Key Developments For Molecular Insight Pharmaceuticals, Inc.
Molecular Insight Pharmaceuticals, Inc. (MIPI.O) (Consolidated Issue listed on NASDAQ Global Market)
Molecular Insight Pharmaceuticals, Inc. Finalizes Onalta Manufacturing And Supply Agreements
Molecular Insight Pharmaceuticals, Inc. announced that it has executed an exclusive 10 year agreement to supply the Onalta 90-Y edotreotide radiotherapeutic to BioMedica Life Sciences S.A., Athens, Greece. The Company also announced that it has entered into a contract manufacturing agreement with Berlin-based Eckert & Ziegler to manufacture and supply Onalta for compassionate use and registration clinical trials within the BioMedica territories. Upon European Medicines Agency (EMEA) approval of a Market Authorization Application, based on clinical studies, Eckert & Ziegler is expected to manufacture Onalta for commercial sales as well. The term of this agreement is for 10 years.
Molecular Insight Pharmaceuticals, Inc. Presents Azedra 12 Month Efficacy Data From Phase I Clinical Trial In Patients With Neuroendocrine Cancers, Pheochromocytoma and Paraganglioma
Molecular Insight Pharmaceuticals, Inc. announced one year follow up data from a Phase I dose escalation clinical study of Azedra demonstrating a positive safety profile and durable objective tumor responses in patients with neuroendocrine cancers, pheochromocytoma and paraganglioma. The study was designed to evaluate the safety and identify the maximum tolerated dose (MTD) of Azedra, as well as to collect clinical data on efficacy. In 12 month data reported, a single dose of Azedra was shown to be well tolerated by patients, and toxicities were predictable and manageable. Additionally, Azedra demonstrated clinical benefit, stabilizing or reducing tumor volumes in a majority of patients. 21 patients were treated at escalating dose levels from 6 to 9 mCi/kg. Best confirmed overall response per RECIST was partial response (PR) for three patients (14%), stable disease for 14 (67%), progressive disease for two (10%), and not evaluable for two (10%) who had no follow-up scans. All three patients with PR demonstrated this response at the first post therapy visit at three months and sustained the response through 12 months. In addition, Azedra has been granted Orphan Drug designation and Fast Track status by the FDA. Under these programs, Molecular Insight plans to file a New Drug Application (NDA) based on the Phase 2 data and anticipates expedited FDA review of its application.
Molecular Insight Pharmaceuticals, Inc. Sub-Licenses Onalta For Development
Molecular Insight Pharmaceuticals, Inc. announced that it 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 and Novartis 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. Under terms of the agreement, Molecular Insight will receive an initial, nonrefundable payment of $4.4 million and will be eligible to receive additional regulatory milestone payments. Overall, Molecular Insight could receive more than $10 million in total regulatory milestone and upfront payments, net of license payments. Molecular Insight also is eligible to receive milestone and tiered royalties on Onalta sales.
Molecular Insight Pharmaceuticals, Inc. Files Universal Shelf Registration Statement
Molecular Insight Pharmaceuticals, Inc. announced that has filed a shelf registration statement on Form S-3 with the Securities and Exchange Commission. The shelf registration statement, when declared effective by the Securities and Exchange Commission, will allow the Company the flexibility to potentially offer and sell from time to time in the future, in one or more public offerings, up to $250 million of common stock, preferred stock, debt securities, warrants, stock purchase contracts or stock purchase units, or any combination thereof. The specifics of any potential future offering, along with the prices, terms, and the use of proceeds of any such securities offered by the Company, will be determined at the time of any applicable offering and will be described in detail in a prospectus supplement at the time of such applicable offering.
Molecular Insight Pharmaceuticals, Inc. Advances Azedra Program Into Pivotal Phase 2 Therapeutic Trial
Molecular Insight Pharmaceuticals, Inc. announced that it has initiated a pivotal Phase 2 clinical trial for Azedra (Ultratrace Iobenguane I 131), its lead oncology candidate for the treatment of malignant pheochromocytoma, a type of neuroendocrine cancer. The single arm trial will evaluate the efficacy and safety of Azedra in adult patients with malignant relapsed/refractory pheochromocytoma and position Molecular Insight to file a New Drug Application (NDA). Azedra has been designated as an Orphan Drug with Fast Track status by the U.S. Food and Drug Administration. Pheochromocytoma tumors are usually found in the adrenal glands, but may arise in other areas of the body. For malignant pheochromocytoma, radiation therapy offers short term symptomatic relief, but no cure. Chemotherapy trials have failed to produce cures or significant remissions. For patients with this malignant disease, for whom surgery is not an option, the five year survival rate is less than 50%. Azedra is a targeted radiotherapeutic, which consists of the known iobenguane I 131 molecule (commonly known as I-131-MIBG) radiolabeled using the Company's Ultratrace technology.
