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Takeda Termination and Transition Agreement - Note 10
3 Months Ended
Mar. 31, 2013
Takeda Termination and Transition Agreement Disclosure  
Termination and Transition Agreement

(10) Takeda Termination and Transition Agreement

On March 18, 2013, the Company entered into a Termination and Transition Agreement (the Agreement), with Takeda GmbH (Takeda GmbH), and Takeda Pharma A/S (Takeda Pharma and, together with Takeda GmbH, Takeda).

The Agreement provides for the termination of the license agreement, dated July 2, 2007, as amended, which granted Takeda Pharma the exclusive license to sell, market and commercialize recombinant parathyroid hormone 1-84 [rDNA origin] (PTH) worldwide, except for the U.S., Israel, and Japan, and a non-exclusive license to manufacture and develop PTH (the PTH License Agreement). Pursuant to the PTH License Agreement the rights were returned to the Company without consideration. Preotact is the brand name that Takeda Pharma has used to market PTH for the treatment of osteoporosis in certain of its licensed territories. The Company is developing PTH in the U.S. under the trade name Natpara for the treatment of hypoparathyroidism.

The Agreement also provides for the termination of the license agreement, dated September 24, 2007, as amended, which granted Takeda GmbH the exclusive license to develop and commercialize teduglutide worldwide, except for North America and Israel (the Revestive License Agreement). Takeda GmbH developed and obtained approval in the EU in August 2012 for teduglutide under the trade name Revestive for the treatment of Short Bowel Syndrome (SBS) in adults. The Company obtained U.S. Food and Drug Administration approval in the U.S. in December 2012 for teduglutide under the trade name Gattex for adult patients with SBS who are dependent on parenteral support. As a result of the termination of the License Agreements, the Company now has the exclusive rights worldwide to develop and commercialize teduglutide and PTH, except as noted in Note 6, whereby DRI would be owed a royalty for sales of PTH in the territory.

Takeda assigned to NPS its assets related to the two products, including all of its active pharmaceutical ingredient inventory and information related to the products' continued development, manufacture, and commercialization, including life cycle management assets. Takeda received 6.1 million shares of NPS common stock that were valued at $54.9 million as of the date of the transaction. Takeda will also earn a $30.0 million milestone payment in the first calendar year that combined worldwide net sales of both products exceed $750 million. This milestone includes an early payment trigger upon a qualified change of control. NPS has the option of making this milestone payment in cash or NPS common stock.

The Company used an independent valuation firm to calculate the fair value of the assets acquired. Using these fair values, the Company preliminarily assigned $15.9 million to the Revestive active pharmaceutical ingredient (API), $20.7 million to the PTH API and $18.2 million to the Revestive product rights. The Company capitalized the Revestive and PTH API as inventory and product rights to intangibles, net on the Company's balance sheet as of March 31, 2013 due to the fact that Revestive and Preotact are approved in the EU for SBS and Osteoporosis, respectively. The Company is currently in the process of evaluating the commercial strategy for both Revestive and PTH.