DUBLIN—Shire plc, a global specialty biopharmaceutical company, announced this week that it has signed an agreement to acquire FerroKin BioSciences 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), with global rights, in a global market currently worth over $900 million and growing."

 

The assets and pipeline Shire will gain are expected to serve chronic patient need for treatment of iron overload following numerous blood transfusions. Excess iron in vital organs such as the liver and heart increases the risk of organ failure and is the principal cause of death in transfusion-dependent patients, Shire notes.

 

The company maintains that the acquisition is consistent with its strategy of developing and commercializing differentiated specialist products prescribed by specialist physicians ( such as hematologists/ hematologist-oncologists) served by a small sales force, and FBS0701 will be developed to demonstrate clinical efficacy and an attractive safety 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

"There remains a significant unmet need for a once-a-day, oral iron chelator in a convenient dosage form for the treatment of transfusional iron overload with a better safety profile than currently available treatments⁽²⁾.," says Ross Murdoch, Shire's senior vice president for specialty pharmaceuticals. "We believe FBS0701 has the potential to meet that need. We hope to use our expertise in hematology coupled with our proven ability to progress products through the development pipeline to bring FBS0701 to the global marketplace. This acquisition marks an important step for Shire in building a business that serves the growing needs of specialty hematologists and their 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 this transaction was Shire's drive, capability and vision to bring new products to the hematology market that promise to raise the standard of care for patients. In Shire's hands, FBS0701 has greater potential to fulfill 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's equityholders, holders of no more than 2 percent of FerroKin's capital stock having exercised or being entitled to exercise appraisal rights under Delaware law and the absence of a material adverse effect on FerroKin BioSciences.

 

FBS0701 is a once-daily oral capsule in development for the treatment of iron overload due to chronic blood transfusions in adults and children. FBS0701 has received orphan product designation from both the U.S. Food and Drug Administration and the European Medicines Agency. FerroKin BioSciences has completed four Phase I clinical trials to evaluate the safety, tolerability, pharmacokinetics and iron clearing activity of FBS0701 in healthy volunteers and patients. Phase II dose-ranging studies in adults and children are ongoing. Initial data from the adult study, presented at the American Society of Hematology in December, reportedly support the potential for FBS0701 as an effective iron chelator with a favorable safety profile.