NPS Pharmaceuticals has acquired from Takeda Pharmaceutical full worldwide rights to develop and commercialize teduglutide, now sold in Europe as Revestive®, and the recombinant human parathyroid hormone 1-84 or PTH 1-84, sold in Europe as Preotact® for post-menopausal osteoporosis, in an up-to-$80 million deal, the two companies disclosed today.
The deal comes as NPS prepares to launch teduglutide, an orphan drug for adult short bowel syndrome, under the trade name Gattex® in the U.S. later this year. Also in 2013, NPS expects to submit a U.S. Biologic License Application for PTH 1-84, to be sold as Natpara with an adult hypoparathyroidism indication. PTH 1-84 was approved by the European Union in April 2006.
In return for the rights, Takeda will receive from NPS $50 million in common stock, and a potential milestone payment of $30 million in cash or common stock. The payment would be made the first calendar year that Takeda achieves combined worldwide net sales for both products that exceed $750 million.
As part of the deal, Takeda also assigned to NPS assets related to teduglutide and PTH 1-84, including all of its active pharmaceutical ingredient inventory and information related to the products' continued development, manufacture, and commercialization, including life cycle management assets.
NPS has licensed outside North America commercial rights for PTH 1-84 in 2004, and for teduglutide in 2007, to Nycomed, which Takeda acquired in 2011 for €9.6 billion ($12.4 billion). Last year, teduglutide was approved in August by the European Union, followed in December by FDA. PTH 1-84 is approved for post-menopausal osteoporosis in the European Union since April 2006.
“This transaction establishes NPS as a global commercial rare disease company,” Francois Nader, M.D., president and CEO of NPS, said in a statement. “Our primary focus is to secure reimbursement for Revestive in Europe and to finalize our commercial strategy for both drugs to maximize their worldwide success.”
That strategy includes a successful U.S. launch for Gattex and the submission to FDA of the rhPTH-84 marketing application for Natpara, Dr. Nader added. In January, he predicted Gattex would generate more than $350 million in sales.
NPS is also developing two calcilytic compounds, NPSP790 and NPSP795, with potential application in rare disorders involving increased calcium receptor activity, such as autosomal dominant hypocalcemia with hypercalciuria.
NPS finished last year by halving its annual net loss, to $18.7 million compared with a $36.3 million net loss in 2011. During the period, revenues zoomed 28.5%, to $130.6 million in 2012.