Cycle Pharmaceuticals Limited (Cycle) is proud to announce the launch of ORMALVI™ (dichlorphenamide) tablets, as a treatment option for patients with hyperkalemic periodic paralysis (HyperPP), hypokalemic periodic paralysis (HypoPP) and related variants, approved by the US Food and Drug Administration (FDA).¹

PPP is thought to affect about 5,000 people in the US.²

ORMALVI™ is being launched in partnership between Cycle and Torrent Pharma Inc. (Torrent).

ORMALVI™ is a treatment option that allows patients with PPP to remain on dichlorphenamide whilst accessing Cycle Vita™, a dedicated support platform that provides individualized product support* for patients.

“Patients with PPP typically have a difficult journey to diagnosis. It can take years and involve numerous studies and misdiagnoses. We’re fully aware of the unique challenges patients face with this rare disorder. We want to provide them with the support that they require to effectively manage their PPP. That’s why we’re providing individualized support, including a Bridge Program*, Co-pay Assistance Program* and a Patient Nutrition Program* tailored to the patient’s type of PPP and known triggers, to reinforce their clinic’s nutrition plan,” says Chikai Lai, SVP & Chief Commercial Officer, Cycle.

ORMALVI™ is Cycle’s sixth 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
• TASCENSO ODT® (fingolimod) in 2023
• TIOPRONIN delayed-release tablets in 2024

To find out more about ORMALVI™, please visit www.ORMALVI.com and find the Full Prescribing Information available at www.ORMALVI.com/PI. To find out more about Cycle Vita, please visit www.cyclevita.life or call +1 (888) 360-8482.

Important Safety Information

Indications

ORMALVI™ is an oral carbonic anhydrase inhibitor indicated for the treatment of primary hyperkalemic periodic paralysis, primary hypokalemic periodic paralysis, and related variants.

Important Safety Information

Contraindications

• Hypersensitivity to dichlorphenamide or other sulfonamides
• Concomitant use of ORMALVI™ and high dose aspirin
• Severe pulmonary disease, limiting compensation to metabolic acidosis caused by ORMALVI™
• Hepatic insufficiency: ORMALVI™ may aggravate hepatic encephalopathy

Warnings and Precautions

Fatalities associated with the administration of sulfonamides have occurred because of adverse reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasias. Discontinue ORMALVI™ at the first sign of skin rash or any sign of immune-mediated or other life-threatening adverse reaction. Carbonic anhydrase inhibitors, including ORMALVI™, can cause metabolic acidosis, increasing the risk of salicylate toxicity. Anorexia, tachypnea, lethargy, and coma have been reported with concomitant use of dichlorphenamide and high-dose aspirin. Concomitant use of ORMALVI™ and high-dose aspirin is contraindicated. Use with caution and carefully monitor patients receiving low-dose aspirin. ORMALVI™ increases potassium excretion and can cause hypokalemia. Baseline and periodic measurements of serum potassium during ORMALVI™ treatment are recommended. If hypokalemia develops or persists, consider reducing the dose or discontinuing ORMALVI™ and correction of potassium levels. ORMALVI™ can cause hyperchloremic non-anion gap metabolic acidosis. Concomitant use of ORMALVI™ with other drugs that cause metabolic acidosis may increase the severity of acidosis. Concomitant use of ORMALVI™ in compensated patients with respiratory acidosis may lead to respiratory decompensation. Baseline and periodic measurements of serum bicarbonate during ORMALVI™ treatment are recommended. If metabolic acidosis develops or persists, consider reducing the dose or discontinuing ORMALVI™. ORMALVI™ increases the risk of falls; risk is greater in the elderly and with higher doses. Consider dose reduction or discontinuation of ORMALVI™ in patients who experience falls. Based on animal data, ORMALVI™ may cause fetal harm. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known in humans whether dichlorphenamide is excreted in human milk; exercise caution when administered to a nursing woman.

Adverse Reactions:

The most common adverse reactions seen in clinical trials (incidence ≥10% and greater than placebo) include paresthesias, cognitive disorder, dysgeusia, and confusional state.

Drug Interactions:

Aspirin: anorexia, tachypnea, lethargy, and coma have been reported with concomitant use of dichlorphenamide and high-dose aspirin. The concomitant use of ORMALVI™ and high-dose aspirin is contraindicated. ORMALVI™ should be used with caution in patients receiving lower doses of aspirin.

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

To report SUSPECTED ADVERSE REACTIONS, contact Cycle Pharmaceuticals Ltd at 1-857-437-3969, or the FDA at: 1-800-FDA-1088 or www.fda.gov/medwatch.

US-DCP-2400017 (March 2024)

References

1. ORMALVI™ (dichlorphenamide). Prescribing Information. Cycle Pharmaceuticals Ltd.
2. Sujatha Gurunathan (2023). Simply Stated: Research Updates in Periodic Paralysis - Quest | Muscular Dystrophy Association [online] Available at: https://mdaquest.org/simply-stated-research-updates-in-periodic-paralysis Accessed 23 Nov. 2023.
3. Cavel-Greant, D., et al (2012). The impact of permanent muscle weakness on quality of life in periodic paralysis: a survey of 66 patients. Acta myologica: myopathies and cardiomyopathies: official journal of the Mediterranean Society of Myology, [online] 31(2), pp.126–33. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3476862/ Accessed 1 Nov. 2023.

*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.

ORMALVI™ is a trademark of Torrent Pharma Inc. in the United States.

Cycle Vita™, SAJAZIR™ and JAVYGTOR™ are trademarks of Cycle Pharmaceuticals Limited in the United States.

NITYR® is a registered trademark of Cycle Pharmaceuticals Ltd 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 www.cyclepharma.com and follow us on X, LinkedIn and Facebook.

About Torrent

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, gynaecology, 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.

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