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EmeraMed Ltd is a biotechnology firm developing the lipophilic, blood-brain-barrier passing metal chelator and antioxidant Irminix® (Code: NBMI, INN: Emeramide).

Mercury poisoning: The Company has Orphan Drug Designation for the Prevention and Treatment of Mercury toxicity in the EU and USA. Phase 1 and Phase 2a clinical studies have been performed. Phase 2b is in planning.

COPD: A Phase 2a clinical trial is ongoing for the treatment of COPD and finished by November 2017.

Other conditions: Preclinical studies ongoing for other indications.

Expanded access/Early access: A SwissMedic (Switzerland) and FDA (USA) have approved Irminix® for Named Patient/Compassionate use. For more information – please click above.

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Veterinary:

EmeraMed strives to bring cures for diseases faced by animals as well as humans. The Company received veterinary Minor Use for Minor Species (MUMS) designation for Irminix® in December 2012. This is similar to orphan designation for human drugs. The Swedish MPA has since approved compassionate-use treatments for predatory birds. The Company has successfully treated a paralyzed eagle and a dizzy and stumbling owl. Both birds were heavily intoxicated with mercury and after short periods of treatment were up and flying in the Swedish countryside again. The Company will continue to develop veterinary uses for Irminix® in the future.

Early Access Program

Download Early Access Application  (.rtf format can be opened in word)

General information: The use of drugs under development can be approved by a regulatory authority on a Individual Patient Use basis. This is also called Expanded Access, Named Patient Use, Compassionate Use, or Specials, depending on the country. An approval from a regulatory authority is based on whether the condition to be treated is serious enough, whether efficient and safe treatments are existing or lacking, and whether the drug has shown relevant efficacy and safety. In general, only a licensed physician can apply to the regulatory authority. In some countries, no approval is needed. By May 2018 there have been over a hundred approvals and shippings to Switzerland, Germany, Austria, New Zealand, UK, Lebanon and the USA.

The treatment: Currently, we can offer a 14-day treatment x 300mg per day. The treatment length and dosing are limited by the clinical studies that have been performed. If this is enough for the individual patient or not, we cannot answer, as it depends on the indication (disease) to be treated, and the nature and severity of the disease of the individual patient.

Application Information: To apply for an Individual Patient treatment, please download the instructions above or here (.rtf format can be opened in word; also available as PDF here, or email us for a word version at earlyaccess@emeramed.com).

Selected Country Information

No approval by the regulatory authority needed for the physician to order the drug:

Approval by the regulatory authority not required under certain circumstances:

  • Austria
  • Germany – the physician can send us an email at earlyaccess@emeramed.com and we will explain how this is handled.

Approval from regulatory authority required in most countries:

  • Switzerland – a filled in application document for SwissMedic is found here (.rtf format can be opened in word). The physician can apply or several treatments, for un-named patients.
  • United Kingdom – A system has been set up through a company that handles the application process to the MHRA; the physician can send us an email at earlyaccess@emeramed.com and we will explain how this is handled.
  • US  – The FDA has a complicated two step process.
    1) Form 3926 is used. Instructions are found here. The physician will need some documents from us – send us an email at earlyaccess@emeramed.com.
    2) An Institutional Review Board (IRB) is required to oversee the actual treatment. There is a free IRB described in this document (.rtf format can be opened in word).
  • Sweden
  • Denmark
  • Australia
  • Canada
  •         Most other countries.

https://emeramed.com/

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