To: Laszlo who wrote (338 ) 1/21/2000 1:46:00 PM From: terri acey Read Replies (1) | Respond to of 347
Unigene Receives First Product Approval;Injectable Calcitonin Product Approved in European Union FAIRFIELD, N.J., Jan. 19 /PRNewswire/ -- Unigene Laboratories, Inc. (Nasdaq: UGNE) today announced that it has received approval from the Commission of the European Communities to market its injectable calcitonin product, FORCALTONIN(TM), in all 15 member states of the European Union. The product has been approved for the treatment of Paget's disease and hypercalcemia associated with malignancy. The Company plans to file a supplementary submission called a Type II Variation later this quarter in order to expand the approved indications to include the treatment of osteoporosis. "European approval of FORCALTONIN, our first product to be commercialized, is a very significant achievement for Unigene," said Warren P. Levy, President of Unigene. "Not only will sales of FORCALTONIN generate our first product revenues, but this approval confirms that our calcitonin is safe and is identical to calcitonin produced using conventional methods. This authenticity concept has always been a crucial component of the Company's global strategy for the other calcitonin products in our development pipeline." Earlier this month, Unigene announced that it had granted its first European license to Strakan Ltd. for the distribution of FORCALTONIN in the United Kingdom and Ireland. Unigene Laboratories, Inc. is a biopharmaceutical company engaged in the research, production and delivery of valuable therapeutic peptide hormones. The Company has developed and patented 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. 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. SOURCE Unigene Laboratories, Inc. CO: Unigene Laboratories, Inc. ST: New Jersey IN: MTC SU: PDT 01/19/99 08:00 EST prnewswire.com