Onalta is Molecular Insight’s radiotherapeutic product candidate under development for the treatment of metastatic carcinoid and pancreatic neuroendocrine tumors in patients whose symptoms are not controlled by conventional therapy. Onalta’s anti-cancer activity is due to its ability to selectively deliver lethal radiation to cancer cells. Onalta is our brand name for yttrium-90 radiolabeled edotreotide, a radiolabeled somatostatin analog. Carcinoid tumors are neuroendocrine tumors of the gastrointestinal (GI) tract and bronchus.
Onalta binds selectively to tumor cells that have receptors for the peptide hormone somatostatin on their surface and serves as a carrier for targeted delivery of a lethal dose of radiation to the cancer cells through the radioactive decay of yttrium-90.
The Market Opportunity
There are about 170,000 people suffering from this condition in the United States. Except for rare, early diagnosis of carcinoid outside the gastrointestinal tract, surgical cure is unlikely. Patients with metastatic disease are at increased risk of severe and debilitating symptoms that greatly diminish their quality of life. Most patients are not diagnosed until the carcinoid syndrome has become life-threatening and/or liver metastases have developed. By then, less than 30% of the patients survive five years. In these cases, surgery provides only amelioration of the disease morbidity and briefly improves quality of life, but only in selected patients. Chemotherapy with single or combination cytotoxic agents has produced little benefit. The therapeutic goal for patients who have an endocrine-active tumor that cannot be treated adequately by surgery is decreasing hormone production to control symptoms by somatostatin or somatostatin analogues. However, treatment benefit often disappears in six to 18 months.
Clinical Development Plan
Three Phase 1 and three Phase 2 clinical trials involving more than 300 patients have been conducted on Onalta, which has been granted Orphan Drug Status by the FDA. In May 2009 Molecular Insight announced that the European Medicines Agency (EMEA) has approved its Phase 3 protocol for Onalta. The Company plans to complete a Phase 3 clinical trial development program for Europe and initiate a study in the United States that would validate an imaging surrogate for Onalta to be used for assessing organ dosimetry and optimize patient dosing preparatory to cancer therapy.
Molecular Insight Sub-Licenses Onalta
Molecular Insight has completed an agreement to sub-license its Onalta™ brand 90-Y edotreotide radiotherapeutic in certain countries in Europe, the Middle East, North Africa, Russia and Turkey to BioMedica Life Sciences, S.A., Athens, Greece. The agreement provides BioMedica an exclusive sub-license to intellectual property rights and know-how of Molecular Insight with respect to Onalta. Under the agreement, BioMedica is expected to perform clinical studies and market, distribute and commercialize Onalta in the specified territories and secure all regulatory approvals. Under the terms of the agreement, BioMedica will purchase finished product, including compassionate use and clinical trial supplies, exclusively from Molecular Insight for a five-year period, with a five-year renewal option. Molecular Insight continues to retain all rights to all other markets and territories, including the United States, Japan and Asia.