MannKind and Vertice to Co-Promote Thyquidity™ (levothyroxine sodium) Oral Solution
17 Dicembre 2020 - 10:43PM
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
HypothyroidismTHYQUIDITY (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)
SuppressionTHYQUIDITY 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 LOSSThyroid 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.
- THYQUIDITY is contraindicated in
patients with uncorrected adrenal insufficiency.
- In the elderly and in patients with
cardiovascular disease, THYQUIDITY should be initiated at lower
doses than those recommended in younger individuals or in patients
without cardiac disease. If cardiac symptoms develop or worsen, the
THYQUIDITY dose should be reduced or withheld for one week and
restarted at a lower dose.
- Patients with coronary artery
disease who are receiving THYQUIDITY should be monitored closely
during surgical procedures for cardiac arrhythmias. Monitor
patients during concomitant administration of THYQUIDITY and
sympathomimetic agents for signs and symptoms of coronary
insufficiency.
- Use of oral thyroid hormone is not
recommended in myxedema coma. Products formulated for IV
administration should be used to treat myxedema coma.
- Patients with adrenal insufficiency
should be treated with replacement glucocorticoids prior to
initiating treatment with THYQUIDITY. Failure to do so may
precipitate an acute adrenal crisis when thyroid hormone therapy is
initiated.
- THYQUIDITY has a narrow therapeutic
index. Regardless of the indication for use, careful dosage
titration is necessary to avoid the consequences of over- or
under-treatment.
- Addition of levothyroxine 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 THYQUIDITY.
- Increased bone resorption and
decreased bone mineral density may occur as a result of
levothyroxine over-replacement, particularly in postmenopausal
women. To mitigate this risk, patients receiving THYQUIDITY should
be given the minimum dose necessary that achieves the desired
response.
- Adverse reactions associated with
THYQUIDITY therapy are primarily those of hyperthyroidism due to
therapeutic overdosage.
- Many drugs and some foods affect
thyroid hormone pharmacokinetics and metabolism and may alter the
therapeutic response to THYQUIDITY. In addition, thyroid hormones
and thyroid status have varied effects on the pharmacokinetics and
actions of other drugs. Administer at least 4 hours before or after
drugs that are known to interfere with absorption. Evaluate the
need for dose adjustments when regularly administering within one
hour of certain foods that may affect absorption. Prescribers
should consult appropriate reference sources for additional
information on drug or food interactions with THYQUIDITY.
- Closely monitor patients from birth
to 3 months of age receiving THYQUIDITY due to the potential for
glycerol- induced gastrointestinal irritation resulting in vomiting
and/or osmotic diarrhea.
- THYQUIDITY should not be
discontinued during pregnancy, and hypothyroidism diagnosed during
pregnancy should be promptly treated. TSH levels may increase
during pregnancy, so TSH should be monitored and THYQUIDITY dose
adjusted as needed.
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
- Hollowell JG, Staehling NW, Flanders WD, Hannon WH, Gunter EW,
Spencer CA, Braverman LE. Serum TSH, T(4), and thyroid antibodies
in the United States population (1988 to 1994): National Health and
Nutrition Examination Survey (NHANES III). J Clin Endocrinol Metab.
2002 Feb;87(2):489-99. doi: 10.1210/jcem.87.2.8182. PMID:
11836274.
- Chaker L, Bianco AC, Jonklaas J, Peeters RP. Hypothyroidism.
Lancet. 2017;390(10101):1550-1562.
https://pubmed.ncbi.nlm.nih.gov/28336049/
- Jonklaas J, Bianco AC, Bauer AJ, et al. Guidelines for the
treatment of hypothyroidism: prepared by the american thyroid
association task force on thyroid hormone replacement. Thyroid.
2014;24(12):1670-1751.
https://www.ncbi.nlm.nih.gov/pubmed/25266247.
Company Contact:MannKind
Corporation818-661-5000ir@mannkindcorp.com
Vertice PharmaKimberly Branchkbranch@vistapharm.com727-530-1633
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