IBSA Pharma and Mark Cuban Cost Plus Drug Company Team Up to Make Tirosint More Affordable

Online Pharmacy to Offer Hypothyroidism Treatments at Low Cost

PARSIPPANY, N.J., March 7, 2023 /PRNewswire/ -- IBSA Pharma announced today that it has entered into an agreement with Mark Cuban Cost Plus Drug Company, PBC (Cost Plus Drugs) to offer Tirosint^® (levothyroxine sodium) oral capsules at a low cash price via the Cost Plus Drugs online pharmacy. The agreement is the first of its kind for a branded levothyroxine drug. Levothyroxine is a synthetic hormone used to treat hypothyroidism. It is one of the most widely dispensed prescription medications in the United States with an estimated 116 million prescriptions filled in 2016.¹

Tirosint capsules is the leading branded gel capsule formulation of levothyroxine in the US. It is formulated without excipients that can cause tolerability and drug absorption problems commonly observed with traditional levothyroxine tablet therapies. Tirosint has money savings options available for patients, their availability in the Cost Plus Drugs program is a first for both companies.

Cost Plus Drugs launched its online pharmacy in 2021 and was co-founded by investor-entrepreneur Mark Cuban to reduce the cost of prescription medications. It offers the most commonly prescribed drugs at low transparent prices by negotiating prices directly with manufacturers and passing along the savings to consumers. "Everyone should have access to safe, affordable prescription drugs at transparent prices" commented Cuban at the company's founding. Currently, most of Cost Plus Drugs' offerings are generic drugs. The agreement with IBSA marks one of the company's first forays into the branded segment of the US pharmaceutical market. Cuban is currently a Tirosint patient.

Commenting on the agreement, IBSA Pharma CEO Nicholas Hart stated that "hypothyroidism is a prevalent condition with significant public health implications.  We are delighted to offer Tirosint capsules to patients via Cost Plus Drugs. Tirosint has been clinically proven to provide the benefits of levothyroxine, the standard of care for treating hypothyroidism, in a formulation that is free of gluten, dyes, lactose, sugars and other excipients commonly found in tablet formulations. These can be problematic for many patients. Studies have shown that up to 31% of levothyroxine-treated patients have gastrointestinal and other problems that can lead to underperformance of levothyroxine therapy and suboptimal control of hypothyroidism.²"

Tirosint capsules is a prescription medication that IBSA Pharma markets to physicians and patients. Tirosint capsules are indicated to treat hypothyroidism in patients six years and older and available in 13,25,50,75,88, 100,112,125,137, 150, 175 and 200 mcg doses. Additional information, including money saving options, can be found at www.Tirosint.com.

About Hypothyroidism

Hypothyroidism is an endocrine disorder with numerous causes resulting in a deficiency in thyroid hormone. More than 27 million adults have been diagnosed with hypothyroidism. ² Up to 13 million Americans have undiagnosed hypothyroidism. ³ About 2% of the U.S. population has pronounced hypothyroidism, and as much as 10% has subclinical (mild) hypothyroidism. The condition is most common in women over 40 years of age and in the elderly of both sexes.⁴ The signs and symptoms of hypothyroidism are nonspecific and may include fatigue, forgetfulness, depression, constipation, muscle cramps, weight gain, dry skin and hair loss.⁵ TSH laboratory tests are recommended as first-line screening tests for thyroid dysfunction.⁶ Levothyroxine sodium is a synthetic version of a hormone that is normally produced by the thyroid gland. It is used to treat patients who suffer from hypothyroidism or inadequate levels of thyroid stimulating hormone (TSH).

About IBSA Pharma Inc.

IBSA Pharma is part of IBSA Group, which is headquartered in Lugano, Switzerland. It currently markets 4 prescription medications in the United States: Tirosint capsules and Tirosint-SOL (levothyroxine sodium) oral solution for the treatment of hypothyroidism; Licart (diclofenac epolamine) topical system 1.3% and Flector (diclofenac epolamine) topical system 1.3% for the treatment of acute pain from minor strains, sprains, and contusions.

IBSA Institut Biochimique SA

IBSA (Institut Biochimique SA) is a Swiss multinational pharmaceutical Company, founded in 1945 in Lugano. Today, its products are present in over 90 Countries on 5 continents, through the Company's 17 subsidiaries located in Europe, China, and the United States. The company has a consolidated turnover of 800 million CHF, and employs over 2,000 people between headquarters, subsidiaries, and production sites. IBSA holds 90 families of approved patents, plus others under development, as well as a vast portfolio of products, covering 10 therapeutic areas: reproductive medicine, endocrinology, pain and inflammation, osteoarticular, aesthetic medicine, dermatology, uro-gynaecology, cardiometabolic, respiratory, consumer health. It is also one of the largest operators worldwide in the area of reproductive medicine, and one of the world's leaders in hyaluronic acid-based products. IBSA has based its philosophy on four pillars: Person, Innovation, Quality and Responsibility.

To report SUSPECTED ADVERSE REACTIONS, contact IBSA Pharma Inc. at 1-800-587-3513 or FDA at 1-800- FDA-1088

For more information about IBSA, visit www.ibsagroup.com/media. For full prescribing information, visit www.Tirosint.com.

References

1. Verble, M. Inappropriate use and overdose of PPIs: a strategy for discontinuation. Pharmacy Times, August 2018:35.
2. IMS Institute for Healthcare Informatics Report, "Medicine Use and the Shifting Costs of Healthcare"; 2014; pg. 46
3. Booth, M, 2019. Published online at: http://www.reviewjournal.com/life/health/thyroid-disease-common-us 
4. Canaris GJ, Manowitz NR, Mayor G, Ridgeway EC, "The Colorado Thyroid Disease Prevalence Study", Arch of Internal Medicine; 2000;160: 526-534 
5. McDermott MT. "In the clinic: hypothyroidism". Annals of Internal Medicine; 2009;151 (11): ITC-6-1 
6. Soh SB. Laboratory testing in thyroid conditions: pitfalls and clinical utility. Ann Lab Med. 2019;39(1):3. 

IMPORTANT SAFETY INFORMATION

Warning: Not for the Treatment of Obesity or for Weight Loss

• Thyroid hormones, including TIROSINT, either alone or with other therapeutic agents, should not be used for the treatment of obesity or for weight loss.
• In euthyroid patients, doses within the range of daily hormonal requirements are ineffective for weight reduction.
• Larger doses may produce serious or even life-threatening manifestations of toxicity, particularly when given in association with sympathomimetic amines such as those used for their anorectic effects.

Contraindications

• Uncorrected adrenal insufficiency

Warnings And Precautions

• Cardiac adverse reactions in the elderly and in patients with underlying cardiovascular disease. Initiate TIROSINT at less than the full replacement dose because of the increased risk of cardiac adverse reactions, including atrial fibrillation
• Myxedema coma: Do no use oral thyroid hormone drug products to treat myxedema coma
• Acute adrenal crisis in patients with concomitant adrenal insufficiency: Treat with replacement glucocorticoids prior to initiation of TIROSINT treatment
• Prevention of hyperthyroidism or incomplete treatment of hypothyroidism: Proper dose titration and careful monitoring is critical to prevent the persistence of hypothyroidism or the development of hyperthyroidism
• Worsening of diabetic control: Therapy in patients with diabetes mellitus may worsen glycemic control and result in increased antidiabetic agent or insulin requirements. Carefully monitor glycemic control after starting, changing, or discontinuing thyroid hormone therapy
• Decreased bone mineral density associated with thyroid hormone over-replacement. Over-replacement can increase bone reabsorption and decrease bone mineral density. Give the lowest effective dose
• Use for the suppression of nontoxic diffuse goiter or nodular thyroid disease: Use is not recommended in iodine-insufficient patients

Limitations of Use

• Not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients
• Not indicated for treatment of transient hypothyroidism during the recovery phase of subacute thyroiditis

Adverse Reactions

Common adverse reactions with levothyroxine therapy are primarily those of hypothyroidism due to therapeutic overdosage. They include the following:

• General: fatigue, increased appetite, weight loss, heat intolerance, fever, excessive sweating
• Central Nervous System: headache, hyperactivity, nervousness, anxiety, irritability, emotional lability, insomnia
• Musculoskeletal: tremors, muscle weakness
• Cardiovascular: palpitations, tachycardia, arrythmias, increased pulse and blood pressure, heart failure, angina, myocardial infarction, cardiac arrest
• Respiratory: dyspnea
• Gastrointestinal (GI): diarrhea, vomiting, abdominal cramps, elevations in liver function tests
• Dermatologic: hair loss, flushing
• Endocrine: decreased bone mineral density
• Reproductive: menstrual irregularities, impaired fertility

Adverse reactions in Children

Pseudotumor cerebri and slipped capital femoral epiphysis have been reported in children receiving levothyroxine therapy. Overtreatment may result in craniosynostosis in infants and premature closure of the epiphyses in children with resultant compromised adult height. Seizures have been reported rarely with the institution of levothyroxine therapy.

Hypersensitivity Reactions

Hypersensitivity reactions to inactive ingredients (in this product or other levothyroxine products) have occurred in patients treated with thyroid ho0rmone products. These include urticaria, pruritis, skin rash, flushing, angioedema, various GI symptoms (abdominal pain, nausea, vomiting and diarrhea), fever, arthralgia, serum sickness and wheezing. Hypersensitivity to levothyroxine itself is not known to occur.

PM-04-23-0001

SOURCE IBSA Pharma Inc.

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