Pfizer Inc. (NYSE: PFE) and FoldRx Pharmaceuticals, Inc., a privately held drug discovery and clinical development company, today announced that they have entered into an agreement under which Pfizer will acquire FoldRx.
FoldRx's portfolio includes clinical and pre-clinical programs for investigational compounds to treat diseases caused by protein misfolding, which is increasingly recognized as an underlying cause in many chronic degenerative diseases. The company's lead product candidate, tafamidis meglumine, is in registration as an oral, disease-modifying therapy for TTR amyloid polyneuropathy (ATTR-PN), a progressively fatal genetic neurodegenerative disease, for which liver transplant is the only treatment option that is currently available.
FoldRx has filed a marketing authorization application (MAA) for tafamidis with the European Medicines Agency, and is currently in communication with the FDA to define its pathway for filing in the U.S. Tafamidis has orphan drug designation in both the U.S. and European Union (EU) and Fast Track designation in the U.S. for the treatment of ATTR-PN.
"By combining FoldRx's proprietary expertise in identifying and developing treatments for protein misfolding diseases with Pfizer's commercial, medical and regulatory expertise, and global strengths in patient services and reimbursement, we are taking a significant step toward potentially bringing, for the first time, a non-surgical treatment option for underserved patients affected by the deadly disease ATTR-PN," said Geno Germano, president and general manager, Pfizer Specialty Care Business Unit. "This transaction will add another important component to the growing portfolio of innovative in-line and investigational medicines for orphan and rare diseases within Pfizer's Specialty Care Business, and will complement the current and planned future research and clinical development taking place in Pfizer's Specialty Care Neuroscience disease area," continued Mr. Germano.
"Over the past five years the FoldRx team has successfully developed tafamidis from the bench stage to MAA submission," said Richard Labaudiniere, Ph.D., president and chief executive officer of FoldRx. "Pfizer's strong clinical and regulatory resources, global marketing reach, and commitment to the treatment of rare diseases will significantly enhance the ability to pursue the goal of efficiently bringing tafamidis to all patients affected by this devastating neurodegenerative disease."
FoldRx has employed its proprietary yeast-based drug target discovery platform to build its portfolio of preclinical and clinical candidates. Its screening engine is rapid and efficient in evaluating potential treatment candidates in a wide range of diseases caused by misfolded proteins. Using this screening engine, FoldRx is also actively engaged in an innovative early drug discovery program to identify therapeutic agents for cystic fibrosis, Parkinson's disease and Huntington's disease.
While specific financial terms were not disclosed, Pfizer will make an upfront payment and contingent payments if certain milestones are achieved. The closing of the transaction is subject to regulatory approval in the United States and is expected to occur later this year.