AM-Pharma BV of the Netherlands is being acquired by a specialist healthcare company in the UK in a deal that will see its enzyme replacement therapy for hypophosphatasia (HPP) advance to Phase 2. The buyer is Ambrose Healthcare Ltd which already has two rare disease programmes in its portfolio and is positioning itself for more. This comes at a time when the US Food and Drug Administration is updating its guidance for the developers of drugs for rare diseases. Current estimates put the number of these diseases at 7,000 to 10,000 globally.
Ambrose is to pay up to €161 million for AM-Pharma comprising an upfront payment and milestone payments contingent on the commercialisation of the Dutch company’s product. Other financial terms were not disclosed in an announcement issued on 20 October.
The product, ilofotase alfa, is a recombinant human alkaline phosphatase enzyme replacement therapy which has been engineered from two human isoforms of the enzyme. The target disease, HPP, is characterised by defective bone and teeth mineralisation and a deficiency of serum and bone alkaline phosphatase activity. The prevalence of severe forms of the disease has been estimated at one person per 100,000, according to the publication, Orphanet Journal of Rare Diseases. Ilofotase alfa has orphan designation from both the FDA and the European Medicines Agency.
Ambrose Healthcare’s two other products are for gastrointestinal manifestations of cystic fibrosis and stage 3-4 pancreatic cancer.
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