Unigene Laboratories Inc. will receive a $2.5 million payment to supply Novartis with specified quantities of a bulk peptide necessary to support Novartis' development programme for a novel osteoporosis treatment.
Over the next several months, Unigene will use its patented manufacturing technology to develop an FDA-compliant process for the peptide, and Novartis will have the opportunity to purchase additional quantities as necessary. Some of this material may be used in clinical studies, a company release stated.
In 2004, Novartis exclusively licensed Unigene's technology to manufacture another peptide, calcitonin, and it now runs the scaled-up process at its manufacturing facility in Kundl, Austria.
"We are very pleased to expand our relationship with Novartis," commented Dr Ronald S Levy, executive vice president of Unigene. "They have a strong commitment to peptide therapeutics as well as to osteoporosis products. Our calcitonin collaboration has been extremely successful, and we hope to have additional opportunities to work with them."
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 US 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 pre clinical 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 commercialisation as oral or nasal therapeutics.