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Note 3 - Glaxosmithkline Agreement
6 Months Ended
Jun. 30, 2012
Glaxosmithkline Agreement [Text Block]
NOTE C - GLAXOSMITHKLINE AGREEMENT

In April 2002, we signed a licensing agreement with GSK for a value before royalties, PTH sales and reimbursement of development expenses, of up to $150,000,000 to develop an oral formulation of an analog of PTH. Under the terms of the agreement, GSK received an exclusive worldwide license to develop and commercialize the product. GSK reimbursed us for certain development activities during the program, including our activities in the production of raw material for development and clinical supplies, and was to pay us a royalty at a rate in the low to mid-teens based on its worldwide sales of the product. An aggregate of $16,000,000 in up-front and milestone payments has been received from inception through termination in December 2011, including the two $4,000,000 payments received in December 2010 and May 2011, described below. We have also received an additional $7,500,000 from GSK for PTH sales and in support of our PTH development activities from inception through December 2011.

In December 2010, we entered into an amended and restated exclusive worldwide license agreement with GSK (the Amended License Agreement) and we received $4,000,000 for Phase 2 development costs. This revenue was recognized in full through December 2011 due to the termination of the Amended License Agreement.

We received an additional $4,000,000 in May 2011 due to the completion of Phase 2 patient enrollment in April 2011. We recognized $642,000 of revenue under these two milestones in the six months ended June 30, 2011.

On August 3, 2011, we entered into a Development Services and Clinical Supply Agreement (the Development Agreement) with GSK. Under the terms of the Development Agreement, we received approximately $2,000,000 in payments from GSK for certain development and manufacturing activities related to the active pharmaceutical ingredient and finished drug product of an oral PTH analog. This agreement has also been terminated.

In December 2011, we terminated the Amended License Agreement and related development services and clinical supply agreement with GSK. The termination of these agreements followed notification by GSK of its decision not to proceed based on its internal evaluation criteria. As a result, we regained the exclusive worldwide rights to our oral PTH program with no financial obligations to GSK. We will now seek to publish the full data set of the statistically significant Phase 2 results in a scientific journal and appropriate scientific conferences in 2012 and we intend to advance the oral PTH program.