Healthcare Industry News: osteoporosis
News Release - May 10, 2006
Unigene Enters into Exclusive Distribution Agreement for Fortical(R) Nasal Spray in IsraelFAIRFIELD, N.J.--(HSMN NewsFeed)--May 10, 2006--Unigene Laboratories, Inc. (OTCBB: UGNE ) has entered into an exclusive distribution agreement with Tzamal Bio Pharma Ltd. to distribute its Fortical® nasal spray in Israel for the treatment of osteoporosis. Tzamal will pay Unigene a fixed price per each unit of product it receives and has guaranteed minimum sales levels for the first three years following the product launch. Tzamal is also responsible for registering the product with the Israeli Ministry of Health, a process that normally requires 6-12 months, and they will reference Unigene's 2005 U.S. approval to facilitate the regulatory review process.
"We are very happy to be the exclusive distributor of Fortical in Israel," commented Eddy Steinberg, General Manager of Tzamal Bio Pharma. "We believe that the product will be well received as a safe alternative to the currently marketed osteoporosis therapies."
"This is a part of our broader strategy to introduce Fortical into additional territories and we feel that Tzamal is well positioned to maximize the product's market penetration in Israel," said Dr. Ronald S. Levy, Unigene's Executive Vice President. "Once the product is approved, we will be supplying them with the identical units that we currently market in the U.S."
Unigene Laboratories, Inc. is a biopharmaceutical company focusing on the oral and nasal delivery of large-market peptide drugs. Due to the size of the worldwide osteoporosis market, Unigene is targeting its initial efforts on developing calcitonin and PTH-based therapies. Fortical®, Unigene's nasal calcitonin product for the treatment of postmenopausal osteoporosis, received FDA approval and was launched in August 2005. Unigene has licensed the U.S. rights for Fortical to Upsher-Smith Laboratories, worldwide rights for its oral PTH technology to GlaxoSmithKline and worldwide rights for its calcitonin manufacturing technology to Novartis. Unigene's patented oral delivery technology has successfully delivered, in preclinical and/or clinical trials, various peptides including calcitonin, PTH and insulin. Unigene's patented manufacturing technology is designed to cost-effectively produce peptides in quantities sufficient to support their worldwide commercialization as oral or nasal therapeutics. For more information about Unigene, call (973) 882-0860 or visit www.unigene.com. For information about Fortical, visit www.fortical.com.
About Tzamal Pharma
Tzamal Pharma is a privately owned sales and marketing organization for Middle Eastern territories. Tzamal is committed to providing hospitals and healthcare funds with high quality pharmaceuticals for defined therapeutic fields such as cancer, infertility and metabolic diseases. For more information, visit www.tzamal-medical.co.il.
Safe Harbor statements under the Private Securities Litigation Reform Act of 1995: This press release contains forward-looking statements regarding us and our business, financial condition, results of operations and prospects. Such forward-looking statements include those which express plans, anticipation, intent, contingency, goals, targets or future development and/or otherwise are not statements of historical fact. We have based these forward-looking statements on our current expectations and projections about future events and they are subject to risks and uncertainties known and unknown which could cause actual results and developments to differ materially from those expressed or implied in such statements. These forward-looking statements include statements about the following: general economic and business conditions, our financial condition, competition, our dependence on other companies to commercialize, manufacture and sell products using our technologies, the uncertainty of results of animal and human testing, the risk of product liability and liability for human trials, our dependence on patents and other proprietary rights, dependence on key management officials, the availability and cost of capital, the availability of qualified personnel, changes in, or the failure to comply with, governmental regulations, the failure to obtain regulatory approvals for our products and other risk factors discussed in our Securities and Exchange Commission filings. Words such as "anticipates," "expects," "intends," "plans," "predicts," "believes," "seeks," "estimates," "may," "will," "should," "would," "potential," "continue," and variations of these words (or negatives of these words) or similar expressions, are intended to identify forward-looking statements. In addition, any statements that refer to expectations, projections, or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. These forward-looking statements are not guarantees of future performance and are subject to certain risks, uncertainties, and assumptions that are difficult to predict. Therefore, our actual results could differ materially and adversely from those expressed in any forward-looking statements as a result of various risk factors.
Source: Unigene Laboratories
Issuer of this News Release is solely responsible for its
Please address inquiries directly to the issuing company.