ACCESS TO INVESTIGATIONAL PRODUCTS
Omeros is committed to helping patients by discovering, developing, and obtaining regulatory approval for novel therapeutics. As part of therapeutic development, we engage in clinical research to evaluate our product candidates’ safety and efficacy. For information about our clinical trials that are currently recruiting, visit clinicaltrials.gov.
Omeros is aware that some patients may not be able to wait until a product is approved to treat their illness or condition and may not be able to participate in a clinical trial. Omeros is sometimes able to provide such patients with early access to investigational products based on considerations including, but not limited to, the following criteria:
- The patient has a serious or immediately life-threatening disease or condition.
- There is no comparable or satisfactory alternative therapy for the disease or condition available for the patient.
- The patient does not qualify for participation in, or have access to, any of Omeros’ ongoing clinical trials.
- There is sufficient clinical evidence to anticipate that the patient may experience a clinically meaningful benefit and that the investigational product will have an acceptable safety profile in the relevant indication such that the potential benefit justifies the potential risks.
- Providing expanded access to the investigational product will not interfere with the development of the product.
- Omeros has adequate supply of the investigational product.
- The request for expanded access to the product has been made by a qualified and licensed physician in the United States with expertise and facilities appropriate for the administration of the therapy and for the monitoring, managing, and reporting of side effects as well as clinical outcomes.
Omeros will consider the above criteria in determining whether to offer expanded access to its investigational products; however, Omeros cannot guarantee that the investigational product will be made available to a particular patient.
A patient’s physician may request additional information on how to apply for access to one of Omeros’ investigational products by contacting Omeros Medical Affairs at email@example.com. Omeros will endeavor to acknowledge expanded access requests within 5-10 business days of receipt. Physicians who receive Omeros investigational product through expanded access are required to comply with all applicable laws and regulations, as well as contractual conditions, including those relating to safety reporting.