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Clinigen partners with US firm to provide access to new ALS drug in Europe - Proactiveinvestors (UK)

Clinigen Group’s (LON:CLIN) Idis business has teamed up with Neuraltus Pharmaceuticals to provide access in Europe to a drug the latter is developing for amyotrophic lateral sclerosis.

Also known as Lou Gehrig's disease, after the New York Yankee’s baseball hero who died from ALS, the neurodegenerative disorder affects 400,000 people worldwide - 50,000 of them here in Europe.

The companies are partnering to initiate a managed access programme in ‘selected countries’ for NP001, Neuraltus' investigational therapy. The plan is to expand coverage over the next year.

"By partnering with companies like Neuraltus, Idis Managed Access plays a vital role in providing ethical access to unapproved medicines, like NP001, for patients with unmet medical needs," said Simon Estcourt, managing director of Idis.

"Our global regulatory and logistical expertise mean that we can deliver a fast and efficient response to physician inquiries. We look forward to working with both Neuraltus and the ALS community, to help patients in Europe who have no other available treatment options."

Managed access programmes such as the one being overseen by Idis give patients the opportunity to receive potentially life-saving medicines and treatments before they are formally approved by regulators.

The Clinigen unit runs a number of similar schemes using its distribution network to get new drugs to those most in need.

Rich Casey, chief executive of Neuraltus, said: "We have received numerous inquiries from physicians, patients and their families regarding access to and inclusion in clinical studies for NP001.

“The planned phase-II study in the United States, coupled with our ability to provide NP001 to qualifying patients under a managed access programme in Europe, underscores our commitment to the ALS community."
 
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