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81 Fulton St
Boonton, NJ 07005 USA
phone:(973)265-1100
fax:(973)335-0972
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| Symbol |
UGNE |
| Exchange |
OTCBB |
| Founded |
1980 |
| Employees |
66 |
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| www.unigene.com
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| Research Sector |
Biotech Specialty Pharma |
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| Summary Description |
| Peptide pharmaceutical for disease prevention, treatment |
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| Management |
| Warren Levy, Ph.D., President and CEO; Ronald Levy, Ph.D., Executive Vice President and Secretary; James Gilligan, Ph.D., Vice President for Product Development; Nozer Mehta, Ph.D., Vice President, Biological Research and Development; Paul Shields, Ph.D., Vice President, Manufacturing Operations |
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| Keywords |
| osteoporosis, osteoarthritis, obesity, endometriosis, prostate, peptide |
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| Description |
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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. Unigene's mission is to leverage the broad utility of 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. Unigene�s technologies for the large-scale recombinant manufacturing of peptides and formulations for compliance-friendly delivery are capable of being applied to a wide variety of peptide and protein-based therapeutics. The company�s clinical and R&D peptide programs cover therapeutic areas of osteoporosis, osteoarthritis, satiety/obesity, endometriosis, prostate cancer, pain, site-directed bone growth (SDBG), and diabetes. |
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| Technology / Differentiation |
| Drugs that are delivered by non-injectable routes of administration have an inherently low bioavailability compared to injectable products. This requires an abundant source of relatively inexpensive active pharmaceutical ingredient (peptide or protein) to support a commercial product. Unigene's proprietary recombinant expression technology in E.coli is ideally suited to solving this problem and offers several significant advantages. In order to deliver peptides and proteins orally, key physiologic barriers must be overcome: degradation resulting from gastric and intestinal enzymes and the limited intestinal permeability to large molecules. Innovative research at Unigene has resulted in the development of solid dosage forms (capsules and tablets) that address these problems and deliver these compounds across the lumen of the intestine with good bioavailability. Amidation of peptides in eukaryotic cells is a post-translational step accomplished by an enzyme called peptidyl-glycine alpha-amidating monooxygenase (PAM). Bacteria do not possess the PAM enzyme. Therefore Unigene expresses peptides as glycine-extended precursors in bacteria (which are relatively simple and inexpensive to grow) and then converts them to the active, amidated form by an in vitro reaction using recombinant PAM enzyme. This two-step process is far more scalable and cost effective than a single-step production process utilizing eukaryotic cells. |
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| Status |
| The U.S. FDA is currently reviewing Unigene's new drug application (NDA) for Fortical. Unigene's patented oral delivery technology has successfully delivered, in preclinical and/or clinical trials, various peptides including calcitonin, PTH and insulin. |
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