BRIDGEWATER, N.J., April 6, 2018 /PRNewswire/ -- Impax
Laboratories, Inc. (NASDAQ: IPXL), a specialty
pharmaceutical company, today announced it has launched a generic
version of Estrace® Cream (estradiol vaginal cream, USP,
0.01%). Impax's manufacturing and development partner,
Perrigo Company plc (NYSE; TASE: PRGO), received final approval
from the U.S. Food and Drug Administration in late
January.
Estrace® Cream had annual U.S. sales of approximately
$469 million according to
IQVIA® for the12 months ending January 2018.
IMPORTANT SAFETY INFORMATION
WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST
CANCER and PROBABLE DEMENTIA
Estrogen-Alone
Therapy
Endometrial Cancer
There is an increased risk of endometrial cancer in a woman with
a uterus who uses unopposed estrogens. Adding a progestin to
estrogen therapy has been shown to reduce the risk of endometrial
hyperplasia, which may be a precursor to endometrial cancer.
Adequate diagnostic measures, including directed or random
endometrial sampling when indicated, should be undertaken to rule
out malignancy in postmenopausal women with undiagnosed persistent
or recurring abnormal genital bleeding [see WARNINGS, Malignant
Neoplasms, Endometrial Cancer].
Cardiovascular Disorders and Probable Dementia
Estrogen-alone therapy should not be used for the prevention of
cardiovascular disease or dementia [see CLINICAL STUDIES and
WARNINGS, Cardiovascular Disorders, and Probable
Dementia].
The Women's Health Initiative (WHI) estrogen-alone substudy
reported increased risks of stroke and deep vein thrombosis (DVT)
in postmenopausal women (50 to 79 years of age) during 7.1 years of
treatment with daily oral conjugated estrogens (CE) [0.625
mg]-alone, relative to placebo [see CLINICAL STUDIES and
WARNINGS, Cardiovascular Disorders].
The WHI Memory Study (WHIMS) estrogen-alone ancillary study of
WHI reported an increased risk of developing probable dementia in
postmenopausal women 65 years of age or older during 5.2 years of
treatment with daily CE (0.625 mg) -alone, relative to placebo. It
is unknown whether this finding applies to younger postmenopausal
women [see CLINICAL STUDIES and WARNINGS, Probable
Dementia and PRECAUTIONS, Geriatric Use].
In the absence of comparable data, these risks should be assumed
to be similar for other doses of CE and other dosage forms of
estrogens.
Estrogens with or without progestins should be prescribed at the
lowest effective doses and for the shortest duration consistent
with treatment goals and risks for the individual woman.
Estrogen Plus Progestin Therapy
Cardiovascular Disorders and Probable Dementia
Estrogen plus progestin therapy should not be used for the
prevention of cardiovascular disease or dementia [see CLINICAL
STUDIES and WARNINGS, Cardiovascular Disorders, and Probable
Dementia].
The WHI estrogen plus progestin substudy reported increased
risks of DVT, pulmonary embolism (PE), stroke and myocardial
infarction (MI) in postmenopausal women (50 to 79 years of age)
during 5.6 years of treatment with daily oral CE (0.625 mg)
combined with medroxyprogesterone acetate (MPA) [2.5 mg], relative
to placebo [see CLINICAL STUDIES and WARNINGS,
Cardiovascular Disorders].
The WHIMS estrogen plus progestin ancillary study of the WHI
reported an increased risk of developing probable dementia in
postmenopausal women 65 years of age or older during 4 years of
treatment with daily CE (0.625 mg) combined with MPA (2.5 mg),
relative to placebo. It is unknown whether this finding applies to
younger postmenopausal women [see CLINICAL STUDIES and
WARNINGS, Probable Dementia and PRECAUTIONS, Geriatric
Use].
Breast Cancer
The WHI estrogen plus progestin substudy also demonstrated an
increased risk of invasive breast cancer [see CLINICAL
STUDIES and WARNINGS, Malignant Neoplasms, Breast
Cancer].
In the absence of comparable data, these risks should be assumed
to be similar for other doses of CE and MPA, and other combinations
and dosage forms of estrogens and progestins.
Estrogens with or without progestins should be prescribed at the
lowest effective doses and for the shortest duration consistent
with treatment goals and risks for the individual woman.
For complete safety information and other important information
about this product please see the Full Prescribing Information.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit FDA MedWatch or call
1-800-FDA-1088. To report SUSPECTED ADVERSE REACTIONS contact Impax
Laboratories, Inc. at 1-877-994-6729.
About Impax Laboratories, Inc.
Impax Laboratories,
Inc. (Impax) is a specialty pharmaceutical company applying its
formulation expertise and drug delivery technology to the
development of controlled-release and specialty generics in
addition to the development of central nervous system disorder
branded products. Impax markets its generic products through its
Impax Generics division and markets its branded products through
the Impax Specialty Pharma division. Additionally, where
strategically appropriate, Impax develops marketing partnerships to
fully leverage its technology platform and pursues partnership
opportunities that offer alternative dosage form technologies, such
as injectables, nasal sprays, inhalers, patches, creams, and
ointments.
For more information, please visit the Company's Web site at:
www.impaxlabs.com.
"Safe Harbor" statement under the Private Securities Litigation
Reform Act of 1995:
To the extent any statements made in this news release contain
information that is not historical, these statements are
forward-looking in nature and express the beliefs and expectations
of management. Such statements are based on current expectations
and involve a number of known and unknown risks and uncertainties
that could cause the Company's future results, performance, or
achievements to differ significantly from the results, performance,
or achievements expressed or implied by such forward-looking
statements. Such risks and uncertainties include, but are not
limited to, fluctuations in the Company's operating results and
financial condition, the volatility of the market price of the
Company's common stock, the Company's ability to successfully
develop and commercialize pharmaceutical products in a timely
manner, the impact of competition, the effect of any manufacturing
or quality control problems, the Company's ability to manage its
growth, risks related to acquisitions of or investments in
technologies, products or businesses, risks relating to goodwill
and intangibles, the reduction or loss of business with any
significant customer, the substantial portion of the Company's
total revenues derived from sales of a limited number of products,
the impact of continuing consolidation of the Company's customer
base, the Company's ability to sustain profitability and positive
cash flows, the impact of any valuation allowance on the Company's
deferred tax assets, the restrictions imposed by the Company's
credit facility and indenture, the Company's level of indebtedness
and liabilities and the potential impact on cash flow available for
operations, the availability of additional funds in the future, any
delays or unanticipated expenses in connection with the operation
of the Company's manufacturing facilities or at its third party
suppliers, the effect of foreign economic, political, legal and
other risks on the Company's operations abroad, the uncertainty of
patent litigation and other legal proceedings, the increased
government scrutiny on the Company's agreements to settle patent
litigations, product development risks and the difficulty of
predicting FDA filings and approvals, consumer acceptance and
demand for new pharmaceutical products, the impact of market
perceptions of the Company and the safety and quality of its
products, the Company's determinations to discontinue the
manufacture and distribution of certain products, the Company's
ability to achieve returns on its investments in research and
development activities, changes to FDA approval requirements, the
Company's ability to successfully conduct clinical trials, the
Company's reliance on third parties to conduct clinical trials and
testing, the Company's lack of a license partner for
commercialization of Numient® (IPX066) outside of the United States and Taiwan, the impact of illegal distribution and
sale by third parties of counterfeits or stolen products, the
availability of raw materials and impact of interruptions in the
Company's supply chain, the Company's policies regarding returns,
rebates, allowances and chargebacks, the use of controlled
substances in the Company's products, the effect of global economic
conditions on the Company's industry, business, results of
operations and financial condition, disruptions or failures in the
Company's information technology systems and network infrastructure
caused by cyber-attacks or other third party breaches or other
events, the Company's reliance on alliance and collaboration
agreements, the Company's reliance on licenses to proprietary
technologies, the Company's dependence on certain employees, the
Company's ability to comply with legal and regulatory requirements
governing the healthcare industry, the regulatory environment, the
effect of certain provisions in the Company's government contracts,
the Company's ability to protect its intellectual property,
exposure to product liability claims, changes in tax regulations,
uncertainties involved in the preparation of the Company's
financial statements, the Company's ability to maintain an
effective system of internal control over financial reporting, the
effect of terrorist attacks on the Company's business, the location
of the Company's manufacturing and research and development
facilities near earthquake fault lines, expansion of social media
platforms, risks related to the Company's proposed business
combination with Amneal Pharmaceuticals, Inc. ("Amneal"), including
whether the transactions (the "Combination") contemplated by the
Business Combination Agreement dated as of October 17, 2017 by and among us, Amneal, Atlas
Holdings, Inc., and K2 Merger Sub Corporation as amended by
Amendment No. 1, dated November 21,
2017 and Amendment No. 2 dated December 16, 2017 (the "Business Combination
Agreement") will be completed on the terms or timeline
contemplated, if at all, the risk that governmental entities could
take actions under antitrust laws to enjoin the completion of the
Combination, business uncertainties and contractual restrictions
while the Combination is pending, challenges related to the
Company's integration with Amneal after the closing, the fact that
ownership interests will not be adjusted if there is a change in
value of the Company or Amneal, provisions in the Business
Combination Agreement that may discourage other companies from
acquiring the Company, transaction related costs related to the
Combination and integration, the lower ownership and voting
interests that the Company's stockholders will have in New Amneal
after the closing, the pending litigation related to the
Combination and other risks described in the Company's periodic
reports filed with the Securities and Exchange Commission.
Forward-looking statements speak only as to the date on which they
are made, and the Company undertakes no obligation to update
publicly or revise any forward-looking statement, regardless of
whether new information becomes available, future developments
occur or otherwise.
Contact:
Mark Donohue
Investor Relations and Corporate
Communications
(215)
558-4526
www.impaxlabs.com
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SOURCE Impax Laboratories, Inc.