With a novel mechanism of action, the potential for more convenient dosing in an every other week or once monthly subcutaneous injectable form and the ability to significantly reduce HAE attacks, DX-2930 has the potential to expand the market to patients currently not treated with prophylaxis therapy.
DX-2930 has received Fast Track, Breakthrough Therapy, and Orphan Drug designations by the FDA and received Orphan Drug status in the EU. It is expected to enter Phase 3 clinical trials by year-end 2015.
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Additional Value from Dyax Pipeline and Phage Display Technology
In addition to DX-2930 for HAE, Dyax brings other early-stage, pre-clinical, antibody pipeline programs, including exploration of DX-2930 for diabetic macular edema; DX-2507, an anti-FcRN for the treatment of antibody-mediated autoimmune diseases, and DX-4012, an anti-factor Xlla antibody for thrombosis.
Dyax has a proven track record of bringing products to market through its phage display discovery platform, a patented antibody generation technology used to improve the speed and cost-effectiveness of internal and partner drug discovery, which produced DX-2930. Through the acquisition, Shire will also acquire an extensive LFRP, which includes the approved product CYRAMZA® (ramucirumab), marketed by Eli Lilly & Co. The LFRP includes additional product candidates by licensees in various clinical development stages for which Shire would receive royalties or milestone payments post-approval.
Transaction Details
Under the agreement, Shire has agreed to acquire Dyax for $37.30 per Dyax share, for aggregate upfront cash consideration of $5.9 billion and a non-tradable contingent value right (CVR) that will pay an additional $4.00 in cash per Dyax share upon FDA approval of DX-2930 for the prevention of type 1 and type 2 HAE, if approved prior to December 31, 2019, representing a potential additional $646 million in aggregate contingent consideration.
The proposed transaction is expected to enhance Shire’s long-term top and bottom line growth profile, and is expected to be slightly dilutive to earnings in 2016 and 2017, and accretive in 2018 and beyond, assuming U.S. approval of DX-2930 in 2018.
Related to the transaction, Shire anticipates that it will realize operating synergies of $50 million starting in 2017 and growing to at least $100 million in 2019 and thereafter when comparing to the Street’s consensus forecast of Dyax’s standalone future operating cost base.
