• Neuren’s breakthrough drug DAYBUE starts selling in the US
  • Orthocell commences nerve repair study

 

Market darling Neuren Pharma (ASX:NEU) jumped 4% today after announcing that DAYBUE (trofinetide) is now officially available for the treatment of Rett syndrome in adult and children (2 years of age and older) in the United States.

DAYBUE was approved by the US FDA on March 10, and is the first and only drug approved by the FDA for the treatment of Rett syndrome.

Neuren and its North American partner Acadia have an exclusive licence agreement for Acadia to develop and commercialise the drug in North America.

As part of that agreement, US$40 million is payable to Neuren following the first commercial sale in the US.

Neuren is also eligible to receive ongoing royalties on net sales in North America, plus milestone payments of up to US$350 million if a series of four annual sales thresholds are achieved.

In addition, Neuren is eligible to receive one-third of the market value of the Rare Pediatric Disease Priority Review Voucher that was awarded to Acadia by the FDA upon approval of the NDA. This one-third share is estimated by Neuren at US$33 million.

No royalties or other costs are payable by Neuren to third parties, which means that Neuren’s revenue from Acadia will flow directly through to pre-tax profit.

Separately, Neuren is currently conducting Phase 2 trials of its second drug candidate, NNZ-2591, for each of Phelan-McDermid syndrome, Angelman syndrome, Pitt Hopkins syndrome and Prader-Willi syndrome.

 

Orthocell commences nerve repair study

Orthocell (ASX:OCC) has commenced a comparison study as part of its pre-clinical and clinical development programs in nerve repair and regeneration.

The study will collect information regarding mechanism of action that is possible or not possible to collect in the human clinical trials.

The outcomes from the study will support product marketing initiatives, as well as international regulatory approval and reimbursement strategies for its nerve repair device, Remplir.

This follows a regulatory approval of Remplir for peripheral nerve repair in Australia in February 2022, and inclusion of the drug on Australia’s Prosthesis List for reimbursement.

Orthocell believes Remplir has the potential to become the leading device in the US with an addressable market estimated to be worth more than US$1.1 billion per annum.

Orthocell CEO Paul Anderson says the outcomes of this study will validate that Remplir is easier to use and reduces the need for sutures, resulting in more consistent and predictable return of muscle function.

“Remplir has shown, in previous studies, to be the superior product for nerve regeneration when compared to an FDA-approved comparator device,” Anderson said.

The study will be undertaken in collaboration with Professor Bill Walsh, at University of New South Wales, with a target study completion Q1 2024.

 

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