMP reduces its review time frame from 210 days to 150 days, although the process can take longer than this as the regulator usually halts reviews to ask for further details.

Sobi – short for Swedish Orphan Biovitrum – earlier this week paid 50 million Swiss francs ($51m) up front for global rights, and could pay another 400 million Swiss francs ($406m) in additional milestone payments over the next eight years. Payments could be accelerated to next year by either party.

HLH is a clinical syndrome of hyperinflammation, driven by high interferon gamma (IFNγ) production, characterised by severely high levels of iron storage protein ferritin in the blood, fever, severely low red blood cells, coagulation defects and swollen organs.

HLH occurs as a familial autosomal recessive disorder (primary HLH) or as an acquired, reactive condition (secondary HLH).

Primary HLH typically arises in paediatric patients, is lethal if untreated, and has a 40% mortality rate with current best available care.

The secondary form of the disease typically arises later in life, and is also associated with significant mortality. HLH is an orphan disease for which no drugs have been approved, representing a high unmet need.

Emapalumab has potential in other serious medical conditions, with studies in secondary HLH and haematopoietic stem cell transplant (HSCT) ongoing or being planned.