Unigene Laboratories ($UGNE) says it has regained the global rights to an oral formulation of a parathyroid hormone analog to treat osteoporosis in postmenopausal women from GlaxoSmithKline ($GSK).
The Boonton, N.J., company announced the news Dec. 5, noting that it gained the drug back after GlaxoSmithKline decided not to move ahead with development of the formulation, "based on its internal evaluation criteria" of the compound's Phase II results announced last month.
As part of the Unigene/GlaxoSmithKline amended licensing deal signed about a year ago, Unigene had agreed to manufacture the oral parathyroid hormone formulation and said it would conduct a Phase II study. GlaxoSmithKline had up to 75 days, based on a review of that trial data, to decide whether or not it would proceed.
Unigene announced Nov. 9 what it termed "positive top-line results" that "achieved its primary endpoint with statistical significance." GlaxoSmithKline apparently disagreed and pulled out. Unigene could have made as much as $140 million, plus global royalties, assuming the drug formulation met regulatory and commercial milestones. With their agreement dead, however, GSK paid Unigene just $8 million for the Phase II study.
Undaunted, Unigene President and CEO Ashleigh Palmer said in a statement that the company will seek to publish its full data from the Phase II trial in 2012, and give the $5 billion global osteoporosis marketplace an alternative to injectable parathyroid hormone treatments.
- here's the release
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