Company Position on Expanded Access to Investigational Products

InnoCare Pharma, Inc. (InnoCare) is dedicated to the discovery and development of novel safe and effective therapies to treat serious and life-threatening diseases. For investigational drugs, InnoCare Pharma focuses its development resources on conducting clinical studies required by regulatory authorities to fully answer important scientific questions about their potential risks and benefits, and to obtain regulatory approvals. InnoCare believes that the best way for a patient to have access to an investigational medication is via a clinical trial. InnoCare’s clinical trials, including eligibility criteria, can be found at  https://www.clinicaltrials.gov/. Patients who are interested in InnoCare’s clinical trials should consult with their treating physicians.

Under certain circumstances, however, individual patients who do not qualify for these trials may inquire InnoCare through their physicians for potential access to the investigational drugs for expanded access or compassionate use. Physicians must make the formal request to InnoCare on behalf of the patient. InnoCare evaluates all requests in a fair and equitable manner on a case-by-case basis, weighing all of the following criteria:

• The patient has a serious or life-threatening illness or condition and is either no longer responsive to or no longer able to tolerate any available treatment option.
• The investigational drug is in active clinical development with sufficient data available to determine an appropriate dose and schedule for the patient’s specific condition.
• A benefit-risk analysis, based on both the available clinical data as well as the requesting physician’s assessment of the individual patient’s condition and history, supports making the investigational drug available.
• Making the investigational drug available will not negatively impact or delay the conduct of clinical trials or regulatory review or approval of the investigational drugs for broader patient access; and
• Adequate supply of the investigational drug is available.

InnoCare Pharma, Inc. may require more detailed information in order to fully evaluate a request and make a final decision.

Physicians seeking expanded access to investigational drugs for patients should submit their requests to clinicaltrialsinfo@innocarepharma.com. InnoCare will make efforts to respond to each submitted request promptly.