Benzinga | Jul 23, 2020 07:16AM EDT

AMAG Pharmaceuticals And Norgine B.V. Enter Into Exclusive Licensing Agreement To Commercialize Ciraparantag In Europe, Australia And New Zealand; AMAG Receives $30M Upfront Payment, Eligible For Up To $260M In Milestones

Agreement provides AMAG with $30 million upfront payment and eligibility to receive up to $260 million in development and commercial milestones in addition to sales royalties

Collaboration further advances the development of ciraparantag

WALTHAM, Mass. and AMSTERDAM, The Netherlands, July 23, 2020 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) and Norgine B.V., a leading European specialist pharmaceutical company, today announced they have entered into an exclusive licensing agreement to develop and commercialize ciraparantag in Europe, Australia and New Zealand. Ciraparantag is in development for use in patients treated with direct oral anticoagulants (DOACs) and low molecular weight heparin (LMWH) when reversal of the anticoagulant effect of these products is needed for emergency surgery, urgent procedures or due to life-threatening or uncontrolled bleeding.

Under the terms of the license agreement, AMAG will receive $30 million of total upfront consideration and up to $260 million contingent upon the achievement of certain regulatory and sales milestones together with escalating double-digit royalties. Additionally, Norgine has committed to contribute one-third of the costs of the Phase 3 clinical program, which would be conducted by AMAG to support regulatory approval of ciraparantag by the U.S. Food and Drug Administration, the European Medicines Agency, and the Medicines and Healthcare Products Regulatory Agency. AMAG will continue to oversee the Phase 3 clinical program, while working closely with Norgine. Norgine will be responsible for the regulatory filings and any subsequent clinical trials required for approval in its territory and will eventually hold all marketing authorizations in the licensed territories.

"This agreement is a significant milestone on our strategic evolution. We are looking forward to partnering with Norgine and working together to unlock the value of ciraparantag, which will further strengthen our company's ability to continue investing in innovative therapies that address urgent unmet medical needs," said Scott Myers, AMAG's Chief Executive Officer. "Norgine's infrastructure and capabilities to develop and commercialize products will help us further advance the program into Phase 3 clinical trials and work towards regulatory approval in countries where providers and patients may benefit from a reversal agent."

There are currently approximately six million patients in the U.S. and nine million patients in certain ex-U.S. countries on DOAC and LMWH therapy.1 A recent study found that approximately 1.5-2% of patients taking certain DOACs can be at risk for serious bleeding complications each year.2

"We are delighted to enter into this new collaboration with AMAG to develop and commercialize ciraparantag in Europe, Australia and New Zealand," said Peter Stein, Chief Executive Officer of Norgine. "Patients who take anticoagulants can be at risk of serious and uncontrolled bleeding, especially in emergency situations, and we are proud to be able to support the development of a new, potentially life-saving treatment, subject to successful completion of ciraparantag's research programme and subsequent regulatory approval."