ArTiMist® – Treatment for Malaria

ArTiMist® was designed with a child in mind; a child living in a challenging environment where healthcare resources can be very scarce and time is of the essence. ArTiMist is the world’s first sub-lingual spray for the treatment of p. falciparum severe paediatric malaria. The active pharmaceutical ingredient in ArTiMist is artemether, which is a widely used anti-malarial and is currently administered by intra muscular injection or orally in a tablet form.

In 2011, ArTiMist was identified by Thompson Reuters as one of the World’s 5 most promising drugs in Phase III clinical development. Its intrinsic characteristics (efficacy, user-and-patient friendly, hygienic and non-toxic) could make ArTiMist the treatment of choice in urban and in rural locations.

In brief, the benefits of ArTiMist include:

  1. was designed with a child in mind; a child living in a challenging environment where healthcare resources can be very scarce and time is of the essence.
  2. is the world’s first sub-lingual spray for the treatment of P. falciparum severe paediatric malaria.
  3. is administered sub-lingually, enters the bloodstream and attacks the parasite.
  4. is especially effective in the treatment of children and young infants who are experiencing malaria-related gastro-intestinal problems and cannot tolerate oral treatments.

In summary, ArTiMist addresses a major unmet medical need in the paediatric treatment of severe malaria and uncomplicated malaria with GI complications. It also directly addresses the WHO requirement to provide a novel solution to minimise treatment delays to reduce morbidity.

ArTiMist has been submitted for Marketing Authorisation Application with the TGA.

The Company has received a preliminary notice of denial for marketing approval of its ArTiMist® oral spray.  The preliminary notice comes as a result of a process to obtain approval to market the ArTiMist® oral spray in Australia.  The process was commenced nearly 24 months ago during which neither SUDA nor its regulatory advisors received any indication that the process would not be successful.

The preliminary notice was provided to SUDA as a copy of the resolution of the Advisory Committee of Medicines (ACM), which provides independent medical and scientific advice to the Minister for Health and the Therapeutic Goods Administration.  SUDA’s regulatory advisors have explained that whilst the resolution has been received, it does not form part of the TGA’s milestones for the evaluation of prescription medicines, and we will still need to wait for the official Delegate’s letter before we can assess the decision in detail and determine the next steps.

Upon receipt of the Delegate’s letter, SUDA, in consultation with our advisors, will review the reasons for the decision and will determine the appropriate actions to be taken. SUDA has been informed that there is a process that will allow SUDA to appeal the decision.

 

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