WESTLAKE VILLAGE, Calif. and NEW PROVIDENCE, N.J., Dec. 17, 2020 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD) and Vertice Pharma today announced that they have entered into a co-promotion agreement for Thyquidity™ (levothyroxine sodium) oral solution through MannKind’s specialty sales force. THYQUIDITY is indicated as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. THYQUIDITY is not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients or hypothyroidism during the recovery phase of subacute thyroiditis.
Under the terms of the agreement, MannKind’s sales force will promote Thyquidity to adult endocrinologists, pediatric endocrinologists and other US healthcare providers who treat hypothyroidism. Vertice will make a specified quarterly payment to MannKind to defray the costs of the additional promotional activity and will pay MannKind royalties on gross profit resulting from all sales of Thyquidity.
“We are excited to co-promote Thyquidity with Vertice Pharma,” said Michael Castagna, Chief Executive Officer of MannKind. “This arrangement allows us to strengthen our relationships with our current customers, expand into pediatric endocrinology and leverage the talent and capabilities of our sales force and reimbursement support systems.”
“The team at Vertice Pharma is thrilled to be joining forces with MannKind to help launch our product to patients and healthcare providers,” said Scott Meyers, Chief Executive Officer of Vertice Pharma. “I look forward to working with MannKind’s commercial team to get ready for the launch of Thyquidity in 1Q 2021.”
Hypothyroidism, also called underactive thyroid disease, is a common disorder in which the thyroid gland does not produce enough thyroid hormone. The prevalence of hypothyroidism is 4.6% in the US population.1 Symptoms include fatigue, lethargy, cold intolerance, weight gain, constipation, change in voice, and dry skin.2 Most patients require lifelong therapy to treat their hypothyroidism.3
INDICATION
Hypothyroidism
THYQUIDITY (levothyroxine sodium) oral solution is indicated as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism.
Pituitary Thyrotropin (Thyroid Stimulating Hormone, TSH) Suppression
THYQUIDITY is indicated as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.
Limitations of Use
THYQUIDITY is not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients, as there are no clinical benefits and over-treatment with THYQUIDITY may induce hyperthyroidism.
THYQUIDITY is not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.
Important Safety Information
WARNING: NOT FOR TREATMENT OF OBESITY OR WEIGHT LOSS
Thyroid hormones, including THYQUIDITY, 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.
Please see: [https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/214047s000lbl.pdf] for full US Prescribing Information including Boxed Warning.
About MannKind Corporation
MannKind Corporation (Nasdaq: MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with endocrine and orphan lung diseases. MannKind is currently commercializing Afrezza® (insulin human) Inhalation Powder, its first FDA-approved product and the only inhaled ultra rapid-acting mealtime insulin in the United States, where it is available by prescription from pharmacies nationwide. MannKind is headquartered in Westlake Village, California, and has a state-of-the art manufacturing facility in Danbury, Connecticut. The Company also employs field sales and medical representatives across the U.S. For further information, visit www.mannkindcorp.com.
About Vertice Pharma
Vertice Pharma is a specialty pharmaceutical company focused on improving patients’ health. Vertice Pharma develops, manufactures, markets, and distributes high-quality and affordable pharmaceutical products through its operating companies. Vertice Pharma has global headquarters in the United Kingdom and United States headquarters in New Jersey. For more information visit www.verticepharma.com.
Forward-Looking Statements
This press release contains forward-looking statements that involve risks and uncertainties. Words such as “believes,” “anticipates,” “plans,” “expects,” “intends,” “will,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon MannKind’s current expectations. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties detailed in MannKind’s filings with the SEC. For a discussion of these and other factors, please refer to MannKind’s annual report on Form 10-K for the year ended December 31, 2019 as well as MannKind’s other filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and MannKind undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release.
References
Company Contact:
MannKind Corporation
818-661-5000
ir@mannkindcorp.com
Vertice Pharma
Kimberly Branch
kbranch@vistapharm.com
727-530-1633 x276