BRONX, N.Y. — Cycle Pharmaceuticals has named LeMed Specialty Pharmacy as the exclusive U.S. distributor and services partner for HARLIKU™ (nitisinone) Tablets, the first and only FDA-approved treatment for adults with alkaptonuria (AKU), a rare genetic disorder.
LeMed will handle both commercial and non-commercial dispensing of HARLIKU nationwide. The partnership expands an already established relationship between the two companies, which also collaborate on treatments for hereditary angioedema (HAE), phenylketonuria (PKU), and primary periodic paralysis (PPP).
“We’re excited to extend our partnership with LeMed Specialty Pharmacy, building on years of successful collaboration across rare diseases,” said Chikai Lai, senior vice president and chief commercial officer at Cycle Pharmaceuticals. “Together, we remain dedicated to putting patients first—ensuring those living with AKU receive the support and treatment they need, now and into the future.”
LeMed, based in New York, is known for its independent specialty pharmacy model focused on rare and ultra-rare diseases. The company has over two decades of experience operating within exclusive distribution networks and emphasizes patient satisfaction through personalized service and data-driven care.
“We are honored Cycle chose LeMed to ensure every eligible AKU patient gets timely access to HARLIKU,” said Nathaniel Keifer, vice president of client strategy at LeMed. “Our one-size-fits-one bespoke model pairs clinical excellence and a patient-experience mindset with real-time data insights and an agile infrastructure, enabling Cycle to monitor outcomes and scale when necessary while patients experience the speed to therapy and support they deserve.”
With the recent FDA approval of HARLIKU, patients with AKU—who previously had no approved treatment options—can now access targeted therapy supported by a dedicated specialty pharmacy partner.
