Contact:
Warren P. Levy, Ph.D. Theresa McNeely
President Director
Unigene Laboratories, Inc. Feinstein Kean Partners Inc.
973/882-0860 617/577-8110
Fairfield, NJ, September 29, 1998 - Unigene Laboratories, Inc. (Nasdaq: UGNE) today announced that the European Committee for Proprietary Medicinal Products (CPMP) has adopted a unanimous Positive Opinion on Unigene’s injectable calcitonin product. The recommendation that the product is approvable for the indications of Paget’s disease and hypercalcemia associated with malignancy will be forwarded to the European Commission, which is expected to issue a Marketing Authorization in due course.
The CPMP, in its Opinion, has agreed that the calcitonin produced by Unigene using its patented manufacturing technology is safe and “authentic”, or that it is identical to calcitonin produced using conventional technologies. This authenticity concept is a crucial component of the regulatory foundation for all of the Company’s calcitonin products. At the final CPMP proceedings the Company, in conjunction with its regulatory advisors and representatives, elected for strategic reasons not to pursue other indications at this time, but intends to file for osteoporosis through a brief supplementary submission, called a “Type II Variation”. This standard submission is typically filed after Marketing Authorization has been granted.
“The CPMP Opinion represents a major step in the execution of our global calcitonin product strategy, and we believe that our actions will provide the most rapid pathway towards commercializing our first calcitonin product in all 15 member states of the European Union,” said Warren P. Levy, President of Unigene. “The Positive Opinion on the safety and authenticity of our manufacturing technology is fundamental not only to our injectable calcitonin, but also to the approval of the oral and nasal calcitonin products that are in our development pipeline.”
Paget’s disease is a chronic disorder that typically results in enlarged and deformed bones in one or more regions of the skeleton. As a result, bone pain, arthritis, noticeable deformities, and fractures can occur. Hypercalcemia occurs in 10% to 20% of people with cancer. The cancers most often associated with hypercalcemia are of the breast, lung, head, neck, and kidney, as well as certain cancers of the blood.
Unigene Laboratories, Inc. is a biopharmaceutical company engaged in the research, production and delivery of valuable therapeutic peptide hormones. The Company has developed manufacturing technology for producing amidated peptides cost-effectively and in quantities sufficient to support the worldwide commercialization of peptide therapeutics for oral delivery. The Company has also developed novel drug delivery technology that has been shown to deliver therapeutic levels of the amidated peptide calcitonin into the bloodstream. Unigene’s first commercial products will be different formulations of calcitonin for the treatment of osteoporosis and other indications. The Company is collaborating with Warner-Lambert on the development of an oral calcitonin product.
Except for historical information, the statements made herein are forward looking statements involving risks and uncertainties. These risks and uncertainties, including those related to the timing or successful completion of the Company’s product commercialization activities, are detailed in the Company’s filings with the Securities and Exchange Commission. |
