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

Rhythm Pharmaceuticals, Inc. recently announced it has entered into a definitive agreement to sell its Rare Pediatric Disease Priority Review Voucher (PRV) for $100 million.

The PRV was granted to Rhythm by the US 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, MD, 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 $100 million upon the closing of the transaction, which is subject to customary closing conditions and is expected to occur following expiration of the applicable US 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.

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.

Rhythm is a commercial-stage biopharmaceutical company committed to transforming the treatment paradigm for people living with rare genetic diseases of obesity. The company’s precision medicine, IMCIVREE (setmelanotide), has been approved by the FDA for chronic weight management in adult and pediatric patients 6 years of age and older with obesity due to POMC, PCSK1 or LEPR deficiency confirmed by genetic testing. IMCIVREE is the first-ever FDA approved therapy for these rare genetic diseases of obesity. Rhythm is advancing a broad clinical development program for setmelanotide in other rare genetic diseases of obesity. The company is leveraging the Rhythm Engine and the largest known obesity DNA database – now with more than 30,000 sequencing samples – to improve the understanding, diagnosis and care of people living with severe obesity due to certain genetic deficiencies. For healthcare professionals, visit www.UNcommonObesity.com for more information. For patients and caregivers, visit www.LEADforRareObesity.com for more information. The company is based in Boston, MA.