ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today
announced that following final approval from the U.S. Food and Drug
Administration (FDA) for its Abbreviated New Drug Application
(ANDA), the Company launched Estradiol Gel, 0.06%. ANI’s Estradiol
Gel, 0.06% is the generic version of the reference listed drug
(RLD) EstroGel® Gel, 0.06%.
"With the FDA approval and commercialization of
Estradiol Gel, 0.06%, we are pleased to bring another
limited-competition product to market and ensure that customers and
patients in need have ready access,” stated Nikhil Lalwani,
President and Chief Executive Officer of ANI.
U.S. annual sales for Estradiol Gel, 0.06% total
approximately $16.7 million, based on August 2024 moving annual
total (MAT) IQVIA data.
About ANI Pharmaceuticals,
Inc.
ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) is a
diversified biopharmaceutical company serving patients in need by
developing, manufacturing, and marketing high-quality branded and
generic prescription pharmaceutical products, including for
diseases with high unmet medical need. The Company is focused on
delivering sustainable growth by scaling up its Rare Disease
business through its lead asset Purified Cortrophin® Gel,
strengthening its Generics business with enhanced research and
development capabilities, delivering innovation in Established
Brands, and leveraging its U.S. based manufacturing footprint. For
more information, visit www.anipharmaceuticals.com.
Forward-Looking Statements
This press release contains not only historical
information, but also forward-looking statements made pursuant to
the safe-harbor provisions of the Private Securities Litigation
Reform Act of 1995. These forward-looking statements represent the
Company’s expectations or beliefs concerning future events,
including statements regarding the benefits of the acquisition of
Alimera Sciences. These forward-looking statements generally are
identified by the words “believe,” “project,” “expect,”
“anticipate,” “estimate,” “intend,” “continue,” “strategy,”
“future,” “opportunity,” “plan,” “may,” “should,” “will,” “shall,”
“would” other words of similar meaning, derivations of such words
and the use of future dates. Forward-looking statements are
predictions, projections and other statements about future events
that are based on current expectations and assumptions and, as a
result, are subject to risks and uncertainties.
The following factors, among others, could cause
actual results to differ materially from those described in these
forward-looking statements: (i) the ability to implement business
plans, forecasts, and other expectations in connection with the
acquisition and integration of Alimera Sciences, Inc. (“Alimera”)
and identify and realize additional opportunities and, in
particular, the possibility that the Company is unable to achieve
anticipated synergies, (ii) costs and regulatory requirements
relating to contract manufacturing arrangements, (iii) costs or
delays associated with manufacturing (including the sources and any
changes in sources thereof) of the Company’s products, (iv) delays
or failures in retaining and obtaining continuing and future
product approvals from the FDA, and other regulatory issues
relating to the Company's business and products, (v) market trends
for the Company’s products, including but not limited to, ILUVIEN,
YUTIQ and Cortrophin Gel, and the ability to achieve anticipated
sales for such products, (vi) risks that the acquisition of Alimera
may disrupt current plans and operations of the Company and
potential difficulties of the Company in retaining employees of
Alimera and/or maintaining business relationships of Alimera, (vii)
the impact of any litigation to which the Company is, or may
become, a party, including in connection with the acquisition and
integration thereof, (viii) volatility in the Company’s stock
price, including as a result of the acquisition, (ix) changes in
competitive and regulated industries in which the Company operates,
variations in operating performance across competitors, changes in
laws and regulations affecting the Company’s business, and changes
in the Company’s capital structure as a result of the acquisition,
(x) regulatory and other approvals relating to product development
and manufacturing, (xi) the Company’s ability, and that of its
suppliers, development partners, and manufacturing partners, to
comply with laws, regulations and standards that govern or affect
the pharmaceutical and biotechnology industries and/or the Company
and its products, (xii) costs incurred in connection with the
acquisition of Alimera and the possibility that the Company is
unable to realize anticipated benefits of the acquisition or to
realize estimated pro forma results and underlying assumptions,
(xiii) delays in production, increased costs and potential loss of
revenues if there is a change in manufacturers or manufacturing
processes due to the limited number of suppliers for the Company’s
raw materials, active pharmaceutical ingredients, excipients and
other materials, (xiv) the Company’s reliance on single source
third-party contract manufacturing supply for certain of its key
products, including ILUVIEN, YUTIQ and Cortrophin Gel, (xv) changes
in policy or actions that may be taken by the FDA, United States
Drug Enforcement Administration, and other regulatory agencies,
including among other things, drug recalls, regulatory approvals,
facility inspections and potential enforcement actions, (xvi) the
impact of legislative or regulatory reform on the pricing for the
Company’s products, (xvii) the Company’ ability to maintain the
services of its key executives and other personnel, and (xviii)
general business and economic conditions, such as inflationary
pressures, geopolitical conditions including, but not limited to,
the conflict between Russia and the Ukraine, the conflict between
Israel and Gaza, conflicts related to the attacks on cargo ships in
the Red Sea, and the effects and duration of outbreaks of public
health emergencies. More detailed information on these and
additional factors that could affect the Company’s actual results
are described in the Company’s filings with the Securities and
Exchange Commission (“SEC”), including its most recent annual
report on Form 10-K and quarterly reports on Form 10-Q, as well as
other filings with the SEC. All forward-looking statements in this
news release speak only as of the date of this news release and are
based on the Company’s current beliefs, assumptions, and
expectations. The Company undertakes no obligation to update or
revise any forward-looking statement, whether as a result of new
information, future events or otherwise.
Investor Relations:Lisa M.
Wilson, In-Site Communications, Inc.T:
212-452-2793E: lwilson@insitecony.com
Source: ANI Pharmaceuticals, Inc.
ANI Pharmaceuticals (NASDAQ:ANIP)
過去 株価チャート
から 10 2024 まで 11 2024
ANI Pharmaceuticals (NASDAQ:ANIP)
過去 株価チャート
から 11 2023 まで 11 2024