EXPANDED ACCESS AND COMPASSIONATE USE Innovation

EXPANDED ACCESS AND COMPASSIONATE USE
Innovation Pharma is dedicated to discovering and advancing innovative medical therapies with dermatology, oncology, anti-inflammatory and antibiotic applications.

At this stage in our drug development program, we are evaluating the safety and efficacy profiles of two first-in-class drug candidates—Kevetrin and Brilacidin—to inform our understanding of their full therapeutic potential. Such work is being conducted in preparation for potential submission to the Food and Drug Administration (FDA) for drug approval, pending continued successful outcomes.

To learn more about our clinical trials, including possible opportunities to participate in ongoing or upcoming studies, visit ClinicalTrials.gov—a government-run database listing private and publicly-funded clinical studies conducted around the world.

As part of drug development, the FDA allows for potential Expanded Access/Compassionate Use of an Investigational New Drug before any regulatory approval might be achieved. This opportunity applies only to patients with serious or life-threatening conditions who are unable to participate in a clinical trial and have exhausted alternative treatment avenues.

For FDA regulations on Expanded Access/Compassionate Use, please visit the FDA website.

Patients and physicians should refer to the following information before contacting us about potential Expanded Access/Compassionate Use opportunities.

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Innovation Pharmaceuticals places patient safety first—whether for an Investigational, Expanded or Approved use of our drug treatments.

We will only consider Expanded Access/Compassionate Use if the following criteria are met:

A sufficient safety profile of an investigational drug has been determined;

if the Expanded Access / Compassionate Use will not interfere with or compromise clinical trials that could be used to support an FDA application for approval of the treatment;

and when there is an adequate supply of drug treatment for the necessary clinical trials before supplying drug treatment for Expanded Access / Compassionate Use patients.

If you are a potential patient and your physician believes you may be a candidate for an Expanded Access / Compassionate Use of one of our drugs—having already prepared the necessary documentation for submission—please ask your physician to contact us at expandedaccess@ipharminc.com. Innovation Pharmaceuticals will review and respond to Expanded Access / Compassionate Use requests within 10 days of receipt.