Unigene Laboratories, developers of one of the top portfolios in existence of peptide-based therapeutics, a portfolio engineered on the Company’s revolutionary Peptelligence™ platform, reported today that patient enrollment in Phase 2 of the oral parathyroid hormone (PTH) analog study targeting postmenopausal women with osteoporosis has been completed.
The Company has thus completed the necessary requirements for the $4M milestone payment from collaborating partner GlaxoSmithKline (GSK), with whom UGNE is developing the oral formulation of a recombinantly produced PTH analog, as part of an extremely promising, exclusive global licensing agreement (signed, Dec. 10, 2010). This payment supplements the initial upfront $4M payment used to implement the Phase 2 study and UGNE stands to gain up to an additional $142M via achievement of agreement-specified regulatory and commercialization milestones.
President and CEO of UGNE, Ashleigh Palmer, called the enrollment target’s completion itself a major milestone for UGNE, as it represents a culmination of the Company’s proprietary PTH analog oral formulation. Palmer called the four-month execution of this study, since the initial signing with GSK, extremely impressive and commended the UGNE team for their diligence, showcasing the Company’s vast experience with trialing.
Additionally, the Company is eligible for tiered double-digit royalties on global sales and GSK may elect to assume total control over all aspects of future development/commercialization, based on a summary review of the Phase 2 data. This is a huge boon for UGNE, which designed the Phase 2 study to help create a solution for the one-in-three women, and one-in-five men over 50 who will suffer from osteoporosis. Osteoporosis is a huge market and its rate of occurrence in postmenopausal women is rising along life-expectancy rates, having a heavy-hitter like GSK potentially drive this product home post-Phase 2 to the tune of double digit royalties in a worldwide market that in the US, Europe and Japan alone totals over 75M.
Let’s take a quick look at the study itself:
• Multicenter, randomized and double-blind with respect to the placebo, repeat dose of which will include an open label Forsteo® injectable formulation comparator arm
• One daily oral PTH analog will be compared to baseline
• Primary target will be increased bone mineral density in the lumbar spine of the some 93 postmenopausal osteoporotic patients at 24 weeks
• Secondary targets will analyze biochemical markers indicating bone formation, resorption, overall safety and tolerability/ pharmacokinetics of the oral formulation itself
For more information on Unigene Laboratories, Inc., visit their website at: www.unigene.com