GSK decided to nix development plans despite positive Phase II trial data.
Unigene has regained worldwide rights to its oral recombinant parathyroid hormone (rPTH) candidate from GlaxoSmithKline (GSK) after the latter decided not to proceed with further clinical development. Positive data from a Unigene-conducted Phase II study evaluating the drug in the treatment of postmenopausal osteoporosis was reported in November. Under terms of their original agreement, GSK had 75 days from review of the Phase II data to decide whether to proceed with clinical development of the PTH analog.
Unigene says it remains confident that it will find a new late-stage development partner and licensee over the course of the coming year to continue development of the product. It projects having enough cash to fund its business operations into the second half of 2012.
The firm claims the injectable PTH market is currently worth about $1 billion, with sales expected to double over the next two to three years. “Our oral PTH product candidate has the potential to transform the lives of the estimated 75 million people in Europe, the U.S., and Japan who are impacted by osteoporosis, while redefining the $5 million global marketplace for pharmaceutical treatments for the disease,” remarks Ashleigh Palmer, Unigene president and CEO.
“We respect GSK’s decision and remain extremely pleased with the positive and statistically significant Phase II data reported last month,” Palmer continues. “These results have further validated Unigene’s proprietary oral peptide drug delivery technology and, importantly, clearly demonstrate the viability of an oral PTH product.”
Unigene specializes in the design and development of peptide therapeutics. The firm is exploiting its Peptelligence™ peptide delivery and E. coli-based production platform through a range of partnerships.