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Polyneuron medication receives orphan drug status in the USA

11.06.2020

The American health authority has granted Polyneuron’s drug PN-1007 orphan designation. This status uses special conditions to balance out commercial disadvantages when developing drugs for rare diseases.

Ruben Herrendorff, CEO Polyneuron Pharmaceuticals

According to a press release, a drug manufactured by Polyneuron Pharmaceuticals AG based in Basel has received orphan drug status from the American health authority, the FDA. This status granted to medicines for use in rare diseases helps pharmaceutical companies to develop drugs for which there is only a very small niche market.

The drug developed by Polyneuron, called PN-1007, was developed to treat the autoimmune disease anti-MAG neuropathy. Over the course of the disease, the peripheral nerves become increasingly damaged, which can lead to physical impairments. There is currently no treatment with marketing authorization for this. PN-1007 neutralizes the autoantibodies responsible for this damage.

PN-1007 was already granted orphan drug status by the European Union back in 2017. Health authorities use this to encourage the development of such drugs through tax breaks and discounted fees, for instance in clinical testing. Additionally, research funds and long-term market exclusivity are guaranteed for ten years in the EU and for seven in the USA.

In a financing round in March this year, Polyneuron secured 22.5 million Swiss francs for its first clinical trial with this active substance.

Dr. Ruben Herrendorff, CEO and Co-Founder of Polyneuron, explains: “Receiving orphan designation in the U.S. provides additional validation to the development of PN-1007 as a treatment for anti-MAG neuropathy.” He goes on to add that data published recently in the Journal of Neurochemistry supports this. “We now look forward to evaluating PN-1007 in patients when our phase I/IIa study in anti-MAG neuropathy starts later in 2020.”

Polyneuron is headquartered at Technologiepark Basel. The company has also received support within the framework of BaseLaunch, the healthcare accelerator of the investment and innovation promotion agency Basel Area Business & Innovation.

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