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News & Trends - Biotechnology

Noxopharm one of few Australian companies to secure Orphan Drug Designation

Health Industry Hub | April 1, 2022 |
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Biotech News: Australian biotech Noxopharm’s lead oncology drug candidate Veyonda has been granted Orphan Drug Designation (ODD) by the United States Food and Drug Administration (FDA) for its use in the treatment of soft tissue sarcoma.

The ODD program has been established by the FDA to encourage companies to develop treatments for less common disorders. The FDA grants orphan status to drugs that show promise to be a safe and effective treatment for diseases affecting fewer than 200,000 people per year in the USA. Receiving the ODD will speed up the Company’s commercial development plan for the important US market.

Noxopharm CEO, Dr Gisela Mautner stated “It is pleasing that the Noxopharm application for Orphan Drug Designation was approved so quickly. Considering that out of approximately 360 approved ODDs last year, only four went to Australian companies, demonstrates the high bar that is being set by the FDA. The 7-year period of market exclusivity is commercially extremely valuable, as it means that the FDA will not approve a subsequent drug for the same use within this timeframe.

“The ODD will significantly increase the value proposition of Veyonda to potential purchasers or licensees by both lowering current development costs and by providing future competitive and financial advantages as Veyonda progresses through the clinical trial stages towards registration and approval for sale in the US. With the FDA orphan drug designation now secured for Veyonda, the Noxopharm team is excited to move our preclinical assets along the drug development process, while continuing to deliver on our clinical program plan.”

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An ODD confers the following benefits:

  • Orphan Drug Exclusivity (ODE) provides seven years of market exclusivity
  • Waiver of New Drug Application fees (value of approximately $2.9 million in 2021)
  • Opportunities for grant funding from the Office of Orphan Products Development and
  • Regulatory guidance and assistance from the FDA with the drug development process

Noxopharm is currently conducting the CEP-2 trial into the treatment of soft tissue sarcoma in the United States and will keep the market informed as the study proceeds.


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