Unigene Laboratories, Inc. announced today that Novartis has released information on the first of two studies on oral calcitonin for the treatment of osteoarthritis conducted by its license partner Nordic Bioscience.
The recently completed Study 2301, which assesses the safety and efficacy of oral calcitonin in the treatment of knee osteoarthritis, had three co-primary endpoints.
Top-level results indicate that the study did not meet the first of three co-primary endpoints, joint space width narrowing. Results from the other two co-primary endpoints indicated clinical efficacy related to symptom modification (WOMAC scale for pain and function). MRI analyses suggested an effect on cartilage.
Novartis and its license partner Nordic Bioscience will continue to work together to further analyze and evaluate the results of this study and determine the appropriate next steps. More detailed information on this clinical trial program will be shared appropriately as it is made available to Unigene from its license partner Novartis.
The second two-year, Phase III Study 2302, which also assesses safety and efficacy of oral calcitonin in patients with osteoarthritis of the knee, is currently ongoing.
Novartis and Nordic Bioscience also have confirmed that a concurrent three-year Phase III study 2303 of oral calcitonin for the treatment of osteoporosis is proceeding as planned.
Novartis has a worldwide license to produce recombinant calcitonin under Unigene’s patented E. coli manufacturing technology. Calcitonin manufactured under the Unigene license is currently being used for all three of the oral calcitonin studies being conducted by Novartis and Nordic Bioscience.
The commercial products also will use calcitonin manufactured with Unigene’s licensed process. Unigene’s Chief Executive Officer Ashleigh Palmer commented that “Unigene continues to be positive about the potential of calcitonin for the treatment of osteoporosis and osteoarthritis.
Unigene is eligible to receive milestones and royalties on the sale of the Novartis calcitonin product for both indications. We anticipate that the launch of oral calcitonin would be a significant revenue driver for the Company.”
SOURCE Unigene Laboratories, Inc.