RELiZORB ®: Alcresta Therapeutics, Inc., a leading commercial-stage company focused on developing and commercializing novel enzyme-based products, today announced a series of commercial milestone achievements.
Alcresta Therapeutics announced its first profitable year in 2021, the completion of royalty payments to the Cystic Fibrosis Foundation (CFF) and a doubling of its sales force to expand the promotion of RELiZORB, a first-of-its-kind digestive enzyme cartridge used in enteral feeding designed to mimic the function of pancreatic lipase. RELiZORB is the only enzyme product cleared by the FDA for use in enteral feeding.
Payer access to RELiZORB has improved significantly over the last two years, resulting in 70% growth year-over-year in net sales with 24% adjusted EBITDA. In December 2013, CFF granted to Alcresta a research award to support the research program that resulted in RELiZORB. As part of the grant agreement, Alcresta agreed to pay certain royalties and milestone payments over time. The rapid net sales growth allowed the company to complete its royalty obligation to CFF, which was an early supporter of the company’s platform. Alcresta’s final royalty payment to CFF was made in March 2022.
“Both broad payer access and profitability have allowed us to further invest to reach deeper into the population of CF patients who are enterally fed,” said Daniel Orlando, Chief Executive Officer at Alcresta Therapeutics.
Supporting this rapid growth is a recently expanded account manager team up from seven sales territories in one region to 16 territories in two regions. RELiZORB is currently used by approximately 23% of treatable patients within the cystic fibrosis total addressable market. Over the past 24 months, RELiZORB has been added as a covered benefit for most commercial payers and state Medicaids. This expanded access follows the recent favorable CMS/Medicare local coverage determination (LCD ID No. 38955) covering RELiZORB for patients who meet the coverage criteria for enteral nutrition and have a diagnosis of exocrine pancreatic insufficiency. The improved access allows the expanded sales team to accelerate execution of Alcresta’s commercial strategy to position RELiZORB as the standard of care for enterally fed patients with CF.