Fingolimod Lauryl Sulfate

BOSTON--(BUSINESS WIRE)-- Cycle Pharmaceuticals Limited (Cycle) is pleased to announce the launch of tiopronin delayed-release tablets as a treatment option for patients with cystinuria.1 Tiopronin delayed-release tablets are available in 100 mg and 300 mg doses, and are approved by the US Food and Drug Administration (FDA).1 Generic tiopronin delayed-release tablets must be taken without food.1 Cystinuria is the most common inheritable cause of kidney stone disease. Incidence of the condition is estimated to be 1 in 7,000 worldwide.2 The launch of tiopronin delayed-release tablets is a partnership between Cycle and Torrent Pharma Inc. (Torrent) utilizing Anovo Specialty Pharmacy (Anovo) in which all three companies are committed to providing patients with rare diseases the medication and patient support they need. Tiopronin delayed-release tablets are a treatment option for patients with cystinuria who want to benefit from the support services provided by Cycle Vita™, a dedicated support platform which provides individualized product support* for patients, and ongoing dispensing and support services provided by Anovo, the exclusive specialty pharmacy for this product. “Cystinuria is a chronic lifelong condition in which stones commonly reoccur.3 In addition, close control of a patient’s diet, specifically a reduction in salt and methionine intake, can have an impact on the likelihood of stones forming.3 We are fully aware of the unique personal challenges these patients face in effectively managing their cystinuria. That’s why we’re providing individualized support including a Bridge Program* and Co-pay Assistance Program*. In addition, a Patient Nutrition Program* will be available to reinforce the clinic’s nutrition plan,” says Chikai Lai, SVP & Chief Commercial Officer, Cycle. Tiopronin delayed-release tablets are Cycle’s fifth commercial product to be launched in the US, building on the launch of: NITYR® (nitisinone) Tablets in 2017 SAJAZIR™ (icatibant) Injection in 2021 JAVYGTOR™ (sapropterin dihydrochloride) Tablets for Oral Use and Powder for Oral Solution in 2022; and TASCENSO ODT® (fingolimod) in 2023 Tiopronin delayed-release tablets are indicated in combination with high fluid intake, alkali, and diet modification, for the prevention of cystine stone formation in adults and pediatric patients 9 years of age and older with severe homozygous cystinuria, who are not responsive to these measures alone. Tiopronin delayed-release tablets must be taken without food.1 To find out more about Cycle Vita, please visit or call +1 (888) 360-8482 and find the Full Prescribing Information available at . Important Safety Information Important Safety Information is below. Full Prescribing Information is available at . INDICATIONS Tiopronin delayed-release tablets are a reducing and complexing thiol indicated, in combination with high fluid intake, alkali, and diet modification, for prevention of cystine stone formation in adult and pediatric patients 9 years of age and older with severe homozygous cystinuria who are not responsive to these measures alone. WARNINGS AND PRECAUTIONS Proteinuria, including nephrotic syndrome, and membranous nephropathy, have been reported with tiopronin use. Pediatric patients receiving greater than 50 mg/kg of tiopronin per day may be at increased risk for proteinuria. Hypersensitivity reactions (drug fever, rash, fever, arthralgia and lymphadenopathy) have been reported. MOST COMMON ADVERSE REACTIONS Most common adverse reactions (≥10%) are nausea, diarrhea or soft stools, oral ulcers, rash, fatigue, fever, arthralgia, proteinuria, and emesis. DRUG INTERACTIONS Alcohol: Tiopronin is released faster from tiopronin delayed-release tablets in the presence of alcohol and the risk for adverse events associated with tiopronin delayed-release tablets when taken with alcohol is unknown. Avoid alcohol consumption 2 hours before and 3 hours after taking tiopronin delayed-release tablets. USE IN SPECIFIC POPULATIONS: Pregnancy: Available published case report data with tiopronin have not identified a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes. Renal stones in pregnancy may result in adverse pregnancy outcomes. Tell your healthcare provider immediately if you become pregnant or planning to become pregnant. Lactation: There are no data on the presence of tiopronin in either human or animal milk or on the effects of the breastfed child. A published study suggests that tiopronin may suppress milk production. Because of the potential for serious adverse reactions, including nephrotic syndrome, advise patients that breastfeeding is not recommended during treatment with tiopronin delayed-release tablets. Tell your healthcare provider immediately if you plan on breast feeding. Pediatric Use: Tiopronin delayed-release tablets are indicated in pediatric patients 9 years of age and older with severe homozygous cystinuria, in combination with high fluid intake, alkali, and diet modification, for the prevention of cystine stone formation who are not responsive to these measures alone. Tiopronin delayed-release tablets are not approved for use in pediatric patients weighing less than 20 kg or in pediatric patients unable to swallow tablets. Geriatric Use: This drug is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. For more detailed information, please refer to the full Prescribing Information at . If you get any side effects, talk to your healthcare provider. This includes possible side effects not listed in this material. You may also report side effects directly by calling Torrent Pharma Inc. at: 1-800-912-9561 or FDA at: 1-800-FDA-1088 or . This material is for education purposes only. It is not intended to be, and should not be used as, a substitute for medical advice. US-TIO-2400004 (February 2024) References Tiopronin Delayed-Release Tablets. Prescribing Information. Torrent Pharma Inc. Leslie, S.W., Sajjad, H. and Nazzal, L. (2023). Cystinuria. [online] Nih.gov. Available at: [Accessed Feb 9 2024]. Cystinuria UK - Diet - what should I eat (2023). Cystinuria UK - Diet - what should I eat? [online] Cystinuriauk.co.uk. Available at: [Accessed Feb 9 2024]. * 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. The US Prescribing Information provides the indications for which the product is approved in the US. Please consult the US Prescribing Information and product labeling for information about the specific uses for which the product is indicated in the US. –ENDS– Cycle Vita™, SAJAZIR™ and JAVYGTOR™ are trademarks of Cycle Pharmaceuticals Limited in the United States. NITYR® is a registered trademark of Cycle Pharmaceuticals Limited in the United States. TASCENSO ODT® is a registered trademark of Handa Neuroscience, LLC. ©2024 Cycle Pharmaceuticals Limited. All rights reserved. About Cycle Pharmaceuticals 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 focuses on rare metabolic, immunological, and neurological genetic conditions. Within neurological conditions, we focus on multiple sclerosis. Cycle is headquartered in Cambridge, UK and has offices in Boston, Massachusetts. For more information, please visit and follow us on X, LinkedIn and Facebook. About Torrent Pharma Inc. Torrent Pharma is one of the leading Pharma companies in India. Torrent is the pioneer in initiating the concept of niche marketing in India and today is ranked amongst the leaders in therapeutic segment of cardiovascular (CV), central nervous system (CNS), gastro-intestinal (GI) and women healthcare (WHC). Torrent also has significant presence in diabetology, pain management, gynecology, oncology and anti-infective segments. Torrent Pharma is present in more than 40 countries. It is ranked first amongst Indian Companies for having largest market share in Brazil and Germany. About Anovo Anovo was founded in 2012 as an exclusive provider of comprehensive end-to-end services for manufacturers of rare disease drugs and patients who need the drugs, including specialty wholesale/3PL distribution services, specialty pharmacy services, and patient support hub programs. Anovo benefits all parties involved by navigating all the complexities of managing rare disease medications and providing the related support needed by patients, caregivers and prescribers. View source version on businesswire.com: Contacts Marketing@cyclepharma.com Cycle Pharmaceuticals Tel: +44 1223 354 118 Source: Cycle Pharmaceuticals Limited View this news release online at:

TASCENSO ODT is available to dispense to US multiple sclerosis (MS) patients TASCENSO ODT is bioequivalent to, but not a generic of, Gilenya® (fingolimod) capsules1,2 On March 31st 2023 the Gilenya patient support program will be withdrawn3 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 31st 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 and 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 . To report SUSPECTED ADVERSE REACTIONS, contact Cycle Pharmaceuticals Ltd at 1-888-533-1625 or the FDA at: 1-800-FDA-1088 or . US-FIN-2300021 (February 2023). References Data on file: REF-00069 FDA., 2023. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Accessed January 3rd 2023. Available: Gilenya. HCP: Frequently Asked Questions. Available: TASCENSO ODT Prescribing Information. Cycle Pharmaceuticals Ltd. Healthline. Multiple Sclerosis: Facts, Statistics, and You. Available: Accessed: December 15 2022. FDA approval for generic Gilenya. Available: . 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 and follow us on Twitter, LinkedIn, Facebook and Instagram.