Skip to main content

Polyneuron medication receives orphan drug status in the USA

Ruben Herrendorff, CEO Polyneuron Pharmaceuticals
| News

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.

Share this article

Sign up to receive our newsletter in your inbox.

You may also be interested in

Building the future of healthtech, digital health and techbio in the Basel Area

Meet our Chief Representative USA: with over 30 years in the biotech industry, Kirsten Detrick brings invaluable expertise for companies...
Read More

The power of a persuasive pitch deck

Are you an entrepreneur striving to secure investment for your biotech startup? Start with an effective pitch deck to catch...
Read More

Roche investing an additional 1.2 billion Swiss francs in Basel

Roche will be putting an additional 1.2 billion Swiss francs towards the renovation of its site in Basel. This investment...
Read More

Nouscom secures 67.5 million euros in financing

Biotech company Nouscom has raised 67.5 million euros in a series C financing round. The Basel-based firm intends to use...
Read More

Celebrating six months of innovation: i4Challenge accelerator New Ideas 2022/2023

On the 5th of July 2023, the 3rd iteration of the i4Challenge accelerator program New Ideas came to its conclusion....
Read More

How open innovation in healthtech hubs is fueling the rise of digital healthcare

How the ever-increasing uptake of digital solutions is enhancing patient engagement, increasing access to care and lowering the cost of...
Read More

Do you have a question? We'd like to hear from you.