Contact Us
Toll Free: 1-844-795-3633
Fax: 718-231-2727
2417 3rd Ave, Ste 406, Bronx, NY 10451
Proven rare-disease expertise, industry-leading patient satisfaction, and 20-plus years of truly independent specialty-pharmacy service set LeMed apart.
Bronx, N.Y. — July 21, 2025
Cycle Pharmaceuticals today announced they have awarded LeMed Specialty Pharmacy the exclusive contract for specialty pharmacy distribution and services for HARLIKU™ (nitisinone) Tablets, the first and only FDA-approved treatment for use in alkaptonuria (AKU). LeMed will manage commercial and non-commercial dispensing for HARLIKU across the United States (US).
“We’re excited to extend our partnership with Le Med Specialty Pharmacy, building on years of successful collaboration across rare diseases. 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.” – Chikai Lai, SVP & CCO, Cycle Pharmaceuticals
LeMed’s rare disease focus includes operating within ultra-limited and exclusive distribution networks - experience that translates into operational agility and true collaboration with biopharma innovators. The expanding partnership between Cycle and LeMed already supports patients living with hereditary angioedema (HAE), phenylketonuria (PKU), and primary period paralysis (PPP).
“We are honored Cycle chose LeMed to ensure every eligible AKU patient gets timely access to HARLIKU,” said Nathaniel Keifer, Vice President, Client Strategy at LeMed Specialty Pharmacy. “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 FDA’s approval of HARLIKU, patients living with AKU in the US now have the option of treatment, guidance and care tailored towards their unique needs. Patients and providers can look forward to working with LeMed Specialty Pharmacy when it comes time to dispense an eagerly awaited treatment.
HARLIKU is the first and only FDA-approved treatment for reducing urinary homogentisic acid (HGA) in adults with Alkaptonuria (AKU). By inhibiting an upstream enzyme, HARLIKU can lower urinary HGA production by up to 97%.¹ Clinical data have shown that treatment with HARLIKU can lead to significant improvements in pain, energy levels, and physical functioning.² To assist patients throughout their treatment journey, HARLIKU is also accompanied with Cycle Vita™ - providing patients with individualized support* from onboarding to continuous product and clinical support.
LeMed Specialty Pharmacy is an independent, national specialty pharmacy headquartered in the Bronx, New York, proud of our 20+ year history of shaping the future of healthcare. With no private-equity investment and no PBM affiliation, LeMed is one of the last truly independent specialty pharmacies dedicated to orphan therapies and serving the people living with rare diseases that they treat. Supported by fully redundant, bi-coastal sites in New York and Arizona, LeMed holds dual-specialty accreditations, offers both commercial and non-commercial dispensing, and is licensed to ship to all 50 states and Puerto Rico while delivering industry-leading patient-satisfaction scores and an agile, data-driven, patient-first team that partners with biopharmaceutical manufacturers, patients, and payers to create bespoke programs that innovate the patient experience and drive measurable outcomes. Learn more at www.lemedrx.com.
Cycle Pharmaceuticals was founded in 2012 with the sole aim of delivering drug treatments and product support to the underserved rare disease patient community. Cycle Pharma focuses on rare genetic conditions in metabolic, immunology, urology, and oncology, as well as neurology, where we focus on multiple sclerosis. Cycle Pharma is headquartered in Cambridge, UK and has offices in Boston, Massachusetts. For more information, please visit www.cyclepharma.com and follow us on X, LinkedIn and Facebook.
LeMed Specialty Pharmacy
bd@lemedrx.com
Cycle Pharmaceuticals
marketing@cyclepharma.com
HARLIKU™ is indicated for the reduction of urine homogentisic acid (HGA) in adult patients with alkaptonuria (AKU).
Ocular Symptoms and Hyperkeratotic Plaques Due to Elevated Plasma Tyrosine Level
Ocular signs and symptoms including keratitis, corneal opacities, corneal irritation, corneal ulcers, conjunctivitis, eye pain, and photophobia, have been reported in patients.
Leukopenia and Severe Thrombocytopenia
In clinical trials, patients with hereditary tyrosinemia type 1 (HT-1) treated with another oral formulation of nitisinone and dietary restriction developed reversible leukopenia (3%), thrombocytopenia (3%), or both (1.5%). No patients developed infections or bleeding as a result of the episodes of leukopenia and thrombocytopenia. Monitor platelet and white blood cell counts during HARLIKU therapy.
The most common adverse reactions (≥1%) reported in patients with AKU taking nitisinone in clinical trials are elevated tyrosine levels, thrombocytopenia and keratitis.
Pregnancy: Limited available data with nitisinone use in pregnant women are not sufficient to determine a drug-associated risk of adverse developmental outcomes. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
Lactation: The developmental and health benefits of breastfeeding should be considered against the mother’s clinical need for HARLIKU, along with potential adverse effects on the breastfed infant from HARLIKU or from the underlying maternal condition.
Pediatric Use: The safety and effectiveness of HARLIKU have not been established in pediatric patients with AKU.
Geriatric Use: Insufficient data from clinical studies of HARLIKU to determine if patients ≥ 65 years of age respond differently. Elderly patients should be cautious reflecting any decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
For more detailed information, please refer to the full Prescribing Information at harliku.com/hcp/pi.
To report SUSPECTED ADVERSE REACTIONS, contact Cycle Pharmaceuticals at 1-855-831-5413, or the FDA at: 1-800-FDA-1088 or www.fda.gov/medwatch.
US-HKU-2500015 | June 2025
*Some areas of support may not be accessible to all patients. Eligibility criteria may apply to ensure compliance with all applicable federal and state requirements, and benefits may be limited to commercially insured patients only. For more detailed information about eligibility, terms and conditions, please contact the Cycle Vita team at 888-360-8482.
HARLIKU™ and Cycle Vita™ are trademarks of Cycle Pharmaceuticals Limited in the United States.
Contact Us
Toll Free: 1-844-795-3633
Fax: 718-231-2727
2417 3rd Ave, Ste 406, Bronx, NY 10451