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Cycle Pharmaceuticals to launch Tascenso ODT® (fingolimod) in US in Q1 2023

Boston, Massachusetts and San Jose, California – November 1, 2022 – Cycle Pharmaceuticals Ltd (Cycle) is pleased to announce its intention to commercialize Tascenso ODT® (fingolimod) in the US multiple sclerosis (MS) market in Q1 2023.

The launch of Tascenso ODT aims to address the withdrawal of the Gilenya® (fingolimod) capsules patient support program (Go Program®) on March 31, 20231. Eligible patients* prescribed Tascenso ODT will have access to patient support from Cycle Vita™, Cycle’s dedicated, in-house patient support hub, designed specifically with the needs of patients in mind.

The launch follows a partnership between Cycle and Handa Neuroscience, LLC (Handa), the developer of Tascenso ODT, to commercialize both the 0.25mg and 0.5mg strengths in the US. The patient support provided through Cycle Vita will ensure that eligible patients are able to continue on, or initiate, fingolimod treatment with Tascenso ODT while receiving access to patient support such as appropriate insurance navigation, financial assistance, first-dose observation and baseline assessments beyond March 31, 2023.

Tascenso ODT is an orally disintegrating tablet that can be taken with or without water and dissolves on the tongue within seconds. The unique formulation of Tascenso ODT may offer an easier-to-swallow, convenient option for patients to take their fingolimod medication.

Chikai Lai, Deputy CEO of Cycle, comments “In our experience, patients with rare diseases face a myriad of challenges in accessing their treatment. Cycle understands that no two patients are the same. In MS, access to treatment that suits patients’ needs can be challenging. Leveraging our experience of supporting patients, our aim is to extend Cycle Vita support to the MS patient population, starting with Tascenso ODT.”

“The imminent withdrawal of Gilenya’s patient support program,1 coupled with the arrival of generic fingolimod capsule products,2 means fingolimod patients may be forced to consider switching to another disease modifying therapy for their MS. Through the launch of Tascenso ODT, we are committed to ensuring these patients have the option to remain on fingolimod whilst having access to essential patient support.”

Bill Liu, President of Handa Neuroscience, added “Handa is pleased to be working with Cycle to commercialize Tascenso ODT, the first and only orally disintegrating tablet product on the market for the treatment of multiple sclerosis. Through Cycle Vita’s extensive support program, patients will continue to have a fingolimod treatment option available that offers essential patient support along with the added benefits of an orally disintegrating tablet dosage form.”

Tascenso ODT 0.25mg is an FDA-approved ODT medication, indicated for the treatment of relapsing forms of MS, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in pediatric patients 10 years of age and older and weighing less than or equal to 40 kg.3 Upon FDA approval, Tascenso ODT will also be available in a 0.5mg strength for the treatment of relapsing forms of MS, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults and pediatric patients 10 years of age and older and weighing more than 40 kg.

Patient support via Cycle Vita is currently available to patients prescribed any of Cycle’s rare disease medications: NITYR® (nitisinone) Tablets, SAJAZIR™ (icatibant) Injections and JAVYGTOR™ (sapropterin dihydrochloride) Tablets and Powder for Oral Solution.

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 pediatric patients 10 years of age and older and weighing less than or equal to 40 kg.

Contraindications

Warnings and Precautions

Patients should be monitored during Tascenso ODT treatment initiation because of a risk for bradyarrhythmia and AV blocks. Tascenso ODT increases the risk of macular edema. 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 patients. Rare cases of Posterior Reversible Encephalopathy Syndrome 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. Multiple Sclerosis 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 and cutaneous T-cell 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.

Common Adverse Reactions

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

Drug Interactions

Closely monitor patients receiving systemic ketoconazole. The use of live attenuated vaccines should be avoided during, and for 2 months after stopping Tascenso ODT.

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 or the FDA at: 1-800-FDA-1088 or www.fda.gov/medwatch.

References

  1. Novartis (2022) Frequently asked questions about Gilenya and generic fingolimod. Available at: https://www.gilenyahcp.com/frequently-asked-questions (Accessed: October 3rd 2022).
  2. Brittain, B. (2022) S. Supreme Court grants Novartis request to halt Gilenya generic rivals. Available at: https://www.reuters.com/legal/litigation/novartis-asks-us-supreme-court-pause-gilenya-ruling-halt-generic-rivals-2022-09-29/ (Accessed: October 3rd 2022).
  3. Tascenso ODT (0.25mg) Prescribing information. Cycle Pharmaceuticals Ltd.

*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. NITYR® is a registered trademark of Cycle Pharmaceuticals Ltd. SAJAZIR™, JAVYGTOR™ and Cycle Vita™ are trademarks of Cycle Pharmaceuticals Ltd. Gilenya® and Go Program® are registered trademarks of Novartis AG.

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.

About Handa Neuroscience

Handa Neuroscience, LLC, based in San Jose, California, is a subsidiary of Taiwan-based Handa Pharmaceuticals, Inc. (6620.TWO), a specialty pharmaceutical company that focuses on the development of innovative specialty pharmaceutical products in the fields of neurology and oncology. For additional information, please visit www.handapharma.com.

Source: Cycle Pharmaceuticals

Posted: November 2022

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