New Drug, TASCENSO ODT® (fingolimod), Launched to Meet the Needs of Multiple Sclerosis Patients in the US Left Without Essential Patient Support

BOSTON--(BUSINESS WIRE)-- Cycle Pharmaceuticals Ltd (Cycle) has today announced the launch of TASCENSO ODT, its first product to treat MS patients in the US. The launch ensures MS patients in the US currently benefitting from Gilenya, or generic fingolimod, can access appropriate patient support services alongside the bioequivalent, non-generic, TASCENSO ODT. Gilenya patient support services are scheduled to be withdrawn on March 31^st 2023.^1,2,3

TASCENSO ODT is 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.⁴

John Reid, Patient Support Director of Cycle commented: “The launch of TASCENSO ODT comes at a critical time for patients already on Gilenya or generic fingolimod therapy. Cycle’s dedicated patient support platform, Cycle Vita™, will provide appropriate patient support services to eligible* patients such as a $0 co-pay and bridge program as well as in-home baseline assessments and first dose observations. Ultimately this will ensure these patients can continue to access patient support services, remain on fingolimod and avoid potential disease advances and worry associated with discontinuing their current fingolimod treatment.”

Reid added: “Furthermore, TASCENSO ODT is the first orally disintegrating tablet, or ODT, approved to treat MS patients in the US. Its unique ODT formulation was developed by our partner Catalent using its best-in-class ZYDIS technology which dissolves on the tongue in seconds, without the need for water. We expect this ODT formulation to be an attractive option for MS patients looking for convenience, and testament to that, we are already receiving TASCENSO ODT enrolment forms.”

Clyde E. Markowitz, MD, Director Emeritus, Multiple Sclerosis Center, Associate Professor of Neurology, Perelman School of Medicine, University of Pennsylvania, commented: “For patients who are stable on fingolimod therapy, TASCENSO ODT provides the opportunity for their ongoing therapy to remain consistent, whilst also accessing important patient support services not available with generic fingolimod and soon not available with Gilenya either. Reducing therapeutic uncertainty for these patients with the same fingolimod in a different formulation is a favorable option.”

Dr Bruce A. C. Cree, MD, PhD, MAS, George A. Zimmermann Endowed Professor in MS, Professor of Clinical Neurology, Clinical Research Director, UCSF Weill Institute for Neurosciences, Department of Neurology, University of San Francisco added: “Recently Gilenya patient co-pay support services became unavailable due to the introduction of generic fingolimod capsules. For some of our patients, co-pay deductibles on generic fingolimod capsules are unaffordable, forcing switches to other treatments. TASCENSO ODT is another option worth considering for our patients who want to remain on fingolimod but need co-pay support.”

MS affects an estimated 1 million people in the US with around 200 new cases being diagnosed each week.⁵ Around 100,000 MS patients in the US have been treated with Gilenya.⁶

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-2300021 (February 2023).

References

1. Data on file: REF-00069
2. FDA., 2023. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Accessed January 3rd 2023. Available: www.accessdata.fda.gov/scripts/cder/ob/index.cfm
3. Gilenya. HCP: Frequently Asked Questions. Available: https://www.gilenyahcp.com/frequently-asked-questions
4. TASCENSO ODT Prescribing Information. Cycle Pharmaceuticals Ltd.
5. Healthline. Multiple Sclerosis: Facts, Statistics, and You. Available: https://www.healthline.com/health/multiple-sclerosis/facts-statistics-infographic#risk-factors Accessed: December 15 2022.
6. FDA approval for generic Gilenya. Available: 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. ZYDIS^® is a registered trademark, in the US, of R.P. Scherer Technologies, Inc.

–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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