Noxopharm (ASX:NOX) - CEO, Dr Gisela Mautner
CEO, Dr Gisela Mautner
Source: Noxopharm
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  • Noxopharm’s (NOX) lead oncology drug Veyonda has been granted Orphan Drug Designation (ODD) by the US Food and Drug Administration (FDA)
  • Veyonda is used to treat soft tissue sarcoma, a broad term for cancers that start in the soft tissues such as in muscles, fat, tendons and the lymph
  • It works in tandem with chemotherapy and radiotherapy with the aim of increasing the number of cancer cells killed by those treatments
  • The FDA grants Orphan Designation to drugs that show a safe and effective treatment for diseases affecting less than 200,000 people in the USA per year
  • Noxopharm is up 17.2 per cent on the market with shares trading at 37.5 cents

Noxopharm’s (NOX) lead oncology drug Veyonda has been granted Orphan Drug Designation (ODD) by the US Food and Drug Administration (FDA).

Veyonda is used to treat soft tissue sarcoma which is a broad term for cancers that start in the soft tissues such as in muscles, fat, tendons and the lymph.

It works in tandem with chemotherapy and radiotherapy with the aim of increasing the number of cancer cells killed by those treatments.

It then acts as an immune-oncology drug by switching on the body’s first-line defence mechanism which is the main system responsible for fighting cancer.

The FDA grants Orphan Designation to drugs that show a safe and effective treatment for diseases affecting less than 200,000 people in the USA per year.

ODD provides seven years of market exclusivity and it waives new drug application fees which were roughly $2.9 million in 2021.

“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,” DEO Dr Gisela Mautner commented.

“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.”

Noxopharm was up 17.2 per cent on the market with shares trading at 37.5 cents at 1:10 pm AEDT.

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