Unigene - Oral and Nasal Delivered Peptide Drugs

Unigene is a biopharmaceutical company that delivers oral and nasal delivered peptide drugs for the global osteoporosis market. Our major products include nasal / oral salmon calcitonin - oral PTH analogs, oral glucose regulatory peptides, oral leuprolide, oral desmopressin and oral PYY(3-36) NH2.

The company's patented manufacturing technology is designed to cost-effectively produce peptides in quantities sufficient to support our worldwide commercialization strategy of oral and nasal therapeutics.

Unigene's R&D work focuses on a range of pharmaceutical products and procedures including recombinant DNA technology, analytical and immunoassay test development, protein chemistry and more. Our cGMP manufacturing facility supports bacterial and mammalian fermentation, high-tech purification methodologies and analytical testing processes.

BUSINESS ALLIANCES

Unigene actively pursues ventures with a range of international pharmaceutical partners. Negotiations are in progress with the Chinese Shijiazhuang Pharmaceutical Group to commercialize injectable and nasal salmon calcitonin in China. Unigene has also secured an exclusive licensing agreement with Upsher-Smith Laboratories to market Fortical®, the patented nasal calcitonin formulation.

Unigene also holds high-profile licensing agreements with GSK, Novartis and Upsher-Smith. We are currently developing several new products and awaiting US marketing approval for Unigene’s lead product, Fortical® Nasal Spray.

INJECTABLE CALCITONIN

Unigene's injectable calcitonin is an important drug in the treatment of osteoporosis and currently commands a global market of $150 million. In 1998 Unigene obtained marketing authorization from the European Union to supply injectable calcitonin for the treatment of Paget's Disease and Hypercalcemia. In 2003 the drug was authrorized for the treatment management of osteoporotic fractures in 2003 and for Osteoporosis treatment in Switzerland. Injectable calcitonin is currently available for licensing in US and other markets (with the exception of China).

ORAL DESMOPRESSIN AND LEUPROLIDE

Oral desmopressin is used extensively in the treatment of primary nocturnal enuresis and possesses a potential worldwide market of approximately $200 million. Preclinical Studies into oral desmopressin have demonstrated the efficacy an of oral delivery application method.

Unigene has developed oral leuprolide for use in the prostate cancer and endometriosis treatment market. With a projected worldwide market in excess of $1 billion, oral leuprolide is available for licensing in US and other international markets.

GLUCOSE REGULATORY PEPTIDES AND ANALOGS

Unigene's glucose regulatory peptides and analogs are used in the treatment of Type I and Type II diabetes, commanding a projected worldwide market in excess of $1 billion. We have developed a recombinant production methodology for the manufacture of our glucose regulatory peptides and analogs, and the success of the oral delivery practice has been verified by preclinical studies.

PHARMACEUTICAL MANUFACTURING TECHNOLOGY

The company's recombinant "direct expression" technology is used for the scalable and effective production of peptides and small proteins. Our cGMP manufacturing plant supports recombinant peptide production, in vitro amidation technology for peptides requiring c-terminal amidation for biological activity, oral peptide and small protein delivery technology and nasal delivery formulation for calcitonin and other peptides.