DUBLIN—Shireplc, a global specialty biopharmaceuticalcompany, announced this week that it has signed an agreement to acquire FerroKinBioSciences Inc., for an upfront payment of $100 million, payable in cash at closing, plus potential post-closing milestone payments of as much $225 million, depending upon the achievement of certain clinical development, regulatory and net sales targets.
What this does for Shire is provide another step on its strategic path to build its hematology business, which already includes Xagrid and what Shire calls "a growing development pipeline." It also adds, the company says, "a differentiated product in development (iron chelator FBS0701), withglobal rights, in a global market currently worth over $900 million and growing."
The assets and pipeline Shire will gain are expected to servechronic patient need for treatment of iron overload following numerousblood transfusions. Excess iron in vital organs such as the liver andheart increases the risk of organ failure and is the principal cause ofdeath in transfusion-dependent patients, Shire notes.
The company maintains that the acquisition is consistentwith its strategy of developing and commercializing differentiatedspecialist products prescribed by specialist physicians ( such as hematologists/hematologist-oncologists) served by a small sales force, and FBS0701will be developed to demonstrate clinical efficacy and an attractivesafety profile relative to currently approved chelating agents, as follows:
- Global filing planned for indications for myelodysplastic syndrome and hemoglobinopathies initially
- Phase II studies underway with additional trials planned
- Potential launch as early as 2016
"Thereremains a significant unmet need for a once-a-day, oral iron chelatorin a convenient dosage form for the treatment of transfusional ironoverload with a better safety profile than currently availabletreatments(2).," says Ross Murdoch, Shire's senior vice president for specialty pharmaceuticals. "We believe FBS0701 has the potential to meetthat need. We hope to use our expertise in hematology coupled with ourproven ability to progress products through the development pipeline tobring FBS0701 to the global marketplace. This acquisition marks an important step for Shire in building abusiness that serves the growing needs of specialty hematologists andtheir patients."
FerroKin BioSciences' key employees, including its founder and CEO, Dr. Hugh Young Rienhoff Jr.,will provide consulting services to Shire during the transition period.
"An important factor for FerroKin BioSciences in agreeing to thistransaction was Shire's drive, capability and vision to bring newproducts to the hematology market that promise to raise the standard ofcare for patients. In Shire's hands, FBS0701 has greater potential tofulfill that promise," said Rienhoff.
The closing of the acquisition is subject to customary conditions, including adoption of the merger agreement by a required proportion of FerroKin'sequityholders, holders of no more than 2 percent of FerroKin's capitalstock having exercised or being entitled to exercise appraisal rightsunder Delaware law and the absence of a material adverse effect on FerroKin BioSciences.
FBS0701is a once-daily oral capsule in development for the treatment of ironoverload due to chronic blood transfusions in adults and children.FBS0701 has received orphan product designation from both the U.S. Foodand Drug Administration and the European Medicines Agency. FerroKinBioSciences has completed four Phase I clinical trials to evaluate thesafety, tolerability, pharmacokinetics and iron clearing activity ofFBS0701 in healthy volunteers and patients. Phase II dose-rangingstudies in adults and children are ongoing. Initial data from the adultstudy, presented at the American Society of Hematology in December,reportedly support the potential for FBS0701 as an effective iron chelator with afavorable safety profile.