Multiple Sclerosis Patients in US Left Without Essential Patient Support Program Will Now Receive Equivalent Backing From Cycle Pharmaceuticals Following FDA’s Approval of TASCENSO ODT® (fingolimod)

BOSTON--(BUSINESS WIRE)-- Cycle Pharmaceuticals Ltd (Cycle) has today welcomed the news that multiple sclerosis (MS) patients in the US currently being treated with Gilenya, or generic fingolimod to have access to appropriate patient support services alongside the bioequivalent, TASCENSO ODT¹ following the withdrawal of Gilenya patient support on March 31^st 2023.

Cycle’s TASCENSO ODT has now been approved by the FDA for the treatment of relapsing forms of multiple sclerosis (RRMS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older, and is available in 0.25 mg and 0.5 mg doses.²

TASCENSO ODT is bioequivalent to Gilenya capsules and it has the same safety, efficacy and side effects.¹ However, Cycle’s unique formulation as a once-daily orally disintegrating tablet (ODT) means that it can be taken with or without food and water and dissolves on the tongue in seconds.²

Chikai Lai, Deputy CEO of Cycle commented: “We’re thrilled that the FDA has approved TASCENSO ODT for MS patients. This will allow patients who were facing a switch to a different disease modifying therapy following the withdrawal of patient support services around Gilenya, to remain on fingolimod and avoid any potential side effects, disease advances and worry that can arise when discontinuing or switching treatment.”

Lai added: “We created Cycle Vita, as our dedicated hub program to deliver individualized product support, and are delighted to offer this to eligible MS patients.* We believe that this wider offering will help any patients transitioning to TASCENSO ODT in 2023 to do so as seamlessly as possible with maximum support.”

Dr Jon Santoro, MD, Associate Professor of Neurology and Pediatrics, Keck School of Medicine of the University of Southern California and Director of Neuroimmunology, Children’s Hospital Los Angeles, stated: “I’m incredibly pleased that eligible persons with MS will be able to continue to be treated with fingolimod, via TASCENSO ODT, where appropriate, meaning that their ongoing therapy remains consistent. This will reduce therapeutic uncertainty given the potentially challenging circumstances they could have faced had an alternative bioequivalent not been made available.”

MS affects an estimated 1 million people in the US with around 200 new cases being diagnosed each week.³ Approximately 85% of diagnoses are the relapsing-remitting form of the condition and without treatment about 50% of those progress to the more serious secondary-progressive form within 10 years.³ Around 100,000 MS patients in the US have been treated with Gilenya.⁴

Cycle expects to make TASCENSO ODT available to eligible patients in February 2023. To find out more about TASCENSO ODT and Cycle Vita please visit www.tascenso.com and www.cyclevita.life respectively.

Important Safety Information

Indications

TASCENSO ODT is a sphingosine 1-phosphate receptor modulator indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older.

Contraindications

• Patients who in the last 6 months experienced myocardial infarction, unstable angina, stroke, transient ischemic attack, decompensated heart failure with hospitalization, or Class III/IV heart failure.
• Patients with a history or presence of Mobitz Type II 2nd degree or 3rd degree AV block or sick sinus syndrome, unless patient has a functioning pacemaker.
• Patients with a baseline QTc interval ≥ 500 msec.
• Patients with cardiac arrhythmias requiring anti-arrhythmic treatment with Class Ia or Class III anti-arrhythmic drugs.
• Patients who had a hypersensitivity to fingolimod or any excipients in TASCENSO ODT.
• Concomitant use with other products containing fingolimod.

Important Safety Information

Warnings and Precautions:

Due to a risk for bradyarrhythmia and AV blocks patients should be monitored during TASCENSO ODT treatment initiation. TASCENSO ODT may increase blood pressure, risk of infections and may cause fetal harm. Cases of Progressive Multifocal Leukoencephalopathy and of clinically significant liver injury have occurred in patients treated with fingolimod in the postmarketing setting. TASCENSO ODT increases risk of macular edema. Rare cases of Posterior Reversible Encephalopathy Syndrome in adults have been reported with fingolimod. Fingolimod can have respiratory effects. Severe increase in disability accompanied by multiple new lesions on MRI has been reported following discontinuation of fingolimod. MS relapses with tumefactive demyelinating lesions on imaging have been observed during fingolimod therapy and after discontinuation. The risk of basal cell carcinoma and melanoma is increased in patients treated with fingolimod. Cases of lymphoma have been reported in patients receiving fingolimod. The reporting rate of non-Hodgkin lymphoma with fingolimod is greater than that expected in the general population. Fingolimod remains in the blood and has pharmacodynamic effects, including decreased lymphocyte counts for up to 2 months following the last dose. Hypersensitivity reactions including rash, urticaria, and angioedema have been reported with fingolimod. Cases of seizures, including status epilepticus, have been reported with the use of fingolimod.

Adverse Reactions:

In clinical trials, the most common adverse reactions (incidence ≥ 10% and >placebo) are headache, liver transaminase elevation, diarrhea, cough, influenza, sinusitis, back pain, abdominal pain, and pain in extremity.

Drug Interactions:

Patients on QT prolonging drugs with a known risk of torsades de pointes should be monitored during initiation of treatment with TASCENSO ODT. Monitor patients during use of systemic ketoconazole. Use of live attenuated vaccines during, and for 2 months after stopping TASCENSO ODT, should be avoided.

For more detailed information, please refer to the full Prescribing Information at www.tascenso.com/PI.

To report SUSPECTED ADVERSE REACTIONS, contact Cycle Pharmaceuticals Ltd at 1-888-533-1625 or the FDA at: 1-800-FDA-1088 or www.fda.gov/medwatch.

US-FIN-2200048 (December 2022).

References

1. Data on file: REF-000064.
2. TASCENSO ODT Prescribing Information. Cycle Pharmaceuticals Ltd.
3. Healthline. Multiple Sclerosis: Facts, Statistics, and You. Available via: https://www.healthline.com/health/multiple-sclerosis/facts-statistics-infographic#risk-factors Accessed: December 15 2022
4. FDA approval for generic Gilenya. Available via: https://www.goodrx.com/gilenya/fda-approval-for-generic-gilenya. Accessed: December 19 2022

*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 +1 (888) 360-8482.

TASCENSO ODT^® is a registered trademark of Handa Neuroscience, LLC. Cycle Vita™ is a trademark of Cycle Pharmaceuticals Ltd. Gilenya^® is a registered trademark of Novartis AG.

–ENDS–

About Cycle Pharmaceuticals

Cycle Pharmaceuticals was founded in 2012 with the sole aim of delivering best-in-class drug treatments and product support to the under-served rare disease patient community. We focus on rare metabolic, immunological, and neurological genetic conditions.

Cycle is headquartered in Cambridge, UK and has offices in Boston, Massachusetts. For more information, please visit www.cyclepharma.com and follow us on Twitter, LinkedIn, Facebook and Instagram.

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