To leverage the broad utility of our patented manufacturing and delivery technologies to create a new generation of safe and effective peptide pharmaceuticals that can provide a more natural approach to the prevention and treatment of disease.
To enable our partners and clients to develop peptide and protein drugs for the treatment of a variety of chronic diseases, thereby enhancing the health and well-being
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Rollover an Orb on the DNA strand to see one of our Corporate Milestones
Founded in 1980, Unigene is a publicly traded biopharmaceutical company with corporate offices, an R&D facility and a state-of-the-art recombinant manufacturing facility in New Jersey. Our broad experience in molecular biology, protein chemistry, immunology and formulation development combined with our entrepreneurial spirit and innovation have led to the development of proprietary technologies, protected by a strong patent portfolio, enabling the commercialization of peptide drugs.
Our technologies and products are licensed and utilized by some of the world’s leading pharmaceutical companies and we have collaborations with world-renowned universities to develop peptides and technologies.
Unigene is unique among biopharmaceutical companies in that we offer a combination of manufacturing and delivery technologies that enable commercialization of peptide-based pharmaceuticals.
Unigene’s extensive product development experience and capabilities will expedite time to market for our partner’s products.
Peptide Product Development Stage Availability/
Preclinical P1 P2 P3 Regulatory Review Approval
sCT nasal U.S. (Fortical®) Upsher Smith
sCT injectable (Forcaltonin®) Worldwide**
sCT nasal Outside US**
sCT oral Worldwide
PTH analogs oral GSK
GLP-1 analogs oral Worldwide
Leuprolide oral Worldwide
*Site Directed Bone Growth **Except Greece and China
MAJOR PRESS RELEASES
Unigene Achieves $5.5 Million Milestone in Calcitonin Collaboration for Phase III Initiation
8:17a ET February 27, 2007 (Business Wire)
The initiation of a Phase III clinical study for osteoporosis by Nordic Bioscience, the development partner of Novartis Pharma AG, with oral calcitonin has triggered a $5.5 million milestone to be paid by Novartis to Unigene Laboratories, Inc. (OTCBB: UGNE).
Salmon calcitonin, the active pharmaceutical ingredient in Novartis' oral product, was produced using Unigene's patented manufacturing process, which was licensed to Novartis in 2004. In 2005, the technology was transferred successfully to Sandoz, an affiliate of Novartis, who produced multiple kilograms of calcitonin at a scale that represents a ten-fold increase above Unigene's current production capacity. Under the terms of that agreement, Unigene is eligible to receive up to $18.7 million in payments before royalties. Upon receipt of this milestone payment, Unigene will have received $13.7 million of that total.
"We are pleased that a pivotal study has started with an oral product made with our calcitonin manufacturing technology," commented Dr. Ronald S. Levy, Executive Vice President of Unigene. "This action confirms Novartis' intention to utilize Unigene's technology to commercialize the product. We believe that this study, combined with Novartis' planned study for oral calcitonin in osteoarthritis, will serve to highlight the significant potential market opportunities for calcitonin-based products in the future."
Shijiazhuang Pharma and Unigene to set up JV to produce osteoporosisdrug
Shanghai. January 4. INTERFAX-CHINA - Shijiazhuang Pharmaceutical Group
Co. Ltd. and U.S.-based Unigene Laboratories have recently signed an
agreement to set up a joint venture that would produce an osteoporosis
drug, a company official told Interfax yesterday.
"The two sides will both inject $15 million to set up the joint venture,
which will produce calcitonin salmon," a Shijiazhuang Pharma manager
overseeing the project, surnamed Wang, said.
An effective osteoporosis treatment, calcitonin salmon is currently
produced through chemical synthesis, which, according to Wang, is an
inefficient production method. Unigene produces the drug using genetic
fermentation technology, which is more cost-effective than chemical
"The joint venture will be competitive when it is up against well-
established domestic companies, in terms of technology and production
costs of calcitonin salmon," Wang said.
The joint venture is expected to produce 70 million calcitonin salmon
injections and 4 million calcitonin salmon nasal sprays per year, with
annual sales expected to reach RMB 708 million ($97.25 million),
including projected exports of $50 million.
Production of the drug is expected to start before the end of this year,
The joint venture also plans to establish a biotechnology development
platform to develop and commercialize other biotech drugs.
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(R), 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. The Company is also manufacturing a second peptide for 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.
Safe Harbor statements under the Private Securities Litigation Reform Act of 1995: This press release contains forward-looking statements as defined in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Such forward-looking statements are based upon Unigene Laboratories, Inc.'s management's current expectations, estimates, beliefs, assumptions, and projections about Unigene's business and industry. 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. These risks and uncertainties include the risks associated with the effect of changing economic conditions, trends in the products markets, variations in Unigene's cash flow, market acceptance risks, technical development risks and other risk factors detailed in Unigene's Securities and Exchange Commission filings.
SOURCE: Unigene Laboratories, Inc.
Investor Contact: The Investor Relations Group Daniel Berg/Dian Griesel, Ph.D., 212-825-3210 or Media: Janet Vasquez, 212-825-3210