Rhythm Pharmaceuticals Announces Sale of Priority Review Voucher for $100M

BOSTON, Jan. 05, 2021 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq:RYTM), a biopharmaceutical company aimed at developing and commercializing therapies for the treatment of rare genetic diseases of obesity, today announced that it has entered into a definitive agreement to sell its Rare Pediatric Disease Priority Review Voucher (PRV) for $100M.

The PRV was granted to Rhythm by the U.S. Food and Drug Administration (FDA) with the approval of IMCIVREE (setmelanotide) for chronic weight management in adult and pediatric patients 6 years of age and older with obesity due to proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1) or leptin receptor (LEPR) deficiency confirmed by genetic testing.

“Rhythm is focused on transforming the care of people living with rare genetic diseases of obesity,” said David Meeker, M.D., Chair, President and Chief Executive Officer of Rhythm. “The non-dilutive capital from the sale of our PRV provides an important source of additional funding to advance the continued development of setmelanotide as a precision medicine for people whose severe obesity and insatiable hunger may be caused by genetic variants associated with the melanocortin-4 (MC4R) receptor pathway.”

According to the agreement, Rhythm will receive an upfront payment of $100M upon the closing of the transaction, which is subject to customary closing conditions and is expected to occur following expiration of the applicable U.S. antitrust clearance requirements. Jefferies LLC acted as exclusive financial advisor to Rhythm on this transaction. Latham & Watkins LLP acted as legal advisor to Rhythm.

The non-dilutive funds expected from this transaction are in addition to the $201.8 million in cash, cash equivalents and short-term investments Rhythm reported as of September 30, 2020.

About the Rare Pediatric Disease Priority Review Voucher Program
The program is intended to encourage development of new drug and biological products for prevention and treatment of certain rare pediatric diseases. A PRV may be issued to the sponsor of a rare pediatric disease product application and would entitle the holder to priority review of a single New Drug Application or Biologics License Application, which reduces the target review time and could lead to an expedited approval. The sponsor receives the PRV upon approval of the rare pediatric disease product application and it can be sold without limitation, subject to applicable FDA requirements for filing and use.